Clinical trial NCT03391466
Conditions: Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Sponsor: Kite, A Gilead Company
Start date: 2018-01-25; Completion date: 2024-11-25
Enrollment: 359 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Detailed description:
This is a phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in participants with relapsed/refractory DLBCL. Adult participants with relapsed/refractory DLBCL after first-line rituximab and anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene ciloleucel or standard of care second-line therapy.

Standard of care will consist of a protocol-defined, platinum-based salvage combination chemotherapy regimen followed by high-dose therapy and autologous stem cell transplant in those who respond to salvage chemotherapy. After completing the treatment period, all participants will be followed in the post-treatment follow-up period for up to 5 years. Thereafter, participants who received at least one dose of axicabtagene ciloleucel as protocol therapy will transition to a separate long term follow up (LTFU) study and complete the remainder of the 15-year follow-up assessments within KT-US-982-5968 (NCT05041309).

Arms: arm 1: Participants will receive cyclophosphamide 500 mg/m\^2/day intravenously (IV) and fludarabine 30 mg/m\^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-cluster of differentiation antigen (CD) 19 CAR transduced autologous T cells/kg on Day 0. arm 2: Participants will receive 2 or 3 21-day cycles of second-line chemotherapy regimen; R-ICE: rituximab 375 mg/m\^2 before chemotherapy,ifosfamide 5 g/m\^2 24hour(hr) infusion on Day 2+mesna,carboplatin area under the curve (AUC) 5 on Day 2, maximum dose 800 mg,etoposide 100 mg/ m\^2/day on Days 1-3; R-ESHAP: rituximab 375 mg/m\^2 Day 1,etoposide 40 mg/m\^2/day IV on Days 1-4,methylprednisolone 500 mg/day IV on Days 1-4 or 5,cisplatin at 25 mg/m\^2/day Days 1-4,cytarabine 2 g/m\^2 on Day 5; R-GDP: rituximab 375 mg/m\^2 Day 1(or Day 8),gemcitabine 1g/m\^2 on Days 1 and 8,dexamethasone 40 mg on Days 1-4,cisplatin 75mg/m\^2 on Day 1 or carboplatin AUC=5; or R-DHAP: Rituximab 375 mg/ m\^2 before chemotherapy,dexamethasone 40 mg/day on Days 1-4,highdose cytarabine 2 g/m\^2 every 12 hours for 2 doses on Day 2 following/platinum,cisplatin 100 mg/m\^2 24hr infusion on Day 1 or oxaliplatin 100 mg/m\^2. Participants who will respond will get high dose therapy and autologous stem cell transplant.
Interventions: intervention 1: Axicabtagene Ciloleucel intervention 2: Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders. intervention 3: Cyclophosphamide intervention 4: Fludarabine
Intervention descriptions: intervention 1: A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide intervention 2: Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders. intervention 3: Administered intravenously intervention 4: Administered intravenously

Protocol documents:
Prot_000.pdf: 
C LI NI C A L S T U D Y P R O T O C O L
Pr ot oc ol Title: 
A P hase 3, Ra n d o mize d, O pe n- La bel St u d y E val uati n g t he Efficac y of 
A xica bta ge ne Cil ole ucel vers us Sta n dar d of Care T hera p y i n S u bjects wit h 
Rela pse d/ Refract or y Diff use Lar ge B Cell L y m p h o ma ( Z U M A- 7)
Pr ot oc ol N u m ber:
K T E- C 1 9- 1 0 7 ( Z U M A- 7)
U S A N/I N N:
A xica bta ge ne cil ole ucel
C o m pa n y C o de:
K T E- C 1 9
I N D N u m ber:
0 1 6 2 7 8
E u dra C T N u m ber:
2 0 1 7- 0 0 2 2 6 1- 2 2 
S p o ns or Na me a n d A d dress:
Kite P har ma, I nc.
2 4 0 0 Br oa d wa y
Sa nta M o nica, C A 9 0 4 0 4
U nite d States of A merica
C o ntact I nf or mati o n:
T he me dical m o nit or na me a n d c o ntact i nf or mati o n is pr o vi de d o n t he Ke y St u d y 
Tea m C o ntact List
Pr ot oc ol Versi o n/ Date:
Ori gi nal: 2 2 Ma y 2 0 1 7
A me n d me nt Hist or y:
A me n d me nt 1: Versi o n 2 2 7 Se pte m ber 2 0 1 7
A me n d me nt 2: 2 1 N o ve m ber 2 0 1 7
A me n d me nt 3: 1 6 Ja n uar y 2 0 1 9
A me n d me nt 4: 1 9 Marc h 2 0 1 9
A me n d me nt 5:  2 5 J u ne 2 0 2 0
A me n d me nt 5. 1: 1 6 Se pte m ber 2 0 2 0 – U S A o nl y
A me n d me nt 6: 1 4 A pril 2 0 2 3
C o u ntr y-s pecific Re q uire me nts:
C o u ntr y-s pecific re q uire me nts are liste d i n A p pe n di x D
T his st u d y will be c o n d ucte d i n c o m plia nce wit h t his pr ot oc ol a n d i n acc or da nce wit h t he et hical 
pri nci ples t hat ha ve t heir ori gi n i n t he Declarati o n of Helsi n ki, a n d t hat are c o nsiste nt wit h 
I nter nati o nal C o u ncil f or Har m o nisati o n (I C H) G o o d Cli nical Practice ( G C P) a n d a p plica ble 
re g ulat or y a n d l ocal re q uire me nts.
C O N FI D E N TI A LI T Y S T A T E M E N T
T his d oc u me nt c o ntai ns c o nfi de ntial i nf or mati o n of Kite P har ma, I nc., a w h oll y o w ne d s u bsi diar y of 
Gilea d Scie nces I nc. T his d oc u me nt m ust n ot be discl ose d t o a n y o ne ot her t ha n t he st u d y site researc h 
staff, c olla b orat ors, a n d me m bers of t he I nstit uti o nal Re vie w B oar d/I n de pe n de nt Et hics C o m mittee, a 
scie ntific re vie w b oar d, or a n e q ui vale nt. T he i nf or mati o n i n t his d oc u me nt ca n n ot be use d f or a n y 
p ur p ose ot her t ha n t he c o n d uct of t he cli nical i n vesti gati o n wit h o ut t he pri or writte n c o nse nt of 
Kite P har ma, I nc. 
 
 
 
 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 2
1 4 A pril 2 0 2 3
P R O T O C O L S Y N O P SI S
Title:
A P hase 3, Ra n d o mize d, O pe n- La bel St u d y E val uati n g t he Efficac y of 
A xica bta ge ne Cil ole ucel vers us Sta n dar d of Care T hera p y i n S u bjects wit h 
Rela pse d/ Refract or y Diff use Lar ge B Cell L y m p h o ma ( Z U M A- 7)
I n dic ati o n:
A d ult s u bjects wit h rela pse d/refract or y diff use lar ge B-cell l y m p h o ma (r/r 
D L B C L).
St u d y Desi g n:
T his is a P hase 3 ra n d o mize d, o pe n-la bel, m ultice nter st u d y e val uati n g t he 
efficac y of a xica bta ge ne cil ole ucel vers us sta n dar d of care t hera p y ( S O C) 
i n s u bjects wit h r/r D L B C L.  A d ult s u bjects wit h r/r D L B C L after first-li ne 
rit u xi ma b a n d a nt hrac ycli ne- base d c he m ot hera p y will be ra n d o mize d i n a 
1: 1 rati o t o recei ve a xica bta ge ne cil ole ucel or S O C.  Ra n d o mizati o n will be 
stratifie d b y res p o nse t o first-li ne t hera p y ( pri mar y refract or y, vs rela pse 
≤ 6 m o nt hs of first-li ne t hera p y vs rela pse > 6 a n d ≤ 1 2 m o nt hs of  first-li ne 
t hera p y) a n d sec o n d-li ne a ge-a dj uste d I nter nati o nal Pr o g n ostic I n de x (I PI) 
( 0 t o 1 vs 2 t o 3) as assesse d at t he ti me of scree ni n g.
F or s u bjects ra n d o mize d t o t he c o ntr ol ar m of t he st u d y, S O C will c o nsist 
of a pr ot oc ol- defi ne d, plati n u m- base d sal va ge c o m bi nati o n c he m ot hera p y 
re gi me n.  S u bjects w h o res p o n d t o sec o n d-li ne c he m ot hera p y ( partial 
res p o nse [ P R] or c o m plete res p o nse [ C R]) s h o ul d pr ocee d t o hi g h- d ose 
t hera p y ( H D T) a n d a ut ol o g o us ste m cell tra ns pla nt ( A S C T).
A n i n de pe n de nt Data Safet y M o nit ori n g B oar d ( D S M B) will meet e ver y 
6 m o nt hs after t he first s u bject is ra n d o mize d t o re vie w safet y data a n d will 
re vie w safet y a n d efficac y data at t he ti me of t he pla n ne d i nteri m f utilit y 
a nal ysis.  T he D S M B will be c hartere d t o ma ke trial c o n d uct 
rec o m me n dati o ns base d o n a n a nal ysis of ris k vers us be nefit.  T he D S M B 
ma y meet m ore ofte n as nee de d.  Refer t o Secti o n 9. 9  f or f urt her details.
F or st u d y re q uire me nts assi g ne d t o eac h st u d y ar m, please refer t o t he 
sc he d ule of assess me nts ( S O A) a n d Secti o n 7  f or details.
A st u d y sc he ma is dra w n o ut a n d descri be d at t he e n d of t he pr ot oc ol 
s y n o psis secti o n.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 3
1 4 A pril 2 0 2 3
Pri mar y O bjecti ve
•
T o deter mi ne if a xica bta ge ne cil ole ucel is s u peri or t o S O C as meas ure d 
b y e ve nt-free s ur vi val ( E F S), as deter mi ne d b y bli n de d ce ntral re vie w
Sec o n dar y O bjecti ves
•
T o e val uate t he effect of a xica bta ge ne cil ole ucel c o m pare d t o S O C o n 
o bjecti ve res p o nse rate ( O R R), as deter mi ne d b y bli n de d ce ntral re vie w
•
T o e val uate t he effect of a xica bta ge ne cil ole ucel c o m pare d t o S O C o n 
o verall s ur vi val ( O S)
•
T o e val uate t he effect of a xica bta ge ne cil ole ucel c o m pare d t o S O C o n 
pr o gressi o n-free s ur vi val ( P F S)
•
T o e val uate t he effect of a xica bta ge ne cil ole ucel c o m pare d t o S O C o n 
d urati o n of res p o nse ( D O R) a n d d urati o n of c o m plete res p o nse a m o n g 
res p o n di n g s u bjects, as deter mi ne d b y bli n de d ce ntral re vie w
•
T o e val uate t he safet y of a xica bta ge ne cil ole ucel c o m pare d t o S O C
•
T o e val uate t he effect of a xica bta ge ne cil ole ucel o n patie nt re p orte d 
o utc o mes ( P R Os) a n d q ualit y of life ( Q o L) c o m pare d t o S O C
St u d y 
O bjecti ves:
E x pl orat or y O bjecti ves
•
E x pl ore mec ha nis ms of resista nce t o treat me nt wit h a xica bta ge ne 
cil ole ucel
•
E val uate mec ha nistic as pects a n d re versi bilit y of t o xicities wit h 
a xica bta ge ne cil ole ucel
•
E x pl ore m olec ular a n d hist ol o gic c haracteristics of t he t u m or 
micr oe n vir o n me nt
•
E val uate i m pact of disease a n d treat me nt o n w or k pr o d ucti vit y a n d 
acti vit y
•
Esti mate ti me t o ne xt t hera p y
H y p ot hesis:
A xica bta ge ne cil ole ucel will pr ol o n g E F S c o m pare d t o S O C t hera p y i n 
a d ult s u bjects wit h rela pse d/refract or y D L B C L.  T he h y p ot hesize d 
treat me nt effect c orres p o n ds t o a 5 0 % i m pr o ve me nt i n E F S.
Pri m ar y 
E n d p oi nt:
E ve nt-free S ur vi val ( E F S):  E F S is defi ne d as t he ti me fr o m ra n d o mizati o n 
t o t he earliest date of disease pr o gressi o n per t he L u ga n o Classificati o n 
{ C hes o n 2 0 1 4 }, c o m me nce me nt of ne w l y m p h o ma t hera p y, or deat h fr o m 
a n y ca use.  S u bje cts n ot meeti n g t he criteria f or t hese e ve nts b y t he a nal ysis 
data c ut off date will be ce ns ore d.  F or t he pri mar y a nal ysis of E F S, disease 
pr o gressi o n e ve nts a n d ce ns ori n g ti mes will be deter mi ne d b y bli n de d 
ce ntral re vie w.  E ve nts of ne w t hera p y a n d deat h will be base d o n t he 
cli nical trial data base.  


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 4
1 4 A pril 2 0 2 3
Sec o n d ar y 
E n d p oi nt(s):
Ke y sec o n dar y e n d p oi nts (i n or der of hierarc hical testi n g)
•
O bjecti ve res p o nse rate
•
O verall s ur vi val
Sec o n dar y e n d p oi nts
•
E F S base d o n i n vesti gat or disease assess me nts
•
M o difie d E F S base d o n bli n de d ce ntral re vie w a n d o n i n vesti gat or 
disease assess me nts
•
Pr o gressi o n-free s ur vi val
•
D urati o n of res p o nse a n d c o m plete res p o nse
•
I nci de nce of a d verse e ve nts a n d cli nicall y si g nifica nt c ha n ges i n safet y 
la b val ues, i ncl u di n g a nti b o dies t o a xica bta ge ne cil ole ucel
•
C ha n ges fr o m scree ni n g t o p ost baseli ne i n t he gl o bal healt h stat us Q o L 
scale a n d t he p h ysical f u ncti o ni n g d o mai n of t he E ur o pea n 
Or ga nisati o n f or Researc h a n d Treat me nt of Ca ncer Q ualit y of Life 
Q uesti o n naire Ca ncer- 3 0 ( E O R T C Q L Q- C 3 0)
•
C ha n ges fr o m scree ni n g t o p ost baseli ne i n t he E ur o- Q O L, Fi ve 
Di me nsi o ns, Fi ve Le vels ( E Q- 5 D- 5 L) i n de x a n d vis ual a nal o g scale 
( V A S) sc ores
E x pl or at or y 
E n d p oi nt(s):
F or a xica bta ge ne cil ole ucel treat me nt ar m o nl y:
•
Le vels of a nti- C D 1 9 c hi meric a nti ge n rece pt or ( C A R) T cells i n bl o o d
•
Le vels of c yt o ki nes i n ser u m
F or b ot h treat me nt ar ms:
•
T u m or m olec ular a n d hist ol o gical c haracteristics b y le vels of P D- L 1 
a n d m olec ular a n d c yt o ge netic s u bclassificati o ns
•
C ha n ges i n t he w or k pr o d ucti vit y a n d acti vit y i m pair me nt ( W P AI) fr o m 
scree ni n g t o p ost baseli ne
•
Ti me t o ne xt t hera p y
S a m ple Size:
A p pr o xi matel y 3 5 0 s u bjects
St u d y 
Eli gi bilit y:
Please refer t o Secti o n 5  f or a c o m plete a n d detaile d list of i ncl usi o n a n d 
e xcl usi o n criteria. 
Tre at me nt:
A xica bta ge ne cil ole ucel ar m
S u bjects ra n d o mize d t o t he a xica bta ge ne cil ole ucel ar m of t he st u d y will 
recei ve a 3- da y c o n diti o ni n g c he m ot hera p y re gi me n c o nsisti n g of 
fl u dara bi ne 3 0 m g/ m2/ da y a n d c ycl o p h os p ha mi de 5 0 0 m g/ m2/ da y o n da y - 5 
t o da y - 3 f oll o we d b y 2 rest da ys ( da y - 2 a n d da y - 1).
A si n gle i nf usi o n of a xica bta ge ne cil ole ucel a d mi nistere d i ntra ve n o usl y at a 
tar get d ose of 2 x 1 06 a nti- C D 1 9 C A R T cells/ k g o n da y 0.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 5
1 4 A pril 2 0 2 3
Tre at me nt:
Sta n dar d of Care ar m
•
S u bject will recei ve a sec o n d-li ne c o m bi nati o n c he m ot hera p y re gi me n 
( R-I C E, R- D H A P, R- E S H A P, or R- G D P) as selecte d b y t he treati n g 
i n vesti gat or.
•
S u bjects res p o n di n g t o sec o n d-li ne c o m bi nati o n c he m ot hera p y after 2 
or 3 c ycles ( P R or C R) s h o ul d pr ocee d t o hi g h- d ose t hera p y ( H D T) a n d 
a ut ol o g o us ste m cell tra ns pla nt ( A S C T).
•
Peri p heral ste m cell c ollecti o n, H D T, a n d A S C T i nf usi o n will be per 
i nstit uti o nal or re gi o nal g ui deli nes.
Pr oce d ures:
As o utli ne d i n t he S O As, s u bjects will u n der g o t he f oll o wi n g pr oce d ures:  
c ollecti o n of i nf or me d c o nse nt; me dical hist or y; p h ysical e xa m; b o ne 
marr o w bi o ps y; disease sta gi n g, i ncl u di n g a baseli ne P E T- C T sca n; a n d 
bl o o d dra ws f or lactate de h y dr o ge nase le vels, c o m plete bl o o d c o u nt ( C B C), 
a n d bl o o d c he mistries.  S u bjects will als o u n der g o baseli ne ec h ocar di o gra m 
( E C H O) a n d electr ocar di o gra m ( E C G) assess me nts a n d Easter n 
C o o perati ve O nc ol o g y Gr o u p ( E C O G) perf or ma nce stat us. W o me n of 
c hil d beari n g p ote ntial will u n der g o a uri ne or ser u m pre g na nc y test.
S u bjects ra n d o mize d t o t he a xica bta ge ne cil ole ucel ar m will u n der g o 
le u ka p heresis f or t he c ollecti o n of peri p heral bl o o d m o n o n uclear cells 
necessar y f or a xica bta ge ne cil ole ucel ma n ufact uri n g.  C o n diti o ni n g 
c he m ot hera p y will be f oll o we d b y 2 rest da ys a n d t he n i nf usi o n of 
a xica bta ge ne cil ole ucel.  S u bjects will be u n der a n o bser vati o n peri o d f or at 
least 7 da ys after a xica bta ge ne cil ole ucel i nf usi o n t o m o nit or f or a n d 
ma na ge a n y a d verse e ve nts, u nless ot her wise re q uire d b y c o u ntr y 
re g ulat or y a ge ncies (refer t o A p pe n di x D ).  Bl o o d dra ws f or t he a nal ysis of 
a nti- C D 1 9 C A R T-cell le vels will be perf or me d.  A d diti o nal bl o o d dra ws 
f or c yt o ki nes, a nti-a xica bta ge ne cil ole ucel a nti b o dies, a n d 
re plicati o n-c o m pete nt retr o vir us ( R C R) ma y be perf or me d as cli nicall y 
i n dicate d.  Treat me nt wit h a xica bta ge ne cil ole ucel is i nte n de d t o be 
defi niti ve t hera p y a n d n ot a bri d ge t o A S C T.
S u bjects ra n d o mize d t o t he S O C ar m will recei ve i n vesti gat or’s c h oice of 
sec o n d-li ne c o m bi nati o n c he m ot hera p y fr o m t he pr ot oc ol- defi ne d o pti o ns. 
U p t o 3 c ycles ( 6 t o 9 wee ks) of c o m bi nati o n c he m ot hera p y will be 
a d mi nistere d e ver y 2 t o 3 wee ks.  S u bjects wit h a P R or C R t o sec o n d-li ne 
t hera p y s h o ul d pr ocee d t o H D T- A S C T.  Peri p heral ste m cell m o bilizati o n 
a n d le u ka p heresis will be perf or me d acc or di n g t o i nstit uti o nal g ui deli nes 
after t he sec o n d or t hir d c ycle of sec o n d-li ne t hera p y t o o btai n a mi ni m u m 
tar get of 2 x 1 06 C D 3 4 + he mat o p oietic ste m cells per kil o gra m.  
H D T- A S C T will be perf or me d per i nstit uti o nal g ui deli nes.
R o uti nel y t hr o u g h o ut t he c o n d uct of t he st u d y, all s u bjects will be as ke d t o 
re p ort c o nc o mita nt me dicati o ns a n d a d verse e ve nts, re p ort s u bse q ue nt 
l y m p h o ma t hera p y, a ns wer patie nt re p orte d o utc o mes ( P R Os), a n d will 
ha ve r o uti ne disease assess me nts as o utli ne d i n t he S O As.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 6
1 4 A pril 2 0 2 3
I n de pe n de nt of t he ra n d o mize d treat me nt ar m, st u d y pr oce d ures a n d 
disease assess me nts will occ ur at t he sa me pr ot oc ol- defi ne d ti me p oi nts.
F or details f or all st u d y re q uire me nts, refer t o Secti o n 7  a n d t he S O As. 
D ur ati o n of 
St u d y 
P artici p ati o n
T he d urati o n of partici pati o n f or i n di vi d ual s u bjects will var y de pe n di n g o n 
a s u bject’s scree ni n g re q uire me nts, res p o nse t o treat me nt, p ote ntial f or 
re-treat me nt, s ur vi val, a n d ti mi n g of t he tra nsiti o n t o a se parate Kite 
L o n g-ter m F oll o w- u p ( L T F U) st u d y.
F or a s u bject w h o c o m pletes t he e ntire pr ot oc ol fr o m t he date of i nf or me d 
c o nse nt t hr o u g h t he c o m pleti o n of t he l o n g-ter m f oll o w- u p peri o d, t he 
st u d y will ta ke a p pr o xi matel y 5 years t o c o m plete f or t h ose ra n d o mize d t o 
t he S O C ar m a n d a p pr o xi matel y 1 5 years t o c o m plete f or t h ose ra n d o mize d 
t o t he a xica bta ge ne cil ole ucel ar m.
D at a S afet y 
M o nit ori n g 
B o ar d 
( D S M B):
A n i n de pe n de nt D S M B will meet e ver y 6 m o nt hs after t he first s u bject is 
ra n d o mize d t o re vie w safet y data a n d will re vie w safet y a n d efficac y data 
at t he ti me of t he pla n ne d i nteri m f utilit y a nal ysis.  T he D S M B will be 
c hartere d t o ma ke trial c o n d uct rec o m me n dati o ns base d o n a n a nal ysis of 
ris k vers us be nefit.  T he D S M B ma y meet m ore ofte n as nee de d. Refer t o 
Secti o n 9. 9  f or f urt her details.
St atistic al 
C o nsi der ati o ns:
T he pri mar y g oal of t he statistical a nal ysis is t o deter mi ne if t here is a 
statisticall y si g nifica nt i m pr o ve me nt i n e ve nt-free s ur vi val ( E F S) bet wee n 
t he treat me nt gr o u ps.  A p pr o xi matel y 3 5 0 s u bjects ( 1 7 5 per ar m) will be 
ra n d o mize d t o attai n 2 5 0 E F S e ve nts.  Ra n d o mizati o n will be stratifie d b y 
res p o nse t o first-li ne t hera p y a n d sec o n d-li ne a ge-a dj uste d I PI assesse d at 
t he ti me of scree ni n g.  Efficac y a nal yses will be c o n d ucte d o n all 
ra n d o mize d s u bjects a nal yze d acc or di n g t o ra n d o mize d treat me nt ar m.  
Safet y a nal yses will be c o n d ucte d o n all s u bjects w h o recei ve 
pr ot oc ol-s pecifie d t hera p y a nal yze d acc or di n g t o treat me nt act uall y 
recei ve d.  T he st u d y will ha ve a n o verall al p ha of 2. 5 % wit h 1-si de d 
testi n g.  T o preser ve t he o verall si g nifica nce le vel, statistical testi n g of t he 
pri mar y a n d ke y sec o n dar y efficac y e n d p oi nts will f oll o w a hierarc hical 
sc he me.  E F S will be teste d first at t he pri mar y E F S a nal ysis.  C o n diti o nal 
o n a statisticall y si g nifica nt i m pr o ve me nt i n E F S, O R R will be teste d at t he 
2. 5 % le vel at t he ti me of t he pri mar y E F S a nal ysis.  C o n diti o nal o n a 
statisticall y si g nifica nt i m pr o ve me nt i n E F S a n d O R R, O S will be teste d u p 
t o 3 ti mes at a n o verall al p ha le vel of 2. 5 %.  T he pri mar y a nal ysis of O S 
will occ ur w he n a p pr o xi matel y 2 1 0 deat hs ha ve bee n o bser ve d or n o later 
t ha n 5 years after t he first s u bject is ra n d o mize d. A first i nteri m a nal ysis of 
O S will occ ur at t he ti me of t he pri mar y E F S a nal ysis a n d a sec o n d i nteri m 
a nal ysis w he n a p pr o xi matel y 1 6 0 deat hs ha ve bee n o bser ve d or n o later 
t ha n 4 years after t he first s u bject is ra n d o mize d.  A s pe n di n g f u ncti o n of 
t he R h o fa mil y will be use d t o all ocate t he al p ha bet wee n t he 2 i nteri m 
a nal yses of O S a n d t he pri mar y a nal ysis of O S.  A d diti o nall y, o ne i nteri m 
f utilit y a nal ysis of E F S will be c o n d ucte d after 1 3 5 E F S e ve nts ha ve bee n 
o bser ve d.  Stratifie d (ra n d o mizati o n fact ors) l o g-ra n k tests will be use d t o 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 7
1 4 A pril 2 0 2 3
test t he n ull h y p ot hesis of n o differe nce i n E F S a n d O S usi n g a n o verall 
1-si de d al p ha le vel of 2. 5 %.  A stratifie d (ra n d o mizati o n fact ors) 
C oc hra n- Ma ntel- Hae nszel test will be use d t o test O R R at a n o verall 
1-si de d al p ha le vel of 2. 5 %.
F or a f ull descri pti o n of statistical a nal ysis met h o ds, refer t o Secti o n 1 0 .


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 8
1 4 A pril 2 0 2 3
S T U D Y  S C H E M A
Scree ni n g
Ra n d o mizati o n
Da y 5 0 (fr o m ra n d o mizati o n) Disease Assess me nt b 
Da y 1 5 0 (fr o m ra n d o mizati o n) Disease Assess me nt b 
Tre at me nt Pe ri o d: St a n d ar d of C are T her a p y Tre at me nt Ar m
S u bjects ra n d o m ize d t o t he S O C ar m will recei ve a sec o n d-li ne 
c o m bi nati o n c he m ot hera p y re gi me n ( R-I C E, R- D H A P, R- E S H A P, 
or R- G D P) as selecte d b y t he treati n g i n vesti gat or.
S u bjects will recei ve 2 or 3 c ycles of c he m ot hera p y a d mi nistere d 
e ver y 2- 3 wee ks.
S u bjects res p o n di n g t o sec o n d-li ne c o m bi nati o n c he m ot hera p y after 
2 or 3 c ycles s h o ul d pr ocee d wit h H D T a n d A S C T. S u bjects w h o d o 
n ot res p o n d t o sec o n d-li ne c he m ot hera p y ca n recei ve a d diti o nal 
treat me nt off pr ot oc ol.
Tre at me nt Pe ri o d: A xic a bt a ge ne Cil ole ucel  Tre at me nt Ar m a
S u bjects ra n d o m ize d t o treat me nt wit h a xica bta ge ne cil ole ucel will 
recei ve a 3 da y c o n diti o ni n g c he m ot hera p y re gi me n c o nsisti n g of 
fl u dara bi ne 3 0 m g/ m2/ da y a n d c ycl o p h os p ha mi de 5 0 0 m g/ m2/ da y 
( da y - 5 t o da y - 3) f oll o we d b y 2 rest da ys ( da y - 2 & da y - 1).
S u bjects will recei ve a si n gle i nf usi o n of a xica bta ge ne cil ole ucel 
a d mi nistere d i ntra ve n o usl y at a tar get d ose of 2 x 1 0 6 a nti- C D 1 9 
C A R T cells/ k g o n treat me nt da y 0.
S u bjects will recei ve a xica bta ge ne cil ole ucel i n a healt h care facilit y 
f oll o we d b y a mi ni m u m 7da y o bser vati o n peri o d.
L o n g Ter m F oll o w- u p Peri o d , b,c 
Da y 1 0 0 (fr o m ra n d o mizati o n) Disease Assess me nt b 
a
Bri d gi n g t her a p y:  At t he discreti o n of t he i n vesti gat or, c ortic oster oi d bri d gi n g t hera p y ma y be c o nsi dere d f or s u bjects wit h hi g h disease 
b ur de n at scree ni n g. Refer t o Secti o n 6. 2. 4. 2  f or details.
b
Dise ase Assess me nts:  Calc ulate d fr o m t he da y of ra n d o mizati o n a n d n ot t he date of d osi n g wit h a xica bta ge ne cil ole ucel or S O C t hera p y.  
I n de pe n de nt of t he ra n d o mize d treat me nt ar m, st u d y pr oce d ures a n d disease assess me nts will occ ur at t he sa me pr ot oc ol defi ne d ti me p oi nts.  
c  
After c o m pleti n g at least 6 0 m o nt hs of assess me nts i n St u d y K T E- C 1 9- 1 0 7, s u bjects w h o recei ve d at least o ne d ose of a xica bta ge ne cil ole ucel 
as pr ot oc ol t hera p y will c o m plete t he re mai n der of t he 1 5- year f oll o w- u p assess me nts i n a se parate L T F U st u d y after pr o vi di n g i nf or me d 
c o nse nt. Refer t o Secti o n 3. 5  
 Mi ni m u m o bser v ati o n peri o d: 7 d a ys u nless ot her wise re q uire d b y c o u ntr y re g ul at or y a ge ncies (refer t o A p pe n di x D ).
 
 
 
 
 
 
 
 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 9
1 4 A pril 2 0 2 3
T A B L E O F C O N T E N T S
P R O T O C O L S Y N O P SI S................................................................................................................................................ 2
S T U D Y S C H E M A.......................................................................................................................................................... 8
T A B L E O F C O N T E N T S................................................................................................................................................ 9
LI S T O F I N- T E X T T A B L E S....................................................................................................................................... 1 1
LI S T O F I N- T E X T FI G U R E S...................................................................................................................................... 1 1
LI S T O F A B B R E VI A TI O N S....................................................................................................................................... 1 2
1.  
O BJ E C TI V E S....................................................................................................................................................... 1 5
1. 1. 
Pri mar y O bjecti ve.................................................................................................................................... 1 5
1. 2. 
Sec o n dar y O bjecti ves.............................................................................................................................. 1 5
1. 3. 
E x pl orat or y O bjecti ves............................................................................................................................ 1 5
2.  
DI S E A S E B A C K G R O U N D A N D R A TI O N A L E............................................................................................... 1 6
2. 1. 
Sta n dar d First-li ne T hera p y..................................................................................................................... 1 6
2. 2. 
Sta n dar d Sec o n d-li ne T hera p y ................................................................................................................ 1 6
2. 3. 
St u d y Rati o nale ....................................................................................................................................... 1 8
2. 4.  
A nti- C D 1 9 C hi meric A nti ge n Rece pt or T Cells..................................................................................... 1 9
2. 4. 1. 
C D 1 9 a n d E x pressi o n............................................................................................................ 1 9
2. 4. 2.  
A nti- C D 1 9 C A R T-cell Pr o d uct ( A xica bta ge ne Cil ole ucel)................................................. 1 9
2. 5. 
Pri or A nti- C D 1 9 C A R T-cell St u d y Desi g ns a n d Res ults....................................................................... 2 0
2. 5. 1. 
Z U M A- 1................................................................................................................................ 2 0
2. 5. 2. 
C A R T-cell Rece pt or I m m u n ot hera p y f or Patie nts wit h B-cell L y m p h o ma 
( Pr ot oc ol 0 9- C- 0 0 8 2, N C T 0 0 9 2 4 3 2 6) .................................................................................. 2 3
3. 
S T U D Y D E SI G N................................................................................................................................................. 2 4
3. 1.  
Ge neral St u d y Desi g n: Z U M A- 7............................................................................................................. 2 4
3. 2. 
Partici pati n g Sites.................................................................................................................................... 2 4
3. 3.  
N u m ber of S u bjects................................................................................................................................. 2 4
3. 4. 
Re place me nt of S u bjects ......................................................................................................................... 2 4
3. 5.  
D urati o n of St u d y a n d S u bject Partici pati o n........................................................................................... 2 5
3. 5. 1. 
St u d y D urati o n f or I n di vi d ual S u bjects................................................................................. 2 5
3. 5. 2. 
E n d- of-st u d y Defi niti o n......................................................................................................... 2 5
3. 5. 3. 
L o n g-ter m F oll o w- u p ............................................................................................................ 2 5
4. 
S U BJ E C T S C R E E NI N G A N D E N R O L L M E N T................................................................................................ 2 6
5. 
S U BJ E C T E LI GI BI LI T Y..................................................................................................................................... 2 7
5. 1. 
I ncl usi o n Criteria..................................................................................................................................... 2 7
5. 2. 
E xcl usi o n Criteria.................................................................................................................................... 2 8
6. 
P R O T O C O L T R E A T M E N T................................................................................................................................ 3 1
6. 1. 
Treat me nt Ter mi n ol o g y........................................................................................................................... 3 1
6. 2.  
A xica bta ge ne Cil ole ucel St u d y Treat me nt Ar m...................................................................................... 3 2
6. 2. 1. 
Le u ka p heresis........................................................................................................................ 3 2
6. 2. 2. 
C o n diti o ni n g C he m ot hera p y ................................................................................................. 3 2
6. 2. 3.  
A xica bta ge ne Cil ole ucel........................................................................................................ 3 3
6. 2. 4. 
Cell C ollecti o n a n d A xica bta ge ne Cil ole ucel St u d y Treat me nt Sc he d ule 
a n d A d mi nistrati o n................................................................................................................ 3 4
6. 2. 5. 
E xcl u de d Me dicati o ns ( A xica bta ge ne Cil ole ucel Ar m)........................................................ 4 2
6. 2. 6. 
S u bse q ue nt T hera p y ( A xica bta ge ne Cil ole ucel Ar m)........................................................... 4 2


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 0
1 4 A pril 2 0 2 3
6. 2. 7. 
T o xicit y Ma na ge me nt ( A xica bta ge ne Cil ole ucel Ar m)........................................................ 4 2
6. 3. 
Sta n dar d of Care T hera p y Ar m ............................................................................................................... 4 3
6. 3. 1. 
Sta n dar d of Care C he m ot hera p y D osi n g a n d A d mi nistrati o n............................................... 4 3
6. 3. 2. 
C o nc o mita nt T hera p y ( Sta n dar d of Care Ar m)..................................................................... 4 4
6. 3. 3. 
E xcl u de d Me dicati o ns ( Sta n dar d of Care Ar m).................................................................... 4 5
6. 3. 4. 
S u bse q ue nt T hera p y ( Sta n dar d of Care Ar m)....................................................................... 4 5
6. 3. 5. 
T o xicit y Ma na ge me nt ( Sta n dar d of Care Ar m)..................................................................... 4 5
7. 
S T U D Y P R O C E D U R E S...................................................................................................................................... 4 6
7. 1. 
I nf or me d C o nse nt.................................................................................................................................... 4 6
7. 2. 
Scree ni n g................................................................................................................................................. 4 6
7. 3. 
Ra n d o mizati o n......................................................................................................................................... 4 7
7. 4.  
De m o gra p hic Data................................................................................................................................... 4 7
7. 5.  
Me dical a n d Treat me nt Hist or y............................................................................................................... 4 7
7. 6. 
P h ysical E xa m, Vital Si g ns, a n d Perf or ma nce Stat us ............................................................................. 4 8
7. 7.  
Ne ur ol o gical E xa mi nati o n....................................................................................................................... 4 8
7. 8. 
Car diac F u ncti o n ..................................................................................................................................... 4 8
7. 9. 
T o xicit y E val uati o n................................................................................................................................. 4 9
7. 1 0.  
Disease Res p o nse Assess me nt ................................................................................................................ 4 9
7. 1 0. 1. 
I ma gi n g.................................................................................................................................. 4 9
7. 1 0. 2. 
B o ne Marr o w Bi o ps y a n d As pirate....................................................................................... 5 0
7. 1 1. 
La b orat or y ............................................................................................................................................... 5 0
7. 1 1. 1. 
L ocal La b A nal ysis................................................................................................................ 5 0
7. 1 1. 2. 
Ce ntral La b A nal ysis............................................................................................................. 5 1
7. 1 2. 
Patie nt Re p orte d O utc o mes..................................................................................................................... 5 2
7. 1 2. 1. 
E ur o pea n Or ga nisati o n f or Researc h a n d Treat me nt of Ca ncer ( E O R T C) 
Q L Q- C 3 0 Versi o n 3. 0........................................................................................................... 5 2
7. 1 2. 2. 
E ur o Q ol Fi ve Di me nsi o ns Q uesti o n naire ( E Q- 5 D- 5 L)......................................................... 5 3
7. 1 2. 3.  
W or k Pr o d ucti vit y a n d Acti vit y I m pair me nt Q uesti o n naire ( W P AI) ................................... 5 3
7. 1 3. 
Bi o mar kers .............................................................................................................................................. 5 4
7. 1 4. 
P ost-treat me nt F oll o w- u p........................................................................................................................ 5 5
7. 1 5. 
L o n g-ter m F oll o w- u p ( A xica bta ge ne Cil ole ucel a n d Sta n dar d of Care Ar ms) ...................................... 6 1
8. 
S U BJ E C T WI T H D R A W A L................................................................................................................................ 6 5
8. 1. 
Reas o ns f or Re m o val fr o m Treat me nt .................................................................................................... 6 6
8. 2. 
Reas o ns f or Re m o val fr o m St u d y............................................................................................................ 6 6
9. 
S A F E T Y R E P O R TI N G........................................................................................................................................ 6 7
9. 1.  
A d verse E ve nts........................................................................................................................................ 6 7
9. 2. 
Re p orti n g of A d verse E ve nts................................................................................................................... 6 7
9. 2. 1. 
Re p orti n g A b n or mal La b orat or y Fi n di n gs............................................................................ 6 8
9. 3.  
Defi niti o n of Seri o us A d verse E ve nts..................................................................................................... 6 9
9. 4. 
Re p orti n g of Seri o us A d verse E ve nts...................................................................................................... 6 9
9. 4. 1. 
Re p orti n g Deat hs................................................................................................................... 7 0
9. 5.  
Dia g n osis Vers us Si g ns a n d S y m pt o ms.................................................................................................. 7 1
9. 6. 
Pre g na nc y a n d Lactati o n ......................................................................................................................... 7 1
9. 7.  
H os pitalizati o n a n d Pr ol o n ge d H os pitalizati o n....................................................................................... 7 2
9. 8.  
A b n or mal Vital Si g n Val ues ................................................................................................................... 7 2
9. 9.  
Data Safet y M o nit ori n g B oar d ................................................................................................................ 7 3
1 0.
S T A TI S TI C A L C O N SI D E R A TI O N S................................................................................................................. 7 4
1 0. 1.  
H y p ot hesis............................................................................................................................................... 7 4
1 0. 2. 
St u d y E n d p oi nts....................................................................................................................................... 7 4
1 0. 2. 1. 
Pri mar y.................................................................................................................................. 7 4
1 0. 2. 2.  
Ke y Sec o n dar y....................................................................................................................... 7 5


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 1
1 4 A pril 2 0 2 3
1 0. 2. 3. 
Sec o n dar y.............................................................................................................................. 7 5
1 0. 2. 4. 
E x pl orat or y............................................................................................................................ 7 6
1 0. 2. 5.  
A nal ysis S u bsets.................................................................................................................... 7 7
1 0. 2. 6. 
C o variates.............................................................................................................................. 7 7
1 0. 3. 
Sa m ple Size C o nsi derati o ns.................................................................................................................... 7 8
1 0. 4.  
Access t o I n di vi d ual S u bject Treat me nt Assi g n me nts............................................................................ 8 0
1 0. 5. 
I nteri m A nal ysis a n d Earl y St o p pi n g G ui deli nes.................................................................................... 8 0
1 0. 5. 1. 
Safet y I nteri m A nal ysis......................................................................................................... 8 0
1 0. 5. 2. 
Efficac y I nteri m A nal ysis...................................................................................................... 8 0
1 0. 6. 
Pla n ne d Met h o d of A nal ysis ................................................................................................................... 8 0
1 0. 6. 1. 
E ve nt-free S ur vi val................................................................................................................ 8 1
1 0. 6. 2.  
O R R....................................................................................................................................... 8 2
1 0. 6. 3.  
O S.......................................................................................................................................... 8 2
1 0. 6. 4. 
Pr o gressi o n-free S ur vi val, D urati o n of Res p o nse, a n d Ti me t o Ne xt 
T hera p y.................................................................................................................................. 8 3
1 0. 6. 5. 
Safet y..................................................................................................................................... 8 3
1 0. 6. 6. 
P har mac o ki netic A nal yses..................................................................................................... 8 3
1 0. 6. 7. 
I m m u n o ge nicit y A nal yses..................................................................................................... 8 3
1 0. 6. 8.  
Healt h-relate d Q ualit y of Life............................................................................................... 8 3
1 0. 6. 9. 
C yt o ki nes, Pr o d uct C haracteristics, a n d M olec ular a n d Hist ol o gical 
C haracteristics....................................................................................................................... 8 3
1 0. 6. 1 0. 
L o n g-ter m Data A nal ysis ...................................................................................................... 8 4
1 1.
R E G U L A T O R Y O B LI G A TI O N S....................................................................................................................... 8 5
1 1. 1. 
I n de pe n de nt Re vie w B oar d/I n de pe n de nt Et hics C o m mittee................................................................... 8 5
1 1. 2. 
S u bject C o nfi de ntialit y............................................................................................................................ 8 5
1 1. 3. 
I n vesti gat or Si g nat or y O bli gati o ns.......................................................................................................... 8 6
1 2.
P R O T O C O L A M E N D M E N T S A N D T E R MI N A TI O N..................................................................................... 8 7
1 3.
S T U D Y D O C U M E N T A TI O N A N D A R C HI V E................................................................................................ 8 8
1 4.
S T U D Y M O NI T O RI N G A N D D A T A C O L L E C TI O N...................................................................................... 9 0
1 5.
P U B LI C A TI O N ................................................................................................................................................... 9 1
1 6.
C O M P E N S A TI O N............................................................................................................................................... 9 2
1 7.
R E F E R E N C E S..................................................................................................................................................... 9 3
1 8.
A P P E N DI C E S...................................................................................................................................................... 9 8
LI S T O F I N- T E X T T A B L E S
Ta ble 1. 
Baseli ne C haracteristics a n d Res ults fr o m Z U M A- 1 Pri mar y A nal ysis ................................. 2 2
Ta ble 2. 
Sc he d ule of Assess me nts A xica bta ge ne Cil ole ucel Ar m........................................................ 5 6
Ta ble 3. 
Sc he d ule of Assess me nts S O C C he m ot hera p y Ar m............................................................... 5 9
Ta ble 4. 
Sc he d ule of Assess me nts L o n g-ter m F oll o w- u p Peri o d.......................................................... 6 3
LI S T O F I N- T E X T FI G U R E S
Fi g ure 1.  
A nti- C D 1 9 C A R C o nstr uct a n d Mec ha nis m of Acti o n........................................................... 2 0
Fi g ure 2. 
St u d y Testi n g Sc he me............................................................................................................. 7 9


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 2
1 4 A pril 2 0 2 3
LI S T O F A B B R E VI A TI O N S
A b bre viati o n
Defi niti o n
A E
A d verse e ve nt
A L L
Ac ute l y m p h o blastic le u ke mia
A L T
Ala ni ne a mi n otra nsferase
A N C
A bs ol ute ne utr o p hil c o u nt
A S C T
A ut ol o g o us ste m cell tra ns pla nt
A S T 
As partate a mi n otra nsferase
A U C
Area u n der t he c ur ve
A xica bta ge ne cil ole ucel 
A ut ol o g o us T cells tra ns d uce d wit h retr o viral vect or c o ntai ni n g a nti- C D 1 9 
C D 2 8/ C D 3ζ c hi meric a nti ge n rece pt or
C A R
C hi meric a nti ge n rece pt or 
C B C
C o m plete bl o o d c o u nt
C L L
C hr o nic l y m p h oc ytic le u ke mia
C M R
C o m plete meta b olic res p o nse
C N S
Ce ntral ner v o us s yste m
C R
C o m plete res p o nse
C R F
Case Re p ort F or m
C R P
C-reacti ve pr otei n 
C R O
C o ntract Researc h Or ga nizati o n
C R R
C o m plete ra di ol o gic res p o nse
C R S
C yt o ki ne release s y n dr o me
C S F
Cere br os pi nal fl ui d
C S R
Cli nical St u d y Re p ort
C T
C o m p ute d t o m o gra p h y
C T C A E
C o m m o n Ter mi n ol o g y Criteria f or A d verse E ve nts
D L B C L
Diff use lar ge B-cell l y m p h o ma
D O R
D urati o n of res p o nse
D S M B
Data Safet y M o nit ori n g B oar d
e C R F
Electr o nic Case Re p ort F or m
E C G
Electr ocar di o gra m
E C H O
Ec h ocar di o gra m
E C O G
Easter n C o o perati ve O nc ol o g y Gr o u p
E E G
Electr oe nce p hal o gra m 
E F S
E ve nt-free s ur vi val
E n d of st u d y ( pri mar y 
c o m pleti o n)
Defi ne d as w he n t he last s u bject has u n der g o ne a n assess me nt f or t he p ur p ose of t he 
e ve nt dri ve n pri mar y a nal ysis
E O R T C Q L Q- C 3 0
E ur o pea n Or ga nisati o n f or Researc h a n d Treat me nt of Ca ncer Q ualit y of Life 
Q uesti o n naire Ca ncer- 3 0 ( Q L Q- C 3 0)
E Q- 5 D- 5 L
E ur o- Q O L, Fi ve Di me nsi o ns, Fi ve Le vels
F A S
F ull a nal ysis set


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 3
1 4 A pril 2 0 2 3
A b bre viati o n
Defi niti o n
F L
F ollic ular l y m p h o ma 
G C P
G o o d Cli nical Practice
G P
Ge neral practiti o ner
H C P
Healt hcare pr o vi der
H D T
Hi g h- d ose t hera p y 
H E E N T
Hea d, ears, e yes, n ose, t hr oat
HI V
H u ma n i m m u n o deficie nc y vir us
H L H
He m o p ha g oc ytic l y m p h o histi oc yt osis
H R Q o L
Healt h-relate d q ualit y of life
I B
I n vesti gat or’s Br oc h ure
I C F
I nf or me d C o nse nt F or m
I C H
I nter nati o nal C o nfere nce o n Har m o nisati o n
I D
I de ntificati o n
I H C
I m m u n o hist oc he mistr y 
I L
I nterle u ki n
I P
I n vesti gati o nal pr o d uct
I PI
I nter nati o nal Pr o g n ostic I n de x  
I P M
I n vesti gati o nal Pr o d uct Ma n ual
I R B/I E C
I nstit uti o nal Re vie w B oar d/I n de pe n de nt Et hics C o m mittee
I V
I ntra ve n o us
I X R S 
I nteracti ve V oice/ We b ( X) Res p o nse S yste m
L D H
Lactate de h y dr o ge nase
L T F U
L o n g-ter m f oll o w u p
L V E F
Left ve ntric ular ejecti o n fracti o n 
M C L
Ma ntle cell l y m p h o ma
Me d D R A
Me dical Dicti o nar y f or Re g ulat or y Acti vities
m E F S
M o difie d E F S; defi ne d t he sa me wa y as E F S, e xce pt t hat fail ure t o attai n C R or P R 
b y Da y 1 5 0 assess me nt is n ot c o nsi dere d as a n e ve nt
M M S E
Mi ni- Me ntal Stat us E xa m
M RI
Ma g netic res o na nce i ma gi n g
M S G V 1
M uri ne ste m cell vir us- base d vect or
N CI
Nati o nal Ca ncer I nstit ute
N E
Ne ur ol o gic e ve nt
N H L
N o n- H o d g ki n l y m p h o ma
N M R
N o meta b olic res p o nse
N P T
Nas o p har y n geal-t hr oat
O R R
O bjecti ve res p o nse rate
O S
O verall s ur vi val
P B M C
Peri p heral bl o o d m o n o n uclear cell
P C R
P ol y merase c hai n reacti o n


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 4
1 4 A pril 2 0 2 3
A b bre viati o n
Defi niti o n
P D
Pr o gressi ve disease
P E T- C T
P ositr o n e missi o n t o m o gra p h y-c o m p ute d t o m o gra p h y
P F S
Pr o gressi o n-free s ur vi val
P K
P har mac o ki netic
P M B C L
Pri mar y me diasti nal B-cell l y m p h o ma 
P M D
Pr o gressi ve meta b olic disease
P M R
Partial meta b olic res p o nse
P R
Partial res p o nse
P R D
Pr o gressi ve ra di ol o gic disease
P R O
Patie nt re p orte d o utc o me
P R R
Partial ra di ol o gic res p o nse
Q o L
Q ualit y of life
q P C R
Q ua ntitati ve p ol y merase c hai n reacti o n
R C R
Re plicati o n-c o m pete nt retr o vir us
r/r
Rela pse d/refract or y
S A E
Seri o us a d verse e ve nt
sc F v
Si n gle-c hai n varia ble fra g me nt
S C T
Ste m cell tra ns pla nt
S D
Sta ble disease
S O A
Sc he d ule of assess me nt
S O C
Sta n dar d of care
S R D
Sta ble ra di ol o gic disease
St u d y Da y 0
Da y of ra n d o mizati o n
S U S A R
S us pecte d u ne x pecte d seri o us a d verse reacti o n
T BI
T otal b o d y irra diati o n
T E A E
Treat me nt-e mer ge nt a d verse e ve nt
T F L
Tra nsf or me d f ollic ular l y m p h o ma
T N F
T u m or necr osis fact or
Treat me nt da y 0
Defi ne d as t he first da y t hat a xica bta ge ne cil ole ucel or C D 3 4 + ste m cells f or A S C T 
are a d mi nistere d t o t he s u bject
U L N
U p per li mit of n or mal
U TI
Uri nar y tract i nfecti o n
V A S
Vis ual a nal o g scale
W B C
W hite bl o o d cell
W P AI: G H
W or k pr o d ucti vit y a n d acti vit y i m pair me nt q uesti o n naire: ge neral healt h


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 5
1 4 A pril 2 0 2 3
1.  
O B J E C TI V E S
1. 1. 
Pri m ar y O bjecti ve
•
T o deter mi ne if a xica bta ge ne cil ole ucel is s u peri or t o sta n dar d of care ( S O C) as meas ure d b y 
e ve nt-free s ur vi val ( E F S), as deter mi ne d b y bli n de d ce ntral re vie w
1. 2. 
Sec o n d ar y O bjecti ves
•
T o e val uate t he effect of a xica bta ge ne cil ole ucel c o m pare d t o S O C o n o bjecti ve res p o nse rate 
( O R R), as deter mi ne d b y bli n de d ce ntral re vie w
•
T o e val uate t he effect of a xica bta ge ne cil ole ucel c o m pare d t o S O C o n o verall s ur vi val ( O S)
•
T o e val uate t he effect of a xica bta ge ne cil ole ucel c o m pare d t o S O C o n pr o gressi o n-free 
s ur vi val ( P F S)
•
T o e val uate t he effect of a xica bta ge ne cil ole ucel c o m pare d t o S O C o n d urati o n of res p o nse 
( D O R) a n d d urati o n of c o m plete res p o nse a m o n g res p o n di n g s u bjects, as deter mi ne d b y 
bli n de d ce ntral re vie w
•
T o e val uate t he safet y of a xica bta ge ne cil ole ucel c o m pare d t o S O C
•
T o e val uate t he effect of a xica bta ge ne cil ole ucel o n patie nt re p orte d o utc o mes ( P R Os) a n d 
q ualit y of life ( Q o L) c o m pare d t o S O C
1. 3. 
E x pl or at or y O bjecti ves
•
E x pl ore mec ha nis ms of resista nce t o treat me nt wit h a xica bta ge ne cil ole ucel
•
E val uate mec ha nistic as pects a n d re versi bilit y of t o xicities wit h a xica bta ge ne cil ole ucel
•
E x pl ore m olec ular a n d hist ol o gic c haracteristics of t he t u m or micr oe n vir o n me nt
•
E val uate i m pact of disease a n d treat me nt o n w or k pr o d ucti vit y a n d acti vit y
•
Esti mate ti me t o ne xt t hera p y


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 6
1 4 A pril 2 0 2 3
2.  
DI S E A S E B A C K G R O U N D A N D R A TI O N A L E
N o n- H o d g ki n l y m p h o ma ( N H L) c o m prises a heter o ge ne o us gr o u p of ca ncers ori gi nati n g 
pri maril y i n B l y m p h oc ytes a n d, t o a lesser e xte nt, i n T l y m p h oc ytes a n d nat ural killer cells.  
N H L is t he m ost pre vale nt he mat ol o gical mali g na nc y a n d is t he se ve nt h m ost c o m m o n ne w 
ca ncer a m o n g me n a n d w o me n, acc o u nti n g f or 4 % of all ne w ca ncer cases a n d 3 % of ca ncer-
relate d deat hs {H o wla der 2 0 1 5 }.
Diff use lar ge B-cell l y m p h o ma ( D L B C L) is t he m ost c o m m o n s u bt y pe of N H L, acc o u nti n g f or 
a p pr o xi matel y 3 0 % t o 4 0 % of all cases { C ha ga nti 2 0 1 6 , M ort o n 2 0 0 6 , Se h n 2 0 1 5 }.  D L B C L 
c o m prises a gr o u p of l y m p h oi d mali g na ncies c o m p ose d of lar ge cells wit h vesic ular n uclei, 
pr o mi ne nt n ucle oli, bas o p hilic c yt o plas m, a n d a hi g h pr oliferati o n rate { Martelli 2 0 1 3 }.  Patie nts 
ofte n prese nt wit h si n gle or m ulti ple ra pi dl y e nlar gi n g s y m pt o matic masses, wit h u p t o 4 0 % 
occ urri n g at e xtra n o dal sites, partic ularl y t he gastr oi ntesti nal tract (st o mac h a n d ile ocecal 
re gi o n).  Ce ntr o blast- a n d i m m u n o blast-li ke cells are t he pre d o mi na nt m or p h ol o g y, a n d t hese 
cells t y picall y e x press t he B-cell mar kers C D 1 9, C D 2 0, C D 2 2, as well as s urface 
i m m u n o gl o b uli n.
2. 1. 
St a n d ar d First-li ne T her a p y
Si nce t he 1 9 7 0s, t he C H O P c he m ot hera p y re gi me n (c ycl o p h os p ha mi de, d o x or u bici n, vi ncristi ne, 
a n d pre d nis o ne) ha d bee n sta n dar d of care first-li ne t hera p y.  M ore i nte nsi ve c o m bi nati o ns faile d 
t o s h o w a d diti o nal s ur vi val be nefit.  T he c urre nt sta n dar d of care f or first-li ne treat me nt is C H O P 
i n c o m bi nati o n wit h a n a nti- C D 2 0 m o n ocl o nal a nti b o d y rit u xi ma b ( R- C H O P, rit u xi ma b- base d 
c he m oi m m u n ot hera p y) { Fl o wers 2 0 1 0 }.  I n t he se mi nal st u d y b y t he Gr o u pe d’ Et u de des 
L y m p h o mes de l’ A d ulte, first-li ne R- C H O P was s u peri or t o C H O P { Fe u gier 2 0 0 5 }, wit h 
1 0- year O S a n d P F S of 4 3. 5 % vers us  2 7. 6 % a n d 3 6. 5 % vers us 2 0 %, res pecti vel y {Fe u gier 
2 0 0 5 }.  T h us, w hile m ore effecti ve t ha n c he m ot hera p y al o ne, first-li ne R- C H O P still o nl y res ults 
i n l o n g-ter m disease re missi o n i n < 4 0 % of s u bjects.  Rece ntl y a P hase 3 trial of first-li ne 
R- C H O P vers us d ose-a dj uste d R- E P O C H de m o nstrate d n o differe nce i n E F S or O S bet wee n t he 
re gi me ns {Wils o n 2 0 1 6 }.
T he I nter nati o nal Pr o g n ostic I n de x (I PI), w hic h i ncl u des a ge, perf or ma nce stat us, lactate 
de h y dr o ge nase ( L D H) le vel, sta ge, a n d e xtra n o dal i n v ol ve me nt, c orrelates wit h o utc o mes t o 
sta n dar d first-li ne t hera p y.  M ore rece ntl y, pr o g n ostic m olec ular feat ures ha ve bee n i de ntifie d.  
Ge ne e x pressi o n pr ofili n g has bee n use d t o cate g orize D L B C L i nt o t he ger mi nal ce nter B-cell 
t y pe, a n d acti vate d B-cell t y pe is ass ociate d wit h w orse o utc o mes.  A d diti o nall y, d o u ble- a n d 
tri ple- hit l y m p h o mas wit h tra nsl ocati o ns of M Y C a n d eit her B C L 2 a n d/ or B C L 6 ha ve bee n 
s h o w n t o ha ve a p o or pr o g n osis wit h R- C H O P c he m ot hera p y {Gree n 2 0 1 2 }.
2. 2. 
St a n d ar d Sec o n d-li ne T her a p y
Patie nts wit h D L B C L w h o rela pse after or are refract or y t o first-li ne t hera p y (rela pse d/refract or y 
[r/r] D L B C L) ha ve p o or pr o g n osis.  I n t he L N H- 9 8. 5 trial, a p pr o xi matel y 4 0 % of patie nts 
rela pse after R- C H O P, a n d 7 0 % of t hese patie nts die wit hi n t he first 2 years after pr o gressi o n 
des pite sal va ge t hera p y, wit h a me dia n O S of 0. 7 years after pr o gressi o n { C oiffier 2 0 1 0 }.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 7
1 4 A pril 2 0 2 3
Patie nts wit h r/r D L B C L ha ve heter o ge ne o us o utc o mes t o sec o n d-li ne t hera p y.  T he g oal of 
sal va ge c he m ot hera p y is t o deter mi ne c he m o-se nsiti vit y pri or t o pr ocee di n g t o hi g h- d ose 
t hera p y-a ut ol o g o us ste m cell tra ns pla nt ( H D T- A S C T).  T he sec o n d-li ne a ge-a dj uste d I PI 
(s A AI PI: L D H, sta ge, a n d perf or ma nce stat us) ca n f urt her pre dict o utc o me f or r/r D L B C L f or 
b ot h c he m ot hera p y-se nsiti ve a n d all patie nts { Ha mli n 2 0 0 3 }.
Res ults of t he P A R M A trial { P hili p 1 9 9 5 } de m o nstrate d s u peri or o utc o me f or sal va ge t hera p y 
pl us A S C T c o m pare d wit h sal va ge t hera p y al o ne f or patie nts wit h r/r D L B C L ( 5- year E F S of 
4 6 % vs 1 2 %, a n d O S of 5 3 % a n d 3 2 %, res pecti vel y), lea di n g t o t he a d o pti o n of sec o n d-li ne 
c he m ot hera p y pl us A S C T as t he sta n dar d of care.  Patie nts w h o are u na ble t o u n der g o A S C T d ue 
t o c o m or bi dities or c he m ot hera p y i nse nsiti ve disease ha ve p o or l o n g-ter m o utc o mes.
Sec o n d-li ne c he m ot hera p y re gi me ns ge nerall y c o nsist of n o n-cr oss-resista nt dr u gs t o first-li ne 
R- C H O P.  C o m m o n re gi me ns i ncl u de R- G D P, R- D H A P, R-I C E, a n d R- E S H A P.  I nstit uti o nal 
prefere nce a n d a d verse e ve nt ( A E) pr ofile ofte n dictate w hic h treat me nt re gi me n is use d.  N o 
re gi me n has de m o nstrate d s u peri orit y i n a ra n d o mize d trial.  T he P hase 3 L Y 1 2 trial c o m pare d 
G D P t o D H A P f oll o we d b y H D T a n d A S C T i n patie nts wit h r/r D L B C L.  O R Rs ( 4 5 % vs 4 4 %), 
E F S ( H R = 0. 9 9), a n d O S ( H R = 1. 0 3) were si milar bet wee n ar ms alt h o u g h he mat ol o gic t o xicit y 
was m ore se vere i n t he D H A P ar m { Cr u m p 2 0 1 4 }.  I n t he P hase 3 C O R A L trial, patie nts wit h r/r 
D L B C L were ra n d o mize d t o R-I C E vers us R- D H A P f oll o we d b y H D T a n d A S C T, f oll o we d b y a 
sec o n d ra n d o mizati o n t o rit u xi ma b mai nte na nce or n o mai nte na nce.  O R Rs ( 6 4 % vs 6 3 %) a n d 
3 year O S ( 4 7 % vs 5 1 %) were si milar bet wee n t he t w o re gi me ns; h o we ver, m ore he mat ol o gic 
t o xicit y was ass ociate d wit h R- D H A P.  Mai nte na nce wit h rit u xi ma b was n ot s h o w n t o be 
be neficial after A S C T.
T h ose wit h c he m o-se nsiti ve disease t hat res p o n ds t o sec o n d-li ne c he m ot hera p y pr ocee d t o H D T 
a n d A S C T.  H D T- A S C T i n v ol ves peri p heral ste m cell c ollecti o n, m yel oa blati ve hi g h- d ose 
c he m ot hera p y wit h or wit h o ut t otal b o d y irra diati o n ( T BI), a n d ste m cell resc ue.  Alt h o u g h 
treat me nt pr oce d ures ma y var y bet wee n differe nt re gi o ns a n d i nstit uti o ns, t he ge neral pr ocess 
re mai ns c o nsiste nt.  Ste m cells are m o bilize d fr o m t he b o ne marr o w t o t he peri p her y wit h G- C S F 
a n d t he n c ollecte d b y le u ka p heresis.  H D T utilizes a m yel oa blati ve c o n diti o ni n g re gi me n 
c o nsisti n g of c o m bi nati o n c he m ot hera p y wit h or wit h o ut T BI.  T he c h oice of re gi me ns varies 
beca use n o si n gle re gi me n has de m o nstrate d s u peri orit y i n a ra n d o mize d trial; h o we ver, 
c he m ot hera p y- o nl y re gi me ns ma y ha ve l o wer rates of sec o n dar y m yel o d ys plastic s y n dr o me a n d 
ac ute m yel oi d le u ke mia { Barri n gt o n 2 0 1 0 , Darri n gt o n 1 9 9 4 , St o ne 1 9 9 4 }.  A c o m m o n re gi me n 
is car m usti ne ( B C N U), et o p osi de, ara- C, a n d mel p hala n ( B E A M), w hic h t y picall y is i nitiate d a 
wee k pri or t o ste m cell i nf usi o n.  G- C S F is a d mi nistere d t he da y f oll o wi n g ste m cell i nf usi o n t o 
s u p p ort e n graft me nt a n d rec o nstit uti o n of t he b o ne marr o w, effecti vel y resc ui n g he mat o p oiesis 
a n d re d uci n g t he peri o d of pr of o u n d ne utr o pe nia d uri n g w hic h life-t hreate ni n g i nfecti o ns ca n 
occ ur.  T he r o uti ne use of G- C S F has le d t o re d ucti o n of earl y tra ns pla nt-relate d m ortalit y, b ut it 
re mai ns as hi g h as 5 % e ve n i n e x perie nce d i nstit uti o ns.
I n t he C O R A L trial, patie nts treate d wit h rit u xi ma b- base d first-li ne t hera p y w h o rela pse wit hi n 
1 year of dia g n osis ha ve p o or o utc o mes.  T he 1- year E F S i n t his gr o u p (a p pr o xi matel y 6 0 % of 
t he patie nts) was bel o w 2 0 % i n t h ose w h o rela pse bef ore 1 year c o m pare d t o 5 0 % i n t h ose wit h 
rela pse after 1 year {Gissel brec ht 2 0 1 0 }.  Als o, half of t he patie nts di d n ot reac h A S C T, 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 8
1 4 A pril 2 0 2 3
pre d o mi na ntl y d ue t o i na de q uate res p o nse t o sec o n d-li ne c he m ot hera p y; a p pr o xi matel y 8 4 % d ue 
t o treat me nt fail ure a n d 9. 4 % d ue t o t o xicit y.  I na de q uate res p o nse t o sec o n d-li ne c he m ot hera p y 
i m plies c he m o-resista nce, a n d A S C T w o ul d n ot be i n dicate d beca use of pr o ba ble i na de q uate 
res p o nse t o hi g h- d ose c he m ot hera p y.  T heir pr o g n osis is p o or, wit h a me dia n O S of a b o ut 
4. 4 m o nt hs { Va n De n Neste 2 0 1 6 }.
T he P hase 3 O R C H A R R D trial, t he lar gest sec o n d-li ne st u d y i n D L B C L wit h p ositr o n e missi o n 
t o m o gra p h y ( P E T)- base d assess me nts, de m o nstrate d t hat patie nts wit h pri mar y refract or y or 
earl y-rela pse d disease ha ve p o or o utc o mes { va n I m h off 2 0 1 7 }.  Patie nts were treate d wit h 
rit u xi ma b- or ofat u m u ma b- base d sal va ge D H A P t hera p y f oll o we d b y H D T- A S C T i n res p o n ders 
base d o n P E T- C T assess me nt.  T h ose wit h pri mar y refract or y disease or w h o rela pse 
≤ 1 2 m o nt hs after c o m pleti o n of first-li ne treat me nt, re prese nti n g 7 0 % of patie nts i n t he trial, 
ha ve l o wer P F S a n d O S c o m pare d t o t h ose w h o rela pse > 1 2 m o nt hs, wit h a hi g hl y si g nifica nt 
hazar d rati o of 0. 3 2 ( 9 5 % c o nfi de nce i nter val [ CI] 0. 2 4 t o 0. 4 4) a n d 0. 4 ( 9 5 % CI 0. 2 9 t o 0. 5 5), 
res pecti vel y.  T his, al o n g wit h res ults fr o m ot her A S C T st u dies {G u gliel mi 1 9 9 8 } { Velle n ga 
2 0 0 8 }, hi g hli g hts t hat pri mar y refract or y or earl y rela pse d disease, re gar dless as defi ne d as 
≤ 1 2 m o nt hs fr o m dia g n osis, fr o m C R, or fr o m e n d of first-li ne treat me nt, are p o or pr o g n ostic 
fact ors.
T h us, treat me nt of patie nts wit h r/r D L B C L re mai ns c halle n gi n g.  T here is a si g nifica nt u n met 
nee d f or better t hera pies i n t hese patie nts.
2. 3. 
St u d y R ati o n ale
Patie nts wit h r/r D L B C L es peciall y pri mar y refract or y a n d earl y rela pse wit hi n 1 year after first-
li ne rit u xi ma b- base d c he m oi m m u n ot hera p y ha ve p o or pr o g n osis e ve n wit h H D T- A S C T.  
Beca use t hese patie nts are resista nt t o c he m ot hera p y, t he y ma y be nefit fr o m t hera pies wit h 
differe nt mec ha nis ms of acti o n.  I m m u n ot hera p y, w hic h is base d o n t he e n ha nce me nt of a n 
i m m u ne res p o nse a gai nst t he t u m or, is a pr o misi n g a p pr oac h t o treati n g ma n y ca ncer t y pes.  
T cells pla y a n i m p orta nt r ole i n destr o yi n g disease d cells t hr o u g h o ut t he b o d y.  St u dies wit h 
i m m u ne c hec k p oi nt i n hi bit ors a n d bi-s pecific T-cell e n ga gers ha ve de m o nstrate d t he p ote ntial of 
T cells t o treat ca ncer.  T cells nee d t o p ossess t he a p pr o priate s pecificit y f or a t u m or, be prese nt 
i n s ufficie nt n u m bers, a n d o verc o me a n y l ocal i m m u n os u p pressi ve fact ors t o be effecti ve.  
C hi meric a nti ge n rece pt or ( C A R) e n gi neere d T cells ma y a d dress t hese iss ues a n d are a 
pr o misi n g a p pr oac h f or ca ncer t hera p y.
A xica bta ge ne cil ole ucel is a n e n gi neere d a ut ol o g o us T-cell i m m u n ot hera p y b y w hic h a patie nt’s 
o w n T cells are c ollecte d a n d s u bse q ue ntl y ge neticall y altere d t o rec o g nize C D 1 9.  C D 1 9 is 
e x presse d o n t he cell s urface of B-cell mali g na ncies.  I n Z U M A- 1, w hic h i n vesti gate d t he safet y 
a n d efficac y of a xica bta ge ne cil ole ucel i n s u bjects wit h refract or y a g gressi ve N H L, a xica bta ge ne 
cil ole ucel si g nifica ntl y i m pr o ve d O R R ( P < 0. 0 0 0 1).  T he O R R was 8 2 % wit h a c o m plete 
res p o nse ( C R) rate of 5 4 %.  At t he pri mar y a nal ysis, 4 4 % of s u bjects ha d o n g oi n g res p o nses 
( 3 9 % i n C R) (s h o w n i n Ta ble 1 ).  A xica bta ge ne cil ole ucel ma y ha ve a n i m pr o ve d efficac y a n d 
t olerabilit y i n patie nts wit h less c he m o-refract or y disease a n d l o wer disease b ur de n.  T heref ore, 
a xica bta ge ne cil ole ucel will be c o m pare d t o S O C i n patie nts wit h r/r D L B C L.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 9
1 4 A pril 2 0 2 3
2. 4.  
A nti- C D 1 9 C hi meric A nti ge n Rece pt or T Cells
2. 4. 1.  
C D 1 9 a n d E x pressi o n
C D 1 9 is a 9 5 k D tra ns me m bra ne pr otei n e x presse d o nl y i n t he B-cell li nea ge.  It is e x presse d i n 
all n or mal B cells starti n g at t he pr o- B-cell sta ge u ntil t he fi nal differe ntiati o n sta ge a n d is n ot 
e x presse d i n pl uri p ote nt he mat o p oietic ste m cells or m ost plas ma cells.  T he patter n of C D 1 9 
e x pressi o n is mai ntai ne d i n B-cell mali g na ncies, i ncl u di n g s u bt y pes of B-cell N H L, D L B C L, 
pri mar y me diasti nal B-cell l y m p h o ma ( P M B C L), tra nsf or me d f ollic ular l y m p h o ma ( T F L), 
ma ntle cell l y m p h o ma ( M C L), ac ute l y m p h oc ytic le u ke mia ( A L L), c hr o nic l y m p h oc ytic 
le u ke mia ( C L L), a n d n o n T-cell ac ute l y m p h o blastic le u ke mia {Bla nc 2 0 1 1 } wit h t he e xce pti o n 
of m ulti ple m yel o ma.
2. 4. 2.  
A nti- C D 1 9 C A R T-cell Pr o d uct ( A xic a bt a ge ne Cil ole ucel)
A nti- C D 1 9 C A R T cells are a ut ol o g o us h u ma n T cells t hat ha ve bee n e n gi neere d t o e x press a n 
e xtracell ular si n gle-c hai n varia ble fra g me nt (sc F v) wit h s pecificit y f or C D 1 9 li n ke d t o a n 
i ntracell ular si g nali n g part c o m prise d of si g nali n g d o mai ns fr o m C D 2 8 a n d C D 3ζ m olec ules 
arra n ge d i n ta n de m.
A n a nti- C D 1 9 C A R vect or c o nstr uct has bee n desi g ne d, o pti mize d, a n d i nitiall y teste d at t he 
S ur ger y Bra nc h of t he Nati o nal Ca ncer I nstit ute ( N CI) (refer t o Fi g ure 1 ); {K oc he n derfer 2 0 0 9 , 
K oc he n derfer 2 0 1 0 }.  T he sc F v is deri ve d fr o m t he varia ble re gi o n of t he a nti- C D 1 9 m o n ocl o nal 
a nti b o d y F M C 6 3 { Nic h ols o n 1 9 9 7 }.  A p orti o n of t he C D 2 8 c osti m ulat or y m olec ule is a d de d, as 
m uri ne m o dels s u g gest t his is i m p orta nt f or t he a nti-t u m or effect a n d e x pa nsi o n of a nti ‑ C D 1 9 
C A R T cells { K o w oli k 2 0 0 6 } .  T he si g nali n g d o mai n of t he C D 3ζ c hai n is esse ntial f or T-cell 
acti vati o n.  T hese fra g me nts were cl o ne d i nt o t he m uri ne ste m cell vir us- base d vect or  ( M S G V 1), 
utilize d t o ge neticall y e n gi neer t he a ut ol o g o us T cells.  T he safet y a n d efficac y of a nti- C D 1 9 
C A R T cells has bee n e val uate d i n s u bjects wit h C D 1 9 + B-cell mali g na ncies at t he N CI 
{ K oc he n derfer 2 0 1 2 , K oc he n derfer 2 0 1 5 , K oc he n derfer 2 0 1 7 }.  T he sa me a nti ‑ C D 1 9 C A R 
vect or c o nstr uct use d i n t he N CI pr ot oc ol a n d Z U M A- 1 will be use d i n t his st u d y.
T he C A R c o nstr uct is i nserte d i nt o t he T cells’ ge n o me b y retr o viral vect or tra ns d ucti o n.  
Briefl y, peri p heral bl o o d m o n o n uclear cells ( P B M Cs) are o btai ne d b y le u ka p heresis a n d Fic oll 
se parati o n.  P B M Cs are acti vate d b y c ult uri n g wit h a n a nti- C D 3 a nti b o d y i n t he prese nce of 
rec o m bi na nt h u ma n i nterle u ki n- 2 (I L- 2).  Sti m ulate d cells are tra ns d uce d wit h a retr o viral vect or 
c o ntai ni n g a n a nti- C D 1 9 C A R ge ne a n d pr o pa gate d i n c ult ure t o ge nerate s ufficie nt e n gi neere d 
T cells f or a d mi nistrati o n.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 2 0
1 4 A pril 2 0 2 3
Fi g ure 1.
A nti- C D 1 9 C A R C o nstr uct a n d Mec h a nis m of Acti o n
A b bre viati o ns:  C D, cl uster of differe ntiati o n; L T R, l o n g ter mi nal re peat; sc F v, si n gle-c hai n varia ble fra g me nt; C A R, c hi meric 
a nti ge n rece pt or.
2. 5. 
Pri or A nti- C D 1 9 C A R T-cell St u d y Desi g ns a n d Res ults
2. 5. 1. 
Z U M A- 1
Kite P har ma, I nc. ( hereafter referre d t o as Kite or Kite P har ma) is de vel o pi n g a xica bta ge ne 
cil ole ucel, w hic h tar gets C D 1 9 e x pressi n g B-cell mali g na ncies.  T he C A R vect or c o nstr uct is 
i de ntical t o t he o ne use d i n N CI pr ot oc ols {K oc he n derfer 2 0 1 7 }.  Kite P har ma, i n c o nj u ncti o n 
wit h t he N CI S ur ger y Bra nc h, has de vel o pe d a strea mli ne d pr ocess f or t he ge nerati o n of t he a nti-
C D 1 9 C A R T cells.  T he Z U M A- 1 st u d y desi g n a n d res ults fr o m t he m ost c urre nt i nteri m 
a nal ysis at t he ti me of pr ot oc ol de vel o p me nt is s u m marize d bel o w.
T o re vie w t he latest data fr o m t he Z U M A- 1 st u d y, please refer t o t he I n vesti gat or’s Br oc h ure 
(I B).
2. 5. 1. 1. 
Z U M A- 1 St u d y Desi g n
Z U M A- 1 is p hase 1/ 2 m ultice nter, o pe n-la bel st u d y e val uati n g t he safet y a n d efficac y of 
a xica bta ge ne cil ole ucel i n s u bjects wit h refract or y a g gressi ve N H L.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 2 1
1 4 A pril 2 0 2 3
T he pri mar y o bjecti ve of P hase 1 was t o e val uate t he safet y of a xica bta ge ne cil ole ucel re gi me ns.  
T he pri mar y o bjecti ve of P hase 2 was t o e val uate t he efficac y of a xica bta ge ne cil ole ucel, as 
meas ure d b y o bjecti ve res p o nse rate i n s u bjects wit h D L B C L, P M B C L, a n d T F L.  Sec o n dar y 
o bjecti ves i ncl u de d assessi n g t he safet y a n d t olera bilit y of a xica bta ge ne cil ole ucel a n d a d diti o nal 
efficac y e n d p oi nts.  P hase 2 s u bjects e nr olle d i nt o 2 se parate c o h orts desi g nate d as C o h ort 1 a n d 
C o h ort 2.  C o h ort 1 w o ul d e nr oll a p pr o xi matel y 7 2 a d ult s u bjects wit h refract or y D L B C L, a n d 
C o h ort 2 i nte n de d t o e nr oll u p t o 4 0 a d ult s u bjects wit h refract or y P M B C L a n d T F L.
S u bjects were treate d wit h c o n diti o ni n g c he m ot hera p y c o nsisti n g of fl u dara bi ne 3 0 m g/ m 2/ da y 
a n d c ycl o p h os p ha mi de 5 0 0 m g/ m 2/ da y, a d mi nistere d f or 3 da ys f oll o we d b y 2 rest da ys bef ore 
recei vi n g a xica bta ge ne cil ole ucel.  A xica bta ge ne cil ole ucel was a d mi nistere d as a si n gle i nf usi o n 
of C A R tra ns d uce d a ut ol o g o us T cells a d mi nistere d i ntra ve n o usl y at a tar get d ose of 2 x 1 0 6 
a nti- C D 1 9 C A R T cells/ k g.  After i n vesti gati o nal pr o d uct (I P) was d ose d, s u bjects were assesse d 
f or p ost-treat me nt res p o nse f oll o we d b y a l o n g-ter m f oll o w- u p peri o d f or d urati o n of res p o nse 
a n d o verall s ur vi val.
2. 5. 1. 2. 
Z U M A- 1 Pri mar y A nal ysis
As of 2 7 Ja n 2 0 1 7, t he ti me of t he pri mar y a nal ysis data c ut off, 7 7 s u bjects i n C o h ort 1 a n d 
2 4 s u bjects i n C o h ort 2 were e val ua ble ( Ta ble 1 ).  A xica bta ge ne cil ole ucel was s uccessf ull y 
ma n ufact ure d i n 9 9 % of s u bjects e nr olle d.  A vera ge t ur nar o u n d ti me fr o m a p heresis t o recei pt of 
a xica bta ge ne cil ole ucel at cli nical sites was 1 7 da ys.
Wit h a n O R R of 8 2 % i n C o h ort 1 + 2, t he st u d y met t he pri mar y e n d p oi nt ( P < 0. 0 0 0 1; e xact 
bi n o mial test c o m pari n g o bser ve d O R R t o hist orical c o ntr ol of 2 0 %), wit h 4 9 % C Rs.  I n all 
1 0 1 s u bjects, O R R was 8 2 %, wit h C R i n 5 4 % a n d a me dia n ti me t o C R of 1 m o nt h ( Ta ble 1 ); 
4 4 % ha d o n g oi n g res p o nses ( C R i n 3 9 %) at t he ti me of t he pri mar y a nal ysis.  O R R was 
c o nsiste nt acr oss a br oa d ra n ge of c o variates, i ncl u di n g refract or y s u b gr o u p, sta ge, I PI, a n d a ge.
Wit h a me dia n f oll o w- u p ti me of 8. 7 m o nt hs, t he me dia n D O R was 8. 1 m o nt hs.  T he me dia n 
D O R i n s u bjects ac hie vi n g C R was n ot reac he d.  T he me dia n P F S was 5. 9 m o nt hs, a n d t he 
me dia n O S was n ot reac he d.  Ka pla n – Meier esti mates of O S at 6, 9, a n d 1 2 m o nt hs were 7 9. 8 %, 
6 8. 4 % a n d 5 4. 5 %.
T he m ost c o m m o n Gra de 3 or hi g her treat me nt-e mer ge nt A Es ( T E A Es) are als o s h o w n i n 
Ta ble 1 .  T here were t w o Gra de 5 a xica bta ge ne cil ole ucel relate d e ve nts, i ncl u di n g 
he m o p ha g oc ytic l y m p h o histi oc yt osis ( H L H) a n d car diac arrest i n t he setti n g of c yt o ki ne release 
s y n dr o me ( C R S).
Pea k C A R T-cell e x pa nsi o n was ass ociate d wit h o n g oi n g res p o nse at 3 m o nt hs ( P = 0. 0 0 4) a n d 
Gra de ≥ 3 ne ur ol o gical e ve nts ( N Es; P = 0. 0 2).  S u bjects wit h Gra de ≥ 3 C R S a n d N Es ha d 
i ncrease d le vels of I L- 1 5 ( P = 0. 0 4 a n d P = 0. 0 0 6, res pecti vel y) a n d I L- 6 ( P = 0. 0 0 1 a n d 
P = 0. 0 0 0 3, res pecti vel y).


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 2 2
1 4 A pril 2 0 2 3
T a ble 1.
B aseli ne C h ar acteristics a n d Res ults fr o m Z U M A- 1 Pri m ar y A n al ysis
C o h ort 1
D L B C L
( N = 7 7)
C o h ort 2
P M B C L/ T F L
( N = 2 4)
T ot al
( N = 1 0 1)
Baseli ne C haracteristics
 
 
 
Me dia n A ge (ra n ge), years
5 8 ( 2 5- 7 6)
5 7 ( 2 3- 7 6)
5 8 ( 2 3- 7 6)
A ge ≥ 6 5 years, n ( %)
1 7 ( 2 2)
7 ( 2 9)
2 4 ( 2 4)
Male, n ( %)
5 0 ( 6 5)
1 8 ( 7 5)
6 8 ( 6 7)
E C O G perf or ma nce stat us 1, n ( %)
4 9 ( 6 4)
1 0 ( 4 2)
5 9 ( 5 8)
Recei ve d ≥ 3 li nes of pri or t hera p y
4 9 ( 6 4)
2 1 ( 8 8)
7 0 ( 7 0)
Refract or y ≥ 2 li nes of pri or t hera p y
5 9 ( 7 7)
1 9 ( 7 9)
7 8 ( 7 7)
Rela pse p ost A S C T
1 6 ( 2 1)
5 ( 2 1)
2 1 ( 2 1)
Res p o nse
 
 
 
O bjecti ve res p o nse rate, n ( %)
6 3 ( 8 2)
2 0 ( 8 3)
8 3 ( 8 2)
9 5 % CI
P- val ue a
( 7 1, 9 0)
( 6 3, 9 5)
( 7 3, 8 9)
P < 0. 0 0 0 1
Best res p o nse, n ( %)
 
 
 
C R
3 8 ( 4 9)
1 7 ( 7 1)
5 5 ( 5 4)
P R
2 5 ( 3 2)
3 ( 1 3)
2 8 ( 2 8)
Safet y
T otal ( N = 1 0 1)
C o m m o n Gra de 3 or hi g her A Es, n ( %) b
 
Ne utr o pe nia/ ne utr o p hil c o u nt decrease d
6 6 ( 6 6)
Le u k o pe nia/ W B C c o u nt decrease d
4 4 ( 4 4)
A ne mia
4 3 ( 4 3)
Fe brile ne utr o pe nia
3 1 ( 3 1)
T hr o m b oc yt o pe nia
2 4 ( 2 4)
E nce p hal o pat h y
2 1 ( 2 1)
Gra de 3 or hi g her A Es of cli nical i nterest, n ( %)
 
C yt o ki ne release s y n dr o me c
1 3 ( 1 3)
Ne ur ol o gical e ve nts c
2 8 ( 2 8)
A b bre viati o ns:  D L B C L, diff use lar ge B-cell l y m p h o ma; P M B C L, pri mar y me diasti nal B-cell l y m p h o ma; T F L, tra nsf or me d 
f ollic ular l y m p h o ma;  E C O G, Easter n C o o perati ve O nc ol o g y Gr o u p; A S C T, a ut ol o g o us ste m cell tra ns pla nt; CI, c o nfi de nce 
i nter val; C R, c o m plete res p o nse; P R, partial res p o nse; A E, a d verse e ve nt; W B C, w hite bl o o d c o u nt.
N otes:  All A Es are treat me nt e mer ge nt.
a 
E xact bi n o mial test c o m pari n g o bser ve d O R R i n D L B C L t o a hist orical c o ntr ol ass u m pti o n of 2 0 %.
b  
Occ urri n g i n > 2 0 % of patie nts.
c
 C o m bi ne d ter ms.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 2 3
1 4 A pril 2 0 2 3
2. 5. 2.  
C A R T-cell Rece pt or I m m u n ot her a p y f or P atie nts wit h B-cell L y m p h o m a 
( Pr ot oc ol 0 9- C- 0 0 8 2, N C T 0 0 9 2 4 3 2 6)
T he N CI cli nical st u d y ( Pr ot oc ol 0 9- C- 0 0 8 2) of a nti- C D 1 9 C A R T-cell t hera p y has de m o nstrate d 
d ura ble o bjecti ve res p o nses i n patie nts wit h a d va nce d B-cell mali g na ncies, i ncl u di n g N H L. T his 
st u d y e nr olle d a d ults a ge 1 8 t o 6 8 wit h B-cell l y m p h o mas or le u ke mias e x pressi n g C D 1 9 as 
c o h orts t o deter mi ne t he safet y a n d feasi bilit y of t he a d mi nistrati o n of a nti- C D 1 9- C A R 
e n gi neere d peri p heral bl o o d l y m p h oc ytes wit h a n o n m yel oa blati ve c o n diti o ni n g re gi me n. T he 
C A R c o nstr uct is i de ntical t o t he o ne use d i n Z U M A- 1.  I n t he N CI c o h ort of 4 3 s u bjects wit h 
rela pse d/refract or y B-cell mali g na ncies, t he O R R was 7 4 %, wit h a C R rate of 5 4 % a n d a partial 
res p o nse ( P R) rate of 2 1 % (as of 1 0 N o v 2 0 1 6, data o n file at Kite P har ma).  T we nt y- o ne of t he 
4 3 s u bjects ( 4 9 %) were still i n res p o nse, wit h a me dia n f oll o w- u p of 3 6 m o nt hs (ra n ge 1 3 t o 
7 8 m o nt hs). Me dia n D O R was 3 5 m o nt hs (ra n ge 2 3 t o 7 7 m o nt hs).  Ni netee n s u bjects ( 4 4 %) ha d 
o n g oi n g res p o nses f or m ore t ha n 1 year.  Me dia n P F S a n d O S ha ve n ot bee n reac he d.
I n t he m ost rece nt re p ort f oc usi n g o n 2 2 s u bjects treate d wit h l o w d ose c o n diti o ni n g 
c he m ot hera p y, 1 9 ha d D L B C L, 2 ha d f ollic ular l y m p h o ma ( F L), a n d o ne ha d M C L 
{ K oc he n derfer 2 0 1 7 }.  T he C R rate was 5 5 % a n d P R rate was 1 8 %.  I n partic ular, a m o n g a 
s u bset of 1 9 s u bjects wit h D L B C L, t he O R R was 6 8 % wit h a C R i n 4 7 % a n d a P R i n 2 1 %.  Of 
t he 1 2 s u bjects w h o ac hie ve d C R, 1 1 re mai n i n C R, wit h a me dia n d urati o n of 1 2. 5 m o nt hs a n d 
l o n gest of 2 4 m o nt hs o n g oi n g at t he ti me of a nal ysis.  P F S was 6 3. 6 % at 1 2 m o nt hs.  Re missi o ns 
were ass ociate d wit h hi g h ser u m I L- 1 5 le vels a n d hi g h pea k bl o o d C A R T-cell e x pa nsi o n.  
Re versi ble Gra de 3 or 4 ne ur ol o gic t o xicities were o bser ve d i n 5 5 % of s u bjects, wit h n o Gra de 5 
e ve nts.  C o m plete res ol uti o n was o bser ve d wit hi n t he maj orit y of s u bjects wit h s u p p orti ve 
treat me nt; o nl y 1 s u bject recei ve d de xa met has o ne a n d 2 recei ve d t ociliz u ma b.  Ne ur ol o gic 
t o xicit y was ass ociate d wit h hi g h pea k bl o o d C A R T-cell le vels a n d hi g h ser u m gra nz y me B, 
I L- 1 0, a n d I L- 1 5 le vels.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 2 4
1 4 A pril 2 0 2 3
3. 
S T U D Y D E SI G N
3. 1.  
Ge ner al St u d y Desi g n: Z U M A- 7
Z U M A- 7 is a P hase 3 ra n d o mize d, o pe n-la bel, m ultice nter st u d y e val uati n g t he efficac y of 
a xica bta ge ne cil ole ucel vers us S O C i n a d ult s u bjects wit h r/r D L B C L.  A d ult s u bjects wit h r/r 
D L B C L after first-li ne rit u xi ma b a n d a nt hrac ycli ne- base d c he m ot hera p y will be ra n d o mize d i n a 
1: 1 rati o t o recei ve a xica bta ge ne cil ole ucel or S O C.  Ra n d o mizati o n will be stratifie d b y 
res p o nse t o first-li ne t hera p y ( pri mar y refract or y, vs rela pse ≤ 6 m o nt hs of first-li ne t hera p y vs 
rela pse > 6 a n d ≤ 1 2 m o nt hs of first-li ne t hera p y) a n d sec o n d-li ne a ge-a dj uste d I PI ( 0 t o 1 vs 2 t o 
3) as assesse d at t he ti me of scree ni n g.
F or s u bjects ra n d o mize d t o t he c o ntr ol ar m of t he st u d y, S O C will c o nsist of a pr ot oc ol- defi ne d, 
plati n u m- base d sal va ge c o m bi nati o n c he m ot hera p y re gi me n.  S u bjects w h o res p o n d t o 
sec o n d-li ne c he m ot hera p y s h o ul d pr ocee d t o H D T a n d A S C T.
A n i n de pe n de nt Data Safet y M o nit ori n g B oar d ( D S M B) will meet e ver y 6 m o nt hs after t he first 
s u bject is ra n d o mize d t o re vie w safet y data a n d will re vie w safet y a n d efficac y data at t he ti me 
of t he pla n ne d i nteri m f utilit y a nal ysis.  T he D S M B will be c hartere d t o ma ke trial c o n d uct 
rec o m me n dati o ns base d o n a n a nal ysis of ris k vers us be nefit.  T he D S M B ma y meet m ore ofte n 
as nee de d.  Refer t o Secti o n 9. 9  f or f urt her details.
F or st u d y re q uire me nts assi g ne d t o eac h st u d y ar m, please refer t o t he sc he d ule of assess me nts 
( S O As) a n d Secti o n 7  f or details.
A st u d y sc he ma is dra w n o ut a n d descri be d at t he e n d of t he pr ot oc ol s y n o psis secti o n.
3. 2. 
P artici p ati n g Sites
A p pr o xi matel y 8 0 ce nters l ocate d i n N ort h A merica, E ur o pe, a n d Israel will partici pate i n t his 
st u d y.  D uri n g t he c o n d uct of t he st u d y, a d diti o nal sites, re gi o ns, or c o u ntries ma y be a d de d as 
necessar y.
3. 3.  
N u m ber of S u bjects
Partici pa nts i n t his trial will be referre d t o as “s u bjects.”  It is a ntici pate d t hat a p pr o xi matel y 
3 5 0 s u bjects will be ra n d o mize d i nt o t his st u d y.
3. 4.  
Re pl ace me nt of S u bjects
S u bjects will n ot be re place d, a n d all s u bjects ra n d o mize d will be i ncl u de d i n t he i nte nt-t o-treat 
a nal ysis.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 2 5
1 4 A pril 2 0 2 3
3. 5.  
D ur ati o n of St u d y a n d S u bject P artici p ati o n
3. 5. 1. 
St u d y D ur ati o n f or I n di vi d u al S u bjects
T he d urati o n of t he st u d y f or i n di vi d ual s u bjects will var y.  F or a s u bject w h o c o m pletes t he 
e ntire pr ot oc ol fr o m t he date of i nf or me d c o nse nt t hr o u g h t he c o m pleti o n of t he l o n g-ter m 
f oll o w- u p peri o d, t he st u d y will ta ke a p pr o xi matel y 5 years t o c o m plete f or t h ose ra n d o mize d t o 
t he S O C ar m a n d a p pr o xi matel y 1 5 years t o c o m plete f or t h ose ra n d o mize d t o t he a xica bta ge ne 
cil ole ucel ar m. I n di vi d ual st u d y d urati o n ma y var y de pe n di n g o n a s u bject’s scree ni n g 
re q uire me nts, res p o nse t o treat me nt, p ote ntial f or re-treat me nt, s ur vi val a n d ti mi n g of tra nsiti o n 
t o a se parate Kite L o n g-ter m F oll o w- u p ( L T F U) st u d y ( disc usse d i n Secti o n 3. 5. 3  a n d 
Secti o n 7. 1 5 ).
T he nee d f or pr ol o n ge d f oll o w- u p is base d o n t he p ote ntial prese nce of re plicati o n-c o m pete nt 
retr o vir us ( R C R) i n treate d s u bjects a n d t he nee d t o u n dersta n d a n d miti gate t he p ote ntial ris ks of 
dela ye d o nset A Es t hat c o ul d be t he p ote ntial c o nse q ue nce of treat me nt wit h t his e mer gi n g 
tec h n ol o g y.
3. 5. 2. 
E n d- of-st u d y Defi niti o n
T he e n d of st u d y is defi ne d as w he n t he last re mai ni n g s u bject c o m pletes t heir last visit o n t his 
st u d y a n d tra nsiti o ns t o a se parate L T F U st u d y ( Secti o n 3. 5. 3 ), or, w he n t he last re mai ni n g 
s u bject, w hile still a partici pa nt i n t his st u d y, is c o nsi dere d l ost t o f oll o w- u p, wit h dra ws f ull 
c o nse nt, or dies.
3. 5. 3. 
L o n g-ter m F oll o w- u p
After c o m pleti n g at least 6 0 m o nt hs of assess me nts i n t his st u d y, all s u bjects w h o recei ve d at 
least o ne d ose of a xica bta ge ne cil ole ucel as pr ot oc ol t hera p y will be tra nsiti o ne d t o a se parate 
L T F U st u d y after pr o vi di n g i nf or me d c o nse nt, w here t he y will be m o nit ore d f or t he p ossi ble 
occ urre nce of late- o nset tar gete d A Es/seri o us A Es ( S A Es) i ncl u di n g sec o n dar y mali g na ncies, 
a n d t he prese nce of R C R s us pecte d t o be relate d t o  a xica bta ge ne cil ole ucel  f or u p t o 1 5 years 
(refer als o t o Secti o n 7. 1 5 ). I n t he L T F U st u d y, s u bjects will c o nti n ue assess me nts at ti me p oi nts 
c o nti g u o us wit h t heir ti me p oi nt i n t his st u d y.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 2 6
1 4 A pril 2 0 2 3
4. 
S U B J E C T S C R E E NI N G A N D E N R O L L M E N T
All s u bjects m ust si g n a n d date t he I nstit uti o nal Re vie w B oar d/I n de pe n de nt Et hics C o m mittee 
(I R B/I E C) a p pr o ve d c o nse nt f or m bef ore i nitiati n g a n y st u d y-s pecific pr oce d ures or acti vities 
t hat are n ot part of a s u bject’s r o uti ne care.  Refer t o Secti o n 7  f or details.
Kite P har ma will assi g n a u ni q ue 9- di git scree ni n g s u bject i de ntificati o n (I D)  n u m ber bef ore a n y 
st u d y pr oce d ures are perf or me d f or all s u bjects w h o e nter i nt o t he scree ni n g peri o d f or t he st u d y 
(e ntr y is defi ne d as t he p oi nt at w hic h t he s u bject si g ns t he i nf or me d c o nse nt) as descri be d i n t he 
I n vesti gati o nal Pr o d uct Ma n ual (I P M).  T his scree ni n g s u bject i de ntificati o n n u m ber will be use d 
t o i de ntif y t he s u bject t hr o u g h o ut t he st u d y a n d m ust be use d o n all st u d y d oc u me ntati o n relate d 
t o t he s u bject.  F urt her m ore, t he scree ni n g s u bject i de ntificati o n n u m ber will re mai n c o nsta nt 
t hr o u g h o ut t he e ntire cli nical st u d y; it will n ot be c ha n ge d after e nr oll me nt or if t he s u bject is 
rescree ne d or retreate d.
F oll o wi n g all scree ni n g acti vities, t he s u bject will be re gistere d i n t he I nteracti ve V oice/ We b 
Res p o nse S yste m (I X R S) f or ra n d o mizati o n u p o n t he i n vesti gat or c o nfir mi n g eli gi bilit y of t he 
s u bject.  F or f urt her details o n t he c o nse nt, scree ni n g, a n d e nr oll me nt pr ocess, refer t o Secti o n 7 , 
t he I P M, a n d t he I X R S ma n ual.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 2 7
1 4 A pril 2 0 2 3
5. 
S U B J E C T E LI GI BI LI T Y
5. 1. 
I ncl usi o n Criteri a
1 0 1)
Hist ol o gicall y pr o ve n lar ge B-cell l y m p h o ma i ncl u di n g t he f oll o wi n g t y pes defi ne d b y 
W H O 2 0 1 6 { S wer dl o w 2 0 1 6 }:

D L B C L n ot ot her wise s pecifie d (i ncl u di n g A B C/ G C B)

H G B L wit h or wit h o ut M Y C a n d B C L 2 a n d/ or B C L 6 rearra n ge me nt

D L B C L arisi n g fr o m F L

T-cell/ histi oc yte ric h lar ge B-cell l y m p h o ma

D L B C L ass ociate d wit h c hr o nic i nfla m mati o n

Pri mar y c uta ne o us D L B C L, le g t y pe

E pstei n- Barr vir us ( E B V) + D L B C L
1 0 2)
Rela pse d or refract or y disease after first-li ne c he m oi m m u n ot hera p y

Refract or y disease defi ne d as n o c o m plete re missi o n t o first-li ne t hera p y; s u bjects w h o 
are i nt olera nt t o first-li ne t hera p y are e xcl u de d
■
Pr o gressi ve disease ( P D) as best res p o nse t o first-li ne t hera p y
■
Sta ble disease ( S D) as best res p o nse after at least 4 c ycles of first-li ne t hera p y (e g, 
4 c ycles of R- C H O P)
■
P R as best res p o nse after at least 6 c ycles a n d bi o ps y- pr o ve n resi d ual disease or 
disease pr o gressi o n ≤ 1 2 m o nt hs of t hera p y

Rela pse d disease defi ne d as c o m plete re missi o n t o first-li ne t hera p y f oll o we d b y bi o ps y-
pr o ve n disease rela pse ≤ 1 2 m o nt hs of first-li ne t hera p y
1 0 3)
S u bjects m ust ha ve recei ve d a de q uate first-li ne t hera p y i ncl u di n g at a mi ni m u m:

A nti- C D 2 0 m o n ocl o nal a nti b o d y u nless i n vesti gat or deter mi nes t hat t u m or is C D 2 0 
ne gati ve, a n d

A n a nt hrac ycli ne c o ntai ni n g c he m ot hera p y re gi me n
1 0 4)
I nte nt t o pr ocee d t o H D T a n d A S C T if res p o nse t o sec o n d-li ne t hera p y
1 0 5)
S u bjects m ust ha ve ra di o gra p hicall y d oc u me nte d disease


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 2 8
1 4 A pril 2 0 2 3
1 0 6)
N o k n o w n hist or y or s us pici o n of ce ntral ner v o us s yste m ( C N S) i n v ol ve me nt b y 
l y m p h o ma
1 0 7)
At least 2 wee ks or 5 half-li ves, w hic he ver is s h orter, m ust ha ve ela pse d si nce a n y pri or 
s yste mic ca ncer t hera p y at t he ti me t he s u bject pr o vi des c o nse nt
1 0 8)
A ge 1 8 years or ol der at t he ti me of i nf or me d c o nse nt
1 0 9)
E C O G perf or ma nce stat us of 0 or 1
1 1 0)
A de q uate b o ne marr o w, re nal, he patic, p ul m o nar y a n d car diac f u ncti o n defi ne d as:

A bs ol ute ne utr o p hil c o u nt ( A N C) ≥1 0 0 0/ µ L

Platelet c o u nt ≥ 7 5, 0 0 0/ µ L

A bs ol ute l y m p h oc yte c o u nt ≥ 1 0 0/ µ L

Creati ni ne cleara nce (as esti mate d b y C oc kcr oft Ga ult) ≥ 6 0 m L/ mi n

Ser u m ala ni ne a mi n otra nsferase/as partate a mi n otra nsferase ( A L T/ A S T) ≤ 2. 5 u p per li mit 
of n or mal ( U L N)

T otal bilir u bi n ≤ 1. 5 m g/ dl, e xce pt i n s u bjects wit h Gil bert’s s y n dr o me

Car diac ejecti o n fracti o n ≥ 5 0 %, n o e vi de nce of pericar dial eff usi o n as deter mi ne d b y a n 
ec h ocar di o gra m ( E C H O), a n d n o cli nicall y si g nifica nt electr ocar di o gra m ( E C G) fi n di n gs

N o cli nicall y si g nifica nt ple ural eff usi o n

Baseli ne o x y ge n sat urati o n > 9 2 % o n r o o m air
1 1 1)
Fe males of c hil d beari n g p ote ntial m ust ha ve a ne gati ve ser u m or uri ne pre g na nc y test 
(fe males w h o ha ve u n der g o ne s ur gical sterilizati o n or w h o ha ve bee n p ost me n o pa usal f or 
at least 2 years are n ot c o nsi dere d t o be of c hil d beari n g p ote ntial)
5. 2. 
E xcl usi o n Criteri a
2 0 1)
Hist or y of mali g na nc y ot her t ha n n o n mela n o ma s ki n ca ncer or carci n o ma i n sit u (e g, 
cer vi x, bla d der, breast) u nless disease free f or at least 3 years
2 0 2)
Hist or y of Ric hter’s tra nsf or mati o n of C L L or P M B C L
2 0 3)
Hist or y of a ut ol o g o us or all o ge neic ste m cell tra ns pla nt
2 0 4)
Recei ve d m ore t ha n o ne li ne of t hera p y f or D L B C L
2 0 5)
Pri or C D 1 9 tar gete d t hera p y


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 2 9
1 4 A pril 2 0 2 3
2 0 6)
Treat me nt wit h s yste mic i m m u n osti m ulat or y a ge nts (i ncl u di n g, b ut n ot li mite d t o, 
i nterfer o n a n d I L- 2) wit hi n 6 wee ks or 5 half-li ves of t he dr u g, w hic he ver is s h orter, pri or 
t o t he first d ose of a xica bta ge ne cil ole ucel or S O C
2 0 7)
Pri or c hi meric a nti ge n rece pt or t hera p y or ot her ge neticall y m o difie d T-cell t hera p y or 
pri or ra n d o mizati o n i nt o Z U M A- 7
2 0 8)
Hist or y of se vere, i m me diate h y perse nsiti vit y reacti o n attri b ute d t o a mi n o gl yc osi des
2 0 9)
Prese nce of f u n gal, bacterial, viral, or ot her i nfecti o n t hat is u nc o ntr olle d or re q uiri n g 
i ntra ve n o us (I V) a nti micr o bials f or ma na ge me nt.  Si m ple uri nar y tract i nfecti o n ( U TI) 
a n d u nc o m plicate d bacterial p har y n gitis are per mitte d if res p o n di n g t o acti ve treat me nt.
2 1 0)
K n o w n hist or y of i nfecti o n wit h h u ma n i m m u n o deficie nc y vir us ( HI V) or he patitis B 
( H Bs A g p ositi ve) or he patitis C vir us (a nti- H C V p ositi ve).  If t here is a p ositi ve hist or y 
of treate d he patitis B or he patitis C, t he viral l oa d m ust be u n detecta ble per q ua ntitati ve 
p ol y merase c hai n reacti o n ( P C R) a n d/ or n ucleic aci d testi n g.
2 1 1)
Acti ve t u berc ul osis
2 1 2)
Prese nce of a n y i n d welli n g li ne or drai n (e g, perc uta ne o us ne p hr ost o m y t u be, i n d welli n g 
F ole y cat heter, biliar y drai n, or ple ural/ perit o neal/ pericar dial cat heter). De dicate d ce ntral 
ve n o us access cat heters, s uc h as a P ort-a- Cat h or Hic k ma n cat heter, are per mitte d.
2 1 3)
S u bjects wit h detecta ble cere br os pi nal fl ui d mali g na nt cells or k n o w n brai n metastases or 
wit h a hist or y of cere br os pi nal fl ui d mali g na nt cells or brai n metastases
2 1 4)
Hist or y or prese nce of n o n- mali g na nt C N S dis or der, s uc h as seiz ure dis or der, 
cere br o vasc ular isc he mia/ he m orr ha ge, de me ntia, cere bellar disease, or a n y a ut oi m m u ne 
disease wit h C N S i n v ol ve me nt
2 1 5)
S u bjects wit h car diac atrial or car diac ve ntric ular l y m p h o ma i n v ol ve me nt
2 1 6)
Hist or y of m y ocar dial i nfarcti o n, car diac a n gi o plast y or ste nti n g, u nsta ble a n gi na, Ne w 
Y or k Heart Ass ociati o n Class II or greater c o n gesti ve heart fail ure, or ot her cli nicall y 
si g nifica nt car diac disease wit hi n 1 2 m o nt hs of e nr oll me nt
2 1 7)
Re q uire me nt f or ur ge nt t hera p y d ue t o t u m or mass effects, s uc h as b o wel o bstr ucti o n or 
bl o o d vessel c o m pressi o n
2 1 8)
Hist or y of a ut oi m m u ne disease re q uiri n g s yste mic i m m u n os u p pressi o n a n d/ or s yste mic 
disease m o dif yi n g a ge nts wit hi n t he last 2 years
2 1 9)
Hist or y of i di o pat hic p ul m o nar y fi br osis, or ga nizi n g p ne u m o nia (e g, br o nc hi olitis 
o blitera ns), dr u g-i n d uce d p ne u m o nitis, i di o pat hic p ne u m o nitis, or e vi de nce of acti ve 
p ne u m o nitis per c hest c o m p ute d t o m o gra p h y ( C T) sca n at scree ni n g.  Hist or y of ra diati o n 
p ne u m o nitis i n t he ra diati o n fiel d (fi br osis) is all o we d.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 3 0
1 4 A pril 2 0 2 3
2 2 0)
Hist or y of s y m pt o matic dee p vei n t hr o m b osis or p ul m o nar y e m b olis m wit hi n 6 m o nt hs of 
e nr oll me nt
2 2 1)
A n y me dical c o n diti o n li kel y t o i nterfere wit h assess me nt of safet y or efficac y of st u d y 
treat me nt
2 2 2)
Hist or y of se vere i m me diate h y perse nsiti vit y reacti o n t o t ociliz u ma b or a n y of t he a ge nts 
use d i n t his st u d y (f or sites i n S witzerla n d, refer t o t he a d diti o nal c o u ntr y-s pecific 
e xcl usi o n criteri o n i n A p pe n di x D )
2 2 3)
Treat me nt wit h a li ve, atte n uate d vacci ne wit hi n 6 wee ks pri or t o i nitiati o n of st u d y 
treat me nt or a ntici pati o n of nee d f or s uc h a vacci ne d uri n g t he c o urse of t he st u d y
2 2 4)
W o me n of c hil d beari n g p ote ntial w h o are pre g na nt or breastfee di n g beca use of t he 
p ote ntiall y da n ger o us effects of c he m ot hera p y o n t he fet us or i nfa nt.  S u bjects of eit her 
se x w h o are n ot willi n g t o practice birt h c o ntr ol fr o m t he ti me of c o nse nt a n d at least 
6 m o nt hs after t he last d ose of a xica bta ge ne cil ole ucel or S O C c he m ot hera p y
2 2 5)
I n t he i n vesti gat or’s j u d g me nt, t he s u bject is u nli kel y t o c o m plete all pr ot oc ol-re q uire d 
st u d y visits or pr oce d ures, i ncl u di n g f oll o w- u p visits, or c o m pl y wit h t he st u d y 
re q uire me nts f or partici pati o n


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 3 1
1 4 A pril 2 0 2 3
6. 
P R O T O C O L T R E A T M E N T
6. 1. 
Tre at me nt Ter mi n ol o g y
F or s u bjects ra n d o mize d t o t he a xica bta ge ne cil ole ucel ar m of t he st u d y:
•
Bri d gi n g t hera p y refers t o c ortic oster oi ds a d mi nistere d after le u ka p heresis t hr o u g h 5 da ys 
pri or t o a d mi nistrati o n of a xica bta ge ne cil ole ucel.
•
C o n diti o ni n g c he m ot hera p y refers t o fl u dara bi ne a n d c ycl o p h os p ha mi de use d f or 
l y m p h o de pleti o n pri or t o a d mi nistrati o n of a xica bta ge ne cil ole ucel.
•
T he i n vesti gati o nal pr o d uct is na me d a xica bta ge ne cil ole ucel.
F or s u bjects ra n d o mize d t o t he S O C ar m of t he st u d y:
•
T he sec o n d-li ne c o m bi nati o n c he m ot hera p y re gi me n refers t o t he rit u xi ma b a n d plati n u m-
base d c he m ot hera p y re gi me n.
•
T he sec o n d-li ne c o m bi nati o n c he m ot hera p y re gi me n will be selecte d b y t he treati n g 
i n vesti gat or.  T he all o we d re gi me ns are R-I C E, R- D H A P, R- E S H A P, or R- G D P.
•
Res p o nse t o sec o n d-li ne c o m bi nati o n c he m ot hera p y refers t o a P R or C R after 2 or 3 c ycles.
•
Ste m cell c ollecti o n refers t o C D 3 4 + he mat o p oietic ste m cells c ollecte d b y le u ka p heresis 
fr o m t he peri p heral bl o o d after G- C S F sti m ulati o n.
H D T refers t o t he m yel oa blati ve re gi me n a d mi nistere d pri or t o a ut ol o g o us ste m cell i nf usi o n.  
T he H D T re gi me n will be selecte d b y t he treati n g i n vesti gat or.
F or s u bjects ra n d o mize d t o eit her t he a xica bta ge ne cil ole ucel or t he S O C ar m of t he st u d y:
•
Le u ka p heresis refers t o:

T he pr oce d ure f or c ollecti o n of peri p heral bl o o d m o n o n uclear cells use d t o ma n ufact ure 
t he s u bject-s pecific a xica bta ge ne cil ole ucel treat me nt (a xica bta ge ne cil ole ucel ar m) or

T he pr oce d ure f or peri p heral C D 3 4 + he mat o p oietic ste m cell c ollecti o n ( S O C ar m).  
Cells c ollecte d wit h t he i nte nt of A S C T will f oll o w i nstit uti o nal g ui deli nes a n d will n ot 
be s hi p pe d t o Kite P har ma.
•
C o nc o mita nt me dicati o n refers t o treat me nt t hat s u bjects ca n recei ve d uri n g t he c o n d uct of 
t he st u d y.
•
E xcl u de d me dicati o ns refer t o treat me nt t hat is n ot t o be a d mi nistere d, u nless ot her wise 
s pecifie d, d uri n g t he c o n d uct of t he st u d y.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 3 2
1 4 A pril 2 0 2 3
S u bse q ue nt ne w l y m p h o ma t hera p y refers t o treat me nt a d mi nistere d after a xica bta ge ne cil ole ucel 
or S O C necessar y t o treat a s u bject’s disease.
6. 2.  
A xic a bt a ge ne Cil ole ucel St u d y Tre at me nt Ar m
6. 2. 1. 
Le u k a p heresis
S u bjects will u n der g o le u ka p heresis t o o btai n T cells f or t he ma n ufact uri n g of a xica bta ge ne 
cil ole ucel.  Le u ka p herese d cells o btai ne d at partici pati n g ce nters will be s hi p pe d t o t he Kite 
ma n ufact uri n g facilit y as descri be d i n t he I P M.
6. 2. 2.  
C o n diti o ni n g C he m ot her a p y
C o n diti o ni n g c he m ot hera p y f or l y m p h o de pleti o n will be s u p plie d b y t he i n vesti gati ve site u nless 
ot her wise n ote d.  Treat me nt s h o ul d be a d mi nistere d per i nstit uti o nal g ui deli nes.  Refer t o t he 
c urre nt pr o d uct la bel f or g ui da nce o n pac ka gi n g, st ora ge, pre parati o n, a d mi nistrati o n, a n d 
t o xicit y ma na ge me nt ass ociate d wit h t he a d mi nistrati o n of c he m ot hera p y a ge nts.
6. 2. 2. 1. 
Fl u d ar a bi ne
Fl u dara bi ne p h os p hate is a s y nt hetic p uri ne n ucle osi de t hat differs fr o m p h ysi ol o gic n ucle osi des 
i n t hat t he s u gar m oiet y is ara bi n ose i nstea d of ri b ose or de o x yri b ose.  Fl u dara bi ne is a p uri ne 
a nta g o nist a nti meta b olite.
6. 2. 2. 2.  
C ycl o p h os p h a mi de
C ycl o p h os p ha mi de is a nitr o ge n m ustar d- deri vati ve al k ylati n g a ge nt.  F oll o wi n g c o n versi o n t o 
acti ve meta b olites i n t he li ver, c ycl o p h os p ha mi de f u ncti o ns as a n al k ylati n g a ge nt; t he dr u g als o 
p ossesses p ote nt i m m u n os u p pressi ve acti vit y.  T he ser u m half-life after I V a d mi nistrati o n ra n ges 
fr o m 3 t o 1 2 h o urs; t he dr u g a n d/ or its meta b olites ca n be detecte d i n t he ser u m f or u p t o 
7 2 h o urs after a d mi nistrati o n.
6. 2. 2. 3.  
Mes n a
Mes na is a det o xif yi n g a ge nt use d t o pre ve nt t he he m orr ha gic c ystitis i n d uce d b y c he m ot hera p y.  
T he acti ve i n gre die nt  i n mes na is a s y nt hetic s ulf h y dr yl c o m p o u n d desi g nate d as 
s o di u m- 2- merca pt oet ha ne s ulf o nate wit h a m olec ular f or m ula of C 2H 5Na O 3S 2.
6. 2. 2. 4.  
R ati o n ale f or C o n diti o ni n g C he m ot her a p y
I ncreasi n g le vels of c o n diti o ni n g c he m ot hera p y c orrelates wit h cli nical res p o nses t o a d o pti ve cell 
t hera p y {D u dle y 2 0 0 8 }.  S pecificall y, t here a p pears t o be a li n k bet wee n a de q uate 
l y m p h o de pleti o n a n d a d o pti vel y tra nsferre d T-cell e x pa nsi o n a n d f u ncti o n i n pre-cli nical m o dels.  
T he de pt h a n d d urati o n of t he l y m p h o de pleti o n i n precli nical m o dels c orrelate wit h a nti-t u m or 
acti vit y of t he a d o pti vel y tra nsferre d t u m or-s pecific C D 8 + T cells { Gatti n o ni 2 0 0 5 }.  
L y m p h o de pleti o n ma y f u ncti o n b y era dicati n g c yt o ki ne si n ks f or t he tra nsferre d cells, 
eli mi nati n g T re g ulat or y cells, or e n ha nci n g a nti ge n prese nti n g cell acti vati o n { Kle ba n off 2 0 0 5 }.  
C ycl o p h os p ha mi de a n d fl u dara bi ne c o m bi nati o n is a p ote nt l y m p h o de pleti n g re gi me n.  
C ycl o p h os p ha mi de ( 5 0 0 m g/ m 2/ da y) a n d fl u dara bi ne ( 3 0 m g/ m2/ da y) b ot h gi ve n f or 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 3 3
1 4 A pril 2 0 2 3
3 c o nsec uti ve da ys has bee n st u die d a n d t olerate d i n s u bjects wit h B-cell mali g na ncies { O' Brie n 
2 0 0 1 } a n d was use d i n t he Z U M A- 1 trial { L oc ke 2 0 1 7 }.
6. 2. 3.  
A xic a bt a ge ne Cil ole ucel
6. 2. 3. 1. 
I n vesti g ati o n al Pr o d uct Descri pti o n
A xica bta ge ne cil ole ucel is s u p plie d cr y o preser ve d i n cr y ost ora ge ba gs.  T he pr o d uct i n t he ba g is 
clear t o o pa q ue i n clarit y a n d w hite t o re d i n c ol or wit h n o visi ble f orei g n particles. T he 
cr y ost ora ge ba g c o ntai ni n g a xica bta ge ne cil ole ucel arri ves fr oze n i n a li q ui d nitr o ge n dr y 
s hi p per.  T he ba g m ust be st ore d i n va p or p hase of li q ui d nitr o ge n, a n d t he pr o d uct m ust re mai n 
fr oze n u ntil t he s u bject is rea d y f or treat me nt t o ass ure via ble li ve a ut ol o g o us cells are 
a d mi nistere d.  Se veral i nacti ve i n gre die nts are a d de d t o t he pr o d uct t o ass ure via bilit y a n d 
sta bilit y of t he li ve cells t hr o u g h t he freezi n g, t ha wi n g, a n d i nf usi o n pr ocess.
A xica bta ge ne cil ole ucel is a s u bject-s pecific pr o d uct, a n d t he i nte n de d s u bject will be i de ntifie d 
b y a u ni q ue s u bject I D n u m ber.  U p o n recei pt, verificati o n t hat t he pr o d uct a n d s u bject-s pecific 
la bels matc h t he s u bject’s i nf or mati o n (e g, s u bject I D n u m ber) is esse ntial.  D o n ot i nf use t he 
pr o d uct if t he i nf or mati o n o n t he s u bject-s pecific la bel d oes n ot matc h t he i nte n de d s u bject.  T he 
v ol u me of a xica bta ge ne cil ole ucel i nf use d, t he t ha w start/st o p ti me, a n d a xica bta ge ne cil ole ucel 
a d mi nistrati o n start/st o p ti me will all be n ote d i n t he s u bject me dical rec or d.  A xica bta ge ne 
cil ole ucel m ust n ot be t ha we d u ntil t he s u bject is rea d y f or t he i nf usi o n. Refer t o t he I P M f or 
details a n d i nstr ucti o n o n st ora ge, t ha wi n g, a n d a d mi nistrati o n of a xica bta ge ne cil ole ucel.
T here ha ve bee n n o i nsta nces of acci de ntal o ver d ose of s u bjects i n t his pr o gra m t o date.  I n case 
of acci de ntal o ver d ose, treat me nt s h o ul d be s u p p orti ve.  C ortic oster oi d t hera p y ma y be 
c o nsi dere d if a n y d ose is ass ociate d wit h se vere t o xicit y.
If a n y pr o ble ms relate d t o t he use of a xica bta ge ne cil ole ucel or a n y pr o d ucts t hat s u p p ort t he 
ma na ge me nt of a xica bta ge ne cil ole ucel (e g, cr y ost ora ge ba gs, s u bject i de ntificati o n la bels) are 
i de ntifie d, researc h staff s h o ul d re p ort t he pr o ble m per t he i nstr ucti o ns i n t he I P M.
6. 2. 3. 2.  
R ati o n ale f or A xic a bt a ge ne Cil ole ucel D ose
T he rati o nale f or t he a xica bta ge ne cil ole ucel d ose i n t his st u d y is base d o n t he a g gre gate safet y 
a n d efficac y data c o m pile d fr o m t he Z U M A- 1 st u d y as o utli ne d i n Secti o n 2. 5. 1. 2  a n d t he I B.  
Base d o n t he fa v ora ble be nefit/ris k rati o see n i n Z U M A- 1, a xica bta ge ne cil ole ucel will be 
a d mi nistere d at a tar get d ose of 2 x 1 0 6 a nti- C D 1 9 C A R T cells/ k g, b ut ma y be d ose d at a 
mi ni m u m of 1 x 1 0 6 a nti- C D 1 9 C A R T cells/ k g.  F or s u bjects wei g hi n g > 1 0 0 k g, a ma xi m u m 
flat d ose of a xica bta ge ne cil ole ucel at 2 x 1 08 a nti- C D 1 9 C A R T cells will be a d mi nistere d.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 3 4
1 4 A pril 2 0 2 3
6. 2. 4.  
Cell C ollecti o n a n d A xic a bt a ge ne Cil ole ucel St u d y Tre at me nt Sc he d ule a n d 
A d mi nistr ati o n
6. 2. 4. 1. 
Le u k a p heresis ( Wit hi n A p pr o xi m atel y 5 D a ys of R a n d o miz ati o n)
If a n y scree ni n g assess me nts or pr oce d ures are re peate d bet wee n c o nfir mati o n of eli gi bilit y a n d 
t he start of le u ka p heresis a n d res ults are o utsi de t he eli gi bilit y criteria liste d i n Secti o n 5 , c o ntact 
t he s p o ns or’s me dical m o nit or pri or t o pr ocee di n g wit h le u ka p heresis.
Bef ore le u ka p heresis c o m me nces, t he bel o w criteria m ust be met:
•
N o e vi de nce or s us pici o n of a n i nfecti o n
•
C ortic oster oi d t hera p y at a p har mac ol o gic d ose ( ≥ 5 m g/ da y of pre d nis o ne or e q ui vale nt 
d oses of ot her c ortic oster oi ds) a n d ot her i m m u n os u p pressi ve dr u gs m ust be a v oi de d f or 
7 da ys pri or t o le u ka p heresis.
If criteria are n ot met, le u ka p heresis m ust be dela ye d u ntil t he e ve nt res ol ves.  If le u ka p heresis is 
dela ye d m ore t ha n 5 da ys after ra n d o mizati o n, baseli ne c o m plete bl o o d c o u nt ( C B C) wit h 
differe ntial a n d c he mistr y pa nel m ust be re peate d.  If res ults are o utsi de t he eli gi bilit y criteria 
liste d i n Secti o n 5 , c o ntact t he me dical m o nit or pri or t o pr ocee di n g wit h le u ka p heresis.
T he le u ka p heresis visit s h o ul d occ ur wit hi n a p pr o xi matel y 5 da ys of ra n d o mizati o n.
After t he a b o ve criteria are met, m o n o n uclear cells will be o btai ne d b y le u ka p heresis ( 1 2 t o 
1 5 liter a p heresis wit h a g oal t o tar get a p pr o xi matel y 5 t o 1 0 x 1 0 9 m o n o n uclear cells).  T he 
le u ka p herese d cells are t he n pac ka ge d f or e x pe dite d s hi p me nt t o t he ma n ufact uri n g facilit y as 
descri be d i n t he I P M.
Refer t o t he S O A Ta ble 2  f or a listi n g of st u d y pr oce d ures t o be c o m plete d d uri n g t he 
le u ka p heresis visit.
6. 2. 4. 2. 
Bri d gi n g T her a p y ( a d mi nistere d after le u k a p heresis a n d c o m plete d at le ast 
5 d a ys pri or t o i niti ati n g a xic a bt a ge ne cil ole ucel)
At t he discreti o n of t he i n vesti gat or, bri d gi n g t hera p y ma y be c o nsi dere d f or s u bjects wit h hi g h 
disease b ur de n at scree ni n g.
Bri d gi n g t hera p y wit h c ortic oster oi ds is all o we d, s uc h as de xa met has o ne at a d ose of 2 0 t o 
4 0 m g or e q ui vale nt, eit her P O or I V dail y f or 1 t o 4 da ys.  C h oice of c ortic oster oi d a n d d osi n g 
ca n be a dj uste d f or a ge/c o m or bi dities or per cli nical j u d ge me nt.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 3 5
1 4 A pril 2 0 2 3
6. 2. 4. 3.  
C o n diti o ni n g C he m ot her a p y ( d a y - 5 t hr o u g h d a y - 3 bef ore i nf usi o n of 
a xic a bt a ge ne cil ole ucel)
A d mi nistrati o n of C A R T cells t o s u bjects wit h o n g oi n g i nfecti o n or i nfla m mati o n, e ve n if s uc h 
pr ocesses are as y m pt o matic, i ncreases t he ris k of hi g h gra de a n d fatal t o xicit y.  All eff orts s h o ul d 
be ma de t o r ule o ut s uc h c o n diti o ns pri or t o cell i nf usi o n.
Si g ns, s y m pt o ms, or a b n or mal la b orat or y res ults attri b ute d t o t he mali g na nc y (e g “t u m or fe ver,” 
ele vate d C-reacti ve pr otei n [ C R P]) are dia g n oses of e xcl usi o n t hat re q uire a d oc u me nte d w or k-
u p t o esta blis h.
C o n diti o ni n g c he m ot hera p y a n d a xica bta ge ne cil ole ucel i nf usi o n s h o ul d be i nitiate d o nl y o nce it 
is reas o na bl y ass ure d t hat cell i nf usi o n ca n safel y pr ocee d.
Refer t o Secti o n 6. 2. 4. 8  f or Re q uire me nts t o W or k- u p P ote ntial I nfecti o us a n d/ or I nfla m mat or y 
States.
6. 2. 4. 3. 1.
Re q uire me nts f or I niti ati o n of C o n diti o ni n g C he m ot her a p y
If a n y of t he f oll o wi n g criteria are met pri or t o t he i nitiati o n of c o n diti o ni n g c he m ot hera p y, t he n 
t he w or k- u p liste d i n Secti o n 6. 2. 4. 8  m ust be perf or me d t o deter mi ne t he p ote ntial ca use if t here 
is n o i de ntifie d s o urce of i nfecti o n.
•
Te m perat ure > 3 8° C wit hi n 7 2 h o urs of c o n diti o ni n g c he m ot hera p y
•
C R P > 1 0 0 m g/ L a n yti me bet wee n e nr oll me nt t o start of c o n diti o ni n g c he m ot hera p y
•
W hite bl o o d cell ( W B C) c o u nt or W B C differe ntial c o ncer ni n g f or i nfecti o us pr ocess 
bet wee n e nr oll me nt t o start of c o n diti o ni n g c he m ot hera p y (e g, W B C > 2 0, 0 0 0, ra pi dl y 
i ncreasi n g W B C, or differe ntial wit h hi g h perce nta ge of se gs/ ba n ds)
A d diti o nall y:
•
If a n y scree ni n g assess me nts or pr oce d ures are re peate d bet wee n c o nfir mati o n of eli gi bilit y 
a n d t he start of c o n diti o ni n g c he m ot hera p y a n d res ults are o utsi de t he eli gi bilit y criteria liste d 
i n Secti o n 5 , t he n t he c o n diti o n m ust res ol ve pri or t o pr ocee di n g wit h c o n diti o ni n g 
c he m ot hera p y.
•
C o m plete hist or y a n d p h ysical e xa m, i ncl u di n g hea d, ears, e yes, n ose, t hr oat ( H E E N T); 
car diac, vasc ular, res pirat or y, gastr oi ntesti nal, i nte g u me ntar y, a n d ne ur ol o gical s yste ms m ust 
n ot re veal e vi de nce of i nfecti o n/i nfla m mati o n.
•
T he s u bject m ust n ot ha ve recei ve d s yste mic a nti- micr o bials f or t he treat me nt of a k n o w n or 
s us pecte d i nfecti o n wit hi n 4 8 h o urs bef ore c o n diti o ni n g c he m ot hera p y ( pr o p h ylactic use of 
a nti- micr o bials is all o we d).


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 3 6
1 4 A pril 2 0 2 3
•
Treat me nt c o urse of a n y a nti micr o bials gi ve n f or k n o w n or s us pecte d a ntece de nt i nfecti o n 
s h o ul d be c o m plete as per i nfecti o us disease c o ns ult (if a p plica ble) rec o m me n dati o n bef ore 
st o p pi n g or s witc hi n g t o pr o p h ylactic a nti micr o bials.
•
If a s u bject is c o nfir me d t o ha ve a n i nfecti o us pr ocess f or w hic h a nti micr o bials are n ot 
a vaila ble (e g, viral p ne u m o nia), t he i nfecti o n m ust be cli nicall y res ol ve d as deter mi ne d b y 
t he i n vesti gat or i n c o ns ultati o n wit h i nfecti o us disease ser vice (if a p plica ble).
•
M ost rece ntl y c ollecte d bl o o d, uri ne, or ot her b o d y fl ui d c ult ures m ust s h o w n o gr o wt h f or at 
least 4 8 h o urs, a n d a n y ot her i nfecti o us w or k- u p perf or me d (e g, bacterial, viral ser ol o gies, 
P C R, st o ol st u dies, i ma gi n g st u dies) m ust be ne gati ve.  If cli nical s us pici o n is f or a n i nfecti o n 
f or w hic h c ult ures are u nli kel y t o be p ositi ve wit hi n 4 8 h o urs (e g, f u n gal i nfecti o n), a de q uate 
ti me m ust be all o we d f or c ult ures t o bec o me p ositi ve.
•
O nce t he a b o ve criteria are met, t he n t he s u bject ca n pr ocee d wit h c o n diti o ni n g 
c he m ot hera p y.
6. 2. 4. 3. 2.  
C o n diti o ni n g C he m ot her a p y A d mi nistr ati o n ( d a y - 5 t hr o u g h d a y - 3 Pri or t o 
A xic a bt a ge ne Cil ole ucel I nf usi o n)
S u bjects will recei ve a c o n diti o ni n g c he m ot hera p y re gi me n c o nsisti n g of c ycl o p h os p ha mi de a n d 
fl u dara bi ne.  T he first d ose of c o n diti o ni n g c he m ot hera p y will be desi g nate d as da y - 5. S u bjects 
will i nitiate c o n diti o ni n g c he m ot hera p y wit h c ycl o p h os p ha mi de a n d fl u dara bi ne be gi n ni n g o n 
da y - 5 t hr o u g h da y - 3 wit h 2 rest da ys bef ore recei vi n g a xica bta ge ne cil ole ucel.  T he 3- da y 
c o n diti o ni n g c he m ot hera p y re gi me n will be a d mi nistere d i n a n o ut patie nt setti n g.
T he 3- da y c o n diti o ni n g re gi me n of fl u dara bi ne a n d c ycl o p h os p ha mi de will be a d mi nistere d i n 
acc or da nce wit h t he bel o w dail y d osi n g i nstr ucti o ns.
•
I V h y drati o n wit h a bala nce d cr ystall oi d acc or di n g t o i nstit uti o nal g ui deli nes pri or t o 
a d mi nistrati o n of c ycl o p h os p ha mi de o n t he da y of i nf usi o n
•
C ycl o p h os p ha mi de 5 0 0 m g/ m 2 I V o ver a p pr o xi matel y 6 0 mi n utes
•
Fl u dara bi ne 3 0 m g/ m 2 I V o ver a p pr o xi matel y 3 0 mi n utes
•
A d diti o nal I V h y drati o n wit h a bala nce d cr ystall oi d acc or di n g t o i nstit uti o nal g ui deli nes t o be 
a d mi nistere d u p o n c o m pleti o n of t he c ycl o p h os p ha mi de i nf usi o n
•
Mes na t o be a d mi nistere d per i nstit uti o nal g ui deli nes
S u bjects s h o ul d be i nstr ucte d t o dri n k ple nt y of li q ui ds d uri n g a n d f or 2 4 h o urs f oll o wi n g t he 
c he m ot hera p y (a p pr o xi matel y 2 liters/ 2 4 h o urs).  I n ge neral, s u bjects s h o ul d be ke pt 
well- h y drate d b ut cl osel y m o nit ore d t o pre ve nt fl ui d o verl oa d.
Refer t o t he S O A Ta ble 2  f or a listi n g of st u d y pr oce d ures t o be c o m plete d d uri n g t he 
a xica bta ge ne cil ole ucel c o n diti o ni n g c he m ot hera p y peri o d.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 3 7
1 4 A pril 2 0 2 3
6. 2. 4. 4.  
Re q uire me nts f or I niti ati n g A xic a bt a ge ne Cil ole ucel I nf usi o n ( Tre at me nt 
d a y 0)
If a n y of t he f oll o wi n g criteria are met pri or t o t he i nitiati o n of a xica bta ge ne cil ole ucel i nf usi o n, 
t he n t he w or k- u p liste d i n Secti o n 6. 2. 4. 8  m ust be perf or me d t o deter mi ne t he p ote ntial ca use if 
t here is n o i de ntifie d s o urce of i nfecti o n.
•
Te m perat ure > 3 8° C wit hi n 7 2 h o urs of a xica bta ge ne cil ole ucel i nf usi o n
•
C R P > 1 0 0 m g/ L a n yti me bet wee n e nr oll me nt t o start of a xica bta ge ne cil ole ucel i nf usi o n
•
W B C c o u nt or W B C differe ntial c o ncer ni n g f or i nfecti o us pr ocess bet wee n e nr oll me nt t o 
start of a xica bta ge ne cil ole ucel i nf usi o n (e g, W B C > 2 0, 0 0 0, ra pi dl y i ncreasi n g W B C, or 
differe ntial wit h hi g h perce nta ge of ne utr o p hils/ ba n ds)
A d diti o nall y:
•
If a n y scree ni n g assess me nts or pr oce d ures are re peate d bet wee n c o nfir mati o n of eli gi bilit y 
a n d t he start of a xica bta ge ne cil ole ucel i nf usi o n a n d res ults are o utsi de t he eli gi bilit y criteria 
liste d i n Secti o n 5 , t he n t he c o n diti o n m ust res ol ve pri or t o pr ocee di n g wit h a xica bta ge ne 
cil ole ucel i nf usi o n (e xce pt f or peri p heral bl o o d cell c o u nts t hat ha ve bee n i m pacte d b y 
c o n diti o ni n g c he m ot hera p y).
•
C o m plete hist or y a n d p h ysical e xa m i ncl u di n g H E E N T; car diac, vasc ular, res pirat or y, 
gastr oi ntesti nal, i nte g u me ntar y, a n d ne ur ol o gical s yste ms m ust n ot re veal e vi de nce of 
i nfecti o n/i nfla m mati o n.
•
T he s u bject m ust n ot ha ve recei ve d s yste mic a nti- micr o bials f or t he treat me nt of a k n o w n or 
s us pecte d i nfecti o n wit hi n 4 8 h o urs bef ore a xica bta ge ne cil ole ucel ( pr o p h ylactic use of 
a nti- micr o bials is all o we d).
•
Treat me nt c o urse of a n y a nti micr o bials gi ve n f or k n o w n or s us pecte d a ntece de nt i nfecti o n 
s h o ul d be c o m plete as per i nfecti o us disease c o ns ult (if a p plica ble) rec o m me n dati o n bef ore 
st o p pi n g or s witc hi n g t o pr o p h ylactic a nti micr o bials.
•
If a s u bject is c o nfir me d t o ha ve a n i nfecti o us pr ocess f or w hic h a nti micr o bials are n ot 
a vaila ble (e g, viral p ne u m o nia), t he i nfecti o n m ust be cli nicall y res ol ve d as deter mi ne d b y 
t he i n vesti gat or i n c o ns ultati o n wit h i nfecti o us disease ser vice (if a p plica ble).
•
M ost rece ntl y c ollecte d bl o o d, uri ne, or ot her b o d y fl ui d c ult ures m ust s h o w n o gr o wt h f or at 
least 4 8 h o urs, a n d a n y ot her i nfecti o us w or k- u p perf or me d (e g, bacterial, viral ser ol o gies, 
P C R, st o ol st u dies, i ma gi n g st u dies) m ust be ne gati ve.  If cli nical s us pici o n is f or a n i nfecti o n 
f or w hic h c ult ures are u nli kel y t o be p ositi ve wit hi n 4 8 h o urs (e g, f u n gal i nfecti o n), a de q uate 
ti me m ust be all o we d f or c ult ures t o bec o me p ositi ve.
O nce t he a b o ve criteria are met, t he n t he s u bject ca n pr ocee d wit h a d mi nistrati o n of a xica bta ge ne 
cil ole ucel.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 3 8
1 4 A pril 2 0 2 3
If t he a xica bta ge ne cil ole ucel i nf usi o n is dela ye d > 2 wee ks, pr ot oc ol g ui deli nes s h o ul d be 
f oll o we d re gar di n g t he nee d f or re peat c o n diti o ni n g c he m ot hera p y.
6. 2. 4. 5.  
A xic a bt a ge ne Cil ole ucel Pre me dic ati o n D osi n g
T he f oll o wi n g pre a xica bta ge ne cil ole ucel i nf usi o n me dicati o ns s h o ul d be a d mi nistere d 
a p pr o xi matel y 1 h o ur pri or t o i nf usi o n.
•
Aceta mi n o p he n 6 5 0 m g P O or e q ui vale nt
•
Di p he n h y dra mi ne 1 2. 5 m g a d mi nistere d eit her orall y or via I V or e q ui vale nt
6. 2. 4. 6.  
A xic a bt a ge ne Cil ole ucel  A d mi nistr ati o n d a y 0
All s u bjects will recei ve a xica bta ge ne cil ole ucel i nf usi o n at a healt hcare facilit y, f oll o we d b y 
dail y m o nit ori n g at a healt hcare facilit y f or at least 7 da ys t o m o nit or f or si g ns a n d s y m pt o ms of 
C R S a n d ne ur ol o gic e ve nts, u nless ot her wise re q uire d b y c o u ntr y re g ulat or y a ge ncies (refer t o 
A p pe n di x D ). Alter nati vel y, s u bjects ma y be h os pitalize d t o recei ve t heir a xica bta ge ne cil ole ucel 
i nf usi o n a n d be o bser ve d f or C R S a n d ne ur ol o gic e ve nts i n t he h os pital setti n g, if dee me d 
a p pr o priate b y t he i n vesti gat or.
If s u bjects are h os pitalize d, s u bjects s h o ul d n ot be disc har ge d fr o m t he h os pital u ntil all 
a xica bta ge ne cil ole ucel relate d n o n- he mat ol o gical t o xicities res ol ve t o ≤ Gra de 1 or ret ur n t o 
baseli ne. S u bjects ma y be disc har ge d wit h n o n-critical a n d cli nicall y sta ble or i m pr o vi n g 
t o xicities (e g, re nal i ns ufficie nc y) e ve n if > Gra de 1, if dee me d a p pr o priate b y t he 
i n vesti gat or.  S u bjects s h o ul d re mai n i n a h os pital f or o n g oi n g a xica bta ge ne cil ole ucel relate d 
fe ver, h y p ote nsi o n, h y p o xia, or o n g oi n g ne ur ol o gic e ve nts > Gra de 1 or if dee me d necessar y b y 
t he i n vesti gat or.
S u bjects s h o ul d be i nstr ucte d t o re mai n wit hi n pr o xi mit y of t he cli nical st u d y site f or at least 
4 wee ks f oll o wi n g a xica bta ge ne cil ole ucel i nf usi o n. S u bjects a n d t heir fa mil y 
me m bers/care gi vers s h o ul d be e d ucate d o n p ote ntial C R S a n d ne ur ol o gic s y m pt o ms, s uc h as 
fe ver, d ys p nea, c o nf usi o n, a p hasia, d ys p hasia, s o m n ole nce, e nce p hal o pat h y, ata xia, or tre m or. 
S u bjects or t heir fa mil y me m bers/care gi vers s h o ul d be i nstr ucte d t o i m me diatel y c o ntact t he 
treati n g i n vesti gat or or see k i m me diate me dical atte nti o n if a n y of t hese s y m pt o ms de vel o p.
Refer t o t he S O A f or a listi n g of st u d y pr oce d ures t o be c o m plete d d uri n g t he a xica bta ge ne 
cil ole ucel treat me nt peri o d.
Ce ntral ve n o us access, s uc h as a p ort or a peri p herall y i nserte d ce ntral cat heter, is re q uire d f or 
t he a d mi nistrati o n of a xica bta ge ne cil ole ucel.  Cat heter care, per i nstit uti o nal g ui deli nes, s h o ul d 
be f oll o we d.  Materials a n d i nstr ucti o ns f or t he t ha wi n g, ti mi n g, a n d a d mi nistrati o n of 
a xica bta ge ne cil ole ucel are o utli ne d i n t he I P M.  Vital si g ns s h o ul d be meas ure d d uri n g a n d after 
a xica bta ge ne cil ole ucel treat me nt (see Secti o n 7. 6 ). T he I P M m ust be re vie we d pri or t o 
a d mi nistrati o n of a xica bta ge ne cil ole ucel.
Researc h sites s h o ul d f oll o w i nstit uti o nal g ui deli nes f or t he i nf usi o n of cell pr o d ucts.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 3 9
1 4 A pril 2 0 2 3
6. 2. 4. 7.  
A xic a bt a ge ne Cil ole ucel Retre at me nt
S u bjects w h o ac hie ve d a P R or C R a n d s u bse q ue ntl y e x perie nce disease pr o gressi o n ma y ha ve 
a n o pti o n t o recei ve a sec o n d c o urse of c o n diti o ni n g c he m ot hera p y a n d a xica bta ge ne cil ole ucel.
I n eit her case, t he f oll o wi n g criteria m ust be met i n or der t o be c o nsi dere d f or a re peat c o urse of 
t hera p y:
•
S u bject ha d a P R or C R at t he first disease assess me nt at Da y 5 0 b ut s u bse q ue ntl y 
e x perie nce d pr o gressi o n of disease at a later ti me
•
T u m or t hat is n ot k n o w n t o be C D 1 9 ne gati ve
•
S u bject c o nti n ues t o meet t he ori gi nal st u d y eli gi bilit y criteria wit h t he e xce pti o n of pri or 
a xica bta ge ne cil ole ucel use i n t his st u d y; scree ni n g assess me nts a n d pr oce d ures s h o ul d be 
re peate d if cli nicall y i n dicate d (e g, ma g netic res o na nce i ma gi n g [ M RI], E C H O)
•
S u bject has n ot recei ve d s u bse q ue nt t hera p y f or t he treat me nt of l y m p h o ma
•
S u bject di d n ot e x perie nce a life-t hreate ni n g t o xicit y relate d t o a xica bta ge ne cil ole ucel 
d uri n g t he ori gi nal c o urse of treat me nt
•
T o xicities relate d t o c o n diti o ni n g c he m ot hera p y (fl u dara bi ne a n d c ycl o p h os p ha mi de), wit h 
t he e xce pti o n of al o pecia, ha ve res ol ve d t o ≤ Gra de 1 or ret ur ne d t o baseli ne pri or t o 
re-treat me nt
•
S u bject d oes n ot ha ve k n o w n a xica bta ge ne cil ole ucel ne utralizi n g a nti b o dies (e xce pti o n: if a 
n o n- ne utralizi n g a xica bta ge ne cil ole ucel a nti b o d y de vel o ps, s u bjects ma y be retreate d if t he y 
meet t he ori gi nal st u d y eli gi bilit y criteria)
•
Sites are str o n gl y e nc o ura ge d t o c ollect a bi o ps y c o nfir mi n g disease pr o gressi o n a n d C D 1 9 
e x pressi o n a n d t o s u b mit t he bi o psie d tiss ue t o t he ce ntral la b orat or y bef ore i nitiati n g 
re-treat me nt
•
S u bject recei ve d t he i nitial a xica bta ge ne cil ole ucel i nf usi o n ≤ 2 4 m o nt hs a g o
T he decisi o n t o re-treat s h o ul d be ma de i n c o ns ultati o n wit h t he Kite me dical m o nit or.  I n 
a d diti o n, bef ore perf or mi n g a n y st u d y-relate d pr oce d ures or treat me nt, it is necessar y t o 
1) disc uss t he ris ks a n d be nefits of retreat me nt wit h t he s u bject, a n d 2) c o nfir m wit h t he s u bject 
h o w t he sec o n d d ose will be ma n ufact ure d. T he sec o n d d ose c o ul d be ma n ufact ure d at t he sa me 
ti me t hat t he first a xica bta ge ne cil ole ucel is ma de wit h e xisti n g cr y o preser ve d P B M Cs. 
Alter nati vel y, t he s u bject ma y nee d t o u n der g o a sec o n d le u ka p heresis a n d s h o ul d be i nf or me d of 
t his p ossi bilit y.  T hese c o n versati o ns s h o ul d als o be rec or de d i n t he s u bject’s s o urce d oc u me nt.
A ma xi m u m of 1 retreat me nt c o urse ma y occ ur per s u bject.  S u bjects w h o are retreate d will 
f oll o w t he sa me treat me nt sc he d ule a n d pr oce d ural re q uire me nts per t he i nitial treat me nt.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 4 0
1 4 A pril 2 0 2 3
All o wa nce f or retreat me nt is base d o n cli nical e x perie nce i n Z U M A- 1, w here a t otal of 
1 0 s u bjects were retreate d wit h a xica bta ge ne cil ole ucel ( 1 s u bject i n P hase 1 a n d 9 s u bjects i n 
P hase 2).  O verall, 6 of 1 0 retreate d s u bjects ha d a P R or C R t o t he retreat me nt.  T he s u bject i n 
P hase 1 ac hie ve d a P R at M o nt h 1 after retreat me nt.  A m o n g t he 9 s u bjects retreate d i n P hase 2, 
fi ve s u bjects res p o n de d ( 2 C R a n d 3 P R) at M o nt h 1.  A nal ysis of d urati o n of retreat me nt 
res p o nse ( D O R R) a m o n g t he retreate d s u bjects i n P hase 2 s h o we d a me dia n D O R R of 
3. 5 m o nt hs as of t he data c ut off date.
After a s u bject is dee me d eli gi ble f or retreat me nt a n d t he mea ns b y w hic h t he sec o n d d ose of 
a xica bta ge ne cil ole ucel has bee n c o nfir me d ( w hic h will i ncl u de deter mi ni n g w het her a sec o n d 
le u ka p heresis is re q uire d), t he s u bject will f oll o w t he sa me st u d y pr oce d ure re q uire me nts t hat 
were f oll o we d d uri n g his or her i nitial c o urse of treat me nt.
Refer t o t he S O A Ta ble 2  f or a listi n g of st u d y pr oce d ures t o be c o m plete d d uri n g t he 
a xica bta ge ne cil ole ucel treat me nt peri o d.
6. 2. 4. 8.  
Re q uire me nts t o W or k- u p P ote nti al I nfecti o us a n d/ or I nfl a m m at or y St ates
I n t he a bse nce of a n i de ntifie d s o urce of i nfecti o n (e g, li ne i nfecti o n, p ne u m o nia o n C X R), t he 
mi ni m u m w or k- u p t o be perf or me d pri or t o a d mi nistrati o n of c o n diti o ni n g c he m ot hera p y a n d/ or 
a xica bta ge ne cil ole ucel c o nsists of:
•
Call Kite me dical m o nit or
•
I nfecti o us disease ser vice c o ns ult (if a p plica ble)
•
C T i ma gi n g of t he c hest, a b d o me n, a n d pel vis wit h I V c o ntrast.  If t here is a me dical 
c o ntrai n dicati o n t o c o ntrast, t he n n o n-c o ntrast C T is all o we d.
•
 T he f oll o wi n g m ust be perf or me d ( pri or t o t he i nitiati o n of a nti micr o bials if cli nicall y 
feasi ble):

Bl o o d c ult ures (aer o bic a n d a naer o bic x 2 b ottles eac h) a n d U A a n d uri ne c ult ure.   
Dee p/i n d uce d s p ut u m c ult ure if cli nicall y i n dicate d.

All i n d welli n g li nes, s uc h as ce ntral ve n o us cat heters, s h o ul d be e xa mi ne d f or a n y si g ns 
of i nfecti o n, a n d a d diti o nal c ult ures s h o ul d be dra w n fr o m t he li ne.

Nas o p har y n geal-t hr oat ( N P T) s wa b or e q ui vale nt assa y f or viral i nfecti o n, s uc h as 
i nfl ue nza A/ B (i ncl u di n g H 1 N 1), parai nfl ue nza 1/ 2/ 3, a de n o vir us, res pirat or y s y nc ytial 
vir us, c or o na vir us, meta p ne u m o vir us

C ollecti o n of f u n gal c ult ures a n d mar kers as a p pr o priate (e g, galact o ma n na n, f u n gitell)

C ollecti o n of a p pr o priate ser u m viral st u dies (e g, c yt o me gal o vir us [ C M V])


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 4 1
1 4 A pril 2 0 2 3
•
If a ce ntral ner v o us s yste m pr ocess is s us pecte d, a p pr o priate brai n i ma gi n g a n d s u bse q ue nt 
l u m bar p u nct ure wit h c yt ol o g y, c ult ure, Gra m stai n, a n d viral P C R s h o ul d be perf or me d.
•
A n y a d diti o nal si g n or s y m pt o m- directe d i n vesti gati o n s h o ul d be perf or me d as cli nicall y 
i n dicate d.
Pri or t o pr ocee di n g wit h c o n diti o ni n g c he m ot hera p y a n d/ or a xica bta ge ne cil ole ucel i nf usi o n, t he 
a b o ve w or k- u p m ust n ot s u g gest t he prese nce of a n acti ve i nfecti o n, a n d all re q uire me nts f or 
c o n diti o ni n g c he m ot hera p y a n d/ or a xica bta ge ne cil ole ucel i nf usi o n m ust be satisfie d.
If t he a xica bta ge ne cil ole ucel i nf usi o n is dela ye d > 2 wee ks f oll o wi n g c o n diti o ni n g 
c he m ot hera p y, pr ot oc ol g ui deli nes s h o ul d be f oll o we d re gar di n g t he nee d f or re peat c o n diti o ni n g 
c he m ot hera p y.
If t he a b o ve w or k- u p was tri g gere d d ue t o C R P > 1 0 0 m g/ L, C R P s h o ul d be re peate d, a n d if 
C R P c o nti n ues t o i ncrease si g nifica ntl y, e val uati o n s h o ul d be perf or me d f or a n y ot her p ote ntial 
i nfecti o us or i nfla m mat or y c o n diti o n n ot pre vi o usl y e val uate d.
6. 2. 4. 9.  
C o nc o mit a nt T her a p y ( A xic a bt a ge ne Cil ole ucel Ar m)
I n vesti gat ors ma y prescri be a n y c o nc o mita nt me dicati o ns or treat me nt dee me d necessar y t o 
pr o vi de a de q uate s u p p orti ve care, i ncl u di n g gr o wt h fact or s u p p ort (e g, G- C S F) a n d r o uti ne 
a nti-e metic pr o p h yla xis e xce pt t h ose me dicati o ns liste d i n t he e xcl u de d me dicati o n Secti o n 6. 2. 5 .  
C o nc o mita nt t hera p y d oes n ot i ncl u de t hera p y use d f or t he treat me nt of t he disease.
F or s u bjects w h o are n ot ra n d o mize d (e g, scree n fail ure), o nl y c o nc urre nt t hera pies relate d t o a n y 
seri o us a d verse e ve nt(s) ( S A Es) will be rec or de d.
F or s u bjects w h o are ra n d o mize d b ut n ot d ose d wit h a xica bta ge ne cil ole ucel, c o nc o mita nt 
c o nc urre nt t hera pies a n d s u bse q ue nt a ntica ncer t hera p y will o nl y be rec or de d fr o m t he date of 
t he i nf or me d c o nse nt t hr o u g h 3 0 da ys after t he last st u d y-s pecific pr oce d ure (e g, le u ka p heresis, 
c o n diti o ni n g c he m ot hera p y).
F or s u bjects w h o are ra n d o mize d t o recei ve a xica bta ge ne cil ole ucel a n d recei ve t he d ose of 
a xica bta ge ne cil ole ucel, all c o nc o mita nt t hera pies, i ncl u di n g me dicati o ns, i nt u bati o n, dial ysis, 
o x y ge n, a n d bl o o d pr o d ucts, s h o ul d be rec or de d fr o m t he date of t he i nf or me d c o nse nt t hr o u g h 
t he Da y 1 5 0 p ost-ra n d o mizati o n visit, a n d tar gete d c o nc o mita nt t hera pies fr o m t his visit u ntil 
M o nt h 1 2, or u ntil a c ha n ge i n l y m p h o ma t hera p y, or disease pr o gressi o n, w hic he ver occ urs first.  
Tar gete d c o nc o mita nt t hera pies i ncl u de ga m ma gl o b uli n, i m m u n os u p pressi ve dr u gs, 
a nti-i nfecti ve dr u gs, a n d vacci nati o ns.   Refer t o Secti o n 6. 2. 6  f or details s urr o u n di n g s u bse q ue nt 
ca ncer t hera p y.
S pecific c o nc o mita nt me dicati o n c ollecti o n re q uire me nts a n d i nstr ucti o ns are i ncl u de d i n t he 
Case Re p ort F or m ( C R F) c o m pleti o n g ui deli nes.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 4 2
1 4 A pril 2 0 2 3
6. 2. 5. 
E xcl u de d Me dic ati o ns ( A xic a bt a ge ne Cil ole ucel Ar m)
C ortic oster oi d t hera p y at a p har mac ol o gic d ose ( ≥ 5 m g/ da y of pre d nis o ne or e q ui vale nt d oses of 
ot her c ortic oster oi ds) a n d ot her i m m u n os u p pressi ve dr u gs m ust be a v oi de d f or 7 da ys pri or t o 
le u ka p heresis a n d 5 da ys pri or t o a xica bta ge ne cil ole ucel a d mi nistrati o n.
S yste mic c ortic oster oi ds ma y n ot be a d mi nistere d as pre me dicati o n t o s u bjects f or w h o m C T 
sca ns wit h c o ntrast are c o ntrai n dicate d (ie, s u bjects wit h c o ntrast aller g y or i m paire d re nal 
cleara nce).  S uc h s u bjects s h o ul d u n der g o M RI wit h c o ntrast a n d  n o n-c o ntrast C T sca ns i nstea d.
C ortic oster oi ds a n d ot her i m m u n os u p pressi ve dr u gs s h o ul d als o be a v oi de d f or 3 m o nt hs after 
a xica bta ge ne cil ole ucel a d mi nistrati o n u nless use d t o ma na ge a xica bta ge ne cil ole ucel relate d 
t o xicities.  Ot her me dicati o ns t hat mi g ht i nterfere wit h t he e val uati o n of a xica bta ge ne cil ole ucel, 
s uc h as n o n-ster oi dal a nti-i nfla m mat or y a ge nts, s h o ul d als o be a v oi de d f or t he sa me peri o d 
u nless me dicall y necessar y.
Treat me nt f or l y m p h o ma, s uc h as c he m ot hera p y, i m m u n ot hera p y, tar gete d a ge nts, ra diati o n, a n d 
hi g h- d ose c ortic oster oi d, ot her t ha n defi ne d/all o we d i n t his pr ot oc ol, a n d ot her i n vesti gati o nal 
a ge nts are pr o hi bite d, e xce pt as nee de d f or treat me nt of disease pr o gressi o n after a xica bta ge ne 
cil ole ucel.
If per missi bilit y of a s pecific me dicati o n/treat me nt is i n q uesti o n, please c o ntact t he Kite P har ma 
me dical m o nit or.  Please refer t o t he I B f or a d diti o nal i nf or mati o n a b o ut e xcl u de d me dicati o ns.
6. 2. 6. 
S u bse q ue nt T her a p y ( A xic a bt a ge ne Cil ole ucel Ar m)
S u bse q ue nt t hera p y a d mi nistere d after a xica bta ge ne cil ole ucel necessar y t o treat a s u bject’s 
disease, s uc h as n o n-st u d y-s pecifie d c he m ot hera p y, i m m u n ot hera p y, tar gete d a ge nts, as well as 
ste m cell tra ns pla nt a n d ra diati o n t hera p y, will be rec or de d f or all s u bjects ra n d o mize d u ntil o ne 
of t he f oll o wi n g ha p pe ns: t he s u bject c o m pletes t he l o n g-ter m f oll o w- u p peri o d, is c o nsi dere d 
l ost t o f oll o w u p, wit h dra ws c o nse nt, or dies.  If a s u bject pr o gresses, sites are str o n gl y 
e nc o ura ge d t o c ollect a bi o ps y c o nfir mi n g disease pr o gressi o n a n d t o s u b mit t he bi o psie d tiss ue 
t o t he ce ntral la b orat or y.  Treat me nt wit h a xica bta ge ne cil ole ucel is i nte n de d t o be defi niti ve 
t hera p y a n d n ot a bri d ge t o A S C T.
6. 2. 7. 
T o xicit y M a n a ge me nt ( A xic a bt a ge ne Cil ole ucel Ar m)
T o date, t he f oll o wi n g i m p orta nt ris ks ha ve bee n i de ntifie d wit h a xica bta ge ne cil ole ucel:  C R S, 
ne ur ol o gic e ve nts, i nfecti o ns, c yt o pe nias, a n d h y p o ga m ma gl o b uli ne mia.  Refer t o Secti o n 6 of 
t he c urre nt I B f or details re gar di n g t hese e ve nts a n d ma na ge me nt g ui da nce.
As t he safet y e x perie nce wit h a xica bta ge ne cil ole ucel i ncreases, t he ma na ge me nt g ui da nce ma y 
be u p date d. T heref ore, it is i m p orta nt t o al wa ys refer t o t he m ost c urre nt versi o n of t he 
a xica bta ge ne cil ole ucel I B f or g ui da nce re gar di n g ma na gi n g a xica bta ge ne cil ole ucel relate d 
t o xicities. A d diti o nal i nf or mati o n a n d ma na ge me nt rec o m me n dati o ns ca n als o be f o u n d i n t he I B 
re gar di n g i m p orta nt p ote ntial ris ks ass ociate d wit h a xica bta ge ne cil ole ucel as well as p ossi ble 
c o m plicati o ns ass ociate d wit h mali g na nc y a n d ca ncer treat me nt.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 4 3
1 4 A pril 2 0 2 3
6. 3. 
St a n d ar d of C are T her a p y Ar m
S O C t hera p y will be s u p plie d b y t he i n vesti gati ve site u nless ot her wise n ote d.  Refer t o t he 
c urre nt pr o d uct la bel f or g ui da nce o n pac ka gi n g, st ora ge, pre parati o n, a n d a d mi nistrati o n of eac h 
c he m ot hera p y re gi me n a n d i n di vi d ual c o m p o ne nt of t he re gi me n.  G- C S F will be a d mi nistere d 
base d o n re gi o nal/i nstit uti o nal sta n dar ds t o pre ve nt c he m ot hera p y dela ys a n d i nfecti o n a n d f or 
le u ka p heresis.
A d mi nistrati o n of S O C t hera p y will be perf or me d i n a setti n g wit h e mer ge nc y me dical facilities 
a n d staff w h o are trai ne d t o m o nit or f or a n d res p o n d t o me dical e mer ge ncies.  A n y o ver d ose or 
i nc orrect a d mi nistrati o n of S O C t hera p y s h o ul d be n ote d o n t he St u d y Dr u g A d mi nistrati o n 
electr o nic Case Re p ort F or m (e C R F).
After S O C t hera p y is a d mi nistere d t o a s u bject, t he s u bject m ust recei ve t he sa me S O C t hera p y 
o pti o n f or s u bse q ue nt c ycles of t hera p y.  I n di vi d ual a ge nts of t he c h oice of treat me nt ma y be 
altere d base d o n s u bject care a n d t o xicit y ma na ge me nt.
6. 3. 1. 
St a n d ar d of C are C he m ot her a p y D osi n g a n d A d mi nistr ati o n
S O C c he m ot hera p y is rec o m me n de d t o start wit hi n a p pr o xi matel y 5 da ys after ra n d o mizati o n.
Rit u xi ma b + if osfa mi de, car b o plati n, a n d et o p osi de ( R-I C E) s u g geste d d osi n g { Gissel brec ht 
2 0 1 0 }:
•
Rit u xi ma b 3 7 5 m g/ m 2 bef ore c he m ot hera p y
•
If osfa mi de 5 g/m 2 2 4 h- CI o n da y 2 wit h mes na
•
Car b o plati n area u n der t he c ur ve ( A U C) 5 o n da y 2, ma xi m u m d ose 8 0 0 m g
•
Et o p osi de 1 0 0 m g/ m 2/ d o n da ys 1- 3
Rit u xi ma b + et o p osi de, met h yl pre d nis ol o ne, c yta ra bi ne, cis plati n ( R- E S H A P) s u g geste d d osi n g 
{ Marti n 2 0 0 8 }:
•
Rit u xi ma b 3 7 5 m g/ m 2 da y 1
•
Et o p osi de 4 0 m g/ m 2/ d I V o n da ys 1- 4
•
Met h yl pre d nis ol o ne 5 0 0 m g/ d I V o n da ys 1- 4 or 5
•
Cis plati n at 2 5 m g/ m 2/ d CI da ys 1- 4
•
C ytara bi ne 2 g/ m 2 o n da y 5


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 4 4
1 4 A pril 2 0 2 3
Rit u xi ma b + ge mcita bi ne, de xa met has o ne a n d cis plati n/car b o plati n ( R- G D P) s u g geste d d osi n g 
{ Cr u m p 2 0 0 4 , G o pal 2 0 1 0 }
•
Rit u xi ma b 3 7 5 m g/ m 2 da y 1 ( or da y 8)
•
Ge mcita bi ne 1 g/ m 2 o n da ys 1 a n d 8
•
De xa met has o ne 4 0 m g o n da ys 1- 4
•
Cis plati n 7 5 m g/ m 2 o n da y 1 ( or car b o plati n A U C = 5) {G o pal 2 0 1 0 }
Rit u xi ma b + de xa met has o ne, hi g h- d ose c ytara bi ne a n d cis plati n ( R- D H A P) s u g geste d d osi n g 
{ Gissel brec ht 2 0 1 0 }:
•
Rit u xi ma b 3 7 5 m g/ m 2 bef ore c he m ot hera p y
•
De xa met has o ne 4 0 m g/ d o n da ys 1- 4
•
Hi g h- d ose c ytara bi ne 2 g/ m 2 e ver y 1 2 h f or 2 d oses o n da y 2 f oll o wi n g plati n u m
•
Cis plati n 1 0 0 m g/ m 2 2 4 h- CI o n da y 1 ( or o xali plati n 1 0 0 m g/ m2) {Li g n o n 2 0 1 0 }
6. 3. 1. 1. 
Rati o nale f or Sta n dar d of Care D ose a n d Sc he d ule
Sec o n d-li ne c he m ot hera p y re gi me ns ge nerall y c o nsist of n o n-cr oss-resista nt dr u gs t o first-li ne 
R- C H O P a n d i ncl u des plati n u m.  C o m m o n re gi me ns i ncl u de R- G D P, R- D H A P, R-I C E, a n d 
R- E S H A P.  I nstit uti o nal prefere nce a n d t o xicit y pr ofile ofte n dictate w hic h treat me nt re gi me n is 
use d beca use n o si n gle sal va ge re gi me n has de m o nstrate d s u peri orit y i n a ra n d o mize d trial.  If 
a de q uate disease res p o nse ( C R or P R) is de m o nstrate d after 2 or 3 c ycles of c he m ot hera p y, 
H D T- A S C T ma y be i nitiate d.
Pri or t o hi g h- d ose t hera p y, w hic h is m yel oa blati ve, peri p heral bl o o d pr o ge nit or cells are 
c ollecte d b y le u ka p heresis t o a mi ni m u m tar get of 2 x 1 0 6 C D 3 4 + he mat o p oietic ste m cells per 
k g b o d y wei g ht, w hic h will be rei nf use d after H D T t o resc ue he mat o p oiesis.  T he H D T 
c o n diti o ni n g re gi me n c o nsists of c o m bi nati o n hi g h- d ose c he m ot hera p y wit h or wit h o ut T BI.  
C o m m o nl y use d hi g h- d ose re gi me ns i ncl u de B E A M ( B C N U, et o p osi de, ara- C, a n d mel p hala n) 
or C B V (c ycl o p h os p ha mi de, B C N U, a n d V P- 1 6).  T here is n o sta n dar d hi g h- d ose re gi me n d ue t o 
lac k of ra n d o mize d st u dies; t heref ore, H D T a n d A S C T pr oce d ures are per re gi o nal a n d 
i nstit uti o nal sta n dar ds.
6. 3. 2.  
C o nc o mit a nt T her a p y ( St a n d ar d of C are Ar m)
I n vesti gat ors ma y prescri be a n y c o nc o mita nt me dicati o ns or treat me nt dee me d necessar y t o 
pr o vi de a de q uate s u p p orti ve care, i ncl u di n g gr o wt h fact or s u p p ort (e g, G- C S F) a n d r o uti ne 
a nti-e metic pr o p h yla xis, e xce pt t h ose me dicati o ns liste d i n t he e xcl u de d me dicati o n 
Secti o n 6. 3. 3 .  C o nc o mita nt t hera p y d oes n ot i ncl u de t hera p y use d f or t he treat me nt of t he 
disease.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 4 5
1 4 A pril 2 0 2 3
F or s u bjects w h o are n ot ra n d o mize d (e g, scree n fail ure), o nl y c o nc urre nt t hera pies relate d t o a n y 
S A Es will be rec or de d.
F or s u bjects w h o are ra n d o mize d b ut n ot d ose d wit h S O C, c o nc urre nt t hera pies will o nl y be 
rec or de d fr o m t he date of t he i nf or me d c o nse nt t hr o u g h 3 0 da ys after t he last st u d y-s pecific 
pr oce d ure.
F or s u bjects w h o are ra n d o mize d a n d recei ve S O C t hera p y, all c o nc urre nt t hera pies, i ncl u di n g 
me dicati o ns, i nt u bati o n, dial ysis, o x y ge n, a n d bl o o d pr o d ucts, s h o ul d be rec or de d fr o m t he date 
of t he i nf or me d c o nse nt t hr o u g h t he Da y 1 5 0 p ost-ra n d o mizati o n visit or disease pr o gressi o n, 
w hic he ver occ urs first.  Refer t o Secti o n 6. 3. 4  f or details s urr o u n di n g s u bse q ue nt ca ncer t hera p y.
S pecific c o nc o mita nt me dicati o n c ollecti o n re q uire me nts a n d i nstr ucti o ns are i ncl u de d i n t he 
C R F c o m pleti o n g ui deli nes.
6. 3. 3. 
E xcl u de d Me dic ati o ns ( St a n d ar d of C are Ar m)
Treat me nt f or l y m p h o ma, s uc h as c he m ot hera p y, i m m u n ot hera p y, tar gete d a ge nts, ra diati o n ( T BI 
f or H D T is all o we d), a n d hi g h- d ose c ortic oster oi d, ot her t ha n defi ne d/all o we d i n t his pr ot oc ol, 
a n d ot her i n vesti gati o nal a ge nts are pr o hi bite d, e xce pt as nee de d f or c ha n ge i n l y m p h o ma 
t hera p y after lac k of res p o nse t o t he pr ot oc ol- defi ne d S O C t hera p y o pti o ns.
If per missi bilit y of a s pecific me dicati o n/treat me nt is i n q uesti o n, please c o ntact t he Kite P har ma 
me dical m o nit or.
6. 3. 4. 
S u bse q ue nt T her a p y ( St a n d ar d of C are Ar m)
S u bse q ue nt t hera p y a d mi nistere d after S O C c he m ot hera p y necessar y t o treat a s u bject’s disease, 
s uc h as n o n-st u d y s pecifie d c he m ot hera p y, i m m u n ot hera p y, tar gete d a ge nts, as well as ste m cell 
tra ns pla nt a n d ra diati o n t hera p y, will be rec or de d f or all s u bjects ra n d o mize d u ntil t he s u bject 
c o m pletes t he l o n g-ter m f oll o w- u p peri o d, is c o nsi dere d l ost t o f oll o w- u p, wit h dra ws c o nse nt, or 
dies.  If a s u bject pr o gresses, sites are str o n gl y e nc o ura ge d t o c ollect a bi o ps y c o nfir mi n g disease 
pr o gressi o n a n d t o s u b mit t he bi o psie d tiss ue t o t he ce ntral la b orat or y.
6. 3. 5. 
T o xicit y M a n a ge me nt ( St a n d ar d of C are Ar m)
Refer t o t he c urre nt re gi o nal pr o d uct la bel, a n d f oll o w i nstit uti o nal g ui deli nes f or t o xicit y 
ma na ge me nt ass ociate d wit h t he a d mi nistrati o n of eac h c he m ot hera p y a ge nt.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 4 6
1 4 A pril 2 0 2 3
7. 
S T U D Y P R O C E D U R E S
Researc h staff s h o ul d refer t o t he S O As f or a n o utli ne of t he pr oce d ures re q uire d.
T he visit sc he d ule f or disease assess me nts, i ncl u di n g C T sca ns, p ositr o n e missi o n t o m o gra p h y 
( P E T) sca ns, b o ne marr o w bi o ps y, assess me nt of B-s y m pt o ms, p h ysical e xa ms nee de d t o assess 
disease, a n d c ollecti o n of s u bse q ue nt ne w l y m p h o ma t hera p y, is calc ulate d fr o m ra n d o mizati o n.
A n o ver vie w of st u d y assess me nts/ pr oce d ures is o utli ne d bel o w.  Refer t o t he C R F c o m pleti o n 
g ui deli nes f or data c ollecti o n re q uire me nts a n d d oc u me ntati o n of st u d y pr oce d ures.
7. 1. 
I nf or me d C o nse nt
Bef ore a s u bject’s partici pati o n i n t he cli nical st u d y, t he i n vesti gat or is res p o nsi ble f or o btai ni n g 
writte n i nf or me d c o nse nt fr o m t he s u bject after a de q uate e x pla nati o n of t he st u d y desi g n, 
a ntici pate d be nefits, a n d t he p ote ntial ris ks.  S u bjects s h o ul d si g n t he m ost c urre nt I R B/I E C 
a p pr o ve d I nf or me d C o nse nt F or m (I C F) pri or t o a n y st u d y-s pecific acti vit y or pr oce d ure is 
perf or me d.
T he c o nse nt pr ocess a n d t he s u bject’s a gree me nt or ref usal t o partici pate i n t he st u d y is t o be 
d oc u me nte d i n t he s u bject’s me dical rec or ds.  If t he s u bject a grees t o partici pate, t he I C F is t o be 
si g ne d a n d pers o nall y date d b y t he s u bject a n d b y t he pers o n w h o c o n d ucte d t he i nf or me d 
c o nse nt disc ussi o n.  T he ori gi nal si g ne d I C F will be retai ne d i n acc or da nce wit h i nstit uti o n 
p olic y a n d I R B/I E C re q uire me nts wit h a c o p y of t he I C F pr o vi de d t o t he s u bject.
All s u bjects w h o are e nr olle d i nt o t he st u d y s h o ul d be re-c o nse nte d wit h a n y u p date d versi o ns of 
t he I R B/I E C a p pr o ve d I C F if rele va nt t o t heir partici pati o n i n t he st u d y.
7. 2. 
Scree ni n g
I n vesti gati ve sites will mai ntai n a l o g of all scree ne d s u bjects w h o were re vie we d a n d e val uate d 
f or st u d y partici pati o n.  I nf or mati o n c ollecte d o n t he scree ni n g l o g s h o ul d i ncl u de li mite d 
i nf or mati o n, s uc h as t he date of scree ni n g, date t he s u bject was e nr olle d, or t he reas o n f or w h y 
t he s u bject faile d scree ni n g.
T he scree ni n g peri o d be gi ns o n t he date t he s u bject si g ns t he I R B/I E C a p pr o ve d I C F a n d 
c o nti n ues t hr o u g h c o nfir mati o n of eli gi bilit y a n d ra n d o mizati o n i nt o t he st u d y.  I nf or me d 
c o nse nt m ust be o btai ne d bef ore c o m pleti o n of a n y n o n-sta n dar d of care st u d y-s pecific 
pr oce d ures.  Pr oce d ures t hat are part of sta n dar d of care are n ot c o nsi dere d st u d y-s pecific 
pr oce d ures a n d ma y be perf or me d pri or t o o btai ni n g c o nse nt a n d use d t o c o nfir m eli gi bilit y.  
C o nfir mati o n of t his data m ust occ ur wit hi n t he ti me all o wa nce as o utli ne d bel o w a n d i n t he 
S O A.
After writte n i nf or me d c o nse nt has bee n o btai ne d, Kite P har ma will assi g n a scree ni n g n u m ber 
t o t he s u bject.  S u bse q ue ntl y, t he s u bject will be re gistere d i nt o t he I X R S as descri be d i n t he 
I X R S user ma n ual.  S u bjects w h o fail t o meet t he eli gi bilit y criteria will be all o we d t o rescree n 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 4 7
1 4 A pril 2 0 2 3
o ne ti me.  S u bjects will perf or m t he assess me nt t hat i nitiall y res ulte d i n t he s u bject faili n g 
scree ni n g, i ncl u di n g a n y ot her pr oce d ures t hat fell o utsi de of t he desi g nate d scree ni n g wi n d o w 
(ie, la b assess me nts or P E T- C T sca ns).
O nl y s u bjects w h o meet t he eli gi bilit y criteria liste d i n Secti o n 5  will be ra n d o mize d i nt o t he 
st u d y.  If at a n y ti me pri or t o e nr oll me nt t he s u bject fails t o meet t he eli gi bilit y criteria, t he 
s u bject s h o ul d be desi g nate d as a scree n fail ure i n t he I X R S a n d o n t he s u bject scree ni n g l o g 
wit h t he reas o ns f or faili n g scree ni n g.
Refer t o t he S O A f or a listi n g of st u d y pr oce d ures t o be c o m plete d d uri n g t he scree ni n g peri o d.
7. 3.  
R a n d o miz ati o n
O nce eli gi bilit y i nt o t he st u d y has bee n c o nfir me d, s u bjects will be ra n d o mize d i n a 1: 1 rati o t o 
recei ve a xica bta ge ne cil ole ucel or i n vesti gat or c h oice of S O C c he m ot hera p y as assi g ne d b y t he 
I X R S.
T o ra n d o mize a s u bject, a n a ut h orize d site re prese ntati ve will l o g i nt o I X R S w here t he s yste m 
will assi g n a ra n d o mizati o n n u m ber t o t he s u bject.  T he ra n d o mizati o n is acc o m plis he d b y 
e nteri n g t he perti ne nt i nf or mati o n detaile d i n t he I X R S user ma n ual.  Ra n d o mizati o n will be 
stratifie d b y res p o nse t o first-li ne t hera p y ( pri mar y refract or y, vs rela pse ≤ 6 m o nt hs of first-li ne 
t hera p y vs rela pse > 6 a n d ≤ 1 2 m o nt hs of first-li ne t hera p y) a n d sec o n d-li ne a ge-a dj uste d I PI 
( 0 t o 1 vs 2 t o 3) as assesse d at t he ti me of scree ni n g.
After data ha ve bee n e ntere d i nt o t he I X R S, a c o nfir mati o n fa x or e mail will be se nt t o t he site t o 
verif y t hat t he c orrect i nf or mati o n has bee n e ntere d.  T he site re prese ntati ve will recei ve a si n gle, 
u ni q ue ra n d o mizati o n n u m ber f or eac h s u bject a n d t he ra n d o mizati o n treat me nt assi g ne d.  A 
s u bject will be c o nsi dere d e nr olle d/ra n d o mize d i nt o t he st u d y w he n a ra n d o mizati o n n u m ber is 
assi g ne d.
T he ra n d o mizati o n date is t o be d oc u me nte d i n t he s u bject’s me dical rec or d a n d o n t he 
e nr oll me nt C R F.
De pe n di n g o n w hic h ar m of t he st u d y s u bjects are ra n d o mize d, s u bjects s h o ul d i nitiate 
le u ka p heresis or S O C t hera p y wit hi n a p pr o xi matel y 5 da ys of ra n d o mizati o n i n I X R S.
7. 4.  
De m o gr a p hic D at a
De m o gra p hic data will be c ollecte d as per c o u ntr y a n d l ocal re g ulati o ns a n d g ui deli nes.  W here 
a p plica ble, de m o gra p hic data will i ncl u de se x, date of birt h, race, et h nicit y, a n d c o u ntr y of 
e nr oll me nt t o st u d y t heir p ossi ble ass ociati o n wit h s u bject safet y a n d treat me nt effecti ve ness.
7. 5.  
Me dic al a n d Tre at me nt Hist or y
Rele va nt me dical hist or y pri or t o t he start of a d verse e ve nt re p orti n g will be c ollecte d.  Rele va nt 
me dical hist or y is defi ne d as data o n t he s u bject’s c o nc urre nt me dical c o n diti o n t hat w o ul d be 
t y picall y s hare d i n a referral letter.  All fi n di n gs will be rec or de d i n t he C R Fs.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 4 8
1 4 A pril 2 0 2 3
I n a d diti o n t o t he me dical hist or y, all hist or y relate d t o t he s u bject’s disease, treat me nt, a n d 
res p o nse t o treat me nt will be c ollecte d a n d m ust date bac k t o t he ori gi nal dia g n osis.
F or s u bjects w h o are bei n g referre d fr o m a n ot her cli nic or i nstit uti o n t o t he partici pati n g researc h 
ce nter, c o pies fr o m t he s u bject’s c hart s h o ul d be o btai ne d.
7. 6. 
P h ysic al E x a m, Vit al Si g ns, a n d Perf or m a nce St at us
P h ysical e xa ms will be perf or me d d uri n g scree ni n g a n d at ti mes n ote d i n t he S O A.  C ha n ges 
n ote d i n s u bse q ue nt e xa ms w he n c o m pare d t o t he baseli ne e xa m will be re p orte d as a n a d verse 
e ve nt.
Vital si g ns, i ncl u di n g bl o o d press ure, heart rate, res pirat or y rate, o x y ge n sat urati o n, a n d 
te m perat ure, will be m o nit ore d a n d rec or de d at ti mes o utli ne d i n t he S O A.
I n a d diti o n t o t he ti me p oi nts o utli ne d i n t he S O A, it is rec o m me n de d t hat vital si g ns be 
m o nit ore d d uri n g a n d after a xica bta ge ne cil ole ucel or S O C t hera p y a n d e ver y 6 h o urs d uri n g a n y 
h os pitalizati o n.  Vital si g ns ma y be m o nit ore d m ore fre q ue ntl y as cli nicall y i n dicate d.
Perf or ma nce stat us as meas ure d b y t he E C O G scale will be perf or me d t o q ua ntif y t he s u bject’s 
ge neral well- bei n g a n d a bilit y t o perf or m acti vities of dail y life.
7. 7.  
Ne ur ol o gic al E x a mi n ati o n
A ne ur ol o gical e xa mi nati o n will be perf or me d wit h a n y a b n or malities of t he f oll o wi n g rec or de d:  
le vel of c o nsci o us ness, orie ntati o n, visi o n, cra nial ner ves a n d brai n ste m f u ncti o ns, p yra mi dal 
a n d e xtra p yra mi dal m ot or s yste m, refle xes, m uscle t o ne a n d tr o p hic fi n di n gs, c o or di nati o n, 
se ns or y s yste m, ne ur o ps yc h ol o gical fi n di n gs (e g, s peec h, c o g niti o n a n d e m oti o n). A ne ur ol o gical 
assess me nt ( w hic h ma y i ncl u de t he Mi ni- Me ntal Stat us E xa m [ M M S E]) s h o ul d be d o ne pri or t o 
a xica bta ge ne cil ole ucel i nf usi o n o n treat me nt da y 0, t he n o n treat me nt da y 1, a n d e ver y ot her da y 
d uri n g t he mi ni m u m 7- da y o bser vati o n peri o d (refer t o A p pe n di x D  f or s pecific re q uire me nts of 
c o u ntr y re g ulat or y a ge ncies re gar di n g d urati o n of o bser vati o n peri o d).
S u bjects will be s pecificall y q uerie d f or ne ur ol o gical s y m pt o ms o bser ve d i n t he i nter val si nce t he 
last baseli ne ne ur ol o gical e xa mi nati o n.
7. 8.  
C ar di ac F u ncti o n
Eac h s u bject’s car diac f u ncti o n, as meas ure d b y left ve ntric ular ejecti o n fracti o n ( L V E F), will be 
assesse d d uri n g t he scree ni n g peri o d t o c o nfir m st u d y eli gi bilit y.  N o e vi de nce of pericar dial 
eff usi o n as re q uire d b y eli gi bilit y will als o be c o nfir me d.  B ot h L V E F a n d pericar dial eff usi o n 
will be assesse d pri or t o st u d y e ntra nce b y E C H O.  A n E C H O perf or me d f oll o wi n g t he s u bjects 
last c he m ot hera p y treat me nt a n d wit hi n 2 8 da ys pri or t o si g ni n g t he c o nse nt ma y be use d f or 
c o nfir mati o n of eli gi bilit y.
T o esta blis h a baseli ne, a 1 2-lea d E C G will als o be perf or me d d uri n g t he scree ni n g peri o d.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 4 9
1 4 A pril 2 0 2 3
7. 9. 
T o xicit y E v al u ati o n
S pecific t o s u bjects w h o are ra n d o mize d i nt o t he a xica bta ge ne cil ole ucel ar m of t he st u d y a n d 
recei ve a xica bta ge ne cil ole ucel as part of t heir i nitial treat me nt, or as part of re-treat me nt, 
s us pecte d relate d t o xicities s h o ul d be e val uate d wit h t he f oll o wi n g:
•
F or ne w o nset s y m pt o ms p ote ntiall y relate d t o C R S, a p h ysical e xa m, a n d assess me nts of 
vital si g ns (i ncl u di n g p ulse o xi metr y) a n d car di o p ul m o nar y stat us s h o ul d be perf or me d.  
Refer t o t he S O A Ta ble 2  f or f urt her details, Secti o n 6. 2. 7 , a n d t he I B f or C R S ma na ge me nt.
•
F or ne w o nset ne ur ol o gic s y m pt o ms, ne ur ol o gic assess me nt s h o ul d be perf or me d at least 
dail y u ntil s y m pt o ms res ol ve t o baseli ne.  F or Gra de ≥ 2 ne ur ol o gical s y m pt o ms, a brai n 
M RI, electr oe nce p hal o gra m ( E E G), a n d e xa mi nati o n of C S F s h o ul d be perf or me d i n a d diti o n 
t o fre q ue nt ne ur ol o gic assess me nt.  A d diti o nal e val uati o ns of t he C S F s h o ul d be perf or me d 
per i nstit uti o nal sta n dar d of care.  C S F sa m ples (ie, if c ollecte d at  baseli ne, a n d c ollecte d o n 
st u d y t o assess ne ur ol o gical s y m pt o ms) will be s u b mitte d t o t he ce ntral la b orat or y.  Refer t o 
t he S O A Ta ble 2  f or f urt her details, Secti o n 6. 2. 7 , a n d t he I B f or ma na ge me nt.
•
F or Gra de ≥ 3 C R S, ne ur ol o gic, or H L H s y m pt o ms, C R P a n d ferriti n le vels s h o ul d be 
e val uate d a n d f oll o we d.
7. 1 0.  
Dise ase Res p o nse Assess me nt
S u bjects will be e val uate d f or disease res p o nse b y t he site i n vesti gat or at ti mes i n dicate d i n t he 
S O A.  Disease assess me nts will be e val uate d per t he L u ga n o Classificati o n { C hes o n 2 0 1 4 }.  
Fl o w c yt o metric, m olec ular, or c yt o ge netic st u dies will n ot be use d t o deter mi ne res p o nse.
7. 1 0. 1. 
I m a gi n g
Scree ni n g fl u or o de o x y gl uc ose ( F D G)- P E T fr o m s k ull base t o mi d-t hi g hs a n d dia g n ostic q ualit y 
c o ntrast-e n ha nce d ( u nless c o ntrai n dicate d) C T fr o m s k ull base t hr o u g h lesser tr oc ha nters 
( P E T- C T), al o n g wit h t he a p pr o priate i ma gi n g of all ot her sites of disease, are re q uire d t o 
c o nfir m eli gi bilit y a n d t o esta blis h a baseli ne, w hic h m ust be perf or me d wit hi n 2 8 da ys pri or t o 
ra n d o mizati o n a n d as cl ose t o t he ra n d o mizati o n date as p ossi ble.  S u bjects will ha ve t heir first 
p ost-treat me nt pla n ne d P E T- C T t u m or assess me nt wit hi n t he Da y 5 0 assess me nt peri o d 
calc ulate d fr o m t he s u bject’s ra n d o mizati o n date.
S u bjects’ disease will f urt her be assesse d a n d at re g ular i nter vals as hi g hli g hte d i n t he S O A 
d uri n g t he p ost treat me nt a n d l o n g-ter m f oll o w- u p p orti o n of t he st u d y.  P E T- C Ts will c o nti n ue 
t hr o u g h M o nt h 9 or u ntil c ha n ge i n l y m p h o ma t hera p y or disease pr o gressi o n, w hic he ver c o mes 
first.  If s u bject’s disease has n ot pr o gresse d b y M o nt h 9, disease assess me nts ca n be e val uate d 
per C T sca ns w here a C R is s us pecte d a n d per P E T- C Ts w here a P R is s us pecte d.  S u bjects wit h 
s y m pt o ms s u g gesti ve of disease pr o gressi o n s h o ul d be e val uate d f or pr o gressi o n at t he ti me 
s y m pt o ms occ ur e ve n if it is off sc he d ule as per t he S O A. P E T- C T ca n be perf or me d at a n y ti me 
disease pr o gressi o n is s us pecte d.  F D G- P E T assess me nt ta kes prece de nce o ver C T assess me nt 
f or ti me p oi nts w he n b ot h are a vaila ble.  If o nl y C T is a vaila ble f or a ti me p oi nt, assess me nt 
s h o ul d i ncl u de a n d ma y be affecte d b y t he P E T- C T assess me nt at t he pri or ti me p oi nt.  Please 
refer t o t he i ma gi n g ma n ual f or f urt her details.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 5 0
1 4 A pril 2 0 2 3
I n a d diti o n t o t he i n vesti gat or’s assess me nt, P E T- C T sca ns of all s u bjects e val uate d f or disease 
res p o nse will be s u b mitte d t o a n d re vie we d b y a n i n de pe n de nt ce ntral re vie wer bli n de d t o 
treat me nt ar m.  F or s u bjects w h o disc o nti n ue pr ot oc ol t hera p y d ue t o a n assess me nt of 
pr o gressi ve disease b ut f or w h o m t here was n o c ha n ge i n l y m p h o ma t hera p y, a n y a d diti o nal 
i ma gi n g data, s u bse q ue nt t o t he i ma ge i n q uesti o n, will be s u b mitte d t o t he ce ntral re vie wer t o 
c o nfir m disease res p o nse.  Re q uire me nts f or P E T- C T sca ns a n d s hi p pi n g re q uire me nts will be 
o utli ne d i n t he st u d y i ma gi n g ma n ual.
If t he s u bject is eli gi ble f or retreat me nt wit h a xica bta ge ne cil ole ucel, t he last sca n pri or t o 
retreat me nt will be c o nsi dere d t he baseli ne f or t he p ur p ose of e val uati n g t he res p o nse t o 
retreat me nt.
7. 1 0. 2. 
B o ne M arr o w Bi o ps y a n d As pir ate
A s u bject’s b o ne marr o w i n v ol ve me nt s h o ul d be c o nfir me d b y P E T- C T or b o ne marr o w bi o ps y 
a n d as pirate pri or t o ra n d o mizati o n.  C o nfir mati o n of marr o w i n v ol ve me nt ca n be deter mi ne d 
u p o n i nitial dia g n osis of disease or if ne gati ve or u n k n o w n at i nitial dia g n osis, at t he ti me of 
rela pse fr o m first-li ne t hera p y.  If b o ne marr o w i n v ol ve me nt was n ot e val uate d at t he ti me of 
rela pse a n d wit hi n 2 8 da ys of st u d y e ntr y, a P E T- C T a n d/ or b o ne marr o w bi o ps y a n d as pirate 
will be perf or me d t o esta blis h a baseli ne.
If t here is e vi de nce of baseli ne b o ne marr o w i n v ol ve me nt, if P E T- C T is n ot a vaila ble or if t here 
are u ne x plai ne d c yt o pe nias or s us pici o n of b o ne marr o w i n v ol ve me nt, a b o ne marr o w as pirate 
a n d bi o ps y will be perf or me d i n s u bjects w h o are bei n g assesse d f or C R i n or der t o c o nfir m 
c o m plete res p o nse.  T he b o ne marr o w as pirate a n d bi o ps y m ust s h o w n o e vi de nce of disease b y 
m or p h ol o g y or, if i n deter mi nate b y m or p h ol o g y, it m ust be ne gati ve b y i m m u n o hist oc he mistr y.  
Refer t o A p pe n di x B  f or treat me nt res p o nse assess me nt re q uire me nts per t he L u ga n o 
Classificati o n { C hes o n 2 0 1 4 }.
7. 1 1.
L a b or at or y
T he bel o w sa m ples will be c ollecte d at t he ti me p oi nts i n dicate d i n t he S O A.  A d diti o nal sa m ples 
(e g, bl o o d, uri ne, C S F, tiss ue) ma y be c ollecte d as nee de d d uri n g t he c o urse of t he st u d y f or 
f urt her safet y testi n g.
7. 1 1. 1. 
L oc al L a b A n al ysis
•
S o di u m ( Na), p otassi u m ( K), c hl ori de ( Cl), bicar b o nate ( C O 2), creati ni ne, gl uc ose, al b u mi n, 
calci u m t otal, ma g nesi u m t otal ( M g), al kali ne p h os p hatase, A L T/ S G P T, A S T/ S G O T, t otal 
bilir u bi n, a nal yze d per t he S O A
•
Baseli ne L D H at scree ni n g fr o m a n o n- he m ol yze d sa m ple t o be use d f or t he assess me nt of 
t he s A AI PI
•
C R P at le u ka p heresis, treat me nt da y 0, treat me nt da ys 1- 7, a n d f or Gra de ≥ 3 C R S, 
ne ur ol o gic, H L H e ve nts.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 5 1
1 4 A pril 2 0 2 3
•
Ferriti n at le u ka p heresis, treat me nt da y 0, treat me nt da ys 1- 7, a n d f or Gra de ≥ 3 C R S, 
ne ur ol o gic, H L H e ve nts.
•
C B C wit h differe ntial a nal yze d per t he S O A
•
A uri ne or ser u m sa m ple will be c ollecte d a n d assesse d l ocall y f or fe males of c hil d beari n g 
p ote ntial.  If t he scree ni n g pre g na nc y test is p ositi ve, t he s u bjects s h o ul d n ot be e nr olle d.  If a 
sta n dar d of care pre g na nc y test is c ollecte d d uri n g t he c o urse of t he st u d y, a n d t he res ult is 
p ositi ve, t he i n vesti gat or s h o ul d c o ntact t he Kite P har ma me dical m o nit or f or i nstr ucti o ns.  If 
a fe male part ner of a male s u bject bec o mes pre g na nt d uri n g t he c o n d uct of t he st u d y, it m ust 
be re p orte d b y c o ntacti n g Kite P har ma me dical m o nit or f or i nstr ucti o ns.
•
Ser ol o g y Testi n g:  F or E ur o pea n U ni o n ( E U) sites, viral ser ol o gic tests (e g, HI V, He p B, He p 
C) will be carrie d o ut per i nstit uti o n g ui deli nes a n d E U re g ulati o ns. T his ma y be d o ne wit hi n 
t he 3 0 da ys pri or t o le u ka p heresis a n d/ or o n t he da y of le u ka p heresis.
7. 1 1. 2.  
Ce ntr al L a b A n al ysis
•
Bl o o d dra ws f or le vels of a nti- C D 1 9 C A R T cells b y q ua ntitati ve p ol y merase c hai n reacti o n 
( q P C R) a nal ysis a n d m o nit ori n g of l y m p h oc ytes s u bsets, i ncl u di n g ret ur n of n or mal B cells, 
will be perf or me d at i nter vals o utli ne d i n t he S O A.
•
Bl o o d dra ws f or re plicati o n-c o m pete nt retr o vir us ( R C R), treat me nt-relate d a nti b o d y 
de vel o p me nt, a n d c yt o ki nes will be perf or me d at i nter vals o utli ne d i n t he S O A or as 
cli nicall y i n dicate d.
•
Arc hi ve d t u m or sa m ples will be s u b mitte d t o ce ntral la b orat or y f or e val uati o n of C D 1 9 
e x pressi o n a n d pr o g n ostic varia bles.  Eit her f or mali n-fi xe d paraffi n-e m be d de d ( F F P E) t u m or 
bl oc k or 3 0 u nstai ne d sli des are re q uire d.  S h o ul d a n arc hi ve d t u m or sa m ple n ot be a vaila ble, 
a fres h t u m or sa m ple is re q uire d pri or t o i nitiati o n of c he m ot hera p y t o c o nti n ue o n st u d y.  
Sli des t hat ha ve bee n pre vi o usl y stai ne d wit h a nti b o dies or ot her rea ge nts are n ot acce pta ble.
•
A d diti o nal a nal ysis ma y i ncl u de C D 1 9 e x pressi o n, ge ne e x pressi o n pr ofili n g, a n d a nal ysis of 
t u m or-s pecific D N A alterati o ns.  Re mai ni n g t u m or sa m ples ma y be st ore d f or f ut ure 
e x pl orat or y a nal ysis of D N A, R N A, or pr otei n mar kers rele va nt t o t his li ne of t hera p y.
7. 1 1. 2. 1. 
Pr o d uct C h ar acteristics
Sa m ples of a p heresis material or fi nal pr o d uct will be retai ne d a n d teste d b y t he s p o ns or or 
s pecialt y la b orat or y f or t he p ur p ose of u n dersta n di n g t he mec ha nis m of acti o n a n d safet y pr ofile 
of a xica bta ge ne cil ole ucel.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 5 2
1 4 A pril 2 0 2 3
7. 1 1. 2. 2.  
R C R Testi n g
A xica bta ge ne cil ole ucel c o m prises T cells tra ns d uce d wit h a γ-retr o viral vect or; he nce, t here is a 
t he oretical ris k f or R C R de vel o pi n g i n e x p ose d s u bjects.  A d diti o nal i nf or mati o n is pr o vi de d i n 
t he I n vesti gat or’s Br oc h ure. T he ti mi n g of bl o o d dra ws f or deter mi nati o n of t he prese nce of R C R 
is s pecifie d i n t he S O A or ma y be d o ne or as cli nicall y i n dicate d.
R C R testi n g will occ ur at baseli ne, st u d y Da y 1 5 0 a n d M o nt h 1 2. T hereafter, sa m ples will be 
c ollecte d yearl y u ntil tra nsiti o n t o t he L T F U st u d y a n d hel d f or u p t o 1 5 years.  If a s u bject tests 
p ositi ve f or R C R at a n y ti me p oi nt wit hi n t he first year, sa m ples will c o nti n ue t o be c ollecte d a n d 
teste d yearl y f or u p t o 1 5 years or as cli nicall y i n dicate d.
7. 1 2. 
P atie nt Re p orte d O utc o mes
All P R Os descri be d bel o w will be c o m plete d b y t he s u bject bef ore a n y pr oce d ures are 
perf or me d, e xcl u di n g bl o o d dra ws, a n d at t he ti me p oi nts n ote d i n t he S O A.
T he s p o ns or will pr o vi de trai ni n g f or rele va nt pers o n nel (e g, ke y i n vesti gat ors) f or t he 
a d mi nistrati o n of t he q uesti o n naires s o t hat s u bjects fill i n t he q uesti o n naires as c o m pletel y a n d 
acc uratel y as p ossi ble.  It is i m p orta nt t hat t he si g nifica nce a n d rele va nce of t he data are 
e x plai ne d caref ull y t o partici pati n g s u bjects s o t hat t he y are m oti vate d t o c o m pl y wit h data 
c ollecti o n { Fall o wfiel d 1 9 8 7 }.  T he meas ures are self-re p orte d, a n d t he s u bject m ust c o m plete 
t he q uesti o n naires i n pri vate a n d s h o ul d n ot be gi ve n hel p fr o m relati ves or cli nic staff; hel p i n 
i nter preti n g t he q uesti o ns is n ot all o we d.
Bel o w is a descri pti o n of eac h patie nt re p orte d o utc o me, w hic h are e x pecte d fr o m all s u bjects 
w h o re mai n o n-st u d y at t he sc he d ule d assess me nts.  All P R O meas ures will be sc ore d usi n g t heir 
p u blis he d a d mi nistrati o n a n d sc ori n g ma n ual.  F or ite ms wit h missi n g res p o nses, t he res p o nse 
will be ma na ge d as per t he sc ori n g ma n ual.
7. 1 2. 1. 
E ur o pe a n Or g a nis ati o n f or Rese arc h a n d Tre at me nt of C a ncer ( E O R T C) 
Q L Q- C 3 0 Versi o n 3. 0.
T his meas ure pr o vi des a m ulti- di me nsi o nal assess me nt of healt h-relate d q ualit y of life ( H R Q o L).  
T he E ur o pea n Or ga nisati o n f or Researc h a n d Treat me nt of Ca ncer ( E O R T C) Q ualit y of Life 
Q uesti o n naire Ca ncer ( Q L Q- C 3 0 versi o n 3. 0 i ncl u des t he f oll o wi n g c o nte nt:
•
Fi ve ( 5) m ulti-ite m f u ncti o nal scales ( p h ysical f u ncti o ni n g, r ole f u ncti o ni n g, e m oti o nal 
f u ncti o ni n g, c o g niti ve f u ncti o ni n g, s ocial f u ncti o ni n g)
•
T hree ( 3) m ulti-ite m s y m pt o m scales (fati g ue, na usea a n d v o miti n g, pai n)
•
Si x ( 6) s y m pt o m si n gle-ite m scales ( d ys p nea, i ns o m nia, a p petite l oss, c o nsti pati o n, diarr hea, 
fi na ncial diffic ulties)
•
O ne ( 1) Gl o bal Healt h Stat us scale a n d
•
O ne ( 1) Gl o bal H R Q o L scale


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 5 3
1 4 A pril 2 0 2 3
Eac h scale is meas ure d fr o m 0 t o 1 0 0 after a li near tra nsf or mati o n.  Hi g her sc ores f or f u ncti o ni n g 
scales a n d f or t he Gl o bal Healt h Stat us or Gl o bal H R Q o L scales i n dicate a hi g her le vel of 
f u ncti o ni n g a n d a better H R Q o L res pecti vel y, w hereas hi g her sc ores i n s y m pt o m scales re prese nt 
a hi g her le vel of s y m pt o ms.
T his i nstr u me nt d oes n ot s u m t o get her all ite ms t hat ca n p ote ntiall y gr o u p differe nces a n d all o ws 
a n assess me nt of c ha n ge acr oss t he 1 5 differe nt d o mai ns.  I n its c urre nt versi o n ( versi o n 3), t he 
q uesti o n naire ta kes a p pr o xi matel y 1 1 mi n utes t o c o m plete.
7. 1 2. 2. 
E ur o Q ol Fi ve Di me nsi o ns Q uesti o n n aire ( E Q- 5 D- 5 L)
T he E ur o- Q O L, Fi ve Di me nsi o ns, Fi ve Le vels ( E Q- 5 D- 5 L) q uesti o n naire is a ge neric meas ure of 
healt h stat us t hat pr o vi des a si m ple descri pti ve pr ofile a n d a si n gle i n de x val ue.  T he E Q- 5 D- 5 L 
c o m prises 2 c o m p o ne nts:  a q uesti o n naire c o veri n g 5 di me nsi o ns a n d a tariff of val ues base d 
u p o n direct val uati o ns of healt h states usi n g a vis ual a nal o g scale ( V A S).
T he E Q- 5 D- 5 L V A S is a 2 0-c m V A S f or rec or di n g self-rate d c urre nt H R Q o L state a n d is use d t o 
descri be t he s u bjects’ healt h stat us o n t he da y of t he assess me nt.  T he E Q- 5 D- 5 L V A S sc ore is 
rec or de d b y eac h s u bject f or his or her c urre nt H R Q o L state a n d sc ore d 0 (“t he w orst healt h y o u 
ca n i ma gi ne”) t o 1 0 0 (“t he best healt h y o u ca n i ma gi ne”).
T his q uesti o n naire ta kes a p pr o xi matel y 5 mi n utes t o c o m plete.
7. 1 2. 3.  
W or k Pr o d ucti vit y a n d Acti vit y I m p air me nt Q uesti o n n aire ( W P AI)
T he W or k Pr o d ucti vit y a n d Acti vit y I m pair me nt Q uesti o n naire ( Ge neral Healt h V 2. 0 
[ W P AI: G H]; see A p pe n di x C ) meas ures w or k a n d acti vit y i m pair me nt d uri n g t he past 7 da ys.  It 
c o ntains 2 d o mai ns:  w or k a n d acti vit y.
•
T he w or k d o mai n i ncl u des 5 ite ms t hat as k t he s u bject a b o ut h o w ma n y h o urs of w or k were 
misse d d ue t o healt h pr o ble ms, h o w ma n y h o urs of w or k misse d d ue t o ot her reas o ns, h o w 
ma n y h o urs t he s u bject w or ke d, a n d h o w healt h pr o ble ms ma y ha ve affecte d pr o d ucti vit y.
•
T he acti vit y d o mai n c o ntai ns a si n gle ite m t hat as ks t he s u bject h o w healt h pr o ble ms affecte d 
his or her a bilit y t o d o re g ular acti vities o utsi de of t heir w or k.
T he W P AI yiel ds 4 t y pes of sc ores: a bse nteeis m, prese nteeis m, w or k pr o d ucti vit y l oss, a n d 
acti vit y i m pair me nt.  W P AI o utc o mes are e x presse d as i m pair me nt perce nta ges, wit h hi g her 
n u m bers i n dicati n g greater i m pair me nt a n d less pr o d ucti vit y.
T his q uesti o n naire ta kes a p pr o xi matel y 2 t o 3 mi n utes t o c o m plete.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 5 4
1 4 A pril 2 0 2 3
7. 1 3. 
Bi o m ar kers
Bi o mar ker a nal ysis will be perf or me d o n pr o d uct, bl o o d, a n d t u m or sa m ples t o e val uate 
pre dicti ve, p har mac o ki netic ( P K), a n d p har mac o d y na mic mar kers f or a xica bta ge ne cil ole ucel.
A F F P E t u m or bl oc k or 3 0 u nstai ne d sli des are re q uire d.  S h o ul d a n arc hi ve d t u m or sa m ple n ot 
be a vaila ble, a fres h t u m or sa m ple is re q uire d pri or t o start of c he m ot hera p y t o c o nti n ue o n 
st u d y.  Sli des t hat ha ve bee n pre vi o usl y stai ne d wit h a nti b o dies or ot her rea ge nts are n ot 
acce pta ble.
T u m or tiss ue a nal ysis will i ncl u de e val uati o n of C D 1 9 e x pressi o n b y i m m u n o hist oc he mistr y 
(I H C), ge ne e x pressi o n pr ofili n g f or cell of ori gi n a nal ysis, a n d ce ntral a nal ysis of D N A 
alterati o ns f or s u b-classificati o n of D L B C L d o u ble- a n d tri ple- hit stat us.  Re mai ni n g sa m ples 
ma y be st ore d f or f ut ure e x pl orat or y a nal ysis of t u m or D N A, R N A, or pr otei n mar kers rele va nt 
t o t his li ne of t hera p y.
A d diti o nal cli nical s peci me ns ma y be o btai ne d as nee de d t o assess safet y i n s u bjects or if n o vel 
fi n di n gs are o bser ve d i n t his st u d y.
F or s u bjects ra n d o mize d t o t he a xica bta ge ne cil ole ucel ar m:
•
Bl o o d dra ws f or le vels of a nti ‑ C D 1 9 C A R T cells i n bl o o d
•
Bl o o d dra ws f or e val uati o n of ser u m c yt o ki nes a n d c he m o ki nes.  T he f oll o wi n g c yt o ki nes 
ma y be i ncl u de d i n t he pa nel:  h o me ostatic, pr o-i nfla m mat or y a n d i m m u ne m o d ulati n g 
c yt o ki nes I L- 2, I L- 6, I L- 1 0, I L- 1 2 p 4 0/ p 7 0, I L- 1 5, I L- 1 7a, t u m or necr osis fact or ( T N F)- α, 
I F N-γ, G M- C S F, a n d C R P, H L H relate d mar kers ferriti n a n d I L- 2 R α a n d c he m o ki nes 
MI P- 1 α, MI P- 1 β, a n d I L- 8.
•
C S F, a n d a d diti o nal s u bject sa m ples (e g, ple ural fl ui d), will be o btai ne d fr o m s u bjects w h o 
de vel o p Gra de ≥ 2 ne ur ol o gic e ve nts t o e na ble e val uati o n of i nfla m mat or y c yt o ki ne a n d 
c he m o ki ne le vels a n d als o prese nce of a nti- C D 1 9 C A R T cells.  As a p plica ble, l y m p h oc yte 
p o p ulati o ns resi di n g i n t he C S F, or ot her s u bject sa m ples, ma y als o be m o nit ore d f or t he 
p ur p ose of u n dersta n di n g t he safet y pr ofile of a xica bta ge ne cil ole ucel.
•
Bl o o d dra ws f or R C R a nal ysis (see Secti o n 7. 1 1. 2. 2 ).
•
A baseli ne ser u m  sa m ple a n d a d diti o nal ser u m sa m ples o utli ne d i n t he S O A ma y be a nal yze d 
f or de vel o p me nt of a nti b o dies if a treat me nt-relate d h y perse nsiti vit y reacti o n is o bser ve d.
•
Baseli ne le u ka p heresis a n d fi nal a xica bta ge ne cil ole ucel sa m ples will be c ollecte d a n d 
a nal yze d b y i m m u n o p he n ot y pi n g, q P C R, a n d/ or ge ne e x pressi o n pr ofili n g.  Re mai ni n g 
sa m ples ma y be st ore d f or f ut ure e x pl orat or y a nal ysis of i m m u ne-relate d mar kers a n d t o ai d 
i n t he u n dersta n di n g of t he safet y a n d efficac y pr ofile of a xica bta ge ne cil ole ucel.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 5 5
1 4 A pril 2 0 2 3
All me nti o ne d sa m ples a n d a n y ot her deri vati ves fr o m t hese sa m ples ma y be st ore d f or u p t o 
1 5 years t o a d dress e x pl orat or y researc h scie ntific q uesti o ns relate d t o t he treat me nt or disease 
u n der st u d y.  Eac h s u bject will ha ve t he ri g ht t o ha ve t he sa m ple material destr o ye d at a n y ti me 
b y c o ntacti n g t he i n vesti gat or w h o, i n t ur n, ca n c o ntact t he ce ntral la b orat or y.  T he i n vesti gat or 
s h o ul d pr o vi de t he s p o ns or wit h t he st u d y a n d s u bject n u m ber s o t hat t he sa m ple ca n be l ocate d 
a n d destr o ye d.
F or s u bjects w h o wit h dra w c o nse nt, a n y sa m ples t hat were n ot re q ueste d t o be ret ur ne d or 
destr o ye d will re mai n wit h t he s p o ns or, a n d a n y data t hat ma y be ge nerate d will be e ntere d i n t he 
st u d y data base.
7. 1 4. 
P ost-tre at me nt F oll o w- u p
After c o m pleti n g st u d y treat me nt, all s u bjects will ret ur n t o t he cli nic f or p ost-treat me nt f oll o w-
u p visits.
F or s u bjects ra n d o mize d t o t he a xica bta ge ne cil ole ucel ar m of t he st u d y, if at a n y ti me d uri n g t he 
p ost-treat me nt assess me nt peri o d a s u bject di d n ot res p o n d t o treat me nt, t he s u bject will c o nti n ue 
t o u n der g o f oll o w- u p pr oce d ures a n d t he n be f oll o we d f or s ur vi val a n d disease o utc o mes i n t he 
l o n g-ter m f oll o w- u p p orti o n of t he st u d y.
S u bjects ra n d o mize d t o t he S O C ar m a n d w h o res p o n d t o S O C t hera p y after 2 or 3 c ycles 
( defi ne d as ac hie vi n g a P R or C R) s h o ul d pr ocee d t o H D T a n d A S C T per i nstit uti o nal or nati o nal 
g ui deli nes as o utli ne d i n Secti o n 6. 3. 1. 1 .  S u bjects w h o are ali ve a n d d o n ot ha ve d oc u me nte d 
disease pr o gressi o n will  c o nti n ue t o be f oll o we d f or disease pr o gressi o n.
Refer t o t he S O As f or a listi n g of st u d y pr oce d ures a n d disease assess me nts t o be c o m plete d 
d uri n g t he p ost-treat me nt f oll o w- u p peri o d.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 5 6
1 4 A pril 2 0 2 3
T a ble 2.
Sc he d ule of Assess me nts A xic a bt a ge ne Cil ole ucel Ar m
Pr oce d ures
Scree ni n g
Le u k a p heresis
C o n diti o ni n g 
C he m ot her a p y
I P A d mi nistr ati o n
P ost Tre at me nt F oll o w- u p
All P ost Tre at me nt visits are c alc ul ate d 
fr o m d ate of  r a n d o miz ati o n
D a y
Wit hi n 1 4 d a ys 
of 
r a n d o miz ati o n
R a n d o miz ati o n
Wit hi n a p pr o x. 
5 d a ys after 
r a n d o miz ati o n
d- 5
d- 4
d- 3
d- 2
d- 1
Tre at me nt
d 0
d 1 – 7 m
D a y 5 0
(- 7 t o + 2 1 d a ys)
D a y 1 0 0
( ± 1 4 d a ys)
D a y 1 5 0
( ± 1 4 d a ys)
Me dical hist or y 
X
P h ysical e xa m a
X
X
X
X
Ne ur ol o gical assess me nt
X
X b
Q O D b
X
Wei g ht ( pl us hei g ht at 
scree ni n g)
X
X 
Vital si g ns ( B P, H R, R R, O 2 
sat, te m p)
X
X
X
X
X
E C O G perf or ma nce stat us
X
E C G
X
E C H O c
X
P E T- C T disease assess me nt d
P E T- C T d
P E T- C T
P E T- C T
P E T- C T
Arc hi ve d t u m or sa m ple e
X e
Pre g na nc y test (ser u m or 
uri ne)
X
X
Bl o o d dra w f or c he mistr y 
pa nel
X
X
X
X
X
X
X
X
Bl o o d dra w f or C B C 
w/ differe ntial
X
X
X
X
X
X
X
X
Bl o o d dra w f or a nti-
a xica bta ge ne cil ole ucel 
a nti b o dies f
X
X f
Bl o o d dra w f or L D H
X
I X R S/ Ra n d o mizati o n call
X
L u m bar P u nct ure g
X g
Bl o o d dra w f or C R P/ Ferriti n
X
X
X


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 5 7
1 4 A pril 2 0 2 3
Pr oce d ures
Scree ni n g
Le u k a p heresis
C o n diti o ni n g 
C he m ot her a p y
I P A d mi nistr ati o n
P ost Tre at me nt F ol l o w- u p
All P ost Tre at me nt visits are c alc ul ate d 
fr o m d ate of  r a n d o miz ati o n
D a y
Wit hi n 1 4 d a ys 
of 
r a n d o miz ati o n
R a n d o miz ati o n
Wit hi n a p pr o x. 
5 d a ys after 
r a n d o miz ati o n
d- 5
d- 4
d- 3
d- 2
d- 1
Tre at me nt
d 0
d 1 – 7 m
D a y 5 0
(- 7 t o + 2 1 d a ys)
D a y 1 0 0
( ± 1 4 d a ys)
D a y 1 5 0
( ± 1 4 d a ys)
Bl o o d dra w f or P B M Cs a n d 
a d diti o nal a nal ysis h
X
d 1, 3 & 
7 h 
X h
X h
X h
Bl o o d dra w f or c yt o ki nes h
X
X
d 1, 3 & 
7 h  
X h 
X h
Bl o o d dra w f or ser ol o g y ( E U 
sites)l
X l
X l
E O R T C Q L Q- C 3 0 i
X
X
X
X
X 
X
E Q- 5 D- 5 L i
X
X
X
X
X 
X
W P AI
i
X
X
X
X
X 
X
Le u ka p heresis 
X
Fl u dara bi ne/ C ycl o p h os p ha mi d
e
X
X
X
A xica bta ge ne cil ole ucel 
i nf usi o n I V
X
A d verse e ve nts j/ C o nc o mita nt 
me dicati o n k 
X
X
X
X
X
X
X
X
X
X
X
 X
A b bre viati o ns:  D, da y; I P, i n vesti gati o nal pr o d uct; B P, bl o o d press ure; H R, heart rate; E C O G, Easter n C o o perati ve O nc ol o g y Gr o u p; E C G, electr ocar di o gra m; E C H O, 
ec h ocar di o gra m; P E T- C T, p ositr o n e missi o n t o m o gra p h y c o m p uter t o m o gra p h y; C B C, c o m plete bl o o d c o u nt; L D H, lactate de h y dr o ge nase; I X R S, I nteracti ve V oice/ We b ( X) 
Res p o nse S yste m; C R P, C-reacti ve pr otei n; P B M C, peri p heral bl o o d m o n o n uclear cell; E O R T C Q L Q- C 3 0, E ur o pea n Or ga nisati o n f or Researc h a n d Treat me nt of Ca ncer Q ualit y 
of Life Q uesti o n naire Ca ncer- 3 0; E Q- 5 D- 5 L, E ur o- Q O L, Fi ve Di me nsi o ns, Fi ve Le vels; W P AI, W or k pr o d ucti vit y a n d acti vit y i m pair me nt q uesti o n naire.
a 
P h ysical E xa m: S u bjects wit h ne w- o nset s y m pt o ms relate d t o C R S s h o ul d u n der g o p h ysical e xa mi nati o n at least dail y u ntil s y m pt o ms res ol ve t o baseli ne.  S u bjects wit h 
s y m pt o ms of ce ntral ner v o us s yste m mali g na nc y s uc h as ne w o nset se vere hea dac hes, nec k stiff ness, seiz ures, e nce p hal o pat h y, cra nial ner ve deficits, or a n y f ocal ne ur ol o gic 
fi n di n gs o n p h ysical e xa m will ha ve a brai n M RI a n d l u m bar p u nct ure f or e xa mi nati o n of cere bral s pi nal fl ui d.
b  
Ne ur ol o gic assess me nt: A ne ur ol o gical assess me nt s h o ul d be d o ne pri or t o a xica bta ge ne cil ole ucel i nf usi o n o n treat me nt da y 0, t he n o n treat me nt da y 1 a n d e ver y ot her da y 
d uri n g t he mi ni m u m 7- da y o bser vati o n peri o d.  F or ne w o nset of ne ur ol o gic s y m pt o ms, ne ur ol o gic assess me nt s h o ul d be perf or me d at least dail y u ntil s y m pt o ms res ol ve t o 
baseli ne.
c 
Ec h o: Perf or me d f oll o wi n g t he s u bjects last c he m ot hera p y treat me nt a n d wit hi n 2 8 da ys pri or t o si g ni n g t he c o nse nt ma y be use d f or c o nfir mati o n of eli gi bilit y
d 
P E T- C T disease assess me nt:  P E T- C T s h o ul d be perf or me d as cl ose t o ra n d o mizati o n as p ossi ble a n d wit hi n 2 8 da ys pri or t o ra n d o mizati o n. If b o ne marr o w i n v ol ve me nt was 
n ot e val uate d at t he ti me of rela pse a n d wit hi n 2 8 da ys of st u d y e ntr y, a P E T- C T or a b o ne marr o w bi o ps y will be perf or me d t o esta blis h a baseli ne. P E T- C T s hall be 
perf or me d at a n y ti me disease pr o gressi o n is s us pecte d. If t here is e vi de nce of baseli ne b o ne marr o w i n v ol ve me nt, if P E T- C T is n ot a vaila ble or if t here are u ne x plai ne d 
c yt o pe nias or s us pici o n of b o ne marr o w i n v ol ve me nt, a b o ne marr o w as pirate a n d bi o ps y will be perf or me d i n s u bjects w h o are bei n g assesse d f or C R i n or der t o c o nfir m 
c o m plete res p o nse.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 5 8
1 4 A pril 2 0 2 3
e  
Arc hi ve d t u m or sa m ple:  Arc hi ve d t u m or sa m ples will be s u b mitte d t o ce ntral la b orat or y f or e val uati o n of C D 1 9 e x pressi o n a n d pr o g n ostic varia bles. Eit her F F P E t u m or 
bl oc k or 3 0 u nstai ne d sli des are re q uire d.  S h o ul d a n arc hi ve d t u m or sa m ple n ot be a vaila ble, a fres h t u m or sa m ple is re q uire d pri or t o start of c he m ot hera p y t o c o nti n ue o n 
st u d y. Sli des t hat ha ve bee n pre vi o usl y stai ne d wit h a nti b o dies or ot her rea ge nts are n ot acce pta ble.  Scree n faile d s u bjects’ arc hi ve d sa m ples s h o ul d n ot be s u b mitte d.
f 
Bl o o d dra w f or a nti-a xica bta ge ne cil ole ucel a nti b o dies: Baseli ne a nti b o d y sa m ples t o be c ollecte d pri or t o start of le u ka p heresis.  If p ositi ve at baseli ne or Da y 5 0 a d diti o nal 
sa m ples will be c ollecte d e ver y 3 m o nt hs u ntil titers ret ur n t o baseli ne or u p t o 1 2 m o nt hs p ost a xica bta ge ne cil ole ucel i nf usi o n.
g
L u m bar P u nct ure:  S u bjects wit h ne w o nset Gra de ≥ 2 ne ur ol o gic s y m pt o ms p ost a xica bta ge ne cil ole ucel i nf usi o n will ha ve l u m bar p u nct ure perf or me d t o assess cere bral 
s pi nal fl ui d.
h 
Bl o o d dra ws f or P B M Cs, c yt o ki nes, a n d a d diti o nal a nal ysis per Secti o n 7. 1 1. 2 : P B M C bl o o d will be use d f or t he a nal ysis of tests t hat i ncl u de a nti- C D 1 9 C A R T cells, 
l y m p h oc ytes, a n d R C R, a n d will be c ollecte d at baseli ne ( pri or t o i nitiati o n of c o n diti o ni n g c he m ot hera p y), da y 1, 3, 7 a n d st u d y Da ys 5 0, 1 0 0, a n d 1 5 0.  Bl o o d dra ws f or 
c yt o ki nes will be c ollecte d at baseli ne ( pri or t o i nitiati o n of c o n diti o ni n g c he m ot hera p y), treat me nt da y 0, 1, 3, 7, a n d st u d y Da ys 5 0 a n d 1 5 0.  Bl o o d dra ws f or R C R will be 
c ollecte d at baseli ne, st u d y Da y 1 5 0, a n d t he n per L T F U S O A.  If, f oll o wi n g t he mi ni m u m 7- da y o bser vati o n peri o d, t he s u bject is a d mitte d t o t he h os pital wit h a n y 
a xica bta ge ne cil ole ucel relate d a d verse e ve nts, bl o o d sa m ples f or a nti- C D 1 9 C A R T cells a n d c yt o ki nes will be c ollecte d o n da y of a d missi o n, t he n wee kl y, a n d o n da y of 
disc har ge. If t he s u bject e x perie nces a Gra de ≥3 a xica bta ge ne cil ole ucel-relate d t o xicit y s uc h as Gra de 3 C R S or ne ur ol o gic e ve nt, o ne a d diti o nal bl o o d dra w f or c yt o ki nes 
will be ta ke n at t he ti me of t he Gra de ≥3 a xica bta ge ne cil ole ucel-relate d t o xicit y a n d u p o n res ol uti o n of t he e ve nt.  Bl o o d a n d ser u m sa m ples ma y als o be use d f or f urt her 
a nti- C D 1 9 C A R T cell, R C R a n d i m m u n o ge nicit y e val uati o n as cli nicall y i n dicate d.
i 
E O R T C Q L Q- C 3 0/ E Q- 5 D- 5 L/ W P AI: T o be c o m plete d b y t he s u bject bef ore a n y pr oce d ures are perf or me d-e xcl u di n g bl o o d dra ws.
j  
A d verse E ve nts: T he i n vesti gat or is res p o nsi ble f or re p orti n g all a d verse e ve nts o bser ve d b y t he i n vesti gat or or re p orte d b y t he s u bject t hat occ ur after ra n d o mizati o n t hr o u g h 
t he Da y 1 5 0 p ost-ra n d o mizati o n visit or u ntil t he i nitiati o n of ne w l y m p h o ma t hera p y, w hic he ver occ urs first.
k 
C o nc o mita nt me dicati o ns s h o ul d be rec or de d fr o m t he date of t he i nf or me d c o nse nt t hr o u g h t he Da y 1 5 0 p ost-ra n d o mizati o n visit, a n d tar gete d c o nc o mita nt t hera pies fr o m 
t his visit u ntil M o nt h 1 2, or u ntil a c ha n ge i n l y m p h o ma t hera p y, or disease pr o gressi o n w hic he ver occ urs first.
l 
F or E ur o pea n U ni o n ( E U) sites, viral ser ol o gic tests (e g, HI V, He p B, He p C) will be carrie d o ut per i nstit uti o n g ui deli nes a n d E U re g ulati o ns. T his ma y be d o ne wit hi n t he 
3 0 da ys pri or t o le u ka p heresis a n d/ or o n t he da y of le u ka p heresis.
m 
S u bjects will be m o nit ore d dail y t hr o u g h da y 7 after treat me nt wit h a xica bta ge ne cil ole ucel u nless ot her wise re q uire d b y c o u ntr y re g ulat or y a ge ncies (refer t o A p pe n di x D ). 
All assess me nts descri be d i n t his ta ble f or da y 1- 7, are a p plica ble bet wee n da ys 7 a n d 1 0 if re q uire d b y c o u ntr y re g ulat or y a ge ncies.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 5 9
1 4 A pril 2 0 2 3
T a ble 3.
Sc he d ule of Assess me nts S O C C he m ot her a p y Ar m
P ost Tre at me nt visits are c alc ul ate d 
fr o m d ate of r a n d o miz ati o n
Pr oce d ures
Scree ni n g
Tre at me nt Peri o d
C ycle 1 a n d C ycle 2
Dise ase Assess me nt
c alc ul ate d fr o m d ate 
of r a n d o miz ati o n
Tre at me nt Peri o d
H D T- A S C T or 
C ycle 3 – H D T-
A S C T ( o pti o n al)
P ost H D T- A S C T
P ost T x F U
D a y
Wit hi n 1 4 
d a ys of 
r a n d o miz ati o n
R a n d o miz ati o n
C ycle 1
Wit hi n 
a p pr o x. 5 d a ys 
after 
r a n d o miz ati o n
C ycle 2
D a y 5 0
(- 7 t o + 2 1 d a ys)
H D T- A S C T or 
C ycle 3- H D T-
A S C T
D 1 0 0
( ± 1 4 d a ys)
D a y 1 5 0
( ± 1 4 d a ys)
Me dical hist or y
X
P h ysical e xa m a
X
X
X
X
Ne ur ol o gical assess me nt
X
X
Wei g ht ( pl us hei g ht at scree ni n g)
X
Vital si g ns ( B P, H R, R R, O 2 sat, 
te m p)
X
X
X
X
E C O G perf or ma nce stat us
X
E C G
X
E C H O b
X
P E T- C T disease assess me nt c
P E T- C T c
P E T- C T
P E T- C T
P E T- C T
Arc hi ve d t u m or sa m ple d
X
Pre g na nc y test (ser u m or uri ne)
X
X
Bl o o d dra w f or c he mistr y pa nel
X
X
X
X
X
X
X
Bl o o d dra w f or C B C w/ differe ntial
X
X
X
X
X
X
X
Bl o o d dra w f or L D H
X
Bl o o d dra w f or a d diti o nal a nal ysis j
X
X
X
X
I X R S / Ra n d o mizati o n call
X
E O R T C Q L Q- C 3 0 e
X
X
X
da y of tra ns pla nt
X
X
E Q- 5 D- 5 L e
X
X
X
da y of tra ns pla nt
X
X
W P AI
e
X
X
X
da y of tra ns pla nt
X
X 
S O C c he m ot hera p y f
X
X
X ( C ycle 3 is 
o pti o nal)


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 6 0
1 4 A pril 2 0 2 3
P ost Tre at me nt visits are  c alc ul ate d 
fr o m d ate of r a n d o miz ati o n
Pr oce d ures
Scree ni n g
Tre at me nt Pe ri o d
C ycle 1 a n d C ycle 2
Dise ase Asse ss me nt
c alc ul ate d fr o m d ate 
of r a n d o miz ati o n
Tre at me nt Pe ri o d
H D T- A S C T or 
C ycle 3 – H D T-
A S C T ( o pti o n al)
P ost H D T- A S C T
P ost T x F U
D a y
Wit hi n 1 4 
d a ys of 
r a n d o miz ati o n
R a n d o miz ati o n
C ycle 1
Wit hi n 
a p pr o x. 5 d a ys 
after 
r a n d o miz ati o n
C ycle 2
D a y 5 0
(- 7 t o + 2 1 d a ys)
H D T- A S C T or 
C ycle 3- H D T-
A S C T
D 1 0 0
( ± 1 4 d a ys)
D a y 1 5 0
( ± 1 4 d a ys)
Le u ka p heresis g
X g
H D T g
X g
C D 3 4 +  ste m cell i nf usi o ng
X g
A d verse e ve nts h/ C o nc o mita nt 
me dicati o n i
X
X
X
X
X
X
X
A b bre viati o ns:  H D T, hi g h- d ose t hera p y; A S C T, a ut ol o g o us ste m cell tra ns pla nt; T x, treat me nt; F U, f oll o w- u p; B P, bl o o d press ure; H R, heart rate; E C O G, Easter n C o o perati ve 
O nc ol o g y Gr o u p; E C G, electr ocar di o gra m; E C H O, ec h ocar di o gra m; P E T- C T, p ositr o n e missi o n t o m o gra p h y c o m p uter t o m o gra p h y; C B C, c o m plete bl o o d c o u nt; L D H, lactate 
de h y dr o ge nase; I X R S, I nteracti ve V oice/ We b ( X) Res p o nse S yste m; E O R T C Q L Q- C 3 0, E ur o pea n Or ga nisati o n f or Researc h a n d Treat me nt of Ca ncer Q ualit y of Life 
Q uesti o n naire Ca ncer- 3 0; E Q- 5 D- 5 L, E ur o- Q O L, Fi ve Di me nsi o ns, Fi ve Le vels; W P AI, W or k pr o d ucti vit y a n d acti vit y i m pair me nt q uesti o n naire; S O C, sta n dar d of care.
a 
P h ysical E xa m: S u bjects wit h s y m pt o ms of ce ntral ner v o us s yste m mali g na nc y s uc h as ne w o nset se vere hea dac hes, nec k stiff ness, seiz ures, e nce p hal o pat h y, cra nial ner ve 
deficits, or a n y f ocal ne ur ol o gic fi n di n gs o n p h ysical e xa m will ha ve l u m bar p u nct ure f or e xa mi nati o n of cere bral s pi nal fl ui d.
b 
Ec h o: Perf or me d f oll o wi n g t he s u bjects last c he m ot hera p y treat me nt a n d wit hi n 2 8 da ys pri or t o si g ni n g t he c o nse nt ma y be use d f or c o nfir mati o n of eli gi bilit y.
c 
P E T- C T disease assess me nt:  P E T- C T s h o ul d be perf or me d as cl ose t o ra n d o mizati o n as p ossi ble a n d wit hi n 2 8 da ys pri or t o ra n d o mizati o n. If b o ne marr o w i n v ol ve me nt 
was n ot e val uate d at t he ti me of rela pse a n d wit hi n 2 8 da ys of st u d y e ntr y, a P E T- C T or a b o ne marr o w bi o ps y will be perf or me d t o esta blis h a baseli ne. P E T- C T s h o ul d be 
perf or me d at a n y ti me disease pr o gressi o n is s us pecte d. If t here is e vi de nce of baseli ne b o ne marr o w i n v ol ve me nt, if P E T- C T is n ot a vaila ble or if t here are u ne x plai ne d 
c yt o pe nias or s us pici o n of b o ne marr o w i n v ol ve me nt, a b o ne marr o w as pirate a n d bi o ps y will be perf or me d i n s u bjects w h o are bei n g assesse d f or C R i n or der t o c o nfir m 
c o m plete res p o nse.
d 
 Arc hi ve d t u m or sa m ple:  Arc hi ve d t u m or sa m ples will be s u b mitte d t o ce ntral la b orat or y f or pr o g n ostic varia bles. Eit her F F P E t u m or bl oc k or 3 0 u nstai ne d sli des are 
re q uire d.  S h o ul d a n arc hi ve d t u m or sa m ple n ot be a vaila ble, a fres h t u m or sa m ple is re q uire d pri or t o t he start of sec o n d-li ne c o m bi nati o n c he m ot hera p y re gi me n t o c o nti n ue 
o n st u d y. Sli des t hat ha ve bee n pre vi o usl y stai ne d wit h a nti b o dies or ot her rea ge nts will n ot be acce pta ble f or st u d y e ntra nce. Scree n faile d s u bjects’ arc hi ve d sa m ples s h o ul d 
n ot be s u b mitte d.
e 
E O R T C Q L Q- C 3 0/ E Q- 5 D- 5 L/ W P AI: T o be c o m plete d b y t he s u bject bef ore a n y pr oce d ures are perf or me d-e xcl u di n g bl o o d dra ws.
f 
S O C D osi n g a n d A d mi nistrati o n Refer t o Secti o n 6. 3. 1  f or i n vesti gat or c h oice of S O C re gi me ns a n d d osi n g details.  If a de q uate disease res p o nse ( C R or P R) is de m o nstrate d 
after t he sec o n d or t hir d c ycle of c he m ot hera p y, H D T- A S C T ma y be i nitiate d.
g 
Le u ka p heresis, H D T, a n d C D 3 4 + ste m cell i nf usi o n pr oce d ures perf or me d f or s u bjects u n der g oi n g H D T- A S C T o nl y.  T his occ urs if a de q uate disease res p o nse ( C R or P R) is 
de m o nstrate d after t w o or t hree c ycles of c he m ot hera p y.
h  
A d verse E ve nts: T he i n vesti gat or is res p o nsi ble f or re p orti n g all a d verse e ve nts o bser ve d b y t he i n vesti gat or or re p orte d b y t he s u bject t hat occ ur after ra n d o mizati o n t hr o u g h 
t he Da y 1 5 0 p ost-ra n d o mizati o n visit or u ntil t he i nitiati o n of ne w l y m p h o ma t hera p y, w hic he ver occ urs first.
i 
C o nc o mita nt me dicati o ns will o nl y be rec or de d fr o m t he date of t he i nf or me d c o nse nt t hr o u g h 3 0 da ys after t he last st u d y s pecific pr oce d ure.
j 
Bl o o d dra ws f or a d diti o nal a nal yses per Secti o n 7. 1 1. 2 .


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 6 1
1 4 A pril  2 0 2 3
7. 1 5. 
L o n g-ter m F oll o w- u p ( A xic a bt a ge ne Cil ole ucel a n d St a n d ar d of C are Ar ms)
All s u bjects will be f oll o we d i n t he l o n g-ter m f oll o w- u p peri o d f or disease assess me nts a n d 
s ur vi val stat us per t he S O A (Ta ble 4 ) u ntil t he tra nsiti o n t o t he se parate L T F U st u d y. S u bjects 
will be gi n t he l o n g-ter m f oll o w- u p peri o d be gi n ni n g at t he M o nt h 9 visit a n d will be assesse d as 
f oll o ws:
•
E ver y 3 m o nt hs ( ± 2 8 da ys) t hr o u g h M o nt h 2 4
•
E ver y 6 m o nt hs ( ± 2 8 da ys) bet wee n M o nt h 2 4 a n d M o nt h 6 0
S O C Ar m O nl y:
•
All s u bjects i n t he S O C ar m will disc o nti n ue partici pati o n i n t he st u d y after c o m pleti o n of 
t he M o nt h 6 0 visit a n d assess me nts.
A xic a bt a ge ne Cil ole ucel Ar m O nl y:
•
After M o nt h 6 0, all s u bjects w h o recei ve d at least o ne d ose of a xica bta ge ne cil ole ucel as 
pr ot oc ol t hera p y will ret ur n t o t he cli nic o nce a n n uall y f or u p t o 1 5 years .
•
All s u bjects w h o recei ve d at least o ne d ose of a xica bta ge ne cil ole ucel  as pr ot oc ol t hera p y 
will be tra nsiti o ne d t o t he se parate L T F U st u d y after pr o vi di n g si g ne d i nf or me d c o nse nt f or 
t he L T F U st u d y a n d after c o m pleti n g at least 6 0 m o nt hs of assess me nts i n t he pare nt st u d y, 
K T E- C 1 9- 1 0 7. U ntil t his ti me p oi nt, s u bjects will c o m plete t he p ost-treat me nt f oll o w u p 
peri o d as per t he S O A ( Ta ble 4 ).
•
I n t he L T F U st u d y, s u bjects will c o nti n ue assess me nts at ti me p oi nts c o nti g u o us wit h t he 
l o n g-ter m f oll o w u p peri o d ti me p oi nts i n t his st u d y.
S O C a n d A xic a bt a ge ne Cil ole ucel Ar ms:
S u bjects w h o di d n ot res p o n d t o treat me nt ma y recei ve off pr ot oc ol t hera p y b ut will c o nti n ue t o 
be f oll o we d f or disease assess me nts (if pr o gressi o n was n ot d oc u me nte d), s u bse q ue nt a ntica ncer 
t hera p y, a n d s ur vi val.
S u bjects ma y als o be c o ntacte d b y tele p h o ne t o c o nfir m s ur vi val stat us a n d s u bse q ue nt ne w 
l y m p h o ma t hera p y use.  S h o ul d a s u bject re q uire la b c ollecti o n, la bs ma y be c ollecte d at t he 
cli nic or at a n o utsi de facilit y t o re d uce t he s u bject b ur de n.
If a s u bject fails t o ret ur n t o t he cli nic f or a sc he d ule d pr ot oc ol s pecific visit, sites will nee d t o 
ma ke 2 atte m pts b y a c o m bi nati o n of tele p h o ne a n d mail/e mail t o c o ntact t he s u bject.  Sites m ust 
d oc u me nt b ot h atte m pts t o c o ntact t he s u bject.  If a s u bject d oes n ot res p o n d wit hi n 1 m o nt h after 
t he sec o n d c o ntact, t he s u bject will be c o nsi dere d l ost t o f oll o w- u p, a n d n o a d diti o nal c o ntact 
will be re q uire d.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 6 2
1 4 A pril  2 0 2 3
S u bjects w h o are u na ble or u n willi n g t o ret ur n t o t he st u d y site ma y ha ve f oll o w u p data f or t his 
peri o d o btai ne d fr o m cli nical, la b orat or y, a n d/ or dia g n ostic assess me nts c o n d ucte d b y t he 
referri n g healt hcare pr o vi der ( H C P) a n d/ or ge neral practiti o ner ( G P). I n a d diti o n, ot her healt h 
stat us i nf or mati o n ma y be o btai ne d fr o m t he s u bject a n d/ or t he s u bject’s referri n g H C P a n d/ or 
G P via tele p h o ne or e mail c o m m u nicati o n. T his i nf or mati o n will be use d t o detect late- o nset 
tar gete d S A Es t hat ma y be relate d t o st u d y t hera p y.
S u bjects a n d/ or t he s u bject’s referri n g H C Ps a n d/ or G Ps ma y be c o ntacte d directl y b y tele p h o ne 
or e mail t o c o nfir m s ur vi val stat us a n d o btai n i nf or mati o n a b o ut tar gete d c o nc o mita nt me dicati o n 
use, s u bse q ue nt a ntica ncer t hera p y use, a n d late- o nset tar gete d S A Es (if t he S A E d oes n ot 
re q uire a test t o be perf or me d i n t he cli nic).
Refer t o t he S O A ( Ta ble 4 ) f or a listi n g of st u d y pr oce d ures a n d disease assess me nts t o be 
c o m plete d d uri n g t he l o n g-ter m f oll o w- u p peri o d.
S u bjects w h o are e nr olle d/ra n d o mize d b ut di d n ot recei ve i n vesti gati o nal pr o d uct, or recei ve d 
t hera p y b ut di d n’t res p o n d t o treat me nt, will be f oll o we d i n t he l o n g-ter m f oll o w- u p peri o d u ntil 
M o nt h 6 0 (refer t o Secti o n 3. 5. 3 ) a n d will u n der g o t he f oll o wi n g assess me nts at t he ti me p oi nts 
o utli ne d i n t he S O A ( Ta ble 4 ):
•
S u bse q ue nt t hera p y f or t he treat me nt of N H L
•
S ur vi val stat us: S u bjects a n d/ or t he s u bject’s referri n g H C Ps a n d/ or G Ps ma y be c o ntacte d 
directl y b y tele p h o ne or e mail t o assess s ur vi val stat us
•
Disease assess me nts per pr ot oc ol
•
A Es/ S A Es per Secti o n 9


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 6 3
1 4 A pril  2 0 2 3
T a ble 4. 
Sc he d ule of Assess me nts L o n g-ter m F oll o w- u p Peri o d
L o n g-ter m F oll o w- u p Peri o d 1
E ac h visit c alc ul ate d fr o m r a n d o miz ati o n
( all visits h a ve ± 2 8 d a y wi n d o w)
L o n g-ter m F oll o w- u p 
Peri o d 2
E ac h visit c alc ul ate d 
fr o m r a n d o miz ati o n
( all visits h a ve 
± 3 m o nt h wi n d o w)
Pr oce d ure 
A xic a bt a ge ne Cil ole ucel Ar m a n d St a n d ar d of C are Ar m
A xic a bt a ge ne 
Cil ole ucel Ar m O nl y
Visit fre q ue nc y
M o nt h
9
M o nt h
1 2
M o nt h
1 5
M o nt h
1 8
M o nt h
2 1
M o nt h
2 4
M o nt h
3 0
M o nt h
3 6
M o nt h
4 2
M o nt h
4 8
M o nt h
5 4
M o nt h
6 0
M o nt h 7 2 a n d 
A n n u all y T here after 
t o 1 5 Ye ars *
P h ysical e xa m a
X
X
X
X
X
X
 
 
 
 
 
 
 
P E T- C T sca n/ C T 
Sca n disease 
assess me nt b
P E T-
C T
P E T-
C T/ C T b
P E T-
C T/ C T b
P E T-
C T/ C T b
P E T-
C T/ C T b
P E T-
C T/ C T b
P E T-
C T/ C T b
P E T-
C T/ C T b
P E T-
C T/ C T b
P E T-
C T/ C T b
P E T-
C T/ C T b
P E T-
C T/ C T b
X b 
S ur vi val stat us c
X
X
X
X
X
X
X
X
X
X
X
X
X c
C B C 
w/ differe ntial d
X
X
X
X
X
X
 
 
 
 
 
 
 
Bl o o d dra w f or 
P B M Cs a n d 
a d diti o nal a nal ysis e
X
X
 
X
 
X
 
X
 
X
 
X
 Xe
Tar gete d S A Es f
X
X
X
X
X
X
X
X
X
X
X
X
X f
S u bse q ue nt 
t hera p y f or N H Lg
X
X
X
X
X
X
X
X
X
X
X
X
X g
P R Os h
X
X
X
X
X
X
 
 
 
 
 
 
 
A b bre viati o ns:  P B M C, peri p heral bl o o d m o n o n uclear cell; P E T- C T, p ositr o n e missi o n t o m o gra p h y c o m p uter t o m o gra p h y; C T, c o m p ute d t o m o gra p h y; C B C, c o m plete bl o o d  
c o u nt; S A E, seri o us a d verse e ve nt; N H L, n o n- H o d g ki n l y m p h o ma; P R O, patie nt re p orte d o utc o me.
* After c o m pleti n g at least 6 0 m o nt hs of assess me nts i n t his st u d y, all s u bjects w h o recei ve d at least o ne d ose of a xica bta ge ne cil ole ucel as pr ot oc ol t hera p y will be tra nsiti o ne d t o a 
se parate L T F U st u d y, after pr o vi di n g i nf or me d c o nse nt, t o c o m plete t he re mai n der of t he 1 5- year f oll o w- u p peri o d.
a 
P h ysical e xa ms will c o nti n ue t hr o u g h t he first 2 4 m o nt hs
b 
P E T- C T will c o nti n ue t hr o u g h M o nt h 9 or u ntil disease pr o gressi o n, w hic he ver c o mes first. If s u bject’s disease has n ot pr o gresse d b y M o nt h 9, disease assess me nts will be 
e val uate d per C T sca ns w here a C R is s us pecte d a n d per P E T- C Ts w here a P R is s us pecte d. P E T- C T s h o ul d be perf or me d at a n y ti me disease pr o gressi o n is s us pecte d. If 
s u bject’s disease has n ot pr o gresse d b y M o nt h 6 0, t he stat us of t he s u bject’s pri mar y mali g na nt disease will be m o nit ore d per l ocal sta n dar d of care. T he s u bject’s disease 
stat us d oes n ot nee d t o be assesse d at t he i n vesti gati ve site. Rec or ds fr o m t he referri n g H C P a n d/ or G P ma y be o btai ne d f or s u bjects w h o are u na ble or u n willi n g t o ret ur n t o 
t he i n vesti gati ve sites.
c 
S ur vi val stat us: S u bjects a n d/ or t he s u bject’s referri n g H C Ps a n d/ or G Ps ma y be c o ntacte d directl y b y tele p h o ne or e mail t o assess s ur vi val stat us.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 6 4
1 4 A pril  2 0 2 3
d 
C B C w/ differe ntial: S u bjects will c o nti n ue t o pr o vi de sa m ples f or C B C w/ diffs a n d l y m p h oc yte s u bsets t hr o u g h M o nt h 2 4.
e 
Bl o o d dra ws f or a nal ysis, s uc h as R C R (f or s u bjects ra n d o mize d i nt o t he a xica bta ge ne cil ole ucel ar m), P B M Cs, a n d a d diti o nal a nal ysis per Secti o n 7. 1 1. 2  a n d t he ti me p oi nts 
s pecifie d i n t he la b orat or y ma n ual. Sa m ples f or R C R will c o nti n ue t o be c ollecte d yearl y u ntil tra nsiti o n t o t he L T F U st u d y a n d teste d as cli nicall y i n dicate d.
f 
Tar gete d S A Es are defi ne d as a n d i ncl u de ne ur ol o gical, he mat ol o gical, i nfecti o ns, a ut oi m m u ne dis or ders, a n d sec o n dar y mali g na ncies a n d s h o ul d be re p orte d f or u p t o 5 or 
1 5 years f or S O C or a xica bta ge ne cil ole ucel ar ms, res pecti vel y, or u ntil disease pr o gressi o n, w hic he ver occ urs first. After M o nt h 6 0 tar gete d S A Es will be re p orte d t hr o u g h 
1 5 years or u ntil disease pr o gressi o n a n d/ or start of s u bse q ue nt a ntica ncer t hera p y, w hic he ver occ urs first. T hese e ve nts will be i de ntifie d fr o m r o uti ne safet y assess me nts (ie, 
p h ysical e xa mi nati o n a n d la b orat or y assess me nts) perf or me d as sta n dar d of care ( n ot re q uire d t o be perf or me d at t he st u d y site).
g 
S u bse q ue nt t hera p y will be c ollecte d f or all e nr olle d s u bjects u ntil t he e n d of t he s u bject’s partici pati o n i n t his st u d y or, w hile still a partici pa nt i n t his st u d y, t he s u bject is 
c o nsi dere d l ost t o f oll o w- u p, wit h dra ws c o nse nt, or dies. S u bjects a n d/ or t he s u bject’s referri n g H C Ps a n d/ or G Ps ma y be c o ntacte d directl y b y  tele p h o ne or e mail t o c ollect 
i nf or mati o n a b o ut s u bse q ue nt t hera p y. Refer t o Secti o ns 6. 2. 6  a n d 6. 3. 4  f or m ore details.
h 
P R Os i ncl u de t he f oll o wi n g assess me nts: E O R T C Q L Q- C 3 0, E Q- 5 D- 5 L, & W P AI


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 6 5
1 4 A pril 2 0 2 3  
8. 
S U B J E C T WI T H D R A W A L
S u bjects ha ve t he ri g ht t o wit h dra w fr o m t he st u d y at a n y ti me a n d f or a n y reas o n wit h o ut 
prej u dice t o t heir f ut ure me dical care b y t he p h ysicia n or at t he i nstit uti o n.
S u bjects ca n decli ne t o c o nti n ue t o recei ve st u d y re q uire d treat me nt a n d/ or ot her pr ot oc ol 
re q uire d pr oce d ures at a n y ti me d uri n g t he st u d y b ut c o nti n ue t o partici pate i n certai n f oll o w- u p 
ele me nts of t he st u d y.  T his is referre d t o as partial wit h dra wal of c o nse nt.
If partial wit h dra wal of c o nse nt occ urs, t he i n vesti gat or m ust disc uss wit h t he s u bject t he 
a p pr o priate pr ocess f or disc o nti n uati o n fr o m i n vesti gati o nal pr o d uct, st u d y treat me nt, or ot her 
pr ot oc ol-re q uire d t hera pies a n d m ust disc uss o pti o ns f or c o nti n ue d partici pati o n, c o m pleti o n of 
pr oce d ures, a n d t he ass ociate d data c ollecti o n as o utli ne d i n t he S O A i ncl u di n g t he f oll o wi n g:
•
S ur vi val stat us, i ncl u di n g t he ca use of deat h
•
Safet y re p orti n g, i ncl u di n g ne w mali g na ncies; S A Es relate d t o a xica bta ge ne cil ole ucel a n d 
tar gete d S A Es i ncl u di n g, b ut n ot li mite d t o, ne ur ol o gic e ve nts, i nfecti o ns, bl o o d dis or ders, or 
i m m u ne dis or ders; a n d pre g na ncies
•
Tar gete d c o nc o mita nt me dicati o ns as per t he S O A a n d Secti o n 6. 2. 4. 9
•
S u bse q ue nt t hera pies
•
Ce ntral la b orat or y sa m ples ( per t he S O A)
T he le vel of f oll o w- u p a n d met h o d of c o m m u nicati o n s h o ul d als o be disc usse d bet wee n t he 
researc h staff a n d t he s u bject a n d d oc u me nte d i n t he s o urce d oc u me nts.
Wit h dra wal of f ull c o nse nt fr o m a st u d y mea ns t hat t he s u bject d oes n ot wis h t o recei ve f urt her 
pr ot oc ol re q uire d t hera p y or u n der g o pr oce d ures a n d t he s u bject d oes n ot wis h t o c o nti n ue 
f urt her st u d y f oll o w- u p.  S u bject data c ollecte d u p t o wit h dra wal of c o nse nt will be retai ne d a n d 
i ncl u de d i n t he a nal ysis of t he st u d y, a n d, w here per mitte d b y l ocal re g ulati o ns, p u blicl y 
a vaila ble data ( deat h rec or ds) ca n be i ncl u de d after wit h dra wal of c o nse nt.  T he i n vesti gat or is t o 
disc uss wit h t he s u bject a p pr o priate pr oce d ures f or wit h dra wal fr o m t he st u d y.
As part of t he st u d y sites ma y be as ke d t o c o n d uct searc hes of p u blic rec or ds, s uc h as t h ose 
esta blis hi n g s ur vi val stat us, if a vaila ble, t o o btai n s ur vi val data f or a n y s u bject f or w h o m t he 
s ur vi val stat us is n ot k n o w n, per t he a p plica ble l ocal la ws.  Sites ma y be als o as ke d t o als o 
retrie ve a ut o ps y re p orts t o c o nfir m t he stat us of disease at t he ti me of deat h, if p ossi ble, per t he 
a p plica ble l ocal la ws.
T he i n vesti gat or a n d/ or s p o ns or ca n als o deci de t o wit h dra w a s u bject fr o m t he i n vesti gati o nal 
pr o d uct a n d/ or ot her pr ot oc ol-re q uire d t hera pies, pr ot oc ol pr oce d ures, or t he st u d y as a w h ole or 
at a n y ti me pri or t o st u d y c o m pleti o n.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 6 6
1 4 A pril 2 0 2 3  
8. 1.  
Re as o ns f or Re m o v al fr o m Tre at me nt
Reas o ns f or re m o val fr o m pr ot oc ol re q uire d i n vesti gati o nal pr o d ucts or pr oce d ures i ncl u de a n y 
of t he f oll o wi n g:
•
A E
•
Disease pr o gressi o n
•
S u bject re q uest/ n o nc o m plia nce
•
Pr o d uct n ot a vaila ble
•
L ost t o f oll o w- u p
•
Deat h
•
Decisi o n b y s p o ns or
8. 2.  
Re as o ns f or Re m o v al fr o m St u d y
Reas o ns f or re m o val of a s u bject fr o m t he st u d y are as f oll o ws:
•
S u bject wit h dra wal of c o nse nt fr o m f urt her f oll o w- u p
•
I n vesti gat or decisi o n
•
L ost t o f oll o w- u p
•
Deat h
•
Ter mi nati o n of t he st u d y b y t he s p o ns or
•
Ot her (e g, n o nc o m plia nce)


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 6 7
1 4 A pril 2 0 2 3  
9. 
S A F E T Y R E P O R TI N G
9. 1.  
A d verse E ve nts
A n A E is defi ne d as a n y u nt o war d me dical occ urre nce i n a cli nical trial s u bject.  T he e ve nt d oes 
n ot necessaril y ha ve a relati o ns hi p wit h st u d y treat me nt.  T he i n vesti gat or is res p o nsi ble f or 
e ns uri n g t hat a n y A Es o bser ve d b y t he i n vesti gat or or re p orte d b y t he s u bject are rec or de d i n t he 
s u bject’s me dical rec or d.
T he defi niti o n of A Es i ncl u des w orse ni n g of a pre-e xisti n g me dical c o n diti o n.  W orse ni n g 
i n dicates t hat t he pre-e xisti n g me dical c o n diti o n has i ncrease d i n se verit y, fre q ue nc y, a n d/ or 
d urati o n or has a n ass ociati o n wit h a w orse o utc o me.  W he n rec or di n g s uc h e ve nts, pr o vi de 
descri pti o ns t hat t he pre-e xisti n g c o n diti o n has c ha n ge d (e g, m ore fre q ue nt hea dac hes f or a 
s u bject wit h pre-e xisti n g hea dac hes).  A pre-e xisti n g c o n diti o n t hat has n ot w orse ne d d uri n g t he 
st u d y or i n v ol ves a n i nter ve nti o n, s uc h as electi ve c os metic s ur ger y or a me dical pr oce d ure w hile 
o n st u d y, is n ot c o nsi dere d a n A E.
I nter ve nti o ns f or pretreat me nt c o n diti o ns (s uc h as electi ve c os metic s ur ger y) or me dical 
pr oce d ures t hat were pla n ne d bef ore st u d y partici pati o n are n ot c o nsi dere d a d verse e ve nts.  
H os pitalizati o n f or st u d y treat me nt i nf usi o ns or preca uti o nar y meas ures per i nstit uti o nal p olic y 
are n ot c o nsi dere d A Es.
T he ter m “ disease pr o gressi o n” as assesse d b y meas ure me nt of mali g na nt lesi o ns o n ra di o gra p hs 
or ot her met h o ds s h o ul d n ot be re p orte d as A Es.  Deat h d ue t o disease pr o gressi o n i n t he a bse nce 
of si g ns a n d s y m pt o ms s h o ul d be re p orte d wit h t he preferre d ter m “ B-cell l y m p h o ma”.
F or sit uati o ns w he n a n A E or S A E is d ue t o t he disease u n der i n vesti gati o n, re p ort t he si g ns a n d 
s y m pt o ms.  W orse ni n g of si g ns a n d s y m pt o ms of t he mali g na nc y u n der st u d y s h o ul d als o be 
re p orte d as A Es i n t he a p pr o priate secti o n of t he C R F.
T he i n vesti gat or’s cli nical j u d g me nt is use d t o deter mi ne w het her a s u bject is t o be re m o ve d 
fr o m treat me nt d ue t o a n A E.  I n t he e ve nt of a s u bject re q uests t o wit h dra w fr o m pr ot oc ol-
re q uire d t hera pies or t he st u d y d ue t o a n A E, t he s u bject s h o ul d u n der g o t he pr oce d ures o utli ne d 
i n t he Da y 1 5 0 p ost-ra n d o mizati o n visit of t he S O A.
9. 2.  
Re p orti n g of A d verse E ve nts
T he i n vesti gat or is res p o nsi ble f or re p orti n g all A Es o bser ve d b y t he i n vesti gat or or re p orte d b y 
t he s u bject t hat occ ur after ra n d o mizati o n t hr o u g h t he Da y 1 5 0 p ost-ra n d o mizati o n visit or 
c ha n ge i n l y m p h o ma t hera p y, w hic he ver occ urs first.  F or s u bjects w h o are e nr olle d b ut d o n ot 
recei ve a xica bta ge ne cil ole ucel, t he A E re p orti n g peri o d e n ds 3 0 da ys after t he last pr oce d ure 
(e g, le u ka p heresis, c o n diti o ni n g c he m ot hera p y).
T he i n vesti gat or m ust pr o vi de t he i nf or mati o n liste d bel o w re gar di n g t he A Es bei n g re p orte d:
•
A E dia g n osis or s y n dr o me (if n ot k n o w n, si g ns or s y m pt o ms)


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 6 8
1 4 A pril 2 0 2 3  
•
Dates of o nset a n d res ol uti o n
•
Se verit y
•
Assess me nt of relate d ness t o i n vesti gati o nal pr o d uct, c o n diti o ni n g c he m ot hera p y, or st u d y 
pr oce d ures
•
Acti o n ta ke n
A d verse e ve nt gra di n g scale use d will be t he N CI C o m m o n Ter mi n ol o g y Criteria f or A d verse 
E ve nts ( C T C A E) versi o n 4. 0 3.  A c o p y of t he gra di n g scale ca n be d o w nl oa de d fr o m t he C T E P 
h o me pa ge ( htt p://cte p.ca ncer. g o v).  C R S e ve nts will be re p orte d usi n g t he gra di n g scale o utli ne d 
i n t he I n vesti gat or Br oc h ure.
I n re vie wi n g a d verse e ve nts, i n vesti gat ors m ust assess w het her t he a d verse e ve nt is p ossi bl y 
relate d t o 1) a xica bta ge ne cil ole ucel or S O C c he m ot hera p y, 2) c o n diti o ni n g c he m ot hera p y (f or 
s u bjects e nr olle d i nt o t he a xica bta ge ne cil ole ucel ar m of t he st u d y), 3) a n y pr ot oc ol-re q uire d 
st u d y pr oce d ure or treat me nt (ie, H D T A S C T), 4) disease pr o gressi o n, 5) c o nc urre nt disease, 6) 
c o nc o mita nt me dicati o n, or 7) ot her.  T he relati o ns hi p is i n dicate d b y a yes or n o res p o nse a n d 
e ntere d i nt o t he C R F.  A yes res p o nse s h o ul d i n dicate t hat t here is e vi de nce t o s u g gest a ca usal 
relati o ns hi p bet wee n t he st u d y treat me nt or pr oce d ure a n d t he A E.  A d diti o nal rele va nt data wit h 
res pect t o descri bi n g t he A E will be c ollecte d i n t he C R Fs.
T he i n vesti gat or is e x pecte d t o f oll o w re p orte d A Es u ntil sta bilizati o n or res ol uti o n.  If a s u bject 
be gi ns a ne w l y m p h o ma t hera p y, t he A E re p orti n g peri o d f or n o n- S A Es e n ds at t he ti me t he ne w 
treat me nt is starte d.
9. 2. 1.  
Re p orti n g A b n or m al L a b or at or y Fi n di n gs
T he i n vesti gat or is res p o nsi ble f or re vie wi n g la b orat or y test res ults a n d deter mi ni n g w het her a n 
a b n or mal val ue i n a n i n di vi d ual st u d y s u bject re prese nts a cli nicall y si g nifica nt c ha n ge fr o m t he 
s u bject’s baseli ne val ues.  I n ge neral, a b n or mal la b orat or y fi n di n gs wit h o ut cli nical si g nifica nce 
( base d o n t he i n vesti gat or's j u d g me nt) are n ot t o be rec or de d as A Es.  H o we ver, a b n or mal 
la b orat or y fi n di n gs t hat res ult i n ne w or w orse ni n g cli nical se q uelae, re q uire t hera p y, or 
a dj ust me nt i n c urre nt t hera p y are c o nsi dere d A Es.  W here a p plica ble, cli nical se q uelae ( n ot t he 
la b orat or y a b n or malit y) are t o be rec or de d as t he A E.
A n a b n or mal la b orat or y test res ult m ust be re p orte d as a n a d verse e ve nt if it is a c ha n ge fr o m 
baseli ne a n d meets a n y of t he f oll o wi n g criteria:
•
Ass ociate d wit h cli nical s y m pt o ms
•
Res ults i n a me dical i nter ve nti o n (e g, p otassi u m s u p ple me ntati o n f or h y p o kale mia or ir o n 
re place me nt t hera p y f or a ne mia) or a c ha n ge i n c o nc o mita nt t hera p y
•
Cli nicall y si g nifica nt i n t he i n vesti gat or’s j u d g me nt


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 6 9
1 4 A pril 2 0 2 3  
9. 3.  
Defi niti o n of Seri o us A d verse E ve nts
A n S A E is defi ne d as a n a d verse e ve nt t hat meets at least 1 of t he f oll o wi n g seri o us criteria:
•
Fatal
•
Life-t hreate ni n g ( places t he s u bject at i m me diate ris k of deat h)
•
Re q uires i n- patie nt h os pitalizati o n or pr ol o n gati o n of e xisti n g h os pitalizati o n
•
Res ults i n persiste nt or si g nifica nt disa bilit y/i nca pacit y
•
C o n ge nital a n o mal y/ birt h defect
•
Ot her me dicall y i m p orta nt seri o us e ve nt
A n A E w o ul d meet t he criteri o n of “re q uires h os pitalizati o n” if t he e ve nt necessitate d a n 
a d missi o n t o a healt hcare facilit y (e g, o ver ni g ht sta y).
E ve nts t hat re q uire a n escalati o n of care w he n t he s u bject is alrea d y h os pitalize d s h o ul d be 
rec or de d as a n S A E.  E xa m ples of s uc h e ve nts i ncl u de m o ve me nt fr o m r o uti ne care i n t he 
h os pital t o t he I C U or if t hat e ve nt res ulte d i n a pr ol o n gati o n of t he e xisti n g pla n ne d 
h os pitalizati o n.
If a n i n vesti gat or c o nsi ders a n e ve nt t o be cli nicall y i m p orta nt, b ut it d oes n ot meet a n y of t he 
seri o us criteria, t he e ve nt c o ul d be classifie d as a n S A E wit h t he criteri o n of “ ot her me dicall y 
i m p orta nt seri o us e ve nt.”
T he ter ms “se vere” a n d “seri o us” are n ot s y n o n y m o us. Se verit y refers t o t he i nte nsit y of a n A E 
acc or di n g t o N CI C T C A E criteria; t he e ve nt itself ma y be of relati vel y mi n or me dical 
si g nifica nce a n d, t heref ore, ma y n ot meet t he seri o us ness criteria. Se verit y a n d seri o us ness nee d 
t o be i n de pe n de ntl y assesse d f or eac h A E rec or de d o n t he electr o nic C R F.
9. 4.  
Re p orti n g of Seri o us A d verse E ve nts
T he i n vesti gat or is res p o nsi ble f or re p orti n g all S A Es o bser ve d b y t he i n vesti gat or or re p orte d b y 
t he s u bject t hat occ ur after si g ni n g of t he i nf or me d c o nse nt t hr o u g h t he Da y 1 5 0 p ost-
ra n d o mizati o n visit or u ntil t he i nitiati o n of ne w l y m p h o ma t hera p y, w hic he ver occ urs first.  
After t he Da y 1 5 0 p ost-ra n d o mizati o n visit o nl y tar gete d S A Es will be re p orte d.  Tar gete d S A Es 
are defi ne d as a n d i ncl u de ne ur ol o gical, he mat ol o gical, i nfecti o ns, a ut oi m m u ne dis or ders, a n d 
sec o n dar y mali g na ncies a n d s h o ul d be re p orte d f or u p t o 5 or 1 5 years f or S O C or a xica bta ge ne 
cil ole ucel ar ms, res pecti vel y, or u ntil disease pr o gressi o n, w hic he ver occ urs first.
Seri o us a d verse e ve nts, w hic h t he i n vesti gat or assesses as relate d t o a xica bta ge ne cil ole ucel, 
s h o ul d be re p orte d re gar dless of t he ti me peri o d.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 7 0
1 4 A pril 2 0 2 3  
F or s u bjects w h o scree n fail or are e nr olle d b ut d o n ot recei ve a xica bta ge ne cil ole ucel, t he 
re p orti n g peri o d f or S A Es e n ds 3 0 da ys after t he last pr oce d ure (e g, scree n pr oce d ure, 
le u ka p heresis, c o n diti o ni n g c he m ot hera p y).
All S A Es m ust be s u b mitte d via e mail t o Safet y _ F C @ gilea d.c o m wit hi n 2 4 h o urs f oll o wi n g t he 
i n vesti gat or’s k n o wle d ge of t he e ve nt. After t he electr o nic S A E s yste m is a vaila ble, all S A Es 
m ust be s u b mitte d t o Kite via t he e S A E s yste m wit hi n 2 4 h o urs of t he i n vesti gat or’s k n o wle d ge 
of t he e ve nt.  If t he e S A E s yste m is u na vaila ble (e g, s yste m o uta ge), t he n t he S A E m ust be 
s u b mitte d usi n g t he S A E Re p ort F or m a n d e maile d t o t he S A E Re p orti n g 
mail b o x: Safet y _ F C @ gilea d.c o m.
After c o m pleti o n of t his st u d y a n d data base cl os ure, a n y rele va nt i nf or mati o n o n o n g oi n g S A Es 
m ust be s u b mitte d t o Kite wit hi n 2 4 h o urs after t he i n vesti gat or’s k n o wle d ge of t he e ve nt usi n g 
t he p orta ble d oc u me nt f or mat ( P D F) versi o n of t he pa per S A E Re p ort F or m a n d se nt via e- mail 
t o t he S A E Re p orti n g mail b o x: Safet y _ F C @ gilea d.c o m.
All S A Es will be re p orte d t o t he healt h a ut h orities per l ocal re p orti n g g ui deli nes.
Disease pr o gressi o n of t he mali g na nc y is n ot c o nsi dere d a n A E.  H o we ver, si g ns a n d s y m pt o ms 
of disease pr o gressi o n ma y be rec or de d as A Es or S A Es a n d i n dicate d as d ue t o disease 
pr o gressi o n o n t he e C R F.  If t he mali g na nc y has a fatal o utc o me bef ore Da y 1 5 0 p ost-
ra n d o mizati o n visit, t he n t he e ve nt “ B-cell l y m p h o ma” m ust be rec or de d as a n S A E wit h t he 
o utc o me fatal.
Deat h m ust be re p orte d if it occ urs d uri n g t he S A E re p orti n g peri o d, irres pecti ve of a n y 
i nter ve ni n g treat me nt.
A n y deat h occ urri n g after ra n d o mizati o n a n d pri or t o Da y 1 5 0 p ost-ra n d o mizati o n visit, 
re gar dless of attri b uti o n t o treat me nt, re q uires e x pe dite d re p orti n g wit hi n 2 4 h o urs.  A n y deat h 
occ urri n g after t he Da y 1 5 0 p ost-ra n d o mizati o n visit re q uires e x pe dite d re p orti n g wit hi n 
2 4 h o urs o nl y if it is c o nsi dere d relate d t o treat me nt.
9. 4. 1.  
Re p orti n g De at hs
Deat hs occ urri n g d uri n g t he pr ot oc ol-s pecifie d A E re p orti n g peri o d t hat i n vesti gat ors attri b ute 
s olel y t o pr o gressi o n of u n derl yi n g l y m p h o ma s h o ul d be rec or de d as S A Es a n d o n t he A E 
electr o nic C R F wit h t he preferre d ter m “ B-cell l y m p h o ma” a n d m ust be re p orte d t o t he s p o ns or 
i m me diatel y. Deat h is a n o utc o me a n d n ot a disti nct e ve nt. F or deat hs n ot d ue t o t he u n derl yi n g 
mali g na nc y, t he e ve nt or c o n diti o n t hat ca use d or c o ntri b ute d t o t he fatal o utc o me s h o ul d be 
rec or de d o n t he A E f or m. T he ter m “ u ne x plai ne d deat h” s h o ul d be ca pt ure d if t he ca use of deat h 
is n ot k n o w n. H o we ver, e ver y eff ort s h o ul d be ma de t o ca pt ure t he esta blis he d ca use of deat h, 
w hic h ma y bec o me a vaila ble later (e g, after a ut o ps y). Deat hs occ urri n g d uri n g t he p ost-st u d y 
s ur vi val f oll o w- u p peri o d t hat are d ue t o u n derl yi n g ca ncer s h o ul d be rec or de d o n t he S ur vi val 
Stat us C R F a n d t he Deat h S u m mar y Pa ge.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 7 1
1 4 A pril 2 0 2 3  
9. 5.  
Di a g n osis Vers us Si g ns a n d S y m pt o ms
F or A Es, a dia g n osis (if k n o w n) s h o ul d be rec or de d o n t he A E f or m i n lie u of si g ns a n d 
s y m pt o ms. T he e xce pti o n is f or C R S, w here b ot h t he dia g n osis a n d si g ns a n d s y m pt o ms s h o ul d 
be ca pt ure d o n t he A E f or m. Si g ns a n d s y m pt o ms of t he u n derl yi n g ca ncer s h o ul d als o be 
rec or de d. H o we ver, t he i n vesti gat or s h o ul d state t hat t hese si g ns a n d s y m pt o ms are d ue t o t he 
u n derl yi n g disease.
9. 6. 
Pre g n a nc y a n d L act ati o n
T here is n o rele va nt cli nical e x perie nce wit h a xica bta ge ne cil ole ucel i n pre g na nt or lactati n g 
w o me n, a n d a ni mal re pr o d ucti ve st u dies ha ve n ot bee n perf or me d.  W o me n of c hil d beari n g 
p ote ntial m ust ha ve a ne gati ve pre g na nc y test pri or t o e nr oll me nt beca use of t he p ote ntiall y 
da n ger o us effects of t he pre parati ve c he m ot hera p y o n t he fet us.  W o me n of c hil d beari n g 
p ote ntial s h o ul d be m o nit ore d acc or di n g t o l ocal a n d c o u ntr y-s pecific re g ulati o ns. T his 
e x peri me ntal t hera p y s h o ul d n ot be a d mi nistere d t o pre g na nt w o me n or w o me n w h o are 
breastfee di n g. Refer t o A p pe n di x E  f or t he defi niti o n of c hil d beari n g p ote ntial.
Fe male s u bjects a n d fe male part ners of male s u bjects are rec o m me n de d t o use hi g hl y effecti ve 
c o ntrace pti o n ( met h o d m ust ac hie ve a n a n n ual fail ure rate of < 1 %) f or at least 6 m o nt hs after 
c o m pleti n g c o n diti o ni n g c he m ot hera p y or 6 m o nt hs after a xica bta ge ne cil ole ucel d osi n g, 
w hic he ver is l o n ger.  Male s u bjects are rec o m me n de d n ot t o fat her a c hil d f or 6 m o nt hs after 
c o m pleti n g c o n diti o ni n g c he m ot hera p y or 6 m o nt hs after a xica bta ge ne cil ole ucel d osi n g, 
w hic he ver is l o n ger. Refer t o A p pe n di x E  f or a c o m plete list of hi g hl y effecti ve c o ntrace pti o n 
met h o ds.
A n y pre g na nc y or breastfee di n g i n a fe male s u bject e nr olle d i nt o t he st u d y m ust be re p orte d, 
re gar dless of t he ti me after a xica bta ge ne cil ole ucel i nf usi o n or wit hi n 6 m o nt hs after 
c o n diti o ni n g c he m ot hera p y, w hic he ver is l o n ger. If t he pre g na nc y occ urs i n a fe male part ner of a 
male s u bject wit hi n 6 m o nt hs after c o m pleti n g c o n diti o ni n g c he m ot hera p y or t he a d mi nistrati o n 
of a xica bta ge ne cil ole ucel, w hic he ver is l o n ger, t he pre g na nc y m ust be re p orte d. All s uc h 
pre g na ncies m ust be re p orte d t o Kite Patie nt Safet y a n d P har mac o vi gila nce usi n g t he Pre g na nc y 
Re p ort F or m wit hi n 2 4 h o urs after bec o mi n g a ware of t he pre g na nc y. I nf or mati o n re gar di n g t he 
pre g na nc y a n d/ or t he o utc o me will be re q ueste d b y t he s p o ns or. Pre g na nc y Re p ort F or ms s h o ul d 
be re p orte d t o Kite Patie nt Safet y a n d P har mac o vi gila nce at Safet y _ F C @ gilea d.c o m or 
fa x: + 1 ( 6 5 0) 5 2 2- 5 4 7 7.
T he pre g na nc y itself is n ot c o nsi dere d a n A E n or is a n i n d uce d electi ve a b orti o n t o ter mi nate a 
pre g na nc y wit h o ut me dical reas o ns. A n y pre mat ure ter mi nati o n of pre g na nc y (e g, a s p o nta ne o us 
a b orti o n, a n i n d uce d t hera pe utic a b orti o n d ue t o c o m plicati o ns or ot her me dical reas o ns) m ust be 
re p orte d wit hi n 2 4 h o urs as a n S A E. T he u n derl yi n g me dical reas o n f or t his pr oce d ure s h o ul d be 
rec or de d as t he A E ter m. A n y S A E occ urri n g as a n a d verse pre g na nc y o utc o me after t he st u d y 
has bee n c o m plete d m ust be re p orte d t o Kite Patie nt Safet y a n d P har mac o vi gila nce.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 7 2
1 4 A pril 2 0 2 3  
T he pre g na nt s u bject or s u bject part ner s h o ul d recei ve a p pr o priate m o nit ori n g a n d care u ntil t he 
c o ncl usi o n of t he pre g na nc y. T he o utc o me s h o ul d be re p orte d t o Kite Patie nt Safet y a n d 
P har mac o vi gila nce usi n g t he Pre g na nc y O utc o me Re p ort F or m. If t he e n d of t he pre g na nc y 
occ urs after t he st u d y has bee n c o m plete d, t he o utc o me s h o ul d be re p orte d directl y t o Kite 
Patie nt Safet y a n d P har mac o vi gila nce.
Pre g na ncies of fe male part ners of male st u d y s u bjects e x p ose d t o a xica bta ge ne cil ole ucel or 
ot her st u d y dr u gs m ust als o be re p orte d a n d rele va nt i nf or mati o n s h o ul d be s u b mitte d t o Kite 
Patie nt Safet y a n d P har mac o vi gila nce usi n g t he pre g na nc y a n d pre g na nc y o utc o me f or ms wit hi n 
2 4 h o urs. If t he e n d of t he pre g na nc y occ urs after t he st u d y has bee n c o m plete d, t he o utc o me 
s h o ul d be re p orte d directl y t o Kite Patie nt Safet y a n d P har mac o vi gila nce.
If a lactati o n case occ urs i n a fe male s u bject i n t he st u d y, t he lactati o n case m ust be re p orte d t o 
Kite Patie nt Safet y a n d P har mac o vi gila nce wit hi n 2 4 h o urs after t he i n vesti gat or’s a ware ness of 
t he e ve nt usi n g t he S pecial Sit uati o ns Re p orti n g F or m. I n a d diti o n t o re p orti n g a lactati o n case 
d uri n g t he st u d y, i n vesti gat ors s h o ul d m o nit or f or pre g na nc y a n d lactati o n cases t hr o u g h o ut t he 
l o n g-ter m f oll o w- u p peri o d. Re p ort t he lactati o n case a n d S pecial Sit uati o ns Re p orti n g F or ms t o 
Kite Patie nt Safet y a n d P har mac o vi gila nce at Safet y _ F C @ gilea d.c o m or fa x: + 1 ( 6 5 0) 5 2 2- 5 4 7 7.
9. 7.  
H os pit aliz ati o n a n d Pr ol o n ge d H os pit aliz ati o n
A n y A E t hat res ults i n h os pitalizati o n or pr ol o n ge d h os pitalizati o n s h o ul d be d oc u me nte d a n d 
re p orte d as a n S A E, as descri be d i n Secti o n 9. 4 .
T he f oll o wi n g h os pitalizati o n sce nari os are n ot c o nsi dere d t o be S A Es:
•
H os pitalizati o n f or palliati ve care or h os pice care
•
Pla n ne d h os pitalizati o n re q uire d b y t he pr ot oc ol (e g, f or m o nit ori n g t he s u bject or t o perf or m 
a n efficac y meas ure me nt f or t he st u d y)
•
Pla n ne d h os pitalizati o n f or a pre-e xisti n g c o n diti o n
•
H os pitalizati o n d ue t o pr o gressi o n of t he u n derl yi n g ca ncer
9. 8.  
A b n or m al Vit al Si g n V al ues
N ot all vital si g n a b n or malities q ualif y as a n A E. A vital si g n res ult m ust be re p orte d as a n A E if 
it is a c ha n ge fr o m baseli ne a n d meets a n y of t he f oll o wi n g criteria:
•
Acc o m pa nie d b y cli nical s y m pt o ms
•
Res ults i n a me dical i nter ve nti o n or a c ha n ge i n c o nc o mita nt t hera p y
•
Cli nicall y si g nifica nt i n t he i n vesti gat or’s j u d g me nt


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 7 3
1 4 A pril 2 0 2 3  
It is t he i n vesti gat or’s res p o nsi bilit y t o re vie w all vital si g n fi n di n gs. Me dical a n d scie ntific 
j u d g me nt s h o ul d be e xercise d w he n deci di n g w het her a n is olate d vital si g n a b n or malit y s h o ul d 
be classifie d as a n A E. H o we ver, if a cli nicall y si g nifica nt vital si g n a b n or malit y is a si g n of a 
disease or s y n dr o me (e g, hi g h bl o o d press ure), o nl y t he dia g n osis (ie, h y perte nsi o n) s h o ul d be 
rec or de d o n t he C R F.
9. 9.  
D at a S afet y M o nit ori n g B o ar d
A n i n de pe n de nt D S M B will meet e ver y 6 m o nt hs after t he first s u bject is ra n d o mize d t o re vie w 
safet y data a n d will re vie w safet y a n d efficac y data at t he ti me of t he pla n ne d i nteri m f utilit y 
a nal ysis.  T he D S M B will be c hartere d t o ma ke trial c o n d uct rec o m me n dati o ns base d o n a n 
a nal ysis of ris k vers us be nefit.  T he D S M B ma y meet m ore ofte n as nee de d.
T he D S M B will als o re vie w S A E i nf or mati o n a n d s us pecte d u ne x pecte d seri o us a d verse 
reacti o ns ( S U S A Rs) o n a re g ular basis t hr o u g h o ut s u bject treat me nt i n t he st u d y.  T he D S M B 
ma y re q uest a d diti o nal safet y or efficac y data or rec o m me n d m o dif yi n g t he st u d y c o n d uct.  T he 
s p o ns or ma y re q uest a d diti o nal re vie ws b y t he D S M B.  Data s u b mitte d t o t he D S M B ma y be 
m o nit ore d or u n m o nit ore d t o facilitate ti mel y D S M B re vie w.
At t he ti me of e x pe dite d re p orti n g of S U S A Rs t o F D A, Kite P har ma ( or desi g nee) will 
c o nc urre ntl y s u b mit t hese re p orts t o t he D S M B C hair.  T he D S M B C hair will als o re vie w S A E 
narrati ve re p orts m o nt hl y.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 7 4
1 4 A pril 2 0 2 3  
1 0. 
S T A TI S TI C A L C O N SI D E R A TI O N S
1 0. 1.  
H y p ot hesis
T he h y p ot hesis is t hat a xica bta ge ne cil ole ucel will pr ol o n g E F S c o m pare d t o S O C t hera p y i n 
a d ult s u bjects wit h rela pse d/refract or y D L B C L.  T he h y p ot hesize d treat me nt effect c orres p o n ds 
t o a 5 0 % i m pr o ve me nt i n t he E F S ti me.
1 0. 2. 
St u d y E n d p oi nts
1 0. 2. 1. 
Pri m ar y
E F S is defi ne d as t he ti me fr o m ra n d o mizati o n t o t he earliest date of disease pr o gressi o n per 
L u ga n o Classificati o n { C hes o n 2 0 1 4 }, c o m me nce me nt of ne w l y m p h o ma t hera p y, or deat h fr o m 
a n y ca use.  T he f oll o wi n g criteria will be use d t o f urt her defi ne e ve nts a n d e ve nt ti mes:
•
S u bjects wit h esta blis he d P R or C R a n d s u bse q ue ntl y c o m me nce ne w l y m p h o ma t hera p y 
(i ncl u di n g ra di ot hera p y, e xce pt f or T BI as n ote d bel o w) i n t he a bse nce of d oc u me nte d 
disease pr o gressi o n will ha ve E F S ti me defi ne d as t he ti me fr o m ra n d o mizati o n t o t he last 
e val ua ble disease assess me nt pri or t o t he ne w l y m p h o ma t hera p y
•
S u bjects wit h best res p o nse of S D a n d s u bse q ue ntl y c o m me nce ne w l y m p h o ma t hera p y 
(i ncl u di n g ra di ot hera p y, e xce pt f or T BI as n ote d bel o w) i n t he a bse nce of d oc u me nte d 
disease pr o gressi o n will ha ve E F S ti me defi ne d as t he ti me fr o m ra n d o mizati o n t o t he first 
ti me S D was esta blis he d pri or t o t he ne w l y m p h o ma t hera p y
•
S u bjects w h o c o m me nce ne w l y m p h o ma t hera p y (i ncl u di n g ra di ot hera p y, e xce pt f or T BI as 
n ote d bel o w) i n t he a bse nce of a n y e val ua ble disease assess me nt will ha ve t he E F S e ve nt 
date i m p ute d as t he ra n d o mizati o n date
•
S u bjects wit h best res p o nse of S D u p t o a n d i ncl u di n g Da y 1 5 0 assess me nt p ost-
ra n d o mizati o n will be c o nsi dere d t o ha ve a n E F S e ve nt.  F or s uc h s u bjects, t he E F S ti me will 
be defi ne d as t he ti me fr o m ra n d o mizati o n t o t he first ti me S D was esta blis he d u p t o a n d 
i ncl u di n g t he Da y 1 5 0 disease assess me nt
T he f oll o wi n g criteria will be use d t o f urt her defi ne ce ns ori n g ti mes:
•
S u bjects ali ve, i n res p o nse, a n d wit h n o ne w t hera p y will be ce ns ore d at t he last e val ua ble 
disease assess me nt
•
S u bjects wit h n o e val ua ble disease assess me nt b y Da y 1 5 0 assess me nt p ost-ra n d o mizati o n 
will n ot be c o nsi dere d t o ha ve a n E F S e ve nt, a n d t he E F S ti me will be ce ns ore d at t he 
ra n d o mizati o n date
•
T he E F S ti me f or s u bjects i n t he a xica bta ge ne cil ole ucel ar m w h o u n der g o S C T i n t he 
a bse nce of a n y d oc u me nte d pr o gressi o n or ne w t hera p y will be ce ns ore d o n t he da y of S C T


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 7 5
1 4 A pril 2 0 2 3  
•
F or s u bjects i n t he S O C ar m, T BI, H D T, a n d S C T t hat occ ur w hile t he s u bject is i n res p o nse 
fr o m pr ot oc ol-s pecifie d i n d ucti o n t hera p y will n ot be c o nsi dere d a n E F S e ve nt.  T he E F S 
ti me f or S O C ar m s u bjects ali ve, pr o gressi o n-free, a n d wit h n o ne w l y m p h o ma t hera p y will 
be ce ns ore d at t he last e val ua ble disease assess me nt date
•
At t he ti me of t he i nteri m a nal ysis of E F S, s u bjects w h o ha ve n ot ha d t he o p p ort u nit y t o be 
f oll o we d t o t he Da y 1 5 0 disease assess me nt a n d w h o d o n ot ha ve a n E F S e ve nt will be 
ce ns ore d at t he last e val ua ble disease assess me nt pri or t o Da y 1 5 0
F or t he pri mar y a nal ysis of E F S, disease pr o gressi o n e ve nts a n d ce ns ori n g ti mes will be 
deter mi ne d b y bli n de d ce ntral re vie w.  E ve nts of s u bse q ue nt ne w l y m p h o ma t hera p y a n d deat h 
will be base d o n t he cli nical trial data base.  A se nsiti vit y a nal ysis f or E F S i n w hic h s u bjects i n 
t he a xica bta ge ne cil ole ucel ar m w h o u n der g o S C T w hile i n a n a xica bta ge ne cil ole ucel-i n d uce d 
res p o nse are i m p ute d t o ha ve a n E F S e ve nt at t he ti me of S C T will be perf or me d.
T he pri mar y a nal ysis of E F S will be c o n d ucte d w he n all s u bjects ha ve ha d t he o p p ort u nit y t o be 
f oll o we d t o t he M o nt h 9 disease assess me nt, a n d 2 5 0 E F S e ve nts ha ve bee n o bser ve d.  If m ore 
t ha n 2 5 0 E F S e ve nts are o bser ve d at t he ti me of t he data c ut off f or t he pri mar y a nal ysis, all 
o bser ve d e ve nts will be use d i n t he a nal ysis.
At t he ti me of t he i nteri m a nal ysis of E F S, s u bjects w h o ha ve n ot ha d t he o p p ort u nit y t o be 
f oll o we d t o t he Da y 1 5 0 disease assess me nt a n d w h o d o n ot ha ve a n E F S e ve nt will be ce ns ore d 
at t he last e val ua ble disease assess me nt pri or t o Da y 1 5 0.
1 0. 2. 2.  
Ke y Sec o n d ar y
O R R is defi ne d as t he i nci de nce of eit her a c o m plete res p o nse or a partial res p o nse b y t he 
L u ga n o Classificati o n { C hes o n 2 0 1 4 } as deter mi ne d b y bli n de d ce ntral re vie w.  All s u bjects t hat 
d o n ot meet t he criteria f or a n o bjecti ve res p o nse b y t he a nal ysis c ut off date will be c o nsi dere d 
n o n-res p o n ders.  F or t he deri vati o n of O R R i n b ot h ar ms, disease assess me nts o btai ne d after 
ra n d o mizati o n a n d u p t hr o u g h a n o bser vati o n of pr o gressi o n per L u ga n o Classificati o n will be 
use d.  I n b ot h ar ms, deri vati o n of best res p o nse will i ncl u de all assess me nts u ntil a n E F S e ve nt, 
i ncl u di n g a n y assess me nts o btai ne d after S C T f or t he S O C ar m.
O S is defi ne d as t he ti me fr o m ra n d o mizati o n t o deat h fr o m a n y ca use.  S u bjects w h o ha ve n ot 
die d b y t he a nal ysis data c ut off date will ha ve s ur vi val ti me ce ns ore d at t heir last date k n o w n t o 
be ali ve.  F or s u bjects ali ve or dea d after t he data c ut off date, s ur vi val ti me will be ce ns ore d at 
t he data c ut off date.
1 0. 2. 3. 
Sec o n d ar y
E F S base d o n i n vesti gat or disease assess me nts:  E F S base d o n i n vesti gat or disease assess me nts 
will use t he sa me defi niti o n as E F S, e xce pt t hat pr o gressi o n e ve nts a n d ce ns ori n g ti mes will be 
base d o n t he i n vesti gat or disease assess me nts.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 7 6
1 4 A pril 2 0 2 3  
M o difie d E F S ( m E F S): m E F S is defi ne d t he sa me wa y as E F S, e xce pt t hat fail ure t o attai n C R or 
P R b y Da y 1 5 0 assess me nt is n ot c o nsi dere d as a n e ve nt.  m E F S will be a nal yze d per bli n de d 
ce ntral re vie w a n d per i n vesti gat or disease assess me nts.
P F S is defi ne d as t he ti me fr o m ra n d o mizati o n t o disease pr o gressi o n per L u ga n o Classificati o n 
{ C hes o n 2 0 1 4 } as deter mi ne d b y i n vesti gat or re vie w or deat h fr o m a n y ca use.  S u bjects ali ve 
a n d n ot meeti n g t he criteria f or pr o gressi o n at t he a nal ysis data c ut off date will ha ve P F S ti me 
ce ns ore d at t he last e val ua ble disease assess me nt.  S u bjects w h o recei ve s u bse q ue nt ne w 
l y m p h o ma t hera p y ( wit h t he e xce pti o n of H D T, T BI f or H D T, a n d S C T w hile i n a pr ot oc ol 
t hera p y i n d uce d res p o nse) i n t he a bse nce of d oc u me nte d disease pr o gressi o n will be ce ns ore d at 
t heir last e val ua ble disease assess me nt date pri or t o t he c o m me nce me nt of t he s u bse q ue nt ne w 
l y m p h o ma t hera p y.  S C T t hat occ urs w hile a s u bject is i n res p o nse fr o m a pr ot oc ol t hera p y will 
n ot be c o nsi dere d a P F S e ve nt, a n d s uc h s u bjects will be ce ns ore d f or P F S at t he of t he last 
e val ua ble disease assess me nt date pri or t o t he S C T f or s u bjects i n t he a xica bta ge ne cil ole ucel 
ar m a n d will be ce ns ore d at t he last e val ua ble disease assess me nt date i ncl u di n g assess me nts 
after S C T f or s u bjects i n t he S O C ar m f or t he pri mar y a nal ysis of P F S. Disease o utc o mes will be 
base d o n i n vesti gat or assess me nt.
D O R is deri ve d o nl y a m o n g s u bjects w h o e x perie nce a n o bjecti ve res p o nse per L u ga n o 
Classificati o n { C hes o n 2 0 1 4 } as deter mi ne d b y bli n de d ce ntral re vie w a n d is defi ne d as t he ti me 
fr o m first o bjecti ve res p o nse t o disease pr o gressi o n per t he L u ga n o Classificati o n or deat h fr o m 
a n y ca use.  S u bjects n ot meeti n g t he criteria f or pr o gressi o n or deat h b y t he a nal ysis data c ut off 
date will ha ve D O R ce ns ore d at t heir last e val ua ble disease assess me nt date.  S u bjects w h o 
recei ve s u bse q ue nt ne w l y m p h o ma t hera p y ( wit h t he e xce pti o n of H D T, T BI f or H D T, a n d S C T 
w hile i n a pr ot oc ol t hera p y i n d uce d res p o nse) i n t he a bse nce of d oc u me nte d pr o gressi o n will 
ha ve D O R ce ns ore d at t he last e val ua ble disease assess me nt pri or t o t he c o m me nce me nt of t he 
ne w l y m p h o ma t hera p y.  F or t he pri mar y a nal ysis of D O R, D O R will be ce ns ore d at t he last 
e val ua ble disease assess me nt date pri or t o t he S C T f or s u bjects u n der g o S C T w hile i n pr ot oc ol 
t hera p y i n d uce d res p o nse i n t he a xica bta ge ne cil ole ucel ar m, a n d will be ce ns ore d at t he last 
e val ua ble disease assess me nt date i ncl u di n g assess me nts after S C T f or s u bjects i n t he S O C ar m.
I nci de nce of a d verse e ve nts a n d cli nical si g nifica nt c ha n ges i n safet y la b val ues, i ncl u di n g 
a nti b o dies t o a xica bta ge ne cil ole ucel.
C ha n ges i n E O R T C Q L Q- C 3 0 d o mai ns fr o m scree ni n g t o p ost baseli ne.
C ha n ges i n t he E Q- 5 D- 5 L i n de x a n d V A S sc ores fr o m scree ni n g t o p ost baseli ne.
1 0. 2. 4. 
E x pl or at or y
F or a xica bta ge ne cil ole ucel treat me nt ar m o nl y:
•
Le vels of a nti- C D 1 9 C A R T cells i n bl o o d
•
Le vels of h o me ostatic (I L- 2, I L- 1 5), pr o-i nfla m mat or y (I L- 6, I L- 1 7, T N F α, I L 2 R α, I L 1 Ra) 
a n d i m m u ne m o d ulati n g c yt o ki nes (I F N-γ, I L 1 0), a n d c he m o ki nes ( MI P 1 α, MI P 1 β, I L- 8) i n 
ser u m.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 7 7
1 4 A pril 2 0 2 3  
F or b ot h treat me nt ar ms:
•
T u m or m olec ular a n d hist ol o gical c haracteristics b y le vel of P D- L 1 a n d m olec ular a n d 
c yt o ge netic s u bclassificati o ns.
•
C ha n ges i n t he W P AI fr o m scree ni n g t o p ost baseli ne.
•
Ti me t o ne xt t hera p y is defi ne d as t he ti me fr o m t he ra n d o mizati o n date t o t he start of t he 
s u bse q ue nt ne w l y m p h o ma t hera p y or deat h fr o m a n y ca use. S u bjects w h o ha ve n ot recei ve d 
s u bse q ue nt ne w t hera p y a n d are still ali ve will be ce ns ore d at t he last c o ntact date.
1 0. 2. 5.  
A n al ysis S u bsets
T he pri mar y a nal ysis of all efficac y e n d p oi nts, u nless n ote d ot her wise, will be c o n d ucte d o n t he 
f ull a nal ysis set ( F A S), defi ne d as all ra n d o mize d s u bjects.  S u bjects will be a nal yze d acc or di n g 
t o t he treat me nt first ra n d o mize d re gar dless of treat me nt recei ve d.
T he safet y a nal ysis set is defi ne d as t he s u bset of all ra n d o mize d s u bjects w h o recei ve at least 
o ne d ose of a xica bta ge ne cil ole ucel as pr ot oc ol t hera p y or S O C c he m ot hera p y as pr ot oc ol 
t hera p y.  S u bjects will be a nal yze d b y t he pr ot oc ol t hera p y recei ve d.
T he safet y a nal ysis set – A S C T is defi ne d as t he s u bset s u bjects ra n d o mize d t o t he S O C ar m w h o 
u n der g o tra ns pla nt as part of pr ot oc ol t hera p y.
T he pri mar y a nal ysis of H R Q o L will be perf or me d o n t he s u bset of s u bjects i n t he F A S w h o 
ha ve a baseli ne a n d at Da y 1 5 0 p ost-ra n d o mizati o n assess me nt.
1 0. 2. 6.  
C o v ari ates
T he f oll o wi n g baseli ne c o variates ma y be use d t o e xa mi ne efficac y a n d/ or safet y i n s u b gr o u ps or 
c o variate a nal yses:
•
Ge o gra p hic re gi o n ( N ort h A merica, E ur o pe)
•
E C O G perf or ma nce stat us at scree ni n g ( 0, 1)
•
A ge at ra n d o mizati o n ( ≥ 6 5, < 6 5)
•
Se x
•
Race/et h nicit y
•
Res p o nse t o first-li ne t hera p y ( pri mar y refract or y, rela pse ≤ 6 m o nt hs of  first li ne t hera p y vs 
rela pse > 6 a n d ≤ 1 2 m o nt hs of first-li ne t hera p y)
•
A ge-a dj uste d I PI ( 0 t o 1 vs 2 t o 3) at ti me of scree ni n g


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 7 8
1 4 A pril 2 0 2 3  
•
Disease t y pe ( D L B C L, T F L)
•
M olec ular s u b gr o u p ( ger mi nal ce nter B-cell li ke [ G B C], acti vate d B-cell li ke [ A B C])
•
D o u ble hit ( C- M Y C alterati o ns a n d eit her B C L- 2 or B C L- 6 alterati o ns) stat us b y FI S H
•
Tri ple hit ( B C L- 2, B C L- 6, a n d C- M Y C alterati o ns) stat us b y FI S H
F or t he pri mar y a nal ysis of efficac y, t he I X R S val ues of res p o nse t o first-li ne t hera p y a n d a ge-
a dj uste d I PI will be use d.  Se nsiti vit y a nal yses ma y be c o n d ucte d wit h val ues c ollecte d i n E D C.  
C o variate le vels t hat are s parse (ie, less t ha n 3 0 e ve nts f or ti me t o e ve nt a nal yses or s u bjects f or 
O R R a nal yses) ma y be c olla pse d f or p ur p oses of statistical m o deli n g.  If t his occ urs, t he strata 
f or rela pse ≤ 6 m o nt hs of first-li ne t hera p y a n d rela pse fr o m 6 t o 1 2 m o nt hs of first-li ne t hera p y 
will be c olla pse d first.
1 0. 3. 
S a m ple Size C o nsi der ati o ns
A n E F S hazar d rati o (test/c o ntr ol ar m) of 0. 6 7 is h y p ot hesize d i n t he F A S set.  Ass u mi n g a n 
e x p o ne ntial distri b uti o n f or E F S a n d a me dia n E F S of 4 m o nt hs i n t he S O C ar m, t his i m plies a 
5 0 % relati ve i m pr o ve me nt i n E F S a n d c orres p o n ds t o me dia n E F S of 4 vers us 6 m o nt hs (c o ntr ol 
vs test ar m).  T he pri mar y a nal ysis is pla n ne d w he n 2 5 0 E F S e ve nts ha ve bee n o bser ve d; t he 
st u d y has bee n size d t o ac hie ve a p pr o xi matel y 9 0 % p o wer at t he 1-si de d 2. 5 % si g nifica nce le vel 
t o detect a 5 0 % i m pr o ve me nt i n E F S.  T he mi ni m u m effect size t hat ca n be deter mi ne d t o be 
statisticall y si g nifica nt is a n E F S hazar d rati o of 0. 7 9, or a 2 7 % relati ve i m pr o ve me nt i n E F S.  
F urt her, ass u mi n g a c o nca ve accr ual distri b uti o n wit h 5 0 % of accr ual i n t he last 3 3 % of t he 
accr ual peri o d of 2 4 m o nt hs a n d a 1 0 % rate ( 5 % b y m o nt h 1 a n d c u m ulati ve 1 0 % b y m o nt h 8) of 
l oss t o f oll o w- u p i n t he a xica bta ge ne cil ole ucel ar m a n d 1 5 % rate ( 1 0 % b y m o nt h 1 a n d 
c u m ulati ve 1 5 % b y m o nt h 8) of l oss t o f oll o w- u p i n t he S O C ar m, it is a ntici pate d t hat t he e ve nt 
g oal will be ac hie ve d if 3 5 0 s u bjects are ra n d o mize d ( 1 7 5/ar m) a n d will occ ur a p pr o xi matel y 
3 1 m o nt hs after t he first s u bject is ra n d o mize d.  O ne i nteri m f utilit y a nal ysis of E F S will be 
c o n d ucte d after 1 3 5 E F S e ve nts ha ve bee n o bser ve d.  T he i nteri m a nal ysis will n ot all o w earl y 
st o p pi n g f or efficac y.
T he st u d y will ha ve a n o verall al p ha of 2. 5 % wit h 1-si de d testi n g.  T o preser ve t he o verall 
si g nifica nce le vel, statistical testi n g of t he pri mar y a n d ke y sec o n dar y efficac y e n d p oi nts will 
f oll o w a hierarc hical sc he me.  E F S will be teste d first at t he pri mar y E F S a nal ysis.  C o n diti o nal 
o n a statisticall y si g nifica nt i m pr o ve me nt i n E F S, O R R will be teste d at t he 2. 5 % le vel at t he 
ti me of t he pri mar y E F S a nal ysis.  C o n diti o nal o n a statisticall y si g nifica nt i m pr o ve me nt i n E F S 
a n d O R R, O S will be teste d u p t o 3 ti mes at a n o verall 1-si de d al p ha le vel of 2. 5 %.
F or t he a nal ysis of O R R, res p o nse rates of 3 6 % a n d 7 8 % i n t he c o ntr ol a n d test ar ms are 
ass u me d.  O R R will be teste d wit h a stratifie d (ra n d o mizati o n fact ors) C oc hra n- Ma ntel- Hae nszel 
test at t he 2. 5 % le vel a m o n g s u bjects wit h meas ura ble disease at baseli ne.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 7 9
1 4 A pril 2 0 2 3  
A n O S hazar d rati o of 0. 7 3 is h y p ot hesize d i n t he F A S set.  Ass u mi n g a n e x p o ne ntial distri b uti o n 
f or O S a n d a me dia n O S of 1 5. 8 m o nt hs i n t he c o ntr ol ar m, t his i m plies a 3 7 % relati ve 
i m pr o ve me nt i n O S a n d c orres p o n ds t o me dia n O S of 1 5. 8 vers us 2 1. 6 m o nt hs.  T he pri mar y O S 
a nal ysis is pla n ne d w he n a p pr o xi matel y 2 1 0 deat hs ha ve bee n o bser ve d or n o later t ha n 5 years 
after t he first s u bject is ra n d o mize d wit h a first i nteri m a nal ysis of O S occ urri n g at t he ti me of 
pri mar y E F S a nal ysis a n d a sec o n d i nteri m a nal ysis w he n a p pr o xi matel y 1 6 0 deat hs ha ve bee n 
o bser ve d or n o later t ha n 4 years after t he first s u bject is ra n d o mize d .
Stratifie d (ra n d o mizati o n fact ors) l o g-ra n k tests will be use d t o test t he n ull h y p ot hesis of n o 
differe nce i n E F S a n d O S usi n g a n o verall 1-si de d al p ha le vel of 2. 5 %.  A stratifie d 
(ra n d o mizati o n fact ors) C oc hra n- Ma ntel- Hae nszel test will be use d t o test O R R at a n o verall 
1-si de d al p ha le vel of 2. 5 %.
T he E F S a nal yses are e ve nt- dri ve n a n d will occ ur w he n t he re q uire d n u m ber of e ve nts ha ve bee n 
o bser ve d.
T he st u d y testi n g sc he me is pr o vi de d i n Fi g ure 2 .
Fi g ure 2.
St u d y Testi n g Sc he me
E nr oll me nt o ver 2 4 m o nt hs
E F S f utilit y 
a n al ysis 
( 1 3 5 
e v e nts)
D S M B
1 9 m os
2 4
E F S pri m ar y 
a n al ysis 2 5 0  
e v e nts)
Al p h a = 2. 5 %
3 1 m os
O R R pri m ar y 
a n al ysis
Al p h a = 2. 5 %
O S i nt eri m a n al ysis 
1
R h o  F a mil y 
Al p h a = 0. 1 % al p h a 
all oc ati o n
O S pri m ar y a n al ysis 
~ 2 1 0 e v e nts)
Al p h a = 2 %
6 0 m os
D S M B s afet y re vie ws Q 6 m o nt hs u ntil t he pri m ar y E F S a n al ysis
All testi n g will be perf or me d at t he 1-si de d 2. 5 % le vel.
Hierarc hi cal testi n g of E F S, f oll o we d b y O R R, f oll o we d b y O S.
T hree a nal yses of O S are pla n ne d; a first i nteri m a nal ysis at t he ti me of t he pri mar y E F S a nal ysis, a sec o n d i nteri m a nal ysis w he n 
a p pr o xi matel y 1 6 0 deat hs ha ve bee n o bser ve d or n o later t ha n 4 years after t he first s u bject is ra n d o mize d, a n d a pri mar y O S a nal ysis 
w he n a p pr o xi matel y 2 1 0 deat hs ha ve bee n o bser ve d or n o later t ha n 5 years after t he first s u bject is ra n d o mize d.
E F S a nal yses are e ve nt- dri ve n a n d will occ ur w he n t he re q uire d n u m ber of e ve nts ha ve bee n o bser ve d re gar dless of a ntici pati n g ti mi n g.
4 8 m os
O S i nt eri m 
a n al ysis  2
R h o F a mil y 
Al p h a = 0. 4 %


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 8 0
1 4 A pril 2 0 2 3  
1 0. 4.  
Access t o I n di vi d u al S u bject Tre at me nt Assi g n me nts
T his is a n o pe n-la bel st u d y w here s u bjects a n d i n vesti gat ors will be a ware of treat me nt recei ve d.  
Data ha n dli n g pr oce d ures will be de vise d t o re d uce p ote ntial s o urces of bias a n d mai ntai n t he 
vali dit y a n d cre di bilit y of t he st u d y.  T hese pr oce d ures will be o utli ne d i n t he st u d y statistical 
a nal ysis pla n a n d Trial I nte grit y D oc u me nt.
1 0. 5. 
I nteri m A n al ysis a n d E arl y St o p pi n g G ui deli nes
1 0. 5. 1. 
S afet y I nteri m A n al ysis
T he D S M B will re vie w safet y data e ver y 6 m o nt hs fr o m t he ti me t he first s u bject is ra n d o mize d 
u ntil t he pri mar y E F S a nal ysis.  A d diti o nall y, t he D S M B will re vie w safet y a n d efficac y data at 
t he ti me of t he pla n ne d i nteri m E F S a nal ysis.  T he D S M B will als o re vie w S A E i nf or mati o n a n d 
S U S A Rs o n a re g ular basis t hr o u g h o ut t he st u d y.  T he s p o ns or ma y re q uest a d diti o nal re vie ws 
b y t he D S M B if safet y c o ncer ns are i de ntifie d.  T he D S M B ma y meet m ore ofte n as nee de d.
1 0. 5. 2. 
Effic ac y I nteri m A n al ysis
O ne i nteri m a nal ysis of E F S a n d 2 i nteri m a nal yses of O S are pla n ne d.
T he i nteri m E F S a nal ysis is f or f utilit y a n d will occ ur w he n 1 3 5 E F S e ve nts ha ve bee n o bser ve d.  
A n O’ Brie n- Fle mi n g s pe n di n g f u ncti o n of t he La n- De Mets fa mil y will be use d t o all ocate t he 
t y pe II err or bet wee n t he i nteri m a n d pri mar y a nal yses.  T he f utilit y st o p pi n g r ule is n o n- bi n di n g.  
U n der t he n ull h y p ot hesis, t he pr o ba bilit y of st o p pi n g f or f utilit y at t his i nteri m a nal ysis is 
a p pr o xi matel y 6 0 %.  O ne h u n dre d t hirt y-fi ve ( 1 3 5) E F S e ve nts are a ntici pate d t o occ ur 
a p pr o xi matel y 1 9 m o nt hs after t he first s u bject is ra n d o mize d.
C o n diti o nal u p o n statisticall y si g nifica nt tests of E F S a n d O R R, testi n g of O S will be perf or me d.  
T w o i nteri m a nal yses of O S will occ ur, a first at t he ti me of t he pri mar y E F S a nal ysis a n d a 
sec o n d w he n a p pr o xi matel y 1 6 0 deat hs ha ve bee n o bser ve d or n o later t ha n 4 years after t he first 
s u bject is ra n d o mize d.  A s pe n di n g f u ncti o n of t he R h o fa mil y wit h para meter (r h o = 6) will be 
use d t o all ocate t he al p ha bet wee n t he 2 i nteri m a nal ysis of O S a n d t he pri mar y a nal ysis of O S 
wit h 0. 1 % a n d 0. 4 % at t he i nteri m O S a nal yses 1 a n d 2 res pecti vel y, a n d 2 % at t he pri mar y 
a nal ysis of O S.  A p pr o xi matel y 1 1 0 a n d 1 6 0 O S e ve nts are a ntici pate d at t he ti me of t he i nteri m 
O S a nal yses 1 a n d 2 res pecti vel y.
1 0. 6. 
Pl a n ne d Met h o d of A n al ysis
T he a nal ysis o bjecti ves a n d ti mi n g of a nal yses are descri be d i n Secti o n 1 0. 1 , Secti o n 1 0. 2 , a n d 
Secti o n 1 0. 3 .  Pri or t o t he pri mar y efficac y a nal ysis, m o deli n g a n d m o nit ori n g of c u m ulati ve 
E F S e ve nts will be perf or me d t o deter mi ne a data c ut off date t o ac hie ve t he pla n ne d a nal ysis 
tar get e ve nt g oal.
T he pri mar y a nal ysis of E F S will be c o n d ucte d w he n all ra n d o mize d s u bjects ha ve ha d t he 
o p p ort u nit y t o be f oll o we d t o t he M o nt h 9  disease assess me nt a n d 2 5 0 E F S e ve nts as deter mi ne d 
b y bli n de d ce ntral re vie w ha ve bee n o bser ve d. If m ore t ha n 2 5 0 E F S e ve nts are o bser ve d at t he 
ti me of t he data c ut off f or t he pri mar y a nal ysis, all o bser ve d e ve nts will be use d i n t he a nal ysis. 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 8 1
1 4 A pril 2 0 2 3  
T he pri mar y a nal ysis of O S will occ ur w he n a p pr o xi matel y 2 1 0 deat hs ha ve bee n o bser ve d or n o 
later t ha n 5 years after t he first s u bject is ra n d o mize d.
S u bse q ue nt t o data c ollecti o n f or t he data c ut off date f or t he pri mar y a nal ysis of E F S a n d O S, t he 
t otal o bser ve d n u m ber of e ve nts will be deter mi ne d.  If t his is bel o w t he s pecifie d l o wer li mit, 
t he n a s ufficie ntl y later data c ut off date will be use d f or w hic h t he o bser ve d t otal e ve nts are at or 
a b o ve t he li mit.
T he i nteri m a n d pri mar y a nal yses of E F S will be base d o n disease pr o gressi o n e ve nts a n d 
ce ns ori n g ti mes as deter mi ne d b y bli n de d ce ntral re vie w.  A se nsiti vit y a nal ysis of E F S will be 
base d o n disease assess me nts a n d ce ns ori n g ti mes base d o n i n vesti gat or disease assess me nt.  
O R R assess me nts will be base d o n bli n de d ce ntral re vie w.  A nal ysis of D O R will use disease 
assess me nts base d o n bli n de d ce ntral re vie w, a n d a nal ysis of P F S will use disease assess me nts 
pr o vi de d b y t he i n vesti gat or.
T he Cli nical St u d y Re p ort ( C S R) will be writte n at t he ti me of t he pri mar y E F S a nal ysis a n d will 
i ncl u de res ults of t he first i nteri m a nal ysis of O S. Res ults of t he sec o n d i nteri m a nal ysis a n d t he 
pri mar y a nal ysis of O S will be writte n s h ortl y after eac h a nal ysis is c o m plete d, or n o later t ha n 
5 years after t he first s u bject is ra n d o mize d.
1 0. 6. 1. 
E ve nt-free S ur vi v al
T he a nal ysis of E F S will be c o n d ucte d o n t he F A S.  A stratifie d (ra n d o mizati o n stratificati o n 
fact ors) l o g-ra n k test will be use d f or t he pri mar y c o m paris o n of E F S.  A d diti o nall y, stratifie d 
(ra n d o mizati o n fact or) C o x re gressi o n m o dels will be use d t o pr o vi de t he esti mate d E F S hazar d 
rati o a n d 2-si de d 9 5 % c o nfi de nce i nter vals f or a xica bta ge ne cil ole ucel relati ve t o S O C.  T he 
me dia n E F S ti me a n d e ve nt-free rates at 3- m o nt h i nter vals will be pr o vi de d.  T he stratificati o n 
fact ors as c ollecte d i n t he ra n d o mizati o n s yste m at t he ti me of t he s u bjects’ ra n d o mizati o n will 
be use d f or stratifie d a nal yses (l o g-ra n k test a n d C o x re gressi o n m o dels). Se nsiti vit y a nal yses 
will be perf or me d usi n g t he act ual stratificati o n fact or val ues, i n w hic h t he strata f or rela pse 
≤ 6 m o nt hs of first-li ne t hera p y a n d rela pse fr o m 6 t o 1 2 m o nt hs of first-li ne t hera p y will be 
deter mi ne d base d o n t he ti me of c o m pleti o n of t he first-li ne t hera p y.
E F S hazar d rati os will be assesse d i n s u b gr o u ps defi ne d b y c o variates i n Secti o n 1 0. 2. 6 .
Se nsiti vit y a nal yses of E F S will be perf or me d t o assess ascertai n me nt ti me bias i n disease 
pr o gressi o n as f oll o ws:
•
Pr o gressi o n e ve nts t hat occ ur i n bet wee n sc he d ule d assess me nts will be m o ve d f or war d t o 
t he ne xt sc he d ule d assess me nt after t he o bser ve d pr o gressi o n
•
Pr o gressi o n e ve nts t hat occ ur i n bet wee n sc he d ule d assess me nts will be m o ve d bac k war d t o 
t he last sc he d ule d assess me nt pri or t o t he pr o gressi o n
•
E F S e ve nts t hat occ ur after m ore t ha n o ne misse d visit will be ce ns ore d at t he last e val ua ble 
disease assess me nt or visit pri or t o t he o bser ve d pr o gressi o n


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 8 2
1 4 A pril 2 0 2 3  
•
A d diti o nall y, a se nsiti vit y a nal ysis f or E F S will be perf or me d as f oll o ws:
•
A se nsiti vit y a nal ysis i n w hic h s u bjects i n t he a xica bta ge ne cil ole ucel ar m w h o u n der g o S C T 
w hile i n a n a xica bta ge ne cil ole ucel i n d uce d res p o nse are c o nsi dere d t o ha ve a n E F S e ve nt o n 
t he date of S C T, wit h E F S ti me defi ne d as ti me fr o m ra n d o mizati o n t o t he date of S C T.
E F S base d o n i n vesti gat or disease assess me nts will be a nal yze d wit h t he sa me met h o ds as E F S.  
T he c o nc or da nce of pr o gressi o n e ve nts a n d E F S ti me per t he i n vesti gat or a n d per bli n de d ce ntral 
re vie w will be s u m marize d.
1 0. 6. 2.  
O R R
T he a nal ysis of O R R will be c o n d ucte d o n t he F A S.  T he s u bject i nci de nce of o bjecti ve res p o nse 
a n d best res p o nse will be s u m marize d.  A n e xact bi n o mial 2-si de d 9 5 % c o nfi de nce i nter val will 
be ge nerate d f or t he o bjecti ve res p o nse rate a n d best res p o nse rates f or eac h treat me nt ar m.  
Wils o n’s sc ore met h o d wit h c o nti n uit y c orrecti o n will be use d t o calc ulate 9 5 % c o nfi de nce 
i nter vals f or t he differe nce i n o bjecti ve res p o nse rates bet wee n treat me nt ar ms {Ne wc o m be 
1 9 9 8 }.
C o n diti o nal u p o n de m o nstrati n g a statisticall y si g nifica nt i m pr o ve me nt i n E F S, testi n g of O R R 
will be perf or me d wit h a stratifie d (ra n d o mizati o n fact or) C oc hra n- Ma ntel- Hae nszel test f or t he 
c o m m o n o d ds rati o of res p o nse.
O d ds rati os f or O R R will be assesse d i n s u b gr o u ps defi ne d b y c o variates i n Secti o n 1 0. 2. 6 .
1 0. 6. 3.  
O S
T he a nal ysis of O S will be c o n d ucte d o n t he F A S.  A stratifie d (ra n d o mizati o n stratificati o n 
fact ors) l o g-ra n k test will be use d f or t he pri mar y c o m paris o n of O S.  A d diti o nall y, stratifie d 
(ra n d o mizati o n fact or) C o x re gressi o n m o dels will be use d t o pr o vi de t he esti mate d O S hazar d 
rati o a n d 2-si de d 9 5 % c o nfi de nce i nter vals f or a xica bta ge ne cil ole ucel relati ve t o S O C.  T he 
me dia n O S ti me a n d e ve nt-free rates at 6- m o nt hl y i nter vals will be pr o vi de d.   T he stratificati o n 
fact ors as c ollecte d i n t he ra n d o mizati o n s yste m at t he ti me of t he s u bjects’ ra n d o mizati o n will 
be use d f or stratifie d a nal yses (l o g-ra n k test a n d C o x re gressi o n m o dels). Se nsiti vit y a nal yses 
will be perf or me d usi n g t he act ual stratificati o n fact or val ues, i n w hic h t he strata f or rela pse 
≤ 6 m o nt hs of first-li ne t hera p y a n d rela pse fr o m 6 t o 1 2 m o nt hs of first-li ne t hera p y will be 
deter mi ne d base d o n t he ti me of c o m pleti o n of t he first-li ne t hera p y. O S hazar d rati os will be 
assesse d i n s u b gr o u ps defi ne d b y c o variates i n Secti o n 1 0. 2. 6 .
Se nsiti vit y a nal yses of O S t o a d dress t he c o nf o u n di n g effect fr o m treat me nt s witc hi n g, will be 
c o n d ucte d usi n g t he Ra n k Preser vi n g Str uct ural Fail ure Ti me M o del a n d I n verse Pr o ba bilit y of 
Ce ns ori n g Wei g hts, 2-sta ge C o x re gressi o n m o del a n d ot her e x pl orat or y treat me nt s witc hi n g 
a dj ust me nt met h o ds.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 8 3
1 4 A pril 2 0 2 3  
1 0. 6. 4. 
Pr o gressi o n-free S ur vi v al, D ur ati o n of Res p o nse, a n d Ti me t o Ne xt T her a p y
T he a nal ysis of P F S, D O R, a n d ti me t o ne xt t hera p y will be perf or me d usi n g t he sa me met h o ds 
as t he a nal ysis of E F S, wit h p- val ues fr o m t he l o g-ra n k test bei n g descri pti ve.
1 0. 6. 5. 
S afet y
A T E A E is defi ne d as a n y A E t hat be gi ns o n or after t he first d ose of st u d y treat me nt 
(a xica bta ge ne cil ole ucel i nf usi o n or S O C), e xcl u di n g bri d gi n g t hera p y.  S u bject i nci de nce rates 
of T E A Es, i ncl u di n g all, seri o us, fatal, C T C A E Gra de 3 or hi g her, a n d treat me nt relate d A Es 
re p orte d will be ta b ulate d b y preferre d ter m a n d s yste m or ga n class c o de d wit h t he Me dical 
Dicti o nar y f or Re g ulat or y Acti vities ( Me d D R A).  C ha n ges i n la b orat or y val ues a n d vital si g ns 
will be s u m marize d wit h descri pti ve statistics.  T he i nci de nce of c o nc o mita nt me dicati o ns will be 
s u m marize d.
Ta bles a n d/ or narrati ves of deat hs t hr o u g h t he l o n g-ter m f oll o w- u p a n d treat me nt relate d S A Es 
will be pr o vi de d.
T he i nci de nce, pre vale nce, d urati o n, a n d re versi bilit y of c yt o pe nias will be s u m marize d.
1 0. 6. 6. 
P h ar m ac o ki netic A n al yses
F or s u bjects i n t he a xica bta ge ne cil ole ucel ar m, a nti- C D 1 9 C A R T le vels meas ure d i n peri p heral 
bl o o d  will be s u m marize d wit h descri pti ve statistics.
1 0. 6. 7. 
I m m u n o ge nicit y A n al yses
T he s u bject i nci de nce of a nti b o dies t o a xica bta ge ne cil ole ucel will be s u m marize d.
1 0. 6. 8.  
He alt h-rel ate d Q u alit y of Life
C ha n ges i n E O R T C Q L Q- C 3 0 d o mai ns a n d t he E Q- 5 D- 5 L i n de x a n d V A S sc ores fr o m 
scree ni n g t o t he M o nt h 2 4 p ost-ra n d o mizati o n visit will be s u m marize d wit h descri pti ve 
statistics. T he W P AI will be sc ore d per t he i nstr u me nt de vel o p me nt al g orit h m 
(htt p:// w w w.reill yass ociates. net/ W P AI _ Sc ori n g. ht ml).  C ha n ges i n t he W P AI sc ore fr o m 
scree ni n g to M o nt h 2 4 p ost-ra n d o mizati o n visit will be s u m marize d wit h descri pti ve statistics.  
I n a d diti o n, t he mea n/ me dia n c ha n ges i n E O R T C Q L Q- C 3 0 d o mai ns, t he E Q- 5 D- 5 L i n de x, V A S 
sc ores, a n d W P AI sc ore fr o m scree ni n g o ver ti me will be prese nt wit h pl ots.
1 0. 6. 9.  
C yt o ki nes, Pr o d uct C h ar acteristics, a n d M olec ul ar a n d Hist ol o gic al 
C h ar acteristics
A m o n g s u bjects i n t he a xica bta ge ne cil ole ucel ar m, s u m maries of c yt o ki nes o ver ti me will be 
pr o vi de d.
T he pr o p orti o ns of cell p he n ot y pes i n t he a xica bta ge ne cil ole ucel pr o d uct will be s u m marize d.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 8 4
1 4 A pril 2 0 2 3  
A nal yses of t u m or m olec ular a n d hist ol o gic c haracteristics b y le vels of P D- L 1, a n d m olec ular 
a n d c yt o ge netic s u bclassificati o ns will be s u m marize d i n t he statistical a nal ysis pla n.
1 0. 6. 1 0. 
L o n g-ter m D at a A n al ysis
All s u bjects w h o recei ve d at least o ne d ose of a xica bta ge ne cil ole ucel as pr ot oc ol t hera p y will be 
f oll o we d f or s ur vi val f or u p t o a p pr o xi matel y 1 5 years after ra n d o mizati o n; L T F U assess me nt 
will be perf or me d o n s u bjects after tra nsiti o n t o t he L T F U st u d y (refer t o Secti o n 3. 5. 2  a n d 
Secti o n 3. 5. 3 ). N o f or mal h y p ot hesis testi n g will be perf or me d base d o n data o btai ne d after t he 
pri mar y a nal ysis of O S.  Descri pti ve esti mates of ke y efficac y a n d safet y a nal yses ma y be 
u p date d t o assess t he o verall treat me nt pr ofile.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 8 5
1 4 A pril 2 0 2 3  
1 1.  
R E G U L A T O R Y O B LI G A TI O N S
T his st u d y will be c o n d ucte d i n acc or da nce wit h t he pr ot oc ol a n d wit h t he f oll o wi n g:
•
C o nse ns us et hical pri nci ples deri ve d fr o m i nter nati o nal g ui deli nes i ncl u di n g t he Declarati o n 
of Helsi n ki
•
A p plica ble I nter nati o nal C o nfere nce o n Har m o nisati o n (I C H) G o o d Cli nical Practice ( G C P) 
G ui deli nes
•
A p plica ble la ws a n d re g ulati o ns
1 1. 1. 
I n de pe n de nt Re vie w B o ar d/I n de pe n de nt Et hics C o m mittee
A c o p y of t he pr ot oc ol, I C F, a n d a n y a d diti o nal s u bject or trial i nf or mati o n s uc h as s u bject 
recr uit me nt materials m ust be s u b mitte d t o eac h site’s res pecti ve I R B/I E C f or a p pr o val.  After 
a p pr o val is o btai ne d fr o m t he I R B/I E C, all d oc u me nts m ust be pr o vi de d t o t he ke y s p o ns or 
c o ntact bef ore s u bject recr uit me nt ca n be gi n.
T he i n vesti gat or m ust als o recei ve I R B/I E C a p pr o val f or all pr ot oc ol a n d I C F c ha n ges or 
a me n d me nts. I n vesti gat ors m ust e ns ure t hat o n g oi n g/c o nti n u o us I R B/I E C a p pr o val (ie, a n n ual 
a p pr o val) is pr o vi de d t hr o u g h o ut t he c o n d uct of t he st u d y  acc or di n g t o a p plica ble la w.  C o pies of 
I R B/I E C a p pr o val are t o be f or war de d t o t he ke y s p o ns or c o ntact f or arc hi vi n g.
D uri n g t he c o urse of t he st u d y, i n vesti gat ors are t o s u b mit site-s pecific a n d st u d y seri o us a d verse 
e ve nts ( pr o vi de d t o t he site b y t he ke y s p o ns or c o ntact) al o n g wit h a n y pr ot oc ol de viati o ns t o 
t heir I R B/I E C i n acc or da nce wit h t heir res pecti ve I R B/I E C p olicies.
1 1. 2. 
S u bject C o nfi de nti alit y
S u bject c o nfi de ntialit y m ust be mai ntai ne d f or all material s u b mitte d t o t he ke y s p o ns or c o ntact.  
T he f oll o wi n g r ules are t o be a p plie d.
•
S u bjects will be i de ntifie d b y a u ni q ue i de ntificati o n n u m ber.
•
Year of birt h/a ge at ti me of e nr oll me nt will be re p orte d acc or di n g wit h l ocal la ws a n d 
re g ulati o ns.
F or re p orti n g of seri o us a d verse e ve nts, s u bjects will be i de ntifie d b y t heir res pecti ve s u bject 
i de ntificati o n n u m ber, i nitials, a n d year of birt h (as per t heir l ocal re p orti n g re q uire me nts f or 
b ot h i nitials a n d year of birt h).
Per c o u ntr y-s pecific re g ulati o ns a n d I C H/ G C P g ui deli nes, i n vesti gat ors a n d i nstit uti o ns are 
re q uire d t o per mit a ut h orizati o n t o t he s p o ns or, C o ntract Researc h Or ga nizati o n ( C R O), 
I R B/I E C, a n d re g ulat or y a ge ncies t o s u bject’s ori gi nal s o urce d oc u me nts f or verificati o n of st u d y 
data.  T he i n vesti gat or is res p o nsi ble f or i nf or mi n g p ote ntial s u bjects t hat s uc h i n di vi d uals will 
ha ve access t o t heir me dical rec or ds w hic h i ncl u des pers o nal i nf or mati o n.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 8 6
1 4 A pril 2 0 2 3  
1 1. 3. 
I n vesti g at or Si g n at or y O bli g ati o ns
Eac h cli nical st u d y re p ort will be si g ne d b y t he c o or di nati n g i n vesti gat or.  T he c o or di nati n g 
i n vesti gat or will be i de ntifie d b y Kite P har ma u n der t he f oll o wi n g criteria:
•
A rec o g nize d e x pert i n t he disease setti n g
•
Pr o vi de d si g nifica nt c o ntri b uti o ns t o t he desi g n or a nal ysis of st u d y data
•
Partici pate i n t he st u d y a n d e nr olle d a hi g h n u m ber of eli gi ble s u bjects


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 8 7
1 4 A pril 2 0 2 3  
1 2. 
P R O T O C O L A M E N D M E N T S A N D T E R MI N A TI O N
If t he pr ot oc ol is a me n de d, t he S p o ns or a n d I n vesti gat or Si g nat ure Pa ge wit h t he a me n d me nt a n d 
t he I R B/I E C a p pr o val of t he a me n d me nt m ust be o btai ne d.  D oc u me ntati o n ac k n o wle d gi n g 
a p pr o val fr o m b ot h parties are t o be s u b mitte d t o t he ke y s p o ns or c o ntact.
B ot h Kite P har ma a n d t he i n vesti gat or reser ve t he ri g ht t o ter mi nate t he i n vesti gat or’s 
partici pati o n i n t he st u d y as per t he ter ms of t he a gree me nt i n t he st u d y c o ntract.  T he 
i n vesti gat or is t o pr o vi de writte n c o m m u nicati o n t o t he I R B/I E C of t he trial c o m pleti o n or earl y 
ter mi nati o n a n d pr o vi de t he C R O wit h a c o p y of t he c orres p o n de nce.
Kite P har ma reser ves t he u nilateral ri g ht, at its s ole discreti o n, t o deter mi ne w het her t o 
ma n ufact ure a xica bta ge ne cil ole ucel a n d pr o vi de it t o sites a n d s u bjects after t he c o m pleti o n of 
t he st u d y a n d bef ore treat me nt bec o mes c o m merciall y a vaila ble.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 8 8
1 4 A pril 2 0 2 3  
1 3. 
S T U D Y D O C U M E N T A TI O N A N D A R C HI V E
T he i n vesti gat or will mai ntai n a list of q ualifie d staff t o w h o m st u d y res p o nsi bilities ha ve bee n 
dele gate d.  T hese i n di vi d uals a ut h orize d t o f ulfil t hese res p o nsi bilities s h o ul d be o utli ne d a n d 
i ncl u de d i n t he Dele gati o n of A ut h orit y F or m.
S o urce d oc u me nts are ori gi nal d oc u me nts, data, a n d rec or ds f or w hic h t he st u d y data are 
c ollecte d a n d verifie d.  E xa m ples of s uc h s o urce d oc u me nts ma y i ncl u de, b ut are n ot li mite d t o, 
h os pital rec or ds a n d patie nt c harts; la b orat or y, p har mac y, ra di ol o g y a n d rec or ds; s u bject diaries; 
micr ofic hes; c orres p o n de nce; a n d deat h re gistries.  C R F e ntries ma y be c o nsi dere d as s o urce data 
if t he site of t he ori gi nal data c ollecti o n is n ot a vaila ble.  H o we ver, use of t he C R Fs as s o urce 
d oc u me ntati o n as a r o uti ne practice is n ot rec o m me n de d.
T he i n vesti gat or a n d st u d y staff are res p o nsi ble f or mai ntai ni n g a c o m pre he nsi ve a n d ce ntralize d 
fili n g s yste m of all s u bject rec or ds t hat are rea dil y retrie ve d t o be m o nit ore d a n d or a u dite d at 
a n y ti me b y t he ke y s p o ns or c o ntact, re g ulat or y a ut h orities a n d I R B/I E Cs.  T he fili n g s yste m will 
i ncl u de at mi ni m u m:
•
S u bject c o nte nt i ncl u di n g I C Fs a n d s u bject i de ntificati o n lists
•
Esse ntial d oc u me nts f or t he c o n d uct of t his cli nical st u d y ( pr ot oc ols a n d pr ot oc ol 
a me n d me nts, I B, c o pies of pre-st u d y d oc u me ntati o n, a n d all I R B/I E C a n d s p o ns or 
c o m m u nicati o n)
•
Pr o of of recei pt, e x peri me ntal treat me nt fl o w rec or ds, a n d e x peri me ntal pr o d uct-relate d 
c orres p o n de nce
Ori gi nal s o urce d oc u me nts s u p p orti n g e ntries i nt o C R Fs m ust be mai ntai ne d at t he site a n d 
rea dil y a vaila ble u p o n re q uest.  N o st u d y d oc u me nts s h o ul d be discar de d wit h o ut pri or writte n 
a gree me nt bet wee n Kite P har ma a n d t he i n vesti gat or.  If st ora ge is n o l o n ger a vaila ble t o arc hi ve 
s o urce d oc u me nts or m ust be m o ve d t o a n alter nati ve l ocati o n, t he researc h staff s h o ul d n otif y 
t he ke y s p o ns or c o ntact pri or t o s hi p pi n g t he d oc u me nts.
Tracea bilit y rec or ds f or t he pr o d uct, fr o m pr oc ure me nt t hr o u g h ma n ufact ure t o a d mi nistrati o n of 
t he pr o d uct, s h o ul d be ke pt b y eac h rele va nt part y (e g, t he s p o ns or a n d i n vesti gat or/i nstit uti o n) 
f or a mi ni m u m of 3 0 years after t he e x pir y date of t he pr o d uct, or l o n ger if re q uire d b y t he ter ms 
of t he cli nical trial a ut h orizati o n or b y a gree me nt wit h Kite. Bef ore, d uri n g, a n d after c o m pleti o n 
or ter mi nati o n of t he st u d y, eac h part y s h o ul d h ol d t he necessar y i nf or mati o n a vaila ble at all 
ti mes t o e ns ure bi directi o nal tracea bilit y, li n ki n g t he s u bject i nf or mati o n at t he pr oc ure me nt site 
t o t he pr o d uct a n d s u bject i nf or mati o n at t he st u d y site t o t he pr o d uct, w hile e ns uri n g t he data 
pr otecti o n le gall y re q uire d f or t he s u bject.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 8 9
1 4 A pril 2 0 2 3  
If t he i n vesti gat or ca n n ot pr o vi de f or t his arc hi vi n g re q uire me nt at t he st u d y site f or a n y or all of 
t he d oc u me nts, s pecial arra n ge me nts m ust be ma de bet wee n t he i n vesti gat or a n d Kite t o st ore 
t hese rec or ds sec urel y a wa y fr o m t he site s o t hat t he y ca n be ret ur ne d seale d t o t he i n vesti gat or 
i n case of a n i ns pecti o n. W he n s o urce d oc u me nts are re q uire d f or t he c o nti n ue d care of t he 
s u bject, a p pr o priate c o pies s h o ul d be ma de f or st ora ge a wa y fr o m t he site.
If a s u bject tra nsfers t o a n ot her st u d y site, t he i n vesti gat or m ust n otif y Kite i n a d va nce bef ore 
assi g ni n g t he s u bject’s st u d y rec or ds t o a n ot her part y or m o vi n g t he m t o a n ot her l ocati o n.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 9 0
1 4 A pril 2 0 2 3  
1 4. 
S T U D Y M O NI T O RI N G A N D D A T A C O L L E C TI O N
T he ke y s p o ns or c o ntacts, m o nit ors, a u dit ors, or re g ulat or y i ns pect ors are res p o nsi ble f or 
c o ntacti n g a n d visiti n g t he i n vesti gat or f or t he p ur p ose of i ns pecti n g t he facilities a n d verif yi n g 
s o urce d oc u me nts a n d rec or ds ass uri n g t hat s u bject c o nfi de ntiall y is res pecte d.
T he m o nit or is res p o nsi ble f or s o urce d oc u me nt verificati o n of C R F data at re g ular i nter vals 
d uri n g t he st u d y.  Pr ot oc ol a d here nce, acc urac y, a n d c o nsiste nc y of st u d y c o n d uct a n d data 
c ollecti o n wit h res pect t o l ocal re g ulati o ns will be c o nfir me d.  M o nit ors will ha ve access t o 
s u bject rec or ds as i de ntifie d i n Secti o n 1 3 .
B y si g ni n g t he i n vesti gat or a gree me nt, t he i n vesti gat or a grees t o c o o perate wit h t he m o nit or t o 
a d dress a n d res ol ve iss ues i de ntifie d d uri n g m o nit ori n g visits.
I n acc or da nce wit h I C H/ G C P, a n d t he a u dit pla n, a site ma y be c h ose n f or a site a u dit.  A site 
a u dit w o ul d i ncl u de, b ut is n ot li mite d t o, a n i ns pecti o n of t he facilit y(ies), re vie w of s u bject- a n d 
st u d y-relate d rec or ds, f or c o m plia nce wit h pr ot oc ol re q uire me nts as well as I C H/ G C P, a n d 
a p plica ble l ocal re g ulati o ns.
All data will be c ollecte d i n a n e C R F s yste m.  All e ntries m ust be c o m plete d i n E n glis h, a n d 
c o nc o mita nt me dicati o ns s h o ul d be i de ntifie d b y tra de na mes.  F or a d diti o nal details a b o ut 
c o m pleti n g C R Fs, please refer t o t he C R F c o m pleti o n g ui deli nes.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 9 1
1 4 A pril 2 0 2 3  
1 5. 
P U B LI C A TI O N
A ut h ors hi p of p u blicati o ns fr o m data ge nerate d i n Z U M A- 7 will be deter mi ne d base d o n t he 
u nif or m re q uire me nts f or ma n uscri pts s u b mitte d t o bi o me dical j o ur nals (as o utli ne d i n t he 
I nter nati o nal C o m mittee of Me dical J o ur nal E dit ors Dece m ber 2 0 1 3), w hic h states a ut h ors hi p 
s h o ul d be base d o n:
•
S u bsta ntial c o ntri b uti o ns t o t he c o nce pti o n or desi g n of t he w or k, ac q uisiti o n of data, 
a nal ysis, or i nter pretati o n of data f or t he w or k; a n d
•
Drafti n g t he article or re visi n g it criticall y f or i m p orta nt i ntellect ual c o nte nt; a n d
•
Fi nal a p pr o val of t he versi o n t o be p u blis he d; a n d
•
A gree me nt t o be acc o u nta ble f or all as pects of t he w or k i n e ns uri n g t hat q uesti o ns relate d t o 
t he acc urac y or i nte grit y of a n y part of t he w or k are a p pr o priatel y i n vesti gate d or res ol ve d
W he n a lar ge, m ultice nter gr o u p has c o n d ucte d t he w or k, t he gr o u p s h o ul d i de ntif y t he 
i n di vi d uals w h o acce pt direct res p o nsi bilit y f or t he ma n uscri pt.  T his i n di vi d ual s h o ul d f ull y 
meet t he criteria f or a ut h ors hi p defi ne d a b o ve.
F u n di n g, c ollecti o n of data, or ge neral s u per visi o n of t he researc h al o ne or i n c o m bi nati o n d oes 
n ot q ualif y a n i n di vi d ual f or a ut h ors hi p.
A n y p u blicati o n, i n a n y f or m, t hat is deri ve d fr o m t his st u d y m ust be s u b mitte d t o Kite P har ma 
f or re vie w a n d a p pr o val.  T he st u d y c o ntract bet wee n t he i nstit uti o n, pri nci pal i n vesti gati o n, a n d 
Kite P har ma or its dele gate will o utli ne t he re q uire me nts f or p u blicati o n re vie w.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 9 2
1 4 A pril 2 0 2 3  
1 6.  
C O M P E N S A TI O N
Kite P har ma will pr o vi de c o m pe nsati o n f or st u d y-relate d ill ness or i nj ur y p urs ua nt t o t he 
i nf or mati o n o utli ne d i n t he i nj ur y secti o n of t he I C F.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 9 3
1 4 A pril 2 0 2 3  
1 7.  
R E F E R E N C E S
Barri n gt o n S F, Mi k haeel N G, K osta k o gl u L, Mei g na n M, H utc hi n gs M, M ueller S P, et al. R ole 
of i ma gi n g i n t he sta gi n g a n d res p o nse assess me nt of l y m p h o ma: c o nse ns us of t he 
I nter nati o nal C o nfere nce o n Mali g na nt L y m p h o mas I ma gi n g W or ki n g Gr o u p. J 
Cli n O nc ol 2 0 1 4; 3 2 ( 2 7): 3 0 4 8- 5 8.
Barri n gt o n S F, Qia n W, S o mer EJ, Fra ncesc hett o A, Ba g ni B, Br u n E, et al. C o nc or da nce 
bet wee n f o ur E ur o pea n ce ntres of P E T re p orti n g criteria desi g ne d f or use i n 
m ultice ntre trials i n H o d g ki n l y m p h o ma. E ur J N ucl Me d M ol I ma gi n g 2 0 1 0; 3 7 
( 1 0): 1 8 2 4- 3 3.
Bla nc V, B o ussea u A, Car o n A, Carrez C, L utz RJ, La m bert J M. S A R 3 4 1 9: A n A nti- C D 1 9-
Ma yta nsi n oi d I m m u n oc o nj u gate f or t he Treat me nt of B- Cell Mali g na ncies. Cli n 
Ca ncer Res 2 0 1 1; 1 7 ( 2 0): 6 4 4 8- 5 8.
C ha ga nti S, Illi d ge T, Barri n gt o n S, Mc Ka y P, Li nt o n K, C w y nars ki K, et al. G ui deli nes f or t he 
ma na ge me nt of diff use lar ge B-cell l y m p h o ma. Br J Hae mat ol 2 0 1 6; 1 7 4 ( 1): 4 3-
5 6.
C hes o n B D, Fis her RI, Barri n gt o n S F, Ca valli F, Sc h wartz L H, Z ucca E, et al. 
Rec o m me n dati o ns f or i nitial e val uati o n, sta gi n g, a n d res p o nse assess me nt of 
H o d g ki n a n d n o n- H o d g ki n l y m p h o ma: t he L u ga n o classificati o n. J Cli n O nc ol 
2 0 1 4; 3 2 ( 2 7): 3 0 5 9- 6 8.
Cli nical Trials Facilitati o n a n d C o or di nati o n Gr o u p ( C T F G). Rec o m me n dati o ns relate d t o 
c o ntrace pti o n a n d pre g na nc y testi n g i n cli nical trials. Versi o n 1. 1.  2 1/ 0 9/ 2 0 2 0, 
2 0 2 0.
C oiffier B, T hie ble m o nt C, Va n De n Neste E, Le pe u G, Pla ntier I, Castai g ne S, et al. L o n g-ter m 
o utc o me of patie nts i n t he L N H- 9 8. 5 trial, t he first ra n d o mize d st u d y c o m pari n g 
rit u xi ma b- C H O P t o sta n dar d C H O P c he m ot hera p y i n D L B C L patie nts: a st u d y b y 
t he Gr o u pe d' Et u des des L y m p h o mes de l' A d ulte. Bl o o d 2 0 1 0; 1 1 6 ( 1 2): 2 0 4 0- 5.
Cr u m p M, Baetz T, C o u ba n S, Belc h A, Marcell us D, H o ws o n-Ja n K, et al. Ge mcita bi ne, 
de xa met has o ne, a n d cis plati n i n patie nts wit h rec urre nt or refract or y a g gressi ve 
hist ol o g y B-cell n o n- H o d g ki n l y m p h o ma: a P hase II st u d y b y t he Nati o nal Ca ncer 
I nstit ute of Ca na da Cli nical Trials Gr o u p ( N CI C- C T G). Ca ncer 2 0 0 4; 1 0 1 
( 8): 1 8 3 5- 4 2.
Cr u m p M, K ur u villa J, C o u ba n S, Mac D o nal d D A, K u kreti V, K o ur o u kis C T, et al. Ra n d o mize d 
C o m paris o n of Ge mcita bi ne, De xa met has o ne, a n d Cis plati n Vers us 
De xa met has o ne, C ytara bi ne, a n d Cis plati n C he m ot hera p y Bef ore A ut ol o g o us 
Ste m- Cell Tra ns pla ntati o n f or Rela pse d a n d Refract or y A g gressi ve L y m p h o mas: 
N CI C- C T G L Y. 1 2. J o ur nal of Cli nical O nc ol o g y 2 0 1 4; 3 2 ( 3 1): 3 4 9 0- 6.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 9 4
1 4 A pril 2 0 2 3  
Darri n gt o n D L, V ose J M, A n ders o n J R, Bier ma n PJ, Bis h o p M R, C ha n W C, et al. I nci de nce a n d 
c haracterizati o n of sec o n dar y m yel o d ys plastic s y n dr o me a n d ac ute m yel o ge n o us 
le u ke mia f oll o wi n g hi g h- d ose c he m ora di ot hera p y a n d a ut ol o g o us ste m-cell 
tra ns pla ntati o n f or l y m p h oi d mali g na ncies. J Cli n O nc ol 1 9 9 4; 1 2 ( 1 2): 2 5 2 7- 3 4.
D u dle y M E, Ya n g J C, S herr y R, H u g hes M S, R o yal R, Ka m m ula U, et al. A d o pti ve cell t hera p y 
f or patie nts wit h metastatic mela n o ma: e val uati o n of i nte nsi ve m yel oa blati ve 
c he m ora diati o n pre parati ve re gi me ns. J Cli n O nc ol 2 0 0 8; 2 6 ( 3 2): 5 2 3 3- 9.
Fall o wfiel d L. Q ualit y- of- Life: t he o bjecti ve meas ure me nt of s u bjecti ve res p o nses t o ca ncer a n d 
its treat me nt. Ca ncer T o pics 1 9 8 7; 6: 9 9- 1 0 0.
Fe u gier P, Va n H o of A, Se b ba n C, S olal- Celi g n y P, B o ua b dalla h R, Fer me C, et al. L o n g-ter m 
res ults of t he R- C H O P st u d y i n t he treat me nt of el derl y patie nts wit h diff use lar ge 
B-cell l y m p h o ma: a st u d y b y t he Gr o u pe d' Et u de des L y m p h o mes de l' A d ulte. J 
Cli n O nc ol 2 0 0 5; 2 3 ( 1 8): 4 1 1 7- 2 6.
Fl o wers C R, Si n ha R, V ose J M. I m pr o vi n g o utc o mes f or patie nts wit h diff use lar ge B-cell 
l y m p h o ma. C A: A Ca ncer J o ur nal f or Cli nicia ns 2 0 1 0; 6 0 ( 6): 3 9 3- 4 0 8.
Gatti n o ni L, Kle ba n off C A, Pal mer D C, Wrzesi ns ki C, Kersta n n K, Y u Z, et al. Ac q uisiti o n of 
f ull effect or f u ncti o n i n vitr o para d o xicall y i m pairs t he i n vi v o a ntit u m or efficac y 
of a d o pti vel y tra nsferre d C D 8 + T cells. J Cli n I n vest 2 0 0 5; 1 1 5 ( 6): 1 6 1 6- 2 6.
Gissel brec ht C, Glass B, M o u nier N, Si n g h Gill D, Li nc h D C, Tr ne n y M, et al. Sal va ge re gi me ns 
wit h a ut ol o g o us tra ns pla ntati o n f or rela pse d lar ge B-cell l y m p h o ma i n t he 
rit u xi ma b era. J Cli n O nc ol 2 0 1 0; 2 8 ( 2 7): 4 1 8 4- 9 0.
G o pal A K, Press O W, S h ust o v A R, Peters d orf S H, G o ole y T A, Da niels J T, et al. Efficac y a n d 
safet y of ge mcita bi ne, car b o plati n, de xa met has o ne, a n d rit u xi ma b i n patie nts wit h 
rela pse d/refract or y l y m p h o ma: a pr os pecti ve m ulti-ce nter p hase II st u d y b y t he 
P u get S o u n d O nc ol o g y C o ns orti u m. Le u k L y m p h o ma 2 0 1 0; 5 1 ( 8): 1 5 2 3- 9.
Gree n T M, Y o u n g K H, Visc o C, X u- M o nette Z Y, Orazi A, G o R S, et al. I m m u n o hist oc he mical 
d o u ble- hit sc ore is a str o n g pre dict or of o utc o me i n patie nts wit h diff use lar ge B-
cell l y m p h o ma treate d wit h rit u xi ma b pl us c ycl o p h os p ha mi de, d o x or u bici n, 
vi ncristi ne, a n d pre d nis o ne. J Cli n O nc ol 2 0 1 2; 3 0 ( 2 8): 3 4 6 0- 7.
G u gliel mi C, G o mez F, P hili p T, Ha ge n bee k A, Martelli M, Se b ba n C, et al. Ti me t o rela pse has 
pr o g n ostic val ue i n patie nts wit h a g gressi ve l y m p h o ma e nr olle d o nt o t he Par ma 
trial. J Cli n O nc ol 1 9 9 8; 1 6 ( 1 0): 3 2 6 4- 9.
Ha mli n P A, Zele netz A D, Ke walra ma ni T, Qi n J, Sata g o pa n J M, Ver bel D, et al. A ge-a dj uste d 
I nter nati o nal Pr o g n ostic I n de x pre dicts a ut ol o g o us ste m cell tra ns pla ntati o n 
o utc o me f or patie nts wit h rela pse d or pri mar y refract or y diff use lar ge B-cell 
l y m p h o ma. Bl o o d 2 0 0 3; 1 0 2 ( 6): 1 9 8 9- 9 6.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 9 5
1 4 A pril 2 0 2 3  
H o wla der N, N o o ne A, Kra pc h o M, Miller D, Bis h o p K, Alte kr use S, et al. S E E R Ca ncer 
Statistics Re vie w, 1 9 7 5- 2 0 1 3. Nati o nal Ca ncer I nstit ute. Bet hes da, M D, 
htt p://seer.ca ncer. g o v/csr/ 1 9 7 5 _ 2 0 1 3/, base d o n N o ve m ber 2 0 1 5 S E E R data 
s u b missi o n, p oste d t o t he S E E R we b site, A pril 2 0 1 6. 2 0 1 5.
Kle ba n off C A, Gatti n o ni L, T ora bi- Parizi P, Kersta n n K, Car d o nes A R, Fi n kelstei n S E, et al. 
Ce ntral me m or y self/t u m or-reacti ve C D 8 + T cells c o nfer s u peri or a ntit u m or 
i m m u nit y c o m pare d wit h effect or me m or y T cells. Pr oc Natl Aca d Sci U S A 
2 0 0 5; 1 0 2 ( 2 7): 9 5 7 1- 6.
K oc he n derfer J N, D u dle y M E, Fel d ma n S A, Wils o n W H, S pa ner D E, Maric I, et al. B-cell 
de pleti o n a n d re missi o ns of mali g na nc y al o n g wit h c yt o ki ne-ass ociate d t o xicit y i n 
a cli nical trial of a nti- C D 1 9 c hi meric-a nti ge n-rece pt or-tra ns d uce d T cells. Bl o o d 
2 0 1 2; 1 1 9 ( 1 2): 2 7 0 9- 2 0.
K oc he n derfer J N, D u dle y M E, Kassi m S H, S o mer ville R P, Car pe nter R O, Stetler- Ste ve ns o n M, 
et al. C he m ot hera p y- Refract or y Diff use Lar ge B- Cell L y m p h o ma a n d I n d ole nt B-
Cell Mali g na ncies Ca n Be Effecti vel y Treate d Wit h A ut ol o g o us T Cells 
E x pressi n g a n A nti- C D 1 9 C hi meric A nti ge n Rece pt or. J Cli n O nc ol 2 0 1 5; 3 3 
( 6): 5 4 0- 9.
K oc he n derfer J N, Fel d ma n S A, Z ha o Y, X u H, Blac k M A, M or ga n R A, et al. C o nstr ucti o n a n d 
Precli nical E val uati o n of a n A nti- C D 1 9 C hi meric A nti ge n Rece pt or. J 
I m m u n ot her 2 0 0 9; 3 2 ( 7): 6 8 9- 7 0 2.
K oc he n derfer J N, S o mer ville R P T, L u T, S hi V, B ot A, R ossi J, et al. L y m p h o ma re missi o ns 
ca use d b y a nti- C D 1 9 c hi meric a nti ge n rece pt or T cells are ass ociate d wit h hi g h 
ser u m i nterle u ki n- 1 5 le vels. J Cli n O nc ol 2 0 1 7; Mar 1 4: d oi: 
1 0. 1 2 0 0/J C O. 2 0 1 6. 7 1. 3 0 2 4.
K oc he n derfer J N, Y u Z, Fras heri D, Restif o N P, R ose n ber g S A. A d o pti ve tra nsfer of s y n ge neic 
T cells tra ns d uce d wit h a c hi meric a nti ge n rece pt or t hat rec o g nizes m uri ne C D 1 9 
ca n era dicate l y m p h o ma a n d n or mal B cells. Bl o o d 2 0 1 0; 1 1 6 ( 1 9): 3 8 7 5- 8 6.
K o w oli k C M, T o p p M S, G o nzalez S, Pfeiffer T, Oli vares S, G o nzalez N, et al. C D 2 8 
c osti m ulati o n pr o vi de d t hr o u g h a C D 1 9-s pecific c hi meric a nti ge n rece pt or 
e n ha nces i n vi v o persiste nce a n d a ntit u m or efficac y of a d o pti vel y tra nsferre d T 
cells. Ca ncer Res 2 0 0 6; 6 6 ( 2 2): 1 0 9 9 5- 1 0 0 4.
Li g n o n J, Si b o n D, Ma delai ne I, Brice P, Fra nc hi P, Briere J, et al. Rit u xi ma b, De xa met has o ne, 
C ytara bi ne, a n d O xali plati n ( R- D H A X) Is a n Effecti ve a n d Safe Sal va ge Re gi me n 
i n Rela pse d/ Refract or y B- Cell N o n- H o d g ki n L y m p h o ma. Cli nical L y m p h o ma 
M yel o ma a n d Le u ke mia 2 0 1 0; 1 0 ( 4): 2 6 2- 9.
L oc ke F L, Neela p u S S, Bartlett N L, Si d di qi T, C ha vez J C, H osi n g C M, et al. P hase 1 Res ults of 
Z U M A- 1: A M ultice nter St u d y of K T E- C 1 9 A nti- C D 1 9 C A R T Cell T hera p y i n 
Refract or y A g gressi ve L y m p h o ma. M ol T her 2 0 1 7; 2 5 ( 1): 2 8 5- 9 5.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 9 6
1 4 A pril 2 0 2 3  
Martelli M, Ferreri AJ M, A g osti nelli C, Di R occ o A, Pfre u n dsc h u h M, Pileri S A. Diff use lar ge 
B-cell l y m p h o ma. Critical Re vie ws i n O nc ol o g y / He mat ol o g y 2 0 1 3; 8 7 ( 2): 1 4 6-
7 1.
Marti n A, C o n de E, Ar na n M, Ca nales M A, De be n G, Sa nc h o J M, et al. R- E S H A P as sal va ge 
t hera p y f or patie nts wit h rela pse d or refract or y diff use lar ge B-cell l y m p h o ma: t he 
i nfl ue nce of pri or e x p os ure t o rit u xi ma b o n o utc o me. A G E L/ T A M O st u d y. 
Hae mat ol o gica 2 0 0 8; 9 3 ( 1 2): 1 8 2 9- 3 6.
M ort o n L M, Wa n g S S, De vesa S S, Hart ge P, Weise n b ur ger D D, Li net M S. L y m p h o ma 
i nci de nce patter ns b y W H O s u bt y pe i n t he U nite d States, 1 9 9 2- 2 0 0 1. Bl o o d 
2 0 0 6; 1 0 7 ( 1): 2 6 5- 7 6.
Ne wc o m be R G. I nter val esti mati o n f or t he differe nce bet wee n i n de pe n de nt pr o p orti o ns: 
c o m paris o n of ele ve n met h o ds. Stat Me d 1 9 9 8; 1 7 ( 8): 8 7 3- 9 0.
Nic h ols o n I C, Le nt o n K A, Little DJ, Dec ors o T, Lee F T, Sc ott A M, et al. C o nstr ucti o n a n d 
c haracterisati o n of a f u ncti o nal C D 1 9 s pecific si n gle c hai n F v fra g me nt f or 
i m m u n ot hera p y of B li nea ge le u kae mia a n d l y m p h o ma. M ol I m m u n ol 1 9 9 7; 3 4 
( 1 6- 1 7): 1 1 5 7- 6 5.
O' Brie n S M, Ka ntarjia n H M, C ortes J, Bera n M, K oller C A, Giles FJ, et al. Res ults of t he 
fl u dara bi ne a n d c ycl o p h os p ha mi de c o m bi nati o n re gi me n i n c hr o nic l y m p h oc ytic 
le u ke mia. J Cli n O nc ol 2 0 0 1; 1 9 ( 5): 1 4 1 4- 2 0.
P hili p T, G u gliel mi C, Ha ge n bee k A, S o mers R, Va n der Lelie H, Br o n D, et al. A ut ol o g o us 
b o ne marr o w tra ns pla ntati o n as c o m pare d wit h sal va ge c he m ot hera p y i n rela pses 
of c he m ot hera p y-se nsiti ve n o n- H o d g ki n's l y m p h o ma. N E n gl J Me d 1 9 9 5; 3 3 3 
( 2 3): 1 5 4 0- 5.
Se h n L H, Gasc o y ne R D. Diff use lar ge B-cell l y m p h o ma: o pti mizi n g o utc o me i n t he c o nte xt of 
cli nical a n d bi ol o gic heter o ge neit y. Bl o o d 2 0 1 5; 1 2 5 ( 1): 2 2- 3 2.
St o ne R M, Ne u ber g D, S oiffer R, Ta k v oria n T, W hela n M, Ra bi n o we S N, et al. M yel o d ys plastic 
s y n dr o me as a late c o m plicati o n f oll o wi n g a ut ol o g o us b o ne marr o w 
tra ns pla ntati o n f or n o n- H o d g ki n's l y m p h o ma. J Cli n O nc ol 1 9 9 4; 1 2 ( 1 2): 2 5 3 5- 4 2.
S wer dl o w S H, Ca m p o E, Pileri S A, Harris N L, Stei n H, Sie bert R, et al. T he 2 0 1 6 re visi o n of t he 
W orl d Healt h Or ga nizati o n classificati o n of l y m p h oi d ne o plas ms. Bl o o d 
2 0 1 6; 1 2 7 ( 2 0): 2 3 7 5- 9 0.
Va n De n Neste E, Sc h mitz N, M o u nier N, Gill D, Li nc h D, Tr ne n y M, et al. O utc o me of patie nts 
wit h rela pse d diff use lar ge B-cell l y m p h o ma w h o fail sec o n d-li ne sal va ge 
re gi me ns i n t he I nter nati o nal C O R A L st u d y. B o ne Marr o w Tra ns pla nt 2 0 1 6; 5 1 
( 1): 5 1- 7.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 9 7
1 4 A pril 2 0 2 3  
va n I m h off G W, Mc Milla n A, Matasar MJ, Ra df or d J, Ar des h na K M, K ulicz k o ws ki K, et al. 
Ofat u m u ma b Vers us Rit u xi ma b Sal va ge C he m oi m m u n ot hera p y i n Rela pse d or 
Refract or y Diff use Lar ge B- Cell L y m p h o ma: T he O R C H A R R D St u d y. J Cli n 
O nc ol 2 0 1 7; 3 5 ( 5): 5 4 4- 5 1.
Velle n ga E, va n P utte n W L, va n 't Veer M B, Zijlstra J M, Fi b be W E, va n Oers M H, et al. 
Rit u xi ma b i m pr o ves t he treat me nt res ults of D H A P- VI M- D H A P a n d A S C T i n 
rela pse d/ pr o gressi ve a g gressi ve C D 2 0 + N H L: a pr os pecti ve ra n d o mize d H O V O N 
trial. Bl o o d 2 0 0 8; 1 1 1 ( 2): 5 3 7- 4 3.
Wils o n W H, si n- H o J, N. P B, Hsi E D, Frie d ber g J, C hes o n B, et al. P hase III Ra n d o mize d St u d y 
of R- C H O P Vers us D A- E P O C H- R a n d M olec ular A nal ysis of U ntreate d Diff use 
Lar ge B- Cell L y m p h o ma: C A L G B/ Allia nce 5 0 3 0 3. Bl o o d ( A S H A n n ual Meeti n g 
A bstracts) 2 0 1 6: A bstract # 4 6 9 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 9 8
1 4 A pril 2 0 2 3  
1 8.  
A P P E N DI C E S
A p pe n di x A. 
S p o ns or a n d I n vesti gat or Si g nat ure Pa ge
A p pe n di x B. 
L u ga n o Classificati o n { C hes o n 2 0 1 4 }
A p pe n di x C. 
Patie nt Re p orte d O utc o mes
A p pe n di x D. 
C o u ntr y-s pecific Re g ulat or y A ge nc y Re q uire me nts
A p pe n di x E. 
C hil d beari n g P ote ntial a n d Birt h C o ntr ol
A p pe n di x F. 
Pa n de mic Ris k Assess me nt a n d Miti gati o n Pla n
A p pe n di x G. 
Pr ot oc ol A me n d me nt Hist or y


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 9 9
1 4 A pril 2 0 2 3  
A p pe n di x A. 
S p o ns or a n d I n vesti g at or Si g n at ure P a ge
KI T E P H A R M A, I N C.
2 4 0 0 B R O A D W A Y
S A N T A M O NI C A, C A 9 0 4 0 4
S T U D Y A C K N O W L E D G M E N T
A P hase 3, Ra n d o mize d, O pe n- La bel St u d y E val uati n g t he Efficac y of A xica bta ge ne Cil ole ucel 
vers us Sta n dar d of Care T hera p y i n S u bjects wit h Rela pse d/ Refract or y Diff use Lar ge B Cell 
L y m p h o ma ( Z U M A- 7)
A me n d me nt 6, 1 4 A pril 2 0 2 3
T his pr ot oc ol has bee n a p pr o ve d b y Kite P har ma, I nc. T he f oll o wi n g si g nat ure d oc u me nts t his 
a p pr o val.
C hristi na T o
[ Refer t o t he a p pe n de d electr o nic si g n at ure]
Kite Me dical M o nit or Na me ( Pri nte d) 
Si g nat ure
[ Refer t o t he a p pe n de d electr o nic si g n at ure]
Date
I N V E S TI G A T O R S T A T E M E N T
I ha ve rea d t he pr ot oc ol, i ncl u di n g all a p pe n dices, a n d I a gree t hat it c o ntai ns all necessar y details 
f or me a n d m y staff t o c o n d uct t his st u d y as descri be d. I will c o n d uct t his st u d y as o utli ne d herei n 
a n d will ma ke a reas o na ble eff ort t o c o m plete t he st u d y wit hi n t he ti me desi g nate d.
I a gree t o c o m pl y wit h t he I nter nati o nal C o u ncil f or Har m o nisati o n of Tec h nical Re q uire me nts 
f or P har mace uticals f or H u ma n Use (I C H) Har m o nise d Tri partite G ui deli ne o n G o o d Cli nical 
Practice a n d a p plica ble nati o nal or re gi o nal re g ulati o ns a n d g ui deli nes. I will pr o vi de all st u d y 
pers o n nel u n der m y s u per visi o n c o pies of t he pr ot oc ol a n d access t o all i nf or mati o n pr o vi de d b y 
Kite P har ma, I nc. I will disc uss t his material wit h t he m t o e ns ure t hat t he y are f ull y i nf or me d 
a b o ut t he i n vesti gati o nal pr o d uct a n d st u d y.
I a gree a n d will e ns ure t hat fi na ncial discl os ure state me nts will be c o m plete d b y:
•
Me (i ncl u di n g, if a p plica ble, m y s p o use, le gal part ner, a n d de pe n de nt c hil dre n)
•
S u bi n vesti gat ors (i ncl u di n g, if a p plica ble, t heir s p o use, le gal part ner, a n d de pe n de nt c hil dre n) 
at t he start of t he st u d y a n d f or u p t o 1 year after t he st u d y is c o m plete d.
I a gree t o e ns ure t hat t he c o nfi de ntial i nf or mati o n c o ntai ne d i n t his d oc u me nt will n ot be use d f or 
a n y p ur p ose ot her t ha n t he c o n d uct of t he cli nical i n vesti gati o n wit h o ut pri or writte n c o nse nt 
fr o m Kite P har ma, I nc.
Pri nci pal I n vesti gat or Na me ( Pri nte d)
Si g nat ure
Date
St u d y Site N u m ber


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 0 0
1 4 A pril 2 0 2 3  
A p pe n di x B. 
L u g a n o Cl assific ati o n { C hes o n 2 0 1 4 }
Please refer t o i ma gi n g ma n ual a n d { C hes o n 2 0 1 4 } f or details of assess me nt.
5- P oi nt Sc ale ( 5 P S) { B arri n gt o n 2 0 1 4 }
Sc ore 
Descri pti o n 
1 
N o u pta ke a b o ve bac k gr o u n d 
2 
U pta ke ≤  me diasti n u m 
3 
U pta ke > me diasti n u m b ut ≤ li ver 
4 
U pta ke m o deratel y hi g her t ha n li ver 
5 
U pta ke mar ke dl y hi g her t ha n li ver a n d/ or ne w lesi o ns
X 
Ne w areas of u pta ke u nli kel y t o be relate d t o l y m p h o ma.  
C o m plete Re missi o n:
C o m plete Met a b olic Res p o nse ( C M R) f or P E T- C T- B ase d Res p o nse
T he desi g nati o n of C M R re q uires all of t he f oll o wi n g:
•
A 5 P S ( 5- p oi nt scale) sc ore of 1, 2, or 3, wit h or wit h o ut a resi d ual mass.

I n Wal de yer’s ri n g or e xtra n o dal sites wit h hi g h p h ysi ol o gic u pta ke or wit h acti vati o n 
wit hi n s plee n or marr o w, u pta ke ma y be greater t ha n n or mal me diasti n u m a n d/ or li ver. I n 
t his circ u msta nce, C M R ma y be i nferre d if u pta ke at sites of i nitial i n v ol ve me nt is n o 
greater t ha n s urr o u n di n g n or mal tiss ue e ve n if t he tiss ue has hi g h p h ysi ol o gic u pta ke.
•
N o ne w sites of disease s h o ul d be o bser ve d.
•
N o e vi de nce of F D G-a vi d disease i n b o ne marr o w
C o m plete R a di ol o gic Res p o nse ( C R R) f or C T- B ase d Res p o nse
T he desi g nati o n of C R R re q uires all of t he f oll o wi n g:
•
Tar get n o des/ n o dal masses m ust re gress t o ≤ 1. 5 c m i n l o n gest tra ns verse dia meter of a lesi o n 
( L Di)
•
N o e xtral y m p hatic sites of disease
•
A bse nt n o n meas ure d lesi o n
•
Or ga n e nlar ge me nt re gress t o n or mal


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 0 1
1 4 A pril 2 0 2 3  
•
N o ne w sites of disease s h o ul d be o bser ve d.
•
B o ne marr o w n or mal b y m or p h ol o g y; if i n deter mi nate, I H C ne gati ve
P arti al Re missi o n:
P arti al Met a b olic Res p o nse ( P M R) f or P E T- C T B ase d Res p o nse
T he desi g nati o n of P M R re q uires all of t he f oll o wi n g:
•
A 5 P S sc ore of 4 or 5, wit h re d uce d u pta ke c o m pare d t o baseli ne (scree ni n g), a n d resi d ual 
mass(es) of a n y size.
N ote:

At i nteri m, t hese fi n di n gs s u g gest res p o n di n g disease.

At e n d of treat me nt ( E O T), t hese fi n di n gs s u g gest resi d ual disease.
•
N o ne w sites of disease s h o ul d be o bser ve d.
•
Resi d ual u pta ke hi g her t ha n u pta ke i n n or mal b o ne marr o w b ut re d uce d c o m pare d wit h 
baseli ne ( diff use u pta ke c o m pati ble wit h reacti ve c ha n ges fr o m c he m ot hera p y all o we d).
If t here are persiste nt f ocal c ha n ges i n t he marr o w i n t he c o nte xt of a n o dal res p o nse, 
c o nsi derati o n s h o ul d be gi ve n t o f urt her e val uati o n wit h M RI or bi o ps y or a n i nter val sca n.
Partial Ra di ol o gic Res p o nse ( P R R) f or C T- Base d Res p o nse
T he desi g nati o n of P R R re q uires all of t he f oll o wi n g:
•
≥ 5 0 % decrease i n s u m of t he pr o d uct of t he per pe n dic ular dia meters ( S P D) of u p t o 6 tar get 
meas ura ble n o des a n d e xtra n o dal sites.

W he n a lesi o n is t o o s mall t o meas ure o n C T, assi g n 5 m m x 5 m m as t he defa ult val ue

W he n n o l o n ger visi ble, 0 x 0 m m

F or a n o de  > 5 m m x 5 m m, b ut s maller t ha n n or mal, use act ual meas ure me nt f or 
calc ulati o n
•
A bse nt/ n or mal, re gresse d, b ut n o i ncrease of n o n meas ure d lesi o ns.
•
S plee n m ust ha ve re gresse d b y > 5 0 % i n le n gt h be y o n d n or mal
•
N o ne w sites of disease s h o ul d be o bser ve d.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 0 2
1 4 A pril 2 0 2 3  
S D:
N o Met a b olic Res p o nse ( N M R) f or P E T- C T B ase d Res p o nse
T he desi g nati o n of N M R re q uires all of t he f oll o wi n g:
•
A 5 P S sc ore of 4 or 5, wit h n o si g nifica nt c ha n ge i n F D G u pta ke c o m pare d t o baseli ne 
(scree ni n g) at a n i nteri m ti me p oi nt or e n d of treat me nt.
•
N o ne w sites of disease s h o ul d be o bser ve d.
•
N o c ha n ge fr o m baseli ne i n b o ne marr o w
St a ble R a di ol o gic Dise ase ( S R D) f or C T- B ase d Res p o nse
T he desi g nati o n of S R D re q uires all of t he f oll o wi n g:
•
< 5 0 % decrease fr o m baseli ne i n t he s u m of t he pr o d uct of t he per pe n dic ular dia meters 
( S P D) of u p t o 6 d o mi na nt, meas ura ble n o des a n d e xtra n o dal sites; n o criteria f or pr o gressi ve 
disease are met
•
N o i ncrease c o nsiste nt wit h pr o gressi o n i n n o n meas ure d lesi o n a n d or ga n e nlar ge me nt
•
N o ne w sites of disease s h o ul d be o bser ve d.
P D:
Pr o gressive Met a b olic Dise ase ( P M D) f or P E T- C T B ase d Res p o nse
T he desi g nati o n of P M D re q uires at least 1 of t he f oll o wi n g:
•
A 5 P S sc ore 4 or 5 wit h a n i ncrease i n i nte nsit y of u pta ke fr o m na dir a n d/ or
•
Ne w F D G-a vi d f oci c o nsiste nt wit h l y m p h o ma at i nteri m or e n d of treat me nt assess me nt
•
Ne w F D G-a vi d f oci c o nsiste nt wit h l y m p h o ma rat her t ha n a n ot her eti ol o g y (e g, i nfecti o n, 
i nfla m mati o n). If u ncertai n re gar di n g eti ol o g y of ne w lesi o ns, bi o ps y or i nter val sca n ma y be 
c o nsi dere d
•
Ne w or rec urre nt F D G-a vi d f oci i n b o ne marr o w.
Pr o gressive R a di ol o gic Dise ase ( P R D) f or C T- B ase d Res p o nse
T he desi g nati o n of P R D re q uires at least 1 of t he f oll o wi n g:
•
A n i n di vi d ual n o de/lesi o n m ust be a b n or mal wit h:

L o n gest tra verse dia meter ( L Di) > 1. 5 c m a n d


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 0 3
1 4 A pril 2 0 2 3  

I ncrease b y ≥ 5 0 % fr o m cr oss pr o d uct of L Di a n d per pe n dic ular dia meter ( P P D) na dir 
a n d

A n i ncrease i n L Di or S Di, s h ortest a xis per pe n dic ular t o t he L Di, ( S Di) fr o m na dir
■
0. 5 c m f or lesi o ns ≤ 2 c m
■
1. 0 c m f or lesi o ns > 2 c m

I n t he setti n g of s ple n o me gal y, t he s ple nic le n gt h m ust i ncrease b y > 5 0 % of t he e xte nt of 
its pri or i ncrease be y o n d baseli ne (e g, a 1 5-c m s plee n m ust i ncrease t o > 1 6 c m). If n o 
pri or s ple n o me gal y, m ust i ncrease b y at least 2 c m fr o m baseli ne;

Ne w or rec urre nt s ple n o me gal y
•
Ne w or clear pr o gressi o n of pree xisti n g n o n meas ure d lesi o ns
•
Ne w lesi o n

Re gr o wt h of pre vi o usl y res ol ve d lesi o ns

A ne w n o de > 1. 5 c m i n a n y a xis

A ne w e xtra n o dal site > 1. 0 c m i n a n y a xis; if < 1. 0 c m i n a n y a xis, its prese nce m ust be 
u ne q ui v ocal a n d m ust be attri b uta ble t o l y m p h o ma

Assessa ble disease of a n y size u ne q ui v ocall y attri b uta ble t o l y m p h o ma
•
Ne w or rec urre nt b o ne marr o w i n v ol ve me nt


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 0 4
1 4 A pril 2 0 2 3  
A p pe n di x C. 
P atie nt Re p orte d O utc o mes
E O R T C Q L Q C- 3 0
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
  
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 0 5
1 4 A pril 2 0 2 3  
 
  
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 0 6
1 4 A pril 2 0 2 3  
E Q- 5 D- 5 L
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 0 7
1 4 A pril 2 0 2 3  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
    
 
 
 
 
 
  
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 0 8
1 4 A pril 2 0 2 3  
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
    
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 0 9
1 4 A pril 2 0 2 3  
W P AI Q uesti o n n aire ( V 2. 0) ( S A M P L E)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
  
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 1 0
1 4 A pril 2 0 2 3  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
  
 
 
  
 
  
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
   
 
 
  
 
  
 
 
 
 
  
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 1 1
1 4 A pril 2 0 2 3  
A p pe n di x D.  
C o u ntr y-s pecific Re g ul at or y A ge nc y Re q uire me nts
Ger m a n y a n d S witzerl a n d 
Pr ot oc ol Secti o n 
C o u ntr y-s pecific Re q uire me nt 
Secti o n 7. 6
Secti o n 7. 7
Secti o n 7. 9
Secti o n 7. 1 1. 1
T he p ost-i nf usi o n m o nit ori n g of s u bjects i n t his pr ot oc ol will be e xte n de d b y 
m o nit ori n g o n da y 8, da y 9, a n d da y 1 0, acc or di n g t o pr oce d ures o utli ne d i n 
Ta ble 2 , c ol u m n “I P a d mi nistrati o n peri o d, 1- 7.” T he s u bject ma y sta y 
h os pitalize d or ret ur n t o t he cli nic dail y f or t his e xte n de d m o nit ori n g at t he 
discreti o n of t he i n vesti gat or.
T he dail y m o nit ori n g will i ncl u de vital si g ns (see Secti o n 7. 6 ), bl o o d dra w 
f or c he mistr y pa nel wit h C R P, bl o o d dra w f or C B C w/ differe ntial (see 
Secti o n 7. 1 1. 1 ), a n d ne ur ol o gical assess me nt ( w hic h ma y i ncl u de M M S E 
[see Secti o n 7. 7 ]). A n y o bser ve d t o xicit y will be e val uate d acc or di n g t o 
Secti o n 7. 9  of t his pr ot oc ol a n d ma na ge d acc or di n g t o t he I B.
A b bre viati o ns: C B C, c o m plete bl o o d c o u nt; C R P, C-reacti ve pr otei n; I P, i n vesti gati o nal pr o d uct; M M S E, Mi ni- Me ntal Stat us 
E xa mi nati o n.
Fr a nce
A b bre viati o ns: A N S M, Nati o nal A ge nc y f or t he Safet y of Me dici nes a n d Healt h Pr o d ucts; C A R, c hi meric a nti ge n rece pt or; 
C B C, c o m plete bl o o d c o u nt; C R P, C-reacti ve pr otei n; I P, i n vesti gati o nal pr o d uct; M M S E, Mi ni- Me ntal Stat us E xa mi nati o n.
S witzerl a n d
Pr ot oc ol Secti o n 
C o u ntr y-s pecific Re q uire me nt 
Secti o n 5. 2
T he a d diti o nal e xcl usi o n criteri o n, a p plica ble t o S witzerla n d o nl y, s pecifies 
t he e xci pie nts of t he Cr y o St or use d i n t he cr y o preser vati o n of C A R T cells 
a n d fre q ue ntl y f or C D 3 4 +  ste m cells, a n d is as f oll o ws:
Hist or y of se vere i m me diate h y perse nsiti vit y reacti o n t o t ociliz u ma b or a n y 
of t he a ge nts use d i n t his st u d y, i ncl u di n g t he e xci pie nts D M S O a n d De xtra n 
4 0 prese nt i n Cr y o St or.
A b bre viati o ns: C A R, c hi meric a nti ge n rece pt or; D M S O, di met h yl s ulf o xi de.
Pr ot oc ol Secti o n 
C o u ntr y-s pecific Re q uire me nt 
Secti o n 7. 6
Secti o n 7. 7
Secti o n 7. 9
Secti o n 7. 1 1. 1
T he p ost-i nf usi o n m o nit ori n g of s u bjects i n t his pr ot oc ol will be e xte n de d b y 
m o nit ori n g o n da y 8, da y 9, a n d da y 1 0, acc or di n g t o pr oce d ures o utli ne d i n 
Ta ble 2 , c ol u m n “I P a d mi nistrati o n peri o d, 1- 7.” T he A N S M rec o m me n ds a 
1 0- da y h os pitalizati o n after i nf usi o n of a n y C A R T-cell pr o d uct.
T he dail y m o nit ori n g will i ncl u de vital si g ns (see Secti o n 7. 6 ), bl o o d dra w 
f or c he mistr y pa nel wit h C R P, bl o o d dra w f or C B C w/ differe ntial (see 
Secti o n 7. 1 1. 1 ), a n d ne ur ol o gical assess me nt ( w hic h ma y i ncl u de M M S E 
[see Secti o n 7. 7 ]). A n y o bser ve d t o xicit y will be e val uate d acc or di n g t o 
Secti o n 7. 9  of t his pr ot oc ol a n d ma na ge d acc or di n g t o t he I B.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 1 2
1 4 A pril 2 0 2 3  
S we de n
Pr ot oc ol Secti o n
C o u ntr y-s pecific Re q uire me nt
N/ A 
1. RI S K A N D B E N E FI T A S S E S S M E N T
Kite P har ma is c o n d ucti n g a gl o bal P hase 3, ra n d o mize d, o pe n-la bel st u d y t o 
e val uate t he efficac y of a xica bta ge ne cil ole ucel vers us sta n dar d of care 
t hera p y i n s u bjects wit h rela pse d/refract or y diff use lar ge B cell l y m p h o ma 
( Pr ot oc ol n u m ber K T E- C 1 9- 1 0 7 [ Z U M A- 7]).
1. 1. I m p ort a nt I de ntifie d a n d P ote nti al Ris ks rel ate d t o I M P
T he ris ks of a xica bta ge ne cil ole ucel/ K T E- C 1 9 t hera p y are well descri be d. 
T w o i m p orta nt i de ntifie d ris ks , w hic h are n ot c o m m o nl y e nc o u ntere d i n 
ge neral o nc ol o g y practice, i ncl u de C R S a n d ne ur ol o gic e ve nts. T hese e ve nts 
ha ve a n earl y o nset, ge nerall y wit hi n 1 wee k after t he t hera p y, a n d are m ostl y 
re versi ble ( > 9 5 %). A d diti o nal i m p orta nt i de ntifie d ris ks i ncl u de c yt o pe nias, 
i nfecti o n a n d h y p o ga m ma gl o b uli ne mia. Strate gies ha ve bee n de vel o pe d t o 
m o nit or f or a n d ma na ge t hese A d verse E ve nts ( A Es) a n d are i ncl u de d i n t he 
m ost rece nt versi o n of t he I n vesti gat or Br oc h ure (I B). T he i m p orta nt p ote ntial 
ris ks ass ociate d wit h a xica bta ge ne cil ole ucel/ K T E- C 1 9 are re plicati o n 
c o m pete nt retr o vir us ( R C R), sec o n dar y mali g na nc y, a ut oi m m u ne dis or ders 
reacti vati o n/ ne w o nset, i m m u n o ge nicit y a n d t u m or l ysis s y n dr o me ( T L S).
1. 2. Miti g ati o n of I M P-rel ate d ris ks
1. 2. 1. S u bject selecti o n (i ncl usi o n/e xcl usi o n criteri a)
T he i ncl usi o n a n d e xcl usi o n criteria descri be d i n secti o n 5 of t he pr ot oc ol 
e ns ure patie nts m ost at ris k wit h re gar ds t o t he i de ntifie d i m p orta nt a n d 
p ote ntial ris ks ass ociate d wit h a xica bta ge ne cil ole ucel are n ot i ncl u de d i n t he 
st u d y.
I ncl usi o n criteria:
•
1 0 6. N o k n o w n hist or y or s us pici o n of ce ntral ner v o us s yste m ( C N S) 
i n v ol ve me nt b y l y m p h o ma
•
1 1 0. A de q uate b o ne marr o w, re nal, he patic, p ul m o nar y a n d car diac 
f u ncti o n defi ne d as:
o
A bs ol ute ne utr o p hil c o u nt ( A N C) ≥1 0 0 0/ μ L
o
Platelet c o u nt ≥ 7 5, 0 0 0/ μ L
o
A bs ol ute l y m p h oc yte c o u nt ≥ 1 0 0/ μ L
o
Car diac ejecti o n fracti o n ≥ 5 0 %, n o e vi de nce of pericar dial eff usi o n 
as deter mi ne d b y a n ec h ocar di o gra m ( E C H O), a n d n o cli nicall y 
si g nifica nt electr ocar di o gra m ( E C G) fi n di n gs
o
Baseli ne o x y ge n sat urati o n > 9 2 % o n r o o m air
E xcl usi o n criteria:
•
2 0 8. Hist or y of se vere, i m me diate h y perse nsiti vit y reacti o n attri b ute d t o 
a mi n o gl yc osi des


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 1 3
1 4 A pril 2 0 2 3  
Pr ot oc ol Secti o n
C o u ntr y-s pecific Re q uire me nt
•
2 0 9. Prese nce of f u n gal, bacterial, viral, or ot her i nfecti o n t hat is 
u nc o ntr olle d or re q uiri n g i ntra ve n o us (I V) a nti micr o bials f or 
ma na ge me nt. Si m ple uri nar y tract i nfecti o n ( U TI) a n d u nc o m plicate d 
bacterial p har y n gitis are per mitte d if res p o n di n g t o acti ve treat me nt.
•
2 1 3. S u bjects wit h detecta ble cere br os pi nal fl ui d mali g na nt cells or 
k n o w n brai n metastases, or wit h a hist or y of cere br os pi nal fl ui d 
mali g na nt cells or brai n metastases
•
2 1 4. Hist or y or prese nce of n o n- mali g na nt C N S dis or der s uc h as seiz ure 
dis or der, cere br o vasc ular isc he mia/ he m orr ha ge, de me ntia, cere bellar 
disease, or a n y a ut oi m m u ne disease wit h C N S i n v ol ve me nt
•
2 1 8. Hist or y of a ut oi m m u ne disease, re q uiri n g s yste mic 
i m m u n os u p pressi o n a n d/ or s yste mic disease m o dif yi n g a ge nts wit hi n t he 
last 2 years.
1. 2. 2. S u bject M o nit ori n g
All s u bjects will recei ve a xica bta ge ne cil ole ucel i nf usi o n at a healt h care 
facilit y, f oll o we d b y dail y m o nit ori n g at a healt h care facilit y f or at least 
7 da ys t o m o nit or f or si g ns a n d s y m pt o ms of C R S a n d ne ur ol o gic e ve nts. 
Alter nati vel y, s u bjects ma y be h os pitalize d t o recei ve t heir a xica bta ge ne 
cil ole ucel i nf usi o n a n d be o bser ve d f or C R S a n d ne ur ol o gic e ve nts i n t he 
h os pital setti n g, if dee me d a p pr o priate b y t he i n vesti gat or.
If s u bjects are h os pitalize d, s u bjects s h o ul d n ot be disc har ge d fr o m t he 
h os pital u ntil all a xica bta ge ne cil ole ucel relate d n o n- he mat ol o gical t o xicities 
res ol ve t o ≤ Gra de 1 or ret ur n t o baseli ne. S u bjects ma y be disc har ge d wit h 
n o n-critical a n d cli nicall y sta ble or i m pr o vi n g t o xicities (e g re nal 
i ns ufficie nc y) e ve n if > Gra de 1, if dee me d a p pr o priate b y t he i n vesti gat or. 
S u bjects s h o ul d re mai n i n a h os pital f or o n g oi n g a xica bta ge ne cil ole ucel 
relate d fe ver, h y p ote nsi o n, h y p o xia, or o n g oi n g ne ur ol o gic e ve nts > Gra de 1, 
or if dee me d necessar y b y t he i n vesti gat or. S u bjects s h o ul d be i nstr ucte d t o 
re mai n wit hi n pr o xi mit y of t he cli nical st u d y site f or at least 4 wee ks 
f oll o wi n g a xica bta ge ne cil ole ucel i nf usi o n. S u bjects a n d t heir fa mil y 
me m bers/care gi vers s h o ul d be e d ucate d o n p ote ntial C R S a n d ne ur ol o gic 
s y m pt o ms s uc h as fe ver, d ys p nea, c o nf usi o n, a p hasia, d ys p hasia, s o m n ole nce, 
e nce p hal o pat h y, ata xia, or tre m or. S u bjects or t heir fa mil y 
me m bers/care gi vers s h o ul d be i nstr ucte d t o i m me diatel y c o ntact t he treati n g 
i n vesti gat or or see k i m me diate me dical atte nti o n if a n y of t hese s y m pt o ms 
de vel o p.
T oxicity m a n a ge me nt
T he g oal of C R S ma na ge me nt i n a nti- C D 1 9 c hi meric a nti ge n rece pt or ( C A R) 
T-cell t hera p y is t o pre ve nt life-t hreate ni n g c o n diti o ns w hile preser vi n g t he 
be nefits of a ntit u m or effects. Caref ull y m o nit or s u bjects f or si g ns a n d 
s y m pt o ms of C R S.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 1 4
1 4 A pril 2 0 2 3  
Pr ot oc ol Secti o n
C o u ntr y-s pecific Re q uire me nt
T he C R S gra di n g scale a n d a C R S ma na ge me nt al g orit h m are pr o vi de d i n 
secti o n 6. 5 of t he I n vesti gat or’s Br oc h ure t o direct t he i n vesti gat ors. T his 
C R S ma na ge me nt strate g y is base d o n t he e x perie nce t o date wit h 
a xica bta ge ne cil ole ucel/ K T E- C 1 9 i n a d diti o n t o ot her a nti- C D 1 9 C A R T-cell 
pr o d ucts ( Lee et al, 2 0 1 4).
Caref ull y m o nit or s u bjects f or si g ns a n d s y m pt o ms of ne ur ol o gic e ve nts. R ule 
o ut ot her ca uses of ne ur ol o gic s y m pt o ms. T he ne ur ol o gic e ve nts ma na ge me nt 
al g orit h m is pr o vi de d i n secti o n 6. 5 of t he i n vesti gat or’s br oc h ure. T his 
ne ur ol o gic e ve nt ma na ge me nt strate g y is base d o n t he e x perie nce t o date wit h 
a xica bta ge ne cil ole ucel/ K T E- C 1 9 i n a d diti o n t o ot her a nti- C D 1 9 C A R T-cell 
pr o d ucts ( Br u d n o a n d K oc he n derfer 2 0 1 6).
1. 3. Be nefit- Ris k A n al ysis
Patie nts wit h r/r D L B C L es peciall y pri mar y refract or y a n d earl y rela pse 
wit hi n 1 year of firstli ne rit u xi ma b- base d c he m oi m m u n ot hera p y ha ve p o or 
pr o g n osis e ve n wit h hi g h- d ose t hera p y-a ut ol o g o us ste m cell tra ns pla nt 
( H D T- A S C T). Beca use t hese patie nts li kel y are resista nt t o c he m ot hera p y, 
t he y ma y be nefit fr o m t hera pies wit h differe nt mec ha nis ms of acti o n. 
I m m u n ot hera p y, w hic h is base d o n t he e n ha nce me nt of a n i m m u ne res p o nse 
a gai nst t he t u m or, is a pr o misi n g a p pr oac h t o treati n g ma n y ca ncer t y pes. 
T-cells pla y a n i m p orta nt r ole i n destr o yi n g disease d cells t hr o u g h o ut t he 
b o d y. St u dies wit h i m m u ne c hec k p oi nt i n hi bit ors a n d bi-s pecific T-cell 
e n ga gers ha ve de m o nstrate d t he p ote ntial of T-cells t o treat ca ncer. T-cells 
nee d t o p ossess t he a p pr o priate s pecificit y f or a t u m or, be prese nt i n s ufficie nt 
n u m bers, a n d o verc o me a n y l ocal i m m u n os u p pressi ve fact ors t o be effecti ve. 
C hi meric a nti ge n rece pt or ( C A R) e n gi neere d T-cells ma y a d dress t hese iss ues 
a n d are a pr o misi n g a p pr oac h f or ca ncer t hera p y.
A xica bta ge ne cil ole ucel is a n e n gi neere d a ut ol o g o us T-cell i m m u n ot hera p y 
b y w hic h a patie nt ’ s o w n T cells are c ollecte d a n d s u bse q ue ntl y ge neticall y 
altere d t o rec o g nize C D 1 9. C D 1 9 is e x presse d o n t he cell s urface of B-cell 
mali g na ncies. I n Z U M A- 1, w hic h i n vesti gate d t he safet y a n d efficac y of 
a xica bta ge ne cil ole ucel i n s u bjects wit h refract or y a g gressi ve N H L, 
a xica bta ge ne cil ole ucel si g nifica ntl y i m pr o ve d O R R ( P < 0. 0 0 0 1) c o m pare d 
t o hist orical c o ntr ol. T he O R R was 8 3 % wit h a c o m plete res p o nse ( C R) rate 
of 5 8 %. Wit h a me dia n f oll o w u p of 2 7. 1 m o nt hs, 3 9 % of s u bjects ha d 
o n g oi n g res p o nses ( 3 7 % i n C R). 7 6 % of patie nts i n Z U M A- 1 were refract or y 
t o 2 n d or later li ne of t hera p y a n d 2 3 % ha d a n earl y rela pse after A S C T. A Es, 
w hic h ca n be se vere or occasi o nall y life-t hreate ni n g, were well defi ne d, 
ge nerall y re versi ble, a n d ma na gea ble, wit h n o a p pare nt l o n g-ter m 
c o nse q ue nces ot her t ha n B-cell a plasia. T he m ost c o m m o n e ve nts were 
c yt o pe nias, w hic h are e x pecte d fr o m t he c o n diti o ni n g c he m ot hera p y, as well 
as C R S a n d ne ur ol o gic e ve nts. T he rates of se vere C R S a n d ne ur ol o gic e ve nts 
decrease d o ver t he c o urse of t he Z U M A- 1 st u d y, w hereas efficac y re mai ne d 
c o nsiste nt. I n a n a nal ysis of data fr o m t he P A R M A a n d C O R A L trial t he 
O R R t o sal va ge t hera p y i n less hea vil y pretreate d patie nts wit h a n earl y 
rela pse after 1st li ne c he m oi m m u n ot hera p y was o nl y 4 0 % a n d 4 6 % 
res pecti vel y ( G u gliel mi et al, 1 9 9 8) ( Gissel brec ht et al, 2 0 1 0). A xica bta ge ne 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 1 5
1 4 A pril 2 0 2 3  
Pr ot oc ol Secti o n
C o u ntr y-s pecific Re q uire me nt
cil ole ucel ma y e ve n ha ve a f urt her i m pr o ve d efficac y a n d t olera bilit y i n t his 
patie nt p o p ulati o n wit h less c he m o-refract or y disease a n d l o wer disease 
b ur de n. T heref ore a xica bta ge ne cil ole ucel will be c o m pare d t o sta n dar d of 
care ( S O C) as 2 n d li ne t hera p y i n patie nts wit h c he m o-refract or y D L B C L or 
a n earl y rela pse after 1st li ne c he m oi m m u n ot hera p y i n t he pr o p ose d Z U M A- 7 
st u d y.
1. 4. C o ncl usi o n
Treat me nt of patie nts wit h r/r D L B C L re mai ns c halle n gi n g a n d t here is a 
si g nifica nt u n met nee d f or better t hera pies i n t hese patie nts. T his patie nt 
p o p ulati o n has a s pecificall y p o or pr o g n osis e ve n wit h H D T- A S C T .
Z U M A- 7 is a ra n d o mize d a n d c o ntr olle d st u d y a gai nst sta n dar d of care as 
deter mi ne d b y t he i n vesti gat or base d o n g ui da nce fr o m t he pr ot oc ol. T his 
desi g n is e x pecte d t o all o w f or a p pr o priate assess me nt of t he be nefit of 
a xica bta ge ne cil ole ucel i n patie nts wit h r/r D L B C L c o m pare d t o c urre nt 
sta n dar d of care treat me nt, w hile mai ntai ni n g a n acce pta ble safet y pr ofile f or 
t he i m p orta nt i de ntifie d ris ks of C R S, ne ur ol o gic e ve nts, c yt o pe nias, 
i nfecti o ns a n d h y p o ga m ma gl o b uli ne mia.
2. S P O N S O R R E P O R TI N G R E Q UI R E M E N T S
De pe n di n g o n rele va nt l ocal le gislati o n or re g ulati o ns, i ncl u di n g t he 
a p plica ble U S F D A C o de of Fe deral Re g ulati o ns, t he E U Cli nical Trials 
Directi ve ( 2 0 0 1/ 2 0/ E C) a n d rele va nt u p dates, a n d ot her c o u ntr y-s pecific 
le gislati o n or re g ulati o ns, Kite ma y be re q uire d t o e x pe dite t o w orl d wi de 
re g ulat or y a ge ncies re p orts of S A Es, seri o us a d verse dr u g reacti o ns ( S A D Rs), 
or s us pecte d u ne x pecte d seri o us a d verse reacti o ns ( S U S A Rs). I n acc or da nce 
wit h t he E U Cli nical Trials Directi ve ( 2 0 0 1/ 2 0/ E C), t he s p o ns or or a s pecifie d 
desi g nee will n otif y w orl d wi de re g ulat or y a ge ncies a n d t he rele va nt I E C i n 
c o ncer ne d Me m ber States of a p plica ble S U S A Rs as o utli ne d i n c urre nt 
re g ulati o ns.
Assess me nt of e x pecte d ness f or S A Es will be deter mi ne d b y Kite usi n g 
refere nce safet y i nf or mati o n s pecifie d i n t he i n vesti gat or’s br oc h ure or 
rele va nt l ocal la bel as a p plica ble.
All i n vesti gat ors will recei ve a safet y letter n otif yi n g t he m of rele va nt 
S U S A R re p orts ass ociate d wit h a n y st u d y I M P. T he i n vesti gat or s h o ul d 
n otif y t he I R B or I E C of S U S A R re p orts as s o o n as is practical, w here t his is 
re q uire d b y l ocal re g ulat or y a ge ncies, a n d i n acc or da nce wit h t he l ocal 
i nstit uti o nal p olic y.
3. C O N T A C T P E R S O N F O R M E DI C A L A N D S A F E T Y Q U E RI E S
I n vesti gat ors ca n c o ntact t he E ur o pea n me dical m o nit or f or me dical a n d 
safet y q ueries:


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 1 6
1 4 A pril 2 0 2 3  
Pr ot oc ol Secti o n
C o u ntr y-s pecific Re q uire me nt
E ur o pea n Me dical M o nit or
Marc o Sc h u p p, M D
E xec uti ve Direct or, Cli nical De vel o p me nt
M o bile P h o ne: + 4 1 7 9 8 9 4 1 5 8 1
E mail: msc h u p p @ kite p har ma.c o m
Ur ge nt Safet y Iss ues C o ntact
A n na va n Tr o oste n b ur g
Vice Presi de nt P har mac o vi gila nce a n d E pi de mi ol o g y
E U Q P P V
P h o ne: + 4 9 8 9 8 9 9 8 9 0 1 8 1
E mail: A n na. va n Tr o oste n b ur g @ gilea d.c o m
A d verse e ve nt a n d S U S A R re p orti n g
Safet y _ F C @ gilea d.c o m
Rele va nt S A Es will be re p orte d t o M P A b y t he s p o ns or i n acc or da nce wit h 
l ocal re q uire me nts. T his i ncl u des S U S A Rs fr o m all a p plica ble trial sites.
4. S T U D Y DI S C O N TI N U A TI O N
B ot h t he s p o ns or a n d t he i n vesti gat or reser ve t he ri g ht t o ter mi nate t he st u d y 
at a n y ti me. S h o ul d t his be necessar y, b ot h parties will arra n ge 
disc o nti n uati o n pr oce d ures a n d n otif y t he a p pr o priate re g ulat or y 
a ut h orit y(ies), I R Bs, a n d I E Cs. I n ter mi nati n g t he st u d y, Kite a n d t he 
i n vesti gat or will ass ure t hat a de q uate c o nsi derati o n is gi ve n t o t he pr otecti o n 
of t he s u bjects’ i nterests.
5. R E F E R E N C E S
Br u d n o J N, K oc he n derfer J N. T o xicities of C hi meric A nti ge n Rece pt or T 
Cells: Rec o g niti o n a n d Ma na ge me nt. Bl o o d. 2 0 1 6; 1 2 7( 2 6): 3 3 2 1- 3 0.
Gissel brec ht C, Glass B, M o u nier N, Si n g h Gill D, Li nc h D C, Tr ne n y M, et 
al. Sal va ge re gi me ns wit h a ut ol o g o us tra ns pla ntati o n f or rela pse d lar ge 
B-cell l y m p h o ma i n t he rit u xi ma b era. J Cli n O nc ol. 2 0 1 0; 2 8( 2 7): 4 1 8 4-
9 0.
G u gliel mi C, G o mez F, P hili p T, Ha ge n bee k A, Martelli M, Se b ba n C, et al. 
Ti me t o rela pse has pr o g n ostic val ue i n patie nts wit h a g gressi ve 
l y m p h o ma e nr olle d o nt o t he Par ma trial. J Cli n O nc ol. 
1 9 9 8; 1 6( 1 0): 3 2 6 4- 9.
Lee D W, Gar d ner R, P orter D L, L o uis C U, A h me d N, Je nse n M, Gr u p p S A, 
Mac kall C L. C urre nt c o nce pts i n t he dia g n osis a n d ma na ge me nt of 
c yt o ki ne release s y n dr o me. Bl o o d. 2 0 1 4; 1 2 4( 2): 1 8 8- 9 5.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 1 7
1 4 A pril 2 0 2 3  
A p pe n di x E.  
C hil d be ari n g P ote nti al a n d Birt h C o ntr ol
T his st u d y will f oll o w t he rec o m me n dati o ns fr o m t he Cli nical Trials Facilitati o n Gr o u p ( C T F G) 
{ Cli nical Trials Facilitati o n a n d C o or di nati o n Gr o u p ( C T F G) 2 0 2 0 }, as descri be d bel o w.
1.
Defi niti o n of C hil d beari n g P ote ntial
A w o ma n is c o nsi dere d of c hil d beari n g p ote ntial (ie, fertile) f oll o wi n g me narc he a n d u ntil 
bec o mi n g p ost me n o pa usal u nless per ma ne ntl y sterile. Per ma ne nt sterilizati o n met h o ds i ncl u de 
h ysterect o m y, bilateral sal pi n gect o m y, a n d bilateral o o p h orect o m y.
A p ost me n o pa usal state is defi ne d as n o me nses f or 1 2 m o nt hs wit h o ut a n alter nati ve me dical 
ca use. A hi g h f ollicle sti m ulati n g h or m o ne ( F S H) le vel i n t he p ost me n o pa usal ra n ge ma y be use d 
t o c o nfir m a p ost me n o pa usal state i n w o me n n ot usi n g h or m o nal c o ntrace pti o n or h or m o nal 
re place me nt t hera p y. H o we ver i n t he a bse nce of 1 2 m o nt hs of a me n orr hea, a si n gle F S H 
meas ure me nt is i ns ufficie nt.
F or t he p ur p ose of t his st u d y, a ma n is c o nsi dere d fertile after p u bert y u nless per ma ne ntl y sterile 
b y bilateral orc hi dect o m y.
2.
Birt h C o ntr ol Met h o ds T hat Ma y Be C o nsi dere d as Hi g hl y Effecti ve
Met h o ds t hat ca n ac hie ve a fail ure rate of less t ha n 1 % per year w he n use d c o nsiste ntl y a n d 
c orrectl y are c o nsi dere d as hi g hl y effecti ve birt h c o ntr ol met h o ds. S uc h met h o ds i ncl u de:
•
C o m bi ne d (estr o ge n- a n d pr o gester o ne-c o ntai ni n g) h or m o nal c o ntrace pti o n ass ociate d wit h 
i n hi biti o n of o v ulati o na:

Oral

I ntra va gi nal

Tra ns der mal
•
Pr o gest o ge n- o nl y h or m o nal c o ntrace pti o n ass ociate d wit h i n hi biti o n of o v ulati o n a:

Oral

I njecta ble

I m pla nta blea
•
I ntra uteri ne de vice (I U D)a
a  C o ntrace pti o n met h o ds t hat i n t he c o nte xt of t his g ui da nce are c o nsi dere d t o ha ve l o w user de pe n de nc y.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 1 8
1 4 A pril 2 0 2 3  
•
I ntra uteri ne h or m o ne-releasi n g s yste m (I U S)a
•
Bilateral t u bal occl usi o n a
•
Vasect o mize d part ner a,b
•
Se x ual a bsti ne nce c
3.
U nacce pta ble Birt h C o ntr ol Met h o ds
Birt h c o ntr ol met h o ds t hat are u nacce pta ble i ncl u de peri o dic a bsti ne nce (cale n dar, 
s y m pt ot her mal, p ost o v ulati o n met h o ds), wit h dra wal (c oit us i nterr u pt us), s per mici des o nl y, a n d 
lactati o nal a me n orr h oea met h o d ( L A M). A fe male c o n d o m a n d a male c o n d o m s h o ul d n ot be 
use d t o get her.
b  Vasect o mize d part ner is a hi g hl y effecti ve birt h c o ntr ol met h o d pr o vi de d t hat part ner is t he s ole se x ual part ner of 
t he w o ma n of c hil d beari n g p ote ntial trial partici pa nt a n d t hat t he vasect o mize d part ner has recei ve d me dical 
assess me nt of t he s ur gical s uccess.
c  I n t he c o nte xt of t his g ui da nce se x ual a bsti ne nce is c o nsi dere d a hi g hl y effecti ve met h o d o nl y if defi ne d as 
refrai ni n g fr o m heter ose x ual i nterc o urse d uri n g t he e ntire peri o d of ris k ass ociate d wit h t he st u d y treat me nts. T he 
relia bilit y of se x ual a bsti ne nce nee ds t o be e val uate d i n relati o n t o t he d urati o n of t he cli nical trial a n d t he 
preferre d a n d us ual lifest yle of t he s u bject.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 1 9
1 4 A pril 2 0 2 3  
A p pe n di x F. 
P a n de mic Ris k Assess me nt a n d Miti g ati o n Pl a n
D uri n g a n o n g oi n g pa n de mic, p ote ntial ris ks ass ociate d wit h s u bjects bei n g u na ble t o atte n d 
st u d y visits ha ve bee n i de ntifie d f or t his st u d y.
T hese ris ks ca n be s u m marize d as f oll o ws:
1)
S u bject safet y m o nit ori n g a n d f oll o w- u p:
a)
S u bjects ma y be u na ble or u n willi n g t o c o me t o t he i n vesti gati o nal site f or t heir 
sc he d ule d st u d y visits as re q uire d per pr ot oc ol.
Miti gati o n pla n: F or s u bjects w h o ma y be u na ble or u n willi n g t o visit t he i n vesti gati o nal 
site f or t heir sc he d ule d st u d y visits as re q uire d per pr ot oc ol, t he pri nci pal i n vesti gat or or 
q ualifie d dele gate will c o n d uct a re m ote st u d y visit, via p h o ne or vi de o c o nfere nci n g, t o 
assess t he s u bjects wit hi n t he tar get visit wi n d o w date w he ne ver p ossi ble. D uri n g t he 
re m ote st u d y visit, t he f oll o wi n g i nf or mati o n at mi ni m u m will be re vie we d:
i)
C o nfir m if s u bject has e x perie nce d a n y a d verse e ve nts ( A Es)/seri o us a d verse e ve nts 
( S A Es)/s pecial sit uati o ns (i ncl u di n g pre g na nc y) a n d f oll o w- u p o n a n y u nres ol ve d 
A Es/ S A Es.
ii)
Re vie w t he c urre nt list of c o nc o mita nt me dicati o ns a n d d oc u me nt a n y ne w 
c o nc o mita nt me dicati o ns.
iii) If a p plica ble, c o nfir m electr o nic/ pa per diar y q uesti o n naires a n d patie nt-re p orte d 
o utc o mes ha ve bee n c o m plete d a n d tra ns mitte d.
b)
S u bjects ma y be u na ble or u n willi n g t o tra vel t o t he site f or pla n ne d assess me nts (e g, 
bl o o d dra ws, i ma gi n g, p h ysical e xa ms).
Miti gati o n pla n: L ocal la b orat ories or ot her ve n d ors ma y be utilize d as a p pr o priate t o 
m o nit or s u bject safet y u ntil t he s u bject ca n ret ur n t o t he site f or t heir re g ular f oll o w- u p 
per pr ot oc ol. A n y c ha n ges i n t he part y c o n d ucti n g la b orat or y assess me nts f or t he st u d y 
beca use of t he pa n de mic will be d oc u me nte d acc or di n gl y. Pre g na nc y testi n g ma y be 
perf or me d usi n g a h o me uri ne pre g na nc y test if l ocal la b orat or y pre g na nc y testi n g is n ot 
feasi ble. Ce ntral la b kits ma y be se nt t o s u bject’s l ocal h os pital la b f or sa m ple c ollecti o n. 
Rele va nt i ma gi n g (e g, P E T- C T, C T) ca n be d o ne at t he s u bject’s l ocal h os pital a n d 
i ma ges tra nsferre d or se nt t o t he i n vesti gati ve site. P h ysical e xa ms ca n be c o m plete d b y a 
l ocal p h ysicia n wit h res ults se nt t o i n vesti gati ve site.
c)
S u bjects ma y be u na ble or u n willi n g t o atte n d t he st u d y visit t o si g n a n u p date d i nf or me d 
c o nse nt f or m versi o n.
Miti gati o n pla n: T he site staff will f oll o w t heir a p pr o ve d i nf or me d c o nse nt pr ocess a n d 
re mai n i n c o m plia nce wit h t he l ocal et hics c o m mittee/i nstit uti o nal re vie w b oar d a n d 
nati o nal la ws a n d re g ulati o ns. Re m ote c o nse nt will be all o we d if has bee n a p pr o ve d b y 


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 2 0
1 4 A pril 2 0 2 3  
t he l ocal et hics c o m mittee/i nstit uti o nal re vie w b oar d. T he c o nse nt pr ocess will be 
d oc u me nte d a n d c o nfir me d b y n or mal c o nse nt pr oce d ure at t he i n vesti gati ve site at t he 
earliest o p p ort u nit y.
2) Pr ot oc ol a n d m o nit ori n g c o m plia nce:
a)
Pr ot oc ol de viati o ns ma y occ ur i n sit uati o ns w here sc he d ule d visits or pr oce d ures ca n n ot 
be c o n d ucte d as pla n ne d per pr ot oc ol.
Miti gati o n pla n: If it is n ot p ossi ble t o c o m plete a re q uire d pr oce d ure at a 
pr ot oc ol-s pecifie d ti me p oi nt, a n u nsc he d ule d visit s h o ul d be c o n d ucte d as s o o n as 
p ossi ble w he n c o n diti o ns all o w s o t hat t he re q uire d pr oce d ure ca n be perf or me d. T he 
sit uati o n s h o ul d be rec or de d a n d e x plai ne d as a pr ot oc ol de viati o n. A n y misse d s u bject 
visits m ust be re p orte d i n t he e C R F, if p ossi ble, a n d rec or de d as de viati o ns t o t he 
pr ot oc ol beca use of t he pa n de mic, s o t hat t he y ca n be a p pr o priatel y d oc u me nte d a n d 
descri be d i n t he cli nical st u d y re p ort. A n y re m ote st u d y visits t hat are c o n d ucte d i n lie u 
of cli nic visits beca use of t he pa n de mic will be d oc u me nte d as a pr ot oc ol de viati o n 
relate d t o t he pa n de mic.
b)
St u d y m o nit ors ma y be u na ble t o carr y o ut s o urce data re vie w or s o urce data verificati o n, 
or st u d y dr u g acc o u nta bilit y or assess pr ot oc ol a n d G o o d Cli nical Practice c o m plia nce. 
T his ma y lea d t o dela ys i n s o urce data verificati o n, a n i ncrease i n pr ot oc ol de viati o ns, or 
u n derre p orti n g of A Es.
Miti gati o n pla n: T he st u d y m o nit or is t o re mai n i n cl ose c o m m u nicati o n wit h t he site t o 
e ns ure o n g oi n g data e ntr y a n d q uer y res ol uti o n. Re m ote s o urce data verificati o n ma y be 
arra n ge d if all o we d b y l ocal re g ulati o n a n d t he St u d y M o nit ori n g Pla n. T he st u d y m o nit or 
is t o refere nce t he St u d y M o nit ori n g Pla n f or g ui da nce o n h o w t o c o n d uct a n off-site 
m o nit ori n g visit. T he st u d y staff is t o sa ve a n d d oc u me nt all rele va nt c o m m u nicati o n i n 
t he st u d y files. T he stat us of sites t hat ca n n ot acce pt m o nit ori n g visits a n d/ or s u bjects 
o n-site, m ust be trac ke d ce ntrall y a n d u p date d o n a re g ular basis.
3) Missi n g data a n d data i nte grit y:
T here ma y be a n i ncrease d a m o u nt of missi n g data beca use of s u bject’s missi n g 
visits/assess me nts. T his c o ul d ha ve a n i m pact o n t he a nal ysis a n d t he i nter pretati o n of 
cli nical st u d y data.
Miti gati o n pla n: I m plicati o ns of a pa n de mic o n met h o d ol o gical as pects f or t he st u d y will be 
t h or o u g hl y assesse d a n d d oc u me nte d, a n d rele va nt acti o ns will be ta ke n as a p pr o priate (e g, 
m o dificati o n of t he statistical a nal ysis pla n) a n d i n c o m plia nce wit h re g ulat or y a ut h orities’ 
g ui da nce. O verall, t he cli nical st u d y re p ort will descri be t he i m pact of t he pa n de mic o n t he 
i nter preta bilit y of st u d y data.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 2 1
1 4 A pril 2 0 2 3  
Ris ks will be assesse d c o nti n u o usl y, a n d te m p orar y meas ures will be i m ple me nte d t o miti gate 
t hese ris ks as part of a miti gati o n pla n, as descri be d a b o ve. T hese meas ures will be 
c o m m u nicate d t o t he rele va nt sta ke h ol ders as a p pr o priate a n d are i nte n de d t o pr o vi de alter nate 
met h o ds t hat will e ns ure t he e val uati o n a n d assess me nt of t he safet y of s u bjects w h o are e nr olle d 
i n t his st u d y.
Si nce t hese p ote ntial ris ks are c o nsi dere d miti gate d wit h t he i m ple me ntati o n of t hese meas ures, 
t he e x pecte d be nefit-ris k assess me nt of a xica bta ge ne cil ole ucel i n st u d y s u bjects re mai ns 
u nc ha n ge d.


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 2 2
1 4 A pril 2 0 2 3  
A p pe n di x G. 
Pr ot oc ol A me n d me nt Hist or y
A hi g h-le vel s u m mar y of t his a me n d me nt is pr o vi de d i n ta b ular f or m i n t he s u bsecti o n bel o w. 
Mi n or c ha n ges s uc h as t he c orrecti o n of t y p o gra p hic err ors, gra m mar, or f or matti n g are n ot 
detaile d.
Earlier se parate s u m maries of c ha n ges are a vaila ble u p o n re q uest.
A se parate trac ke d c ha n ge (re d-li ne d) d oc u me nt c o m pari n g t he pre vi o us pr ot oc ol versi o n 
( A me n d me nt 5, date d 2 5 J u ne 2 0 2 0) a n d U S A c o u ntr y-s pecific versi o n ( A me n d me nt 5. 1, date d 
1 6 Se pte m ber 2 0 2 0) t o t his a me n d me nt will be ma de a vaila ble u p o n t he p u blicati o n of t his 
pr ot oc ol.
•
A me n d me nt 6 ( D ate d 1 4 A pril 2 0 2 3)
•
C ha n ges fr o m A me n d me nt 5 ( date d 2 5 J u ne 2 0 2 0) t o A me n d me nt 6 ( date d 1 4 A pril 2 0 2 3) 
are detaile d bel o w:
Secti o n N u m ber a n d N a me
Hi g h-le vel Descri pti o n of C h a n ge
Brief R ati o n ale
Title Pa ge
Secti o n 7. 1 5 L o n g-ter m F oll o w-
u p ( A xica bta ge ne Cil ole ucel 
a n d Sta n dar d of Care Ar ms)
Secti o n 8 S u bject Wit h dra wal
Secti o n 1 3 St u d y 
D oc u me ntati o n a n d Arc hi ve
Secti o n 1 8, A p pe n di x A: 
S p o ns or a n d I n vesti gat or 
Si g nat ure Pa ge
Secti o n 1 8, A p pe n di x E: 
C hil d beari n g P ote ntial a n d 
Birt h C o ntr ol
Mi n or a d mi nistrati ve c ha n ges ha ve bee n 
ma de t hr o u g h o ut t he pr ot oc ol t o ali g n wit h 
Kite’s latest pr ot oc ol te m plate.
T o ali g n wit h Kite’s latest 
rec o m me n dati o ns a n d 
pr ocesses
Pr ot oc ol S y n o psis
St u d y Sc he ma
Secti o n 3. 5 D urati o n of St u d y 
a n d S u bject Partici pati o n
Secti o n 7. 1 1. 2. 2 R C R Testi n g
Secti o n 7. 1 5 L o n g-ter m F oll o w-
u p ( A xica bta ge ne Cil ole ucel 
a n d Sta n dar d of Care Ar ms)
Ta ble 4 Sc he d ule of Assess me nt 
L o n g-ter m F oll o w- u p Peri o d
Clarificati o n pr o vi de d re gar di n g st u d y 
d urati o n, visit fre q ue nc y, a n d assess me nts f or 
s u bjects ra n d o mize d t o t he S O C a n d 
a xica bta ge ne cil ole ucel ar ms.
A d diti o nal u p dates i ncl u de d t o clarif y t he 
tra nsiti o n of s u bjects t o t he se parate L T F U 
st u d y. 
F or clarificati o n
Pr ot oc ol S y n o psis, Statistical 
C o nsi derati o ns secti o n
Secti o n 1 0. 2. 1 St u d y E n d p oi nts 
Pri mar y
Refere nce t o a n acce pta ble l o wer li mit f or t he 
o bser ve d t otal E F S e ve nts t o tri g ger t he 
pri mar y a nal ysis has bee n re m o ve d at t he 
re q uest of t he re g ulat or y a ge nc y.
A d diti o nal mi n or c ha n ges ma de f or 
ali g n me nt of la n g ua ge i n pr ot oc ol 
Re q ueste d b y a re g ulat or y 
a ge nc y


A xica bta ge ne cil ole ucel; K T E- C 1 9
Kite P har ma, I nc.
Cli nical Pr ot oc ol: K T E- C 1 9- 1 0 7 ( Z U M A- 7)
A me n d me nt 6
C O N FI D E N TI A L
Pa ge 1 2 3
1 4 A pril 2 0 2 3  
Secti o n N u m ber a n d N a me
Hi g h-le vel Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n 1 0. 3 Sa m ple Size 
C o nsi derati o ns
Secti o n 1 0. 6 Pla n ne d Met h o d of 
A nal ysis
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a xica bta ge ne cil ole ucel i nf usi o n a s u bject ca n 
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peri p heral bl o o d will be s u m marize d wit h 
descri pti ve statistics.
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Secti o n 1 8 A p pe n di x D 
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A ge nc y Re q uire me nts
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SAP_001.pdf: 
STATISTICAL ANALYSIS PLAN (SAP)
Sponsor:
Kite Pharma, Inc.
2400 Broadway
Santa Monica, CA 90404
United States of America
Product Name:
Axicabtagene Ciloleucel
Protocol
A Phase 3, Randomized, Open-Label Study Evaluating the 
Efficacy of Axicabtagene Ciloleucel versus Standard of Care 
Therapy in Subjects with Relapsed/Refractory Diffuse Large B 
Cell Lymphoma (ZUMA-7)
Version Number:
Version 1.0
Release Date:
22 June 2020
Replaces Previous 
Version(s):
Version 0.3: 17 November 2017
CONFIDENTIALITY NOTICE
This document contains confidential information of Kite Pharma Inc., a wholly owned 
subsidiary of Gilead Sciences Inc. This Document must not be disclosed to anyone other 
than the site research staff and members of the institutional review board/independent ethics 
committee, a scientific review board or an equivalent. The information in this document 
cannot be used for any purpose other than the conduct of the clinical investigation without 
the prior written consent of Kite Pharma Inc. Questions regarding how this document should 
be used or the conduct of the clinical trial should be directed to the key sponsor contacts.


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Statistical Analysis Plan
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TABLE OF CONTENTS
STATISTICAL ANALYSIS PLAN (SAP)...................................................................................................................1
TABLE OF CONTENTS ..............................................................................................................................................2
LIST OF TABLES.........................................................................................................................................................4
LIST OF FIGURES.......................................................................................................................................................4
LIST OF ABBREVIATIONS AND DEFINTIONS OF TERMS .................................................................................5
1.
INTRODUCTION ................................................................................................................................................7
2.
OBJECTIVES.......................................................................................................................................................8
3.
STUDY OVERVIEW...........................................................................................................................................9
3.1.
Study Design............................................................................................................................................9
3.2.
Hypothesis..............................................................................................................................................10
3.3.
Sample Size Considerations...................................................................................................................10
3.4.
Interim Analysis and Early Stopping Guidelines ...................................................................................13
3.4.1.
Safety Interim Analysis........................................................................................................13
3.4.2.
Efficacy Interim Analysis.....................................................................................................13
3.5.
Statistical Assumptions ..........................................................................................................................14
4.
STUDY ENDPOINTS AND COVARIATES ....................................................................................................15
4.1.
Endpoints ...............................................................................................................................................15
4.2.
Covariates...............................................................................................................................................16
5.
DEFINITIONS....................................................................................................................................................18
5.1.
General...................................................................................................................................................18
5.2.
Safety .....................................................................................................................................................19
5.3.
Efficacy..................................................................................................................................................23
6.
ANALYSIS SUBSETS.......................................................................................................................................26
6.1.
Full Analysis Set (FAS) .........................................................................................................................26
6.2.
Safety Analysis Set ................................................................................................................................26
6.3.
Safety Analysis Set - ASCT...................................................................................................................26
6.4.
QoL Analysis Set ...................................................................................................................................26
6.5.
Retreatment Analysis Sets......................................................................................................................26
6.6.
Subgroup Analysis Sets..........................................................................................................................26
7.
INTERIM ANALYSIS AND EARLY STOPPING GUIDELINES...................................................................27
7.1.
Safety Interim Analyses .........................................................................................................................27
7.2.
Efficacy Interim Analyses......................................................................................................................27
7.3.
Access to Aggregate and Subject-level Data and Individual Subject Treatment Assignments..............27
8.
DATA SCREENING AND ACCEPTANCE......................................................................................................28
8.1.
General Principles ..................................................................................................................................28
8.2.
Electronic Transfer and Archival of Data ..............................................................................................28
8.3.
Handling of Missing and Incomplete Data.............................................................................................28
8.3.1.
Efficacy ................................................................................................................................28
8.3.2.
Safety....................................................................................................................................28
8.4.
Detection of Bias....................................................................................................................................29
8.5.
Outliers...................................................................................................................................................29


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8.6.
Distributional Characteristics.................................................................................................................29
8.7.
Validation and Configuration Management ...........................................................................................29
9.
STATISTICAL METHODS OF ANALYSIS ....................................................................................................30
9.1.
General Principles ..................................................................................................................................30
9.2.
Subject Accountability...........................................................................................................................30
9.3.
Important Protocol Deviations ...............................................................................................................30
9.4.
Demographic and Baseline Characteristics............................................................................................31
9.5.
Efficacy Analyses...................................................................................................................................31
9.5.1.
EFS.......................................................................................................................................32
9.5.2.
Analyses of Objective Response ..........................................................................................33
9.5.3.
Analyses of Overall Survival ...............................................................................................34
9.5.4.
Analyses of Progression-free Survival, Duration of Response, and Time 
to Next Therapy....................................................................................................................34
9.6.
Safety Analyses......................................................................................................................................35
9.6.1.
Adverse Events.....................................................................................................................35
9.6.2.
Laboratory Test Results........................................................................................................36
9.6.3.
Anti-Axicabtagene Ciloleucel Antibodies............................................................................36
9.6.4.
Replication Competent Retrovirus (RCR)............................................................................36
9.6.5.
Exposure to Study Treatment and Product Characteristics ..................................................36
9.6.6.
Exposure to Concomitant Medications and Procedures .......................................................37
9.7.
Health-related Quality of Life................................................................................................................37
9.8.
Subsequent Lymphoma Therapy............................................................................................................37
9.9.
Schedule of Study Treatment .................................................................................................................38
9.10.
CAR T Cells Measured in Peripheral Blood..........................................................................................38
9.11.
Other 
10.
CHANGES FROM PROTOCOL-SPECIFIED ANALYSES.............................................................................39
11.
REFERENCES ...................................................................................................................................................40
12.
APPENDICES ....................................................................................................................................................42
Appendix 1.
Conventions for Clinical Data That Require Imputation for Partial or Missing Dates...........43
Appendix 2.
Planned Event and Censoring Rules for the EFS analysis......................................................45
Appendix 3.
Derivation of Last Date Known to Be Alive ..........................................................................48
CCI


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LIST OF TABLES
Table 1.
Imputation Rules for Partial or Missing Start Dates...............................................................43
Table 2.
Primary Analysis of EFS........................................................................................................45
Table 3.
(Sensitivity Analysis 1):  progression events that occur in between scheduled 
assessments will be moved forward to the next scheduled assessment after the 
observed progression..............................................................................................................46
Table 4.
(Sensitivity analysis 2):  progression events that occur in between scheduled 
assessments will be moved backward to the last scheduled assessment prior to 
progression .............................................................................................................................46
Table 5.
(Sensitivity analysis 3):  EFS events that occur after more than one missed disease 
assessment visit will be censored at the last evaluable disease assessment prior to 
the observed progression ........................................................................................................46
Table 6.
(Sensitivity Analysis 4):  subjects in the axicabtagene ciloleucel arm who undergo 
ASCT while in axicabtagene induced response are imputed to have an EFS event at 
the time of ASCT ...................................................................................................................47
LIST OF FIGURES
Figure 1.
Study Testing Scheme ............................................................................................................12


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LIST OF ABBREVIATIONS AND DEFINTIONS OF TERMS
ADaM
Analysis data model
AE
Adverse event
ALC
Absolute lymphocyte count
ASCT
Autologous stem cell transplant
BSA
Bovine serum albumin
CAR
Chimeric antigen receptor 
CMH
Cochran-Mantel-Haenszel
CR
Complete response
CRF
Case report form
CRP
C-reactive protein 
CRS
Cytokine release syndrome
CSR
Clinical study report
CT
Computed tomography
CTCAE
Common Terminology Criteria for Adverse Events
DLBCL
Diffuse large B-cell lymphoma
DOR
Duration of response
DSMB
Data Safety Monitoring Board
ECOG
Eastern Cooperative Oncology Group
EFS
Event-free survival
EORTC QLQ-C30
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire Cancer-30
EQ-5D-5L
European quality of life five dimensions five levels
FAS
Full analysis set
FISH
Fluorescence in situ hybridization
HDT
High-dose therapy 
HLGT
High-level group term
IPI
International Prognostic Index  
IXRS 
Interactive Voice/Web (X) Response System
KM
Kaplan-Meier
LLOQ
Lower limit of quantitation
MedDRA
Medical Dictionary for Regulatory Activities
NALT
Next anti-lymphoma therapy
NCI
National Cancer Institute
NE
Neurologic event
ORR
Objective response rate
OS
Overall survival
PET
Positron emission tomography
PFS
Progression-free survival


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PR
Partial response
PRO
Patient reported outcome
QoL
Quality of life
RCR
Replication-competent retrovirus
r/r
Relapsed/refractory
SAE
Serious adverse event
scFv
Single-chain variable fragment
SCT
Stem cell transplant
SDTM
Study data tabulation model 
SOC
Standard of care
SMQ
Standardized MedDRA query
SUSAR
Suspected unexpected serious adverse reaction
TBI
Total body irradiation
TEAE
Treatment-emergent adverse event
TFL
Transformed follicular lymphoma
VAS
Visual analog scale
WPAI
Work productivity and activity impairment


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1.
INTRODUCTION
This statistical analysis plan provides the pre-specification and details for the statistical analyses 
outlined within Protocol KTE-C19-107 entitled “A Phase 3, Randomized, Open-label Study 
Evaluating the Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects 
with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (ZUMA-7).” The scope of this plan 
includes the interim and primary analyses that are planned.


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2.
OBJECTIVES
The primary objective of this study is to determine whether axicabtagene ciloleucel is superior to 
standard of care (SOC) as measured by event-free survival (EFS).  
The secondary objectives of this study are:

To evaluate the effect of axicabtagene ciloleucel compared to SOC on objective response rate 
(ORR), defined as the incidence of partial response (PR) and complete response (CR)

To evaluate the effect of axicabtagene ciloleucel compared to SOC on overall survival (OS)

To evaluate the effect of axicabtagene ciloleucel compared to SOC on progression-free 
survival (PFS)

To evaluate the effect of axicabtagene ciloleucel compared to SOC on duration of response
(DOR) among responding subjects (CR and PR) and subjects attaining a CR

To evaluate the safety of axicabtagene ciloleucel compared to SOC

To evaluate the effect of axicabtagene ciloleucel on patient reported outcomes (PROs) and 
quality of life (QoL) compared to SOC
CCI


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3.
STUDY OVERVIEW
3.1.
Study Design
ZUMA-7 is a Phase 3 randomized, open-label, multicenter study evaluating the efficacy of 
axicabtagene ciloleucel versus SOC in adult subjects with relapsed/refractory (r/r) diffuse large 
B-cell lymphoma (DLBLC).  Adult subjects with r/r DLBCL after first-line rituximab and 
anthracycline-based chemotherapy will be randomized in a 1:1 ratio to receive axicabtagene 
ciloleucel or SOC.  Randomization will be stratified by response to first-line therapy (primary 
refractory versus relapse ≤6 months of first-line therapy versus relapse > 6 and ≤12 months of 
first-line therapy) and second-line age-adjusted International Prognostic Index (IPI) (0 to 1 
versus 2 to 3) as assessed at the time of screening.  
For subjects randomized to the control arm of the study, SOC will consist of a protocol-defined, 
platinum-based salvage combination chemotherapy regimen.  Subjects who respond to 
second-line chemotherapy should proceed to high-dose therapy (HDT) and autologous stem cell 
transplant (ASCT).  
An independent Data Safety Monitoring Board (DSMB) will meet every 6 months after the first 
subject is randomized to review safety data and will review safety and efficacy data at the time 
of the planned interim futility analysis of EFS.  The DSMB will be chartered to make trial 
conduct recommendations based on an analysis of risk versus benefit.  The DSMB may meet 
more often as needed.  
Subjects will be evaluated by the investigator for disease response and progression and blinded 
central review per the Lugano Classification {Cheson 2014}.  Subjects in both treatment arms 
are to be assessed for response and progression at the same times relative to randomization: 
Day 50, Day 100, Day 150, Month 9, and then every 3 months thereafter until Month 24.  
Subjects will be assessed every 6 months from Month 30 to Month 60.  New non-protocol-
specified therapy for disease will be recorded for all subjects randomized until a subject 
completes the long-term follow-up period, is considered lost to follow-up, withdraws consent, or 
has died.  Survival status will be ascertained at each clinic visit up through Month 9 after which 
subjects will be contacted every 3 months up through Month 24 and then every 6 months 
thereafter until Month 60.
The primary analysis of EFS will be conducted when all subjects have had the opportunity to be 
followed for the Month 9 disease assessment and approximately 250 EFS events have been 
observed.  The acceptable lower limit for the observed total EFS events is 225, which is to 
maintain the power for the primary analysis of EFS to within 5% of the targeted 90%. One 
interim analysis of EFS is planned after 135 EFS events have been observed.  This interim 
analysis is for safety and futility.  The DSMB will review the futility analysis and make a 
recommendation on trial conduct based on an evaluation of risk versus benefit.  The interim and 
primary analyses of EFS will be based on blinded central review of progression and censoring 
times.  The primary analysis of ORR will occur at the time of the primary analysis of EFS.  The 
primary analysis of OS will occur after 210 OS events have been observed or no later than 


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5 years after the first subject is randomized.  Details on the testing methods and interim analyses 
are provided in Sections 3.3 and 3.4.
3.2.
Hypothesis
The hypothesis for this study is that axicabtagene ciloleucel will prolong EFS compared to SOC 
therapy in adult subjects with relapsed/refractory DLBCL.  The hypothesized treatment effect 
corresponds to a 50% improvement in EFS.
3.3.
Sample Size Considerations  
The anticipated enrollment in this study is approximately 350 subjects.
An EFS hazard ratio (test/control arm) of 0.67 is hypothesized in the full analysis set (FAS).  
Assuming an exponential distribution for EFS and a median EFS of 4 months in the SOC arm, 
this implies a 50% relative improvement in EFS and corresponds to median EFS of 4 versus
6 months (control versus test arm).  The primary analysis is planned when approximately 
250 EFS events have been observed; the study has been sized to achieve approximately 90% 
power at the 1-sided 2.5% significance level to detect a 50% improvement in EFS.  The 
minimum effect size that can be determined to be statistically significant is an EFS hazard ratio 
of 0.79 or a 27% relative improvement in EFS.  Further, assuming a concave accrual distribution 
with 50% of accrual in the last 33% of the accrual period of 24 months and a 10% rate (5% by 
Month 1 and cumulative 10% by Month 8) of loss to follow-up in the axicabtagene ciloleucel 
arm and 15% rate (10% by Month 1 and cumulative 15% by Month 8) of loss to follow-up in the 
SOC arm, it is anticipated that the event goal will be achieved if 350 subjects are randomized 
(175/arm) and will occur approximately 31 months after the first subject is randomized.  One 
interim futility analysis of EFS will be conducted after 135 EFS events have been observed.  
The study will have an overall alpha of 2.5% with 1-sided testing.  To preserve the overall 
significance level, statistical testing of the primary and key secondary efficacy endpoints will 
follow a hierarchical scheme.  EFS will be tested first at the primary EFS analysis.  Conditional
on a statistically significant improvement in EFS, ORR will be tested at the 2.5% level at the 
time of the primary EFS analysis.  Conditional on demonstrating a statistically significant 
improvement in EFS and ORR at the time of the primary EFS analysis, OS will be tested up to 
3 times at an overall alpha level of 2.5%.  If a statistically significant improvement in EFS is not 
demonstrated at the time of the primary EFS analysis, hierarchical testing of ORR and OS will 
not occur.  If a statistically significant improvement in EFS is demonstrated, but a statistically 
significant improvement in ORR is not demonstrated at the time of the primary EFS analysis, 
hierarchical testing of OS will not occur.
For the analysis of ORR, response rates of 36% and 78% in the control and test arms are 
assumed.  ORR will be tested with a stratified (randomization factors) Cochran-Mantel-Haenszel 
(CMH) test at the 2.5% level among subjects in the FAS.


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An OS hazard ratio of 0.73 is hypothesized in the FAS.  Assuming an exponential distribution 
for OS and a median OS of 15.8 months in the control arm, this implies a 37% relative 
improvement in OS and corresponds to median OS of 15.8 versus 21.6 months.  The primary OS 
analysis is planned when approximately 210 deaths have been observed or no later than 5 years 
after the first subject is randomized, with a first interim analysis of OS occurring at the time of 
primary EFS analysis and a second interim analysis when approximately 160 deaths have 
occurred or no later than 4 years after the first subject is randomized.  
Stratified (randomization factors) log-rank tests will be used to test the null hypothesis of no 
difference in EFS and OS using an overall 1-sided alpha level of 2.5%.  A stratified 
(randomization factors) CMH test will be used to test ORR at an overall 1-sided alpha level of 
2.5%.
The EFS analysis is event-driven and will occur when the required number of events have been 
observed.
The study testing scheme is provided in Figure 1.  




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The timing of the EFS, ORR, and OS analyses are described in Figure 1.  The clinical study 
report (CSR) will be written at the time of the primary EFS analysis and will include results of 
the first interim analysis of OS.  The study will continue to be conducted per the protocol, and 
the results of the second interim and primary analyses of OS will be written shortly after each 
analysis is completed.
3.4.
Interim Analysis and Early Stopping Guidelines
3.4.1.
Safety Interim Analysis
The DSMB will review safety data every 6 months from the time the first subject is randomized 
until the primary EFS analysis.  Additionally, the DSMB will review safety and efficacy data at 
the time of the planned interim EFS analysis.  The DSMB will also review serious adverse event 
(SAE) information and suspected unexpected serious adverse reactions (SUSARs) on a regular 
basis throughout the study.  The sponsor may request additional reviews by the DSMB if safety 
concerns are identified.  The DSMB may meet more often as needed.  Timing of DSMB 
meetings will be further specified in the DSMB charter; meetings may be combined as practical 
depending on accrual and analysis milestone times.
3.4.2.
Efficacy Interim Analysis
One interim analysis of EFS and 2 interim analyses of OS are planned.
The interim EFS analysis is for futility and will occur when 135 EFS events have been observed.  
An O’Brien-Fleming spending function of the Lan-DeMets family will be used to allocate the 
type II error between the interim and primary analyses.  Under the null hypothesis, the 
probability of stopping for futility at this interim analysis is approximately 60%.  One hundred 
thirty-five (135) EFS events are anticipated to occur approximately 19 months after the first 
subject is randomized.
Conditional upon statistically significant tests of EFS and ORR at the primary EFS analysis, 
testing of OS will be performed.  A first interim analysis of OS will occur at the time of the 
primary EFS analysis and a second interim analysis when approximately 160 deaths have 
occurred or no later than 4 years after the first subject is randomized. A spending function of the 
Rho family with parameter (rho
 6) will be used to allocate the alpha between the 2 interim 
analyses of OS and the primary analysis of OS.  Approximately 110 OS events and 160 OS 
events are anticipated at the time of the first and second interim OS analyses, respectively. The 
1-sided alpha of 0.1% and 0.4% will be allocated at the first and second interim analysis of OS,
respectively.
This procedure preserves the designated 1-sided alpha level of 0.025 and has approximately 90% 
power.  EAST 6.4 was used to evaluate the operating characteristics of this design.


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3.5.
Statistical Assumptions
This trial will enroll patients with r/r DLBCL after first-line chemotherapy.  Outcomes for this 
patient population treated with SOC have been described in {Crump 2014, Gisselbrecht 2010, 
Gisselbrecht 2012, Van Den Neste 2016, van Imhoff 2017}.  EFS and OS in the control arm 
were simulated based on results from these studies and assuming exponential time to event 
distributions.  Based on these simulations, the median EFS in the control arm is assumed to 
follow an exponential distribution with median 4.0 months, and the median OS in the control 
arm is assumed to follow an exponential distribution with median 15.8 months.




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4.2.
Covariates
The following baseline covariates may be used to examine efficacy in subgroups or covariate 
analyses:  

Geographic region (North America, Europe)

Eastern Cooperative Oncology Group (ECOG) performance status at screening (0, 1)

Age at randomization (≥ 65, < 65)

Sex

Race/ethnicity

Response to first-line therapy (primary refractory, relapse ≤ 6 months of initiation of first-
line therapy versus relapse > 6 and ≤ 12 months of initiating first-line therapy)

Second-line age-adjusted IPI (0 to 1 versus 2 to 3) at time of screening

Disease type (DLBCL, transformed follicular lymphoma [TFL])

Molecular subgroup (germinal center B-cell like [GCB] vs. activated B-cell like [ABC], or 
GCB vs. non-GCB)

Double hit (C-MYC genomic alterations and either BCL-2 or BCL-6 genomic alterations) 
status by fluorescence in situ hybridization (FISH)

Triple hit (BCL-2, BCL-6, and C-MYC alterations) status by FISH
For the primary analysis of efficacy, the Interactive Voice/Web (X) Response System (IXRS)
values of response to first-line therapy and second-line age-adjusted IPI will be used.  Sensitivity 
analyses may be conducted with values collected in the clinical trial database (EDC).  Covariate 
levels that are sparse (ie, less than 30 events for time to event analyses or subjects for ORR 
analyses) may be collapsed for purposes of statistical modeling.  If this occurs, the strata for 
relapse ≤ 6 months of first-line therapy and relapse from 6 to 12 months of first-line therapy will 
be collapsed first.  
The following baseline covariates may be used to examine safety in subgroups or covariate 
analyses:

Geographic region (North America, Europe)

ECOG performance status at screening (0, 1)

Age at randomization (≥ 65, < 65)


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
Sex

Race/ethnicity

Response to first-line therapy (primary refractory, relapse ≤ 6 months of first-line therapy 
versus relapse > 6 and ≤ 12 months of first-line therapy, or PD vs. SD vs. PR as best overall 
response)

Second-line age-adjusted IPI (0 to 1 versus 2 to 3) at time of screening

Disease type (DLBCL, TFL, etc.)
Axicabtagene ciloleucel arm only:

Ferritin measured prior to conditioning chemotherapy (≤ median value, > median value)

Ferritin at Treatment Day 0 (≤ median value, > median value)

C-reactive protein (CRP) measured prior to conditioning chemotherapy (≤ median value, 
> median value)

CRP at Treatment Day 0 (≤ median value, > median value)

Absolute lymphocyte count (ALC) measured prior to conditioning chemotherapy (≤ median 
value, > median value)

ALC at Treatment Day 0 (≤ median value, > median value)
The following non-baseline covariates may be explored for efficacy subgroup or covariate 
analyses:

Best response on study 

Occurrence of stem cell transplant (SCT) at any time after randomization

Commencement of any non-protocol-specified cancer therapy
When these covariates are used in time-to-event analyses, the time to the event will be counted 
from the measurement time of the covariate, not study randomization.
Covariate levels that are sparse may be collapsed for purposes of statistical modeling.


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5.
DEFINITIONS
5.1.
General
Study enrollment:  Study enrollment is defined as randomization (e.g., the assignment of a 
randomization number to a subject) into the study.
Study Day 0:  Randomization Study Day 0 is defined as the day of randomization.
Treatment Day 0:  In the axicabtagene ciloleucel arm, Treatment Day 0 is defined as the day the 
subject received the first axicabtagene ciloleucel infusion.  The day prior to Treatment Day 0 will 
be Treatment Day 1.  The day of randomization and any days after randomization and before 
Treatment Day 1 will be sequential and negative integer-valued.
In the SOC arm, Treatment Day 0 is defined as the day the subject underwent SOC.  The day 
prior to Treatment Day 0 will be Treatment Day 1.  The day of randomization and any days 
after randomization and before Treatment Day 1 will be sequential and negative integer-valued.
Leukapharesis period:  The leukapharesis period is defined for the axicabtagene ciloleucel arm 
and is defined as the day (negative integer-valued) the subject undergoes leukapheresis 
calculated relative to Treatment Day 0.
Conditioning chemotherapy period:  The conditioning chemotherapy period is defined for the 
axicabtagene ciloleucel arm and begins on the day of the first chemotherapy administration until 
the day immediately prior to the axicabtagene ciloleucel infusion.  These days are numbered as 
sequential negative integer values relative to Treatment Day 0.
SOC and HDT therapy period:  The SOC and HDT period are defined for the SOC arm and 
begin the day of the first chemotherapy administration until the day immediately prior to SCT.  
These days are numbered as sequential negative integer values relative to Treatment Day 0.
Re-treatment conditioning chemotherapy period:  The re-treatment conditioning 
chemotherapy period is defined for the axicabtagene ciloleucel arm and begins on the day of the 
first chemotherapy administration of re-treatment until the day immediately prior to the 
axicabtagene ciloleucel re-treatment infusion.  In the event that the axicabtagene ciloleucel 
re-treatment infusion is delayed, the numbering of the re-treatment conditioning chemotherapy 
period will remain relative to the axicabtagene ciloleucel re-treatment infusion.
Baseline:  The baseline value is defined as the last value taken prior to randomization.


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Study therapy:  

Axicabtagene ciloleucel arm:  Study therapy is defined as conditioning chemotherapy or 
axicabtagene ciloleucel.

SOC arm:  Study therapy is defined as induction chemotherapy, total body irradiation (TBI) 
(given as part of conditioning for ASCT), conditioning chemotherapy for ASCT (HDT), and 
ASCT.
On-study:  Time from randomization to the last date of contact.
End of study: This will occur after both of the following criteria are met:

Axicabtagene ciloleucel arm:  all subjects have been followed for 15 years post-
randomization, have withdrawn consent, been lost to follow-up, or have died.

SOC arm: all subjects have been followed for 5 years post-randomization, have withdrawn 
consent, been lost to follow-up, or have died.
Actual follow-up time:  Actual follow-up time is calculated as the time from the date of 
randomization (Study Day 0) to the date of death, last date known alive, lost to follow-up, or 
withdrawal of consent, whichever is later.
Potential follow-up time:  Potential follow-up time is defined as the time from the date of 
randomization (Study Day 0) to the data cutoff date for the analysis.
Follow-up time for response:  Follow-up time for response is derived as the time from the date 
of randomization (Study Day 0) to the last disease assessment or censoring date.  Follow-up time 
for response is derived using the reverse Kaplan-Meier approach in which the censoring times 
and event times are reversed to derive the median follow-up time.
5.2.
Safety
Treatment-emergent adverse event (TEAE):  
Axicabtagene ciloleucel arm:  Any AE with onset on or after the axicabtagene ciloleucel 
infusion. For subjects receiving retreatment with axicabtagene ciloleucel, TEAEs after
retreatment may be summarized separately. 
SOC arm:  Any AE with onset on or after the first dose of induction chemotherapy.  
Deaths:  All deaths that occur from randomization up through the end of study.
Adverse events of interest:  AEs of interest for axicabtagene ciloleucel treatment include AEs
in the categories of:


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Important identified risks:

cytokine release syndrome (CRS)

neurologic toxicity 

infections

cytopenias, including 
neutropenia
thrombocytopenia 
anemia

hypogammaglobulinemia 
Important potential risks:

Secondary malignancies

Tumor lysis syndrome

Bone marrow failure

Graft-versus-host-disease (GVHD)

Replication competent retrovirus (RCR)

Immunogenicity (anti-axicabtagene ciloleucel antibodies)
Neurological toxicity (Neurotoxicity):  Neurological AEs are identified with a search strategy 
based on known neurologic toxicities associated with anti-CD19 immunotherapy {Topp 2015}. 
The search strategy focuses on central nervous system toxicity, without regard to temporal 
relationship and concomitant conditions (eg, CRS).  Additionally, the Medical Dictionary for 
Regulatory Activities (MedDRA) system organ classes of Psychiatric Disorders and Nervous 
System Disorders will be reviewed for additional events; these events will then be evaluated for 
potential inclusion as neurologic AEs. Neurologic toxicity will be reported separately from CRS.
Cytokine release syndrome (CRS):  CRS as a syndrome (ie, a collection of individual 
symptoms) is identified via collection of the syndrome on a case report form specifically 
designed to collect CRS. Individual symptoms of CRS are separately collected on the AE log and 
are linked to the CRS syndrome.  CRS syndrome severity is graded according to a modification 
of the grading system proposed by Lee {Lee 2014}.  In the modified grading scale, neurologic 
AEs are not reported as part of the CRS syndrome; rather, they are reported on the AE log form 
separately based on specific symptoms per Common Terminology Criteria for Adverse Events 
(CTCAE).  


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Cytopenias: Cytopenias (neutropenia or thrombocytopenia, or anemia including aplastic 
anemia) are identified as follows:

Thrombocytopenia will be identified using the standardized MedDRA query (SMQ) for 
haematopoietic thrombocytopenia (narrow search)

Neutropenia will be identified using Kite Pharma, Inc. (hereafter referred to as Kite)-
specified MedDRA search term (MST)

Anemia (including aplastic anemia) will be identified using the SMQ haematopoietic 
erythropenia (broad search)
Subjects with cytopenias (neutropenia or thrombocytopenia or anemia) present on or after 
Day 30 post study treatment will be summarized separately by cell lineage.
Bone marrow failure:  Bone marrow failure will be identified using the narrow SMQ of 
haematopoietic cytopenias affecting more than one type of blood cell.
Hypogammaglobulinemia: Hypogammaglobulinemia will be identified using a MST search 
strategy defined by Kite.  
B-cell aplasia:  Laboratory data will be used to assess the incidence of B-cell aplasia.  B-cell 
aplasia will be assessed using a qualified flow cytometry assay on cryopreserved subject 
peripheral blood mononuclear cells (PBMCs) and is defined as B cells < lower limit of
quantitation (LLOQ).  The LLOQ is defined as CD19+, CD20+, or double positive CD19+ and 
CD20+ events < 0.017 B cells as a percentage of viable leukocytes, with 10000 or more viable 
leukocyte events required in the assay.
Infections:  Infections are identified as AEs within the system organ class of Infections and 
Infestations that occur on or after Treatment Day 0 and in MedDRA high-level group terms 
(HLGT) that capture events of:

Bacterial infection, encompassing preferred terms within the MedDRA HLGT of 
Bacterial infectious disorders 
Chlamydial infectious disorders

Viral infection, encompassing preferred terms within the MedDRA HLGT of viral infectious 
disorders

Opportunistic infections, encompassing preferred terms within the MedDRA HLGT of 
Fungal infectious disorders
Mycobacterial infectious disorders

Other infections, encompassing preferred terms within the MedDRA HLGT of Infections 
pathogen unspecified


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B-cell aplasia will be examined as part of the analysis of infections.
Secondary malignancy:  Secondary malignancies are identified with the AEs that are coded into 
the system organ class of Neoplasms benign, malignant, and unspecified (including cysts and 
polyps) will be reviewed to identify other potential events.  
Tumor lysis syndrome:  Tumor lysis syndrome is identified as events with MedDRA preferred 
terms in the Tumor Lysis Syndrome SMQ (MedDRA).  The narrow version of this SMQ will be 
used.
Graft-versus-host disease (GVHD):  GVHD will be identified using a MST search strategy 
defined by Kite by using subsets of PT from HLGT of procedural related injuries and 
complications NEC and HLT of immune and associated conditions NEC.
Immunogenicity (Anti-axicabtagene ciloleucel antibody):  Immunogenicity will be identified 
for subjects who have treatment emergent anti-axicabtagene ciloleucel antibody and have 
developed any AE belonging to the SMQ of anaphylactic reaction and the SMQ of 
hypersensitivity.  The narrow version of these 2 SMQs will be used.  
Cardiac failure: Cardiac failure will be identified using the SMQ of cardiac failure. The narrow 
version of this SMQ will be used. 
Cardiac arrhythmias: Cardiac arrhythmias will be identified using the SMQ of cardiac 
arrhythmias. The narrow version of this SMQ with selected broad SMQ preferred terms will be 
used. 
Time to Onset of Event/Syndrome: Time to onset of an event/syndrome is defined as the time 
from Treatment Day 0 to the day of the first occurrence of the event/syndrome.  Time to Onset of 
Grade 3 or Higher Events/Syndromes are defined in the same way, but restricted to Grade 3 or 
higher events/syndromes.
Duration of Event/Syndrome:  The duration across all events is the last day of the last 
event - first day of the first event +1, regardless of whenever the events are consecutive, 
overlapping, or neither. 
Durations of events will not be calculated for events that are ongoing at the time of the data 
cutoff date or subject death.  For events defined by laboratory criteria, time to onset and duration 
will not be calculated.  For events defined by both laboratory criteria and AEs, only the AE
component will be used to define time to onset and duration.


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5.3.
Efficacy
Event-free survival (EFS):  EFS is defined as the time from randomization to the earliest date of 
disease progression per Lugano Classification {Cheson 2014}, commencement of new 
lymphoma therapy, or death from any cause.  The following criteria will be used to further define 
events and event times:

Subjects with established PR or CR and subsequently commence new lymphoma therapy 
(including radiotherapy, except for TBI as noted below) in the absence of documented 
disease progression will have EFS time defined as the time from randomization to the last 
evaluable disease assessment prior to the new lymphoma therapy

Subjects with best response of SD and subsequently commence new lymphoma therapy 
(including radiotherapy, except for TBI as noted below) in the absence of documented 
disease progression will have EFS time defined as the time from randomization to the first 
time SD was established prior to the new lymphoma therapy

Subjects who commence new lymphoma therapy (including radiotherapy, except for TBI as 
noted below) in the absence of any evaluable disease assessment will have the EFS event 
date imputed as the randomization date

Subjects with best response of SD up to and including Day 150 assessment post 
randomization will be considered to have an EFS event.  For such subjects, the EFS time will 
be defined as the time from randomization to the first time SD was established up to and 
including the Day 150 disease assessment 
The following criteria will be used to further define censoring times:

Subjects alive, in response, and with no new therapy will be censored at the last evaluable 
disease assessment

Subjects with no evaluable disease assessment by Day 150 assessment post randomization 
will not be considered to have an EFS event, and the EFS time will be censored at the 
randomization date

The EFS time for subjects in the axicabtagene ciloleucel arm who undergo ASCT in the 
absence of any documented progression or new therapy will be censored on the day of ASCT

For subjects in the SOC arm, TBI, HDT, and ASCT that occur while the subject is in 
response from protocol-specified induction therapy will not be considered an EFS event.  The 
EFS time for SOC arm subjects alive, progression-free, and with no new lymphoma therapy 
will be censored at the last evaluable disease assessment date

At the time of the interim analysis of EFS, subjects who have not had the opportunity to be 
followed to the Day 150 disease assessment and who do not have an EFS event will be 
censored at the last evaluable disease assessment prior to Day 150


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For the primary analysis of EFS, disease progression events and censoring times will be 
determined by blinded central review.  Events of new therapy and death will be based on the 
clinical trial database.    
A sensitivity analysis for EFS in which subjects in the axicabtagene ciloleucel arm who undergo 
ASCT while in an axicabtagene ciloleucel-induced response are imputed to have an EFS event at 
the time of ASCT will be performed.
Objective response rate (ORR):  ORR is defined as the incidence of either a CR or a PR by the 
Lugano Classification {Cheson 2014}.  All subjects who do not meet the criteria for an objective 
response by the analysis cutoff date will be considered non-responders.  

For the SOC arm, the derivation of the primary analysis of ORR will include all disease 
assessments until an EFS event, including any assessments obtained after SCT.  

For the axicabtagene ciloleucel arm, the derivation of the primary analysis of ORR will 
include disease assessments up to any new therapy (including ASCT)
For the primary analysis of ORR, disease responses will be determined by blinded central 
review.
Overall survival (OS): Overall survival is defined as the time from randomization to death from 
any cause.  Subjects who have not died by the analysis data cutoff date will have survival time 
censored at their last date known to be alive.  For subjects alive or dead after the data cutoff date, 
survival time will be censored at the data cutoff date.
Modified event-free survival (mEFS): mEFS is defined the same way as EFS, with the exception
that having SD as the best response by Day 150 assessment post randomization will not be 
considered as an event. mEFS will be analyzed per blinded central review and per investigator 
disease assessments.
Progression-free survival (PFS):  PFS is defined as the time from randomization to disease 
progression per Lugano Classification {Cheson 2014} as determined by investigator review or 
death from any cause.  Subjects alive and not meeting the criteria for progression at the analysis 
data cutoff date will have PFS time censored at the last evaluable disease assessment.  Subjects 
who receive subsequent new lymphoma therapy (with the exception of HDT, TBI for HDT, and 
SCT while in a protocol therapy-induced response) in the absence of documented disease 
progression will be censored at their last evaluable disease assessment date prior to the 
commencement of the subsequent new lymphoma therapy.  SCT that occurs while a subject is in 
response from a protocol therapy will not be considered a PFS event, and such subjects will be 
censored for PFS at the last evaluable disease assessment prior to the SCT for subjects in the 
axicabtagene ciloleucel arm and will be censored at the last evaluable disease assessment date 
(including assessments after SCT) for subjects in the SOC arm for the primary analysis of PFS.
Disease outcomes will be based on investigator assessment.  A sensitivity analysis for PFS in 
which subjects in the axicabtagene ciloleucel arm who undergo SCT while in an axicabtagene 
ciloleucel-induced response are imputed to have a PFS event at the time of ASCT.


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Duration of response (DOR):  DOR is derived only among subjects who experience an objective 
response per Lugano Classification {Cheson 2014} as determined by blinded central review and 
is defined as the time from first response to disease progression per the Lugano Classification or 
death from any cause.  Subjects not meeting the criteria for progression or death by the analysis 
data cutoff date will have DOR censored at their last evaluable disease assessment date.  Subjects 
who receive subsequent new lymphoma therapy (with the exception of HDT, TBI for HDT, and 
SCT while in a protocol therapy induced response) in the absence of documented progression 
will have DOR censored at the last evaluable disease assessment prior to the commencement of 
the new lymphoma therapy.  For the primary analysis of DOR, DOR will be censored at the last 
evaluable disease assessment date prior to the SCT for subjects undergoing SCT while in 
protocol therapy induced response in the axicabtagene ciloleucel arm, and will be censored at the 
last evaluable disease assessment date (including assessments after SCT) for subjects in the SOC 
arm. A sensitivity analysis for DOR in which subjects in the axicabtagene ciloleucel arm who 
undergo ASCT while in an axicabtagene ciloleucel-induced response are imputed to have an
event at the time of ASCT.
Time to next therapy: Time to next therapy is defined as the time from the randomization date to 
the start of the subsequent new lymphoma therapy or death from any cause.  Subjects who have 
not received subsequent new therapy and are still alive will be censored at the last contact date. 


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6.
ANALYSIS SUBSETS
The following analysis sets are defined.
6.1.
Full Analysis Set (FAS)
The FAS consists of all randomized subjects. The primary analysis of EFS, ORR, PFS, and OS 
will be conducted on the FAS.  The FAS will exclude some disease assessments as described in 
the definition of the endpoints for ORR.  Subjects will be analyzed based on randomized 
treatment arm.
6.2.
Safety Analysis Set
The safety analysis set is defined as the subset of all randomized subjects who receive at least 
1 dose of axicabtagene ciloleucel as protocol therapy or SOC chemotherapy as protocol therapy.  
Subjects will be analyzed by the protocol therapy received.
6.3.
Safety Analysis Set - ASCT
The safety analysis set ASCT is defined as the subset of subjects randomized to the SOC arm 
who undergo transplant as part of protocol therapy.  
6.4.
QoL Analysis Set 
The QoL analysis set is defined as the subset of subjects in the FAS who have a baseline and 
Day 150 post-randomization QoL assessment.
6.5.
Retreatment Analysis Sets
For any subjects in the axicabtagene ciloleucel arm who undergo retreatment, safety and efficacy 
will be examined in the set of subjects who receive any dose of axicabtagene ciloleucel as 
retreatment.  
6.6.
Subgroup Analysis Sets
Subgroup analyses of selected efficacy and safety endpoints may be performed for the baseline 
covariates defined in Section 4.2.  


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7.
INTERIM ANALYSIS AND EARLY STOPPING GUIDELINES  
7.1.
Safety Interim Analyses  
The DSMB will review safety data every 6 months from the time the first subject is randomized 
until the primary EFS analysis.  Additionally, the DSMB will review safety and efficacy data at 
the time of the planned interim EFS analysis.  The DSMB will also review SAE information and 
SUSARs on a regular basis throughout the study.  The sponsor may request additional reviews 
by the DSMB if safety concerns are identified.  The DSMB may meet more often as needed.
7.2.
Efficacy Interim Analyses
One interim analysis of EFS and 2 interim analyses of OS are planned.  The DSMB will review 
the interim analysis of EFS.
The interim EFS analysis is for futility and will occur when 135 EFS events have been observed.  
An O’Brien-Fleming spending function of the Lan-DeMets family will be used to allocate the 
type II error between the interim and primary analyses.  Under the null hypothesis, the 
probability of stopping for futility at this interim analysis is approximately 60%.  One hundred 
thirty-five (135) EFS events are anticipated to occur approximately 19 months after the first 
subject is randomized.
Conditional upon statistically significant tests of EFS and ORR at the primary EFS analysis, 
testing of OS will be performed.  A first interim analysis of OS will occur at the time of the 
primary EFS analysis and a second interim analysis when approximately 160 deaths have 
occurred or no later than 5 years after the first subject is randomized.  A spending function of the 
Rho family with parameter (rho  6) will be used to allocate the alpha between the interim 
analysis of OS and the primary analysis of OS with 0.1% and 0.4% at the first and second 
interim OS analyses respectively and 2% at the primary analysis of OS.   Approximately 110 and 
160 OS events are anticipated at the time of the first and second interim OS analyses,
respectively.
7.3.
Access to Aggregate and Subject-level Data and Individual Subject 
Treatment Assignments
This study is open label.  Subjects, the study sponsor, and investigators will be aware of subject 
treatment assignments.  Data handling procedures designed to maintain the trial credibility and 
validity in this study will be described in the Trial Integrity Document.
An independent statistician will perform the interim safety and efficacy analyses and provide 
these reports to the DSMB.  Members of the DSMB and independent statistician will not have 
any direct contact with study center personnel or subjects.  The DSMB will communicate 
recommendations to Kite in accordance with the DSMB charter.


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8.
DATA SCREENING AND ACCEPTANCE
8.1.
General Principles
The database will be subject to the edit checks outlined in the Data Management Plan and 
additional manual data reviews defined by the study team.  Data inconsistencies will be reviewed 
and resolved before the database snapshot for the primary analyses and the final database lock.  
For interim analyses, snapshots may include data that have not passed all data cleaning 
procedures at the time the data are extracted for snapshot.  
8.2.
Electronic Transfer and Archival of Data
The database for this study will be a Medidata RAVE system, managed and maintained by Kite 
or designee.  Raw data, study data tabulation model (SDTM) data, and analysis data model 
(ADaM) datasets will be generated by Kite or designee and will be archived for all planned 
analyses.  Any additional unplanned analyses that occur after the primary analyses and prior to 
the final analysis will also be archived.  Key data external to the clinical study database will be 
included in the relevant SDTM and ADaM modules when the external data are available.  
Data from the central pathology laboratory, the product characteristics central laboratory 
assessment of subject serum samples (CAR T-cell levels in the peripheral blood, antibody 
assays, replication-competent retrovirus [RCR] testing), and central radiology review will be 
generated from contract laboratories and Kite.  These data will be transferred to Kite and held in 
a peripheral directory and not built into the clinical trial database.  At the time these data are 
required for analyses, they may be merged with the SDTM and ADaM datasets.
8.3.
Handling of Missing and Incomplete Data
8.3.1.
Efficacy
The method for handling missing data is described in the definition for each efficacy endpoint.  
Every effort will be made to obtain complete dates for deaths.  In the event of a partial or missing 
death date and the corresponding censoring date for survival, the algorithm in Appendix 1 will be 
used.
8.3.2.
Safety
Partial AE start dates will be imputed.  If dates are missing or incomplete for AE start dates, the 
algorithm defined in Appendix 1 will be used.  Completely missing death dates or death dates 
with only year reported will not be imputed.  


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8.4.
Detection of Bias
A listing of subjects with important protocol deviations will be generated.  The deviations 
included in this list will include violations of eligibility criteria and use of exclusionary 
medication during the study.  Lack of protocol compliance will be evaluated by summarizing the 
subject incidence of important protocol deviations.  High rates of important protocol deviations 
may indicate bias.
Endpoints derived from investigator assessment of radiologic scans and disease assessments may 
be subject to assessment time bias due to unscheduled or off-schedule disease assessments per 
the protocol specified assessment times.  The frequency and timing of scheduled and 
unscheduled tumor assessments will be tabulated by treatment arm.  Sensitivity analyses will be 
conducted in which the time of detection of progressive disease is moved forward and backward 
to the closest scheduled assessment days.  
The concordance between investigator and central review of radiologic scans and disease 
assessments will be summarized.
8.5.
Outliers
Descriptive statistics will be used to identify potential outliers in any key variables analyzed.  
Suspected outliers will be included in all analyses unless there is sufficient scientific justification 
to exclude them.
8.6.
Distributional Characteristics
A Cox regression model stratified by the randomization stratification factors will be used as the 
primary method to obtain estimates of the EFS and OS treatment effect. This is a semi-
parametric model that assumes that the EFS hazards within each stratum for the 2 treatment 
groups are proportional over time. Section 9.5.1.1 provides details on the means by which this 
assumption will be assessed and the alternative analyses that may be performed if those 
assumptions are violated. 
A stratified CMH test will be used to compare the observed response rates between the treatment 
arms.  The CMH test produces valid results only if there is no substantial change in the 
magnitude and/or direction of the relationship between response and treatment arm across strata.  
To evaluate this assumption, the stratum-specific odds ratios describing the relationship between 
response and treatment arm study will be calculated along with exact 95% confidence intervals.  
The Breslow-Day test of the null hypothesis of homogeneity of the odds ratios across strata will 
be used.  
8.7.
Validation and Configuration Management
Programs for the development of the SDTM and ADaM datasets and the generation of the tables, 
figures, and listings will be developed and maintained. The software and version used to 
generate analyses will be indicated in the archived documentation.


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9.
STATISTICAL METHODS OF ANALYSIS
9.1.
General Principles
The goal of the primary statistical analysis of the study is to test the difference in EFS between 
subjects treated with axicabtagene ciloleucel and subjects treated with SOC with a stratified log 
rank test.  The primary analysis of EFS will be conducted when all subjects have had the 
opportunity to be followed for the Month 9 disease assessment, and approximately 250 EFS 
events have been observed.  The acceptable lower limit for the observed total EFS events is 225, 
which is to maintain the power for the primary analysis of EFS to within 5% of the targeted 90%.  
If more than 250 EFS events are observed at the time of the data cutoff for the primary analysis, 
all observed events will be used in the analysis.  At this time, the CSR will be written and will 
include results of the first interim analysis of OS. The study will continue to be conducted per 
the protocol, and the results of the second interim and primary analyses of OS will be written 
shortly after each analysis is completed. 
Significance levels will be 2-sided unless stated otherwise.  A 2-sided 95% confidence interval 
for the EFS treatment hazard ratio (axicabtagene ciloleucel relative to SOC) will be obtained 
from a Cox proportional hazards model stratified by the randomization stratification factors.  
Descriptive statistics including confidence intervals, if appropriate, will be calculated for the 
study endpoints. Kaplan-Meier (KM) estimates will be provided for time-to-event endpoints.
9.2.
Subject Accountability
The number of subjects screened, enrolled, leukapheresed, and treated with study therapy will be 
summarized.  The reasons for discontinuing treatment and the disease assessment and survival 
follow-up periods will be summarized.
Summaries of actual and potential follow-up time will be provided.
The number of subjects enrolled by country and site will be summarized.  
The number of subjects in each analysis set along with reasons for exclusion will be provided.
9.3.
Important Protocol Deviations
The clinical study team will define important protocol deviation categories and review all 
potential important protocol deviations at minimum, prior to the database snapshot for the 
primary efficacy analysis.  Important protocol deviations will be categorized by deviation type 
(eg, entry/eligibility, use of excluded medication).  The subject incidence of important protocol 
deviations will be summarized overall and by deviation category.


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9.4.
Demographic and Baseline Characteristics
Summary statistics and frequencies for the following demographic and baseline characteristics 
will be tabulated:

Geographic region (North America, Europe, Israel)

ECOG performance status at screening (0, 1)

Age at randomization (≥ 65, < 65)

Sex

Race/ethnicity

Response to first-line therapy (primary refractory, relapse ≤ 6 months of initiation of 
first-line therapy versus relapse > 6 and ≤ 12 months of initiating first-line therapy, or PD vs. 
SD vs. PR as best overall response)

Second-line age-adjusted IPI (0 to 1 versus 2 to 3) at time of screening

Disease type (DLBCL, TFL, etc.)

Molecular subgroup (germinal center B-cell like [GCB] vs. activated B-cell like [ABC], or 
GCB vs. non-GCB)

Double hit (C-MYC alterations and either BCL-2 or BCL-6 alterations) status by FISH

Triple hit (BCL-2, BCL-6, and C-MYC alterations) status by FISH
9.5.
Efficacy Analyses
Efficacy analyses will be conducted on the FAS analysis sets as described in Section 6.  For the 
primary analysis of EFS, ORR, and DOR, the blinded central assessment of disease status per 
Lugano Classification {Cheson 2014} will be used.  Sensitivity analyses will be conducted with 
disease assessments based on the investigator review per Lugano Classification {Cheson 2014}.  
For the primary analysis of efficacy, the IXRS values of response to first-line therapy and 
second-line age-adjusted IPI will be used.  Sensitivity analyses may be conducted with values 
collected in EDC.  Covariate levels that are sparse (ie, fewer than 30 events for time-to-event 
analyses or subjects for ORR analyses) may be collapsed for purposes of statistical modeling.  If 
this occurs, the strata for relapse ≤6 months of first-line therapy and relapse from 6 to 12 months 
of first-line therapy will be collapsed first.  


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For subjects retreated with axicabtagene ciloleucel, disease assessments obtained prior to 
retreatment, but not disease assessment obtained after retreatment, will be included in the 
primary summaries of objective response, best response, DOR, and PFS.  The subject’s overall 
survival time will be derived from the last date known alive regardless of retreatment or 
subsequent therapy.
9.5.1.
EFS
9.5.1.1.
Primary Analysis of EFS
The analysis of EFS will be conducted on the FAS.  
A stratified (randomization stratification factors) log-rank test will be used for the primary 
comparison of EFS.  
Additionally, stratified (randomization factor) Cox regression models will be used to provide the 
estimated EFS hazard ratio and 2-sided 95% confidence intervals for axicabtagene ciloleucel 
relative to SOC.  The median EFS time and event-free rates at 3-month intervals will be 
provided. The Breslow method and the Efron method will be used to handle the ties for the Cox 
regression models.
Non-proportionality among the treatment groups will be assessed by comparing the standardized 
martingale residuals over time to a normal distribution (SAS PHREG ASSESS option) {Lin 
1993}. This comparison will be performed at the 5% level. A plot of the standardized residuals 
over time will be provided. If the comparison of the standardized martingale residuals over time 
is significant, a piece-wise Cox model will be used for the analysis. For the stratified piece-wise 
Cox model, 2 or more equal length intervals of length 12 weeks will be considered {Collett 
2003}. This will include 1 scheduled tumor assessment in each interval. These models will 
allow estimation of the overall as well as within interval treatment hazard ratio. Additional 
sensitivity analyses may also be considered with alternative interval selection. The hazard ratio 
for relevant time point differences and intervals over which the proportional hazards assumption 
holds will be presented. The overall log hazard ratio will be calculated from the weighted 
average of the interval log hazard ratios. The weight for each interval log hazard ratio estimate 
will be inversely proportional to the variance of the interval log hazard ratio estimate. If there 
are intervals where one or more stratum is too sparse, the stratified piece-wise Cox model will be 
collapsed as specified for the primary analysis. 
KM curves will be presented, and KM estimates and 2-sided 95% confidence intervals will be 
calculated for event time quartiles, event-free rate at 3-month intervals, and for the difference in 
event-free rates between treatment arms at these times. The primary analysis of EFS will utilize 
the stratification factors as collected via IXRS; a sensitivity analysis will be performed that 
utilizes the stratification factors as collected on the CRF. In addition, the un-stratified analyses 
will be conducted for EFS as a sensitivity analysis.


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9.5.1.2.
Subgroup Analyses of EFS
The consistency of the treatment effect on the EFS hazard ratio for axicabtagene ciloleucel 
versus SOC will be examined by estimating Cox model hazard ratios within meaningful subsets 
defined by the baseline covariates in Section 4.2. Non-proportionality may be assessed as 
described in Section 9.5.1.1. A forest plot of the hazard ratios across subsets will be provided.
9.5.1.3.
Assessment Time Bias
Sensitivity analyses of EFS will be performed to assess ascertainment time bias in disease 
progression as follows:

Progression events that occur between scheduled assessments will be moved forward to the 
next scheduled assessment after the observed progression.

Progression events that occur between scheduled assessments will be moved backward to the 
last scheduled assessment prior to the progression.

EFS events that occur after more than one missed visit will be censored at the last evaluable 
disease assessment or visit prior to the observed progression.
9.5.1.4.
Additional Sensitivity Analyses of EFS
A sensitivity analysis for EFS in which subjects in the axicabtagene ciloleucel arm who undergo 
ASCT while in an axicabtagene ciloleucel-induced response are imputed to have an EFS event at 
the time of ASCT will be performed.
9.5.1.5.
Investigator Assessment
EFS based on investigator disease assessments will be analyzed with the same methods as EFS
per blinded central review.  The concordance of progression events and EFS time per the 
investigator and per blinded central review will be summarized.
The tables that define EFS and censoring rules for the primary efficacy analysis and planned 
sensitivity analyses are provided in Appendix 2.
9.5.2.
Analyses of Objective Response
9.5.2.1.
Primary Analysis of ORR
The analysis of ORR will be conducted on the FAS and will be based on central blinded disease 
assessments.  The subject incidence of objective response and best response will be summarized.  
An exact binomial 2-sided 95% confidence interval will be generated for the ORR and best 
response rates for each treatment arm.  Wilson’s score method with continuity correction will be 
used to calculate 95% confidence intervals for the difference in ORRs {Newcombe 1998}
between treatment arms.  


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Conditional upon demonstrating a statistically significant improvement in EFS, testing of ORR 
will be performed with a stratified (randomization factor) CMH test for the common odds ratio 
of response.  
9.5.2.2.
Subgroup Analyses of ORR
Odds ratios for ORR will be assessed in subgroups defined by covariates in Section 4.2.  A forest 
plot of response and CR rates by subgroups will be generated.
9.5.2.3.
Investigator Assessment of ORR
ORR based on investigator disease assessments will be analyzed with the same methods as ORR.  
The concordance of response per the investigator and per blinded central review will be 
summarized.
9.5.3.
Analyses of Overall Survival
The analysis of OS will be conducted on the FAS.  The analysis of OS will be as per the analysis 
of EFS, except that sensitivity analyses for assessment time bias will not apply.  
A stratified (randomization stratification factors) log-rank test will be used for the primary 
comparison of OS.  Additionally, stratified (randomization factor) Cox regression models will be 
used to provide the estimated OS hazard ratio and 2-sided 95% confidence intervals for 
axicabtagene ciloleucel relative to SOC.  The median OS time and event-free rates at 6-month 
intervals will be provided.
Sensitivity analyses of OS to address the confounding effect from treatment switching will be 
conducted using the Rank Preserving Structural Failure Time Model by {Robins 1991} with g-
estimation and with the iterative parameter estimation algorism, and Inverse Probability of 
Censoring Weights, and 2-stage cox regression model, and other exploratory treatment switching 
adjustment methods.
OS hazard ratios will be assessed in subgroups defined by covariates in Section 4.2.
9.5.4.
Analyses of Progression-free Survival, Duration of Response, and Time to 
Next Therapy
The analysis of PFS, DOR, and time to next therapy will be performed using the same methods 
as the analysis of EFS, with p-values from the log-rank test descriptive.
The analysis of PFS will be performed on the FAS.  The analysis of DOR will be conducted on 
the FAS, with the exceptions noted in the definition of DOR.


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9.6.
Safety Analyses  
Among subjects in the safety analysis set, all AEs will be reported from randomization up 
through the Day 150 post-randomization visit or change in lymphoma therapy, whichever occurs 
first.  After the Day 150 visit, only targeted SAEs will be reported up to 5 or 15 years for SOC or 
axicabtagene ciloleucel arms, respectively, or until disease progression, whichever occurs first.  
Safety analyses will be conducted on the safety analysis set.  The primary analysis of safety data 
will summarize all TEAEs and laboratory values.    
AEs will be coded with the MedDRA at the time of each analysis.  The version of the MedDRA 
may vary over time because the current version in use is updated.  The severity of AEs will be 
graded using the National Cancer Institute (NCI) CTCAE version 4.03 or above.  CRS will be 
graded using a modified CRS grading scale developed by Lee et al {Lee 2014}.  The incidence 
and severity of CRS will be reported as a syndrome with severity per Lee et al.  Individual 
symptoms associated with CRS will be graded per CTCAE version 4.03 or above.
AEs and deaths due to disease progression will be denoted as such on CRFs.
Subjects enrolled, but not dosed with study therapy, will be followed for AEs for 30 days after 
the last study procedure.  AEs reported in these subjects will be archived in the study database 
and available in SDTM and ADaM datasets, but will not be tabulated in AE summaries.
9.6.1.
Adverse Events
A summary of the subject incidence of key AEs (any, worst severity, serious, related, CRS, NE) 
will be provided.
The subject incidence of the following AEs, serious AEs, and Grade 3 or higher AEs will be 
tabulated for:

All TEAEs

All AEs related to conditioning chemotherapy (for axicabtagene ciloleucel arm only)

All TEAEs related to axicabtagene ciloleucel (for axicabtagene ciloleucel arm only)

All SOC chemotherapy-related TEAEs (for SOC arm only)

All ASCT-related TEAEs (for SOC arm only)

Fatal TEAEs

TEAEs of interest, including identified and potential risks
Summary statistics for the onset time, duration, and resolution of TEAEs of interest will be 
provided.


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The subject incidence of deaths will be provided.
A subject listing of deaths and SAEs (including narratives) will be provided.
Subgroup analyses of TEAEs may be generated for the covariates listed in Section 4.2.  
Besides TEAEs, the subject incidence of the following AEs by PT and severity will also be 
tabulated: 

AEs related to leukapheresis (for axicabtagene ciloleucel arm only)
9.6.2.
Laboratory Test Results
Laboratory results will be graded according to NCI CTCAE version 4.03 or above.  Laboratory 
data collected at baseline and throughout the axicabtagene ciloleucel treatment period or SOC 
and HDT therapy period will be summarized. Change from baseline to each visit at post-baseline 
will be presented for select analytes. The incidence of worst CTCAE grade post Treatment Day 0 
by grade for all analytes will be provided. Additional laboratory tables for subjects who had 
worsening grade change from the last assessment prior to Treatment Day 0 to post Treatment 
Day 0 may be generated by the worst post-Treatment Day 0 CTCAE grade. 
9.6.3.
Anti-Axicabtagene Ciloleucel Antibodies
The subject incidence of any anti-axicabtagene ciloleucel antibodies will be tabulated. For 
subjects testing positive for antibodies, the persistence of the antibody over time will be 
summarized.
9.6.4.
Replication Competent Retrovirus (RCR)
The subject incidence of RCR detected in blood samples will be tabulated overall and by 
assessment time. The persistence of RCR over time will be summarized.
9.6.5.
Exposure to Study Treatment and Product Characteristics
Summary statistics and subject listings will be provided for the following:

Total bovine serum albumin (BSA)-adjusted dose of cyclophosphamide

Total BSA-adjusted dose of fludarabine

Total dose of SOC chemotherapy

Total dose of HDT for ASCT

Weight-adjusted dose of axicabtagene ciloleucel


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
Number and percentage of subjects who received a dose of axicabtagene ciloleucel 
within +/- 10% of the planned dose

Total CAR T cells of the axicabtagene ciloleucel infusion

Total T cells of the axicabtagene ciloleucel infusion

Transduction ratio

Percentages of CD4 and CD8 T cells

Percentages of T-cell memory phenotypes
The analysis by patient demographics (age, sex, etc.) as well as by tumor burden may be 
provided. 
Separate summaries will be presented for the second administration of axicabtagene ciloleucel 
for subjects in the safety retreatment analysis set.
9.6.6.
Exposure to Concomitant Medications and Procedures  
The subject incidence of concomitant medications will be provided and summarized by 
medication category (general, steroids, tocilizumab, vasopressors, nonsteroidal 
immunosuppressive agents, and immunoglobins) and WHO Drug coded term. 
9.7.
Health-related Quality of Life
Changes in EORTC QLQ-C30 domains from screening to the Day 150 post-randomization visit 
will be summarized with descriptive statistics.
Changes in the EQ-5D-5L index and VAS scores from screening to the Day 150 post-
randomization visit will be summarized with descriptive statistics.
Further model-based analyses of these endpoints will be described in a supplemental statistical 
analysis plan.
9.8.
Subsequent Lymphoma Therapy
The incidence and type (by WHO Drug coded term and categories) of subsequent lymphoma 
therapy and non-protocol-specified SCT (autologous, allogeneic) will be summarized.




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10.
CHANGES FROM PROTOCOL-SPECIFIED ANALYSES
No changes to protocol-specified analyses have been made.


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11.
REFERENCES
Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, et al. 
Recommendations for initial evaluation, staging, and response assessment of 
Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol 
2014;32 (27):3059-68.
Collett D. Modelling Survival Data in Medical Research. 2nd ed. London, UK: Chapman & 
Hall/CRC; 2003. 
Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, et al. Randomized 
comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, 
cytarabine, and cisplatin chemotherapy before autologous stem-cell 
transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG 
LY.12. J Clin Oncol 2014;32 (31):3490-6.
Gisselbrecht C, Glass B, Mounier N, Singh Gill D, Linch DC, Trneny M, et al. Salvage regimens 
with autologous transplantation for relapsed large B-cell lymphoma in the 
rituximab era. J Clin Oncol 2010;28 (27):4184-90.
Gisselbrecht C, Schmitz N, Mounier N, Singh Gill D, Linch DC, Trneny M, et al. Rituximab 
maintenance therapy after autologous stem-cell transplantation in patients with 
relapsed CD20(+) diffuse large B-cell lymphoma: final analysis of the 
collaborative trial in relapsed aggressive lymphoma. J Clin Oncol 2012;30 
(36):4462-9.
Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, et al. Current concepts in the 
diagnosis and management of cytokine release syndrome. Blood 2014;124 
(2):188-95.
Lin DY, Wei LJ, Ying Z. Checking the Cox Model with Cumulative Sums of Martingale-Based 
Residuals. Biometrika 1993;80 (3):557-72.
Newcombe RG. Interval estimation for the difference between independent proportions: 
comparison of eleven methods. Stat Med 1998;17 (8):873-90.
Robins JM, Tsiatis AA. Correcting for Non-Compliance in Randomized Trials Using Rank 
Preserving Structural Failure Time Models. Commun Statist Theroy Meth 
1991;20 (8):2609-31.
Topp MS, Gokbuget N, Stein AS, Zugmaier G, O'Brien S, Bargou RC, et al. Safety and activity 
of blinatumomab for adult patients with relapsed or refractory B-precursor acute 
lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol 
2015;16 (1):57-66.


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Van Den Neste E, Schmitz N, Mounier N, Gill D, Linch D, Trneny M, et al. Outcome of patients 
with relapsed diffuse large B-cell lymphoma who fail second-line salvage 
regimens in the International CORAL study. Bone Marrow Transplant 2016;51 
(1):51-7.
van Imhoff GW, McMillan A, Matasar MJ, Radford J, Ardeshna KM, Kuliczkowski K, et al. 
Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy in Relapsed or 
Refractory Diffuse Large B-Cell Lymphoma: The ORCHARRD Study. J Clin 
Oncol 2017;35 (5):544-51.


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12.
APPENDICES
Appendix 1.
Conventions for Clinical Data That Require Imputation for Partial or Missing Dates
Appendix 2.
Planned Event and Censoring Rules for the EFS analysis
Appendix 3.
Derivation of Last Date Known to Be Alive


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Appendix 1.
Conventions for Clinical Data That Require Imputation for Partial or 
Missing Dates
The following data will be imputed using the following algorithm (refer to Table 1):

AE start dates

Deaths (see exceptions below)

Concomitant medications start dates

Subsequent new lymphoma therapy start dates
Table 1.
Imputation Rules for Partial or Missing Start Dates
Start Date
Stop Date
Complete  yyyymmdd
Partial
yyyymm
Partial
yyyy
Missing
< 
Treatment 
Day 0 
≥ 
Treatment 
Day 0 
< 
Treatment 
Day 0 
yyyymm
≥ 
Treatment 
Day 0 
yyyymm
< 
Treatment 
Day 0 
yyyy
≥ 
Treatment 
Day 0 
yyyy
Partial
yyyymm
 
Treatment 
Day 0 
yyyymm
2
1
2
1
n/a
1
1
≠ 
Treatment 
Day 0 
yyyymm
2
2
2
2
2
Partial
yyyy
Treatment 
Day 0 
yyyy
3
1
3
1
n/a
1
1
≠ Treatment 
Day 0 
yyyy
3
3
3
3
3
Missing
4
1
4
1
4
1
1
1  impute the date of Treatment Day 0 
2  impute the first of the month
3  impute January 1 of the year
4  impute January 1 of the stop year
Note:  If the start date imputation leads to a start date that is after the stop date, then do not impute the start date.
Imputation rules for partial or missing death dates:


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
If death year and month are available, but day is missing:
If mmyyyy for the last contact date  mmyyyy for death date, set death date to the day 
after the last date known to be alive.
If mmyyyy for the last date known to be alive < mmyyyy for death date, set death date to 
the first day of the death month.
If mmyyyy for last date known to be alive > mmyyyy for death date, data error, and do 
not impute.

If both month and day are missing for death date or a death date is completely missing, do 
not impute, and censor the subject survival time at the last date known to be alive.


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Appendix 2.
Planned Event and Censoring Rules for the EFS analysis
Table 2.
Primary Analysis of EFS
Circumstance
Treatment Arm
Event / Censored
Date of Event / Censoring
Disease progression at 
planned disease assessment, 
prior to initiation of NALT or 
ASCT
Both
Event
Progression date
Disease progression in 
between planned disease 
assessments, prior to NALT
or ASCT
Both
Event
Progression date
Subject with PR or CR and 
subsequently received NALT 
in the absence of disease 
progression
Both
Event
Last evaluable disease assessment 
date prior to NALT
Subject with best response of 
SD and subsequently 
received NALT in the 
absence of disease 
progression
Both
Event
Date of the first time SD was 
established prior to NALT
NALT in the absence of any 
evaluable disease assessment
Both
Event
Randomization date
Subject with best response of 
SD by Day 150 assessment 
post randomization in the 
absence of documented 
progression or death or 
NALT
Both
Event
Date of the first time SD was 
established up to and including Day 
150 assessment 
ASCT while in an 
axicabtagene ciloleucel 
induced response 
Axicabtagene 
ciloleucel
Censored
ASCT Date
Remain event free after 
ASCT
SOC
Censored
Last evaluable disease assessment 
date
Remain event free without 
ASCT
Both
Censored
Last evaluable disease assessment 
date
Disease progression or death 
after ASCT 
SOC
Event
Death or PD Date
Death without documented 
prior event
Both
Event
Death Date
Withdrawal of consent or lost 
to follow up prior to 
documented event
Both
Censored
Date of last evaluable disease 
assessment prior to data cutoff for 
analysis
Note: NALT  next anti lymphoma therapy, it is defined the same as subsequent new lymphoma therapy
Note: For subjects without any evaluable disease assessment and any EFS event at the time of analysis, their EFS will be 
censored at the date of the randomization. Day 150 disease assessment includes any disease assessment up through the protocol 
specified window (+/ 14 days; up through Day 164).


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Table 3.
(Sensitivity Analysis 1):  progression events that occur in between 
scheduled assessments will be moved forward to the next scheduled 
assessment after the observed progression
Circumstance
Treatment Arm
Event / Censored
Date of Event / Censoring
Disease progression in 
between planned disease 
assessments, prior to NALT 
or ASCT
Both
Event
First scheduled assessment 
after the observed 
progression
For all other circumstances, follow the same derivation rule as the primary analysis of EFS.
Table 4.
(Sensitivity analysis 2):  progression events that occur in between 
scheduled assessments will be moved backward to the last scheduled 
assessment prior to progression
Circumstance
Treatment Arm
Event / Censored
Date of Event / Censoring
Disease progression in 
between planned disease 
assessments, prior to NALT 
or ASCT
Both
Event
Last scheduled assessment 
prior to the observed 
progression
For all other circumstances, follow the same derivation rule as the primary analysis of EFS.
Table 5.
(Sensitivity analysis 3):  EFS events that occur after more than one 
missed disease assessment visit will be censored at the last evaluable 
disease assessment prior to the observed progression
Circumstance
Treatment Arm
Event / Censored
Date of Event / Censoring
Disease progression at 
planned disease assessment, 
prior to initiation of NALT 
or ASCT
Both
Event*
Progression date**
Disease progression in 
between planned disease 
assessments, prior to NALT 
or ASCT
Both
Event*
Progression date**
Subject with PR or CR and 
subsequently received 
NALT in the absence of 
disease progression
Both
Event*
Last evaluable disease 
assessment date prior to 
NALT **
Subject with best response 
of SD and subsequently 
received NALT in the 
absence of disease 
progression
Both
Event
Date of the first time SD 
was established prior to 
NALT


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Circumstance
Treatment Arm
Event / Censored
Date of Event / Censoring
NALT in the absence of any 
evaluable disease 
assessment
Both
Event
Randomization date
Subject with best response 
of SD by Day 150 
assessment post 
randomization in the 
absence of documented 
progression or death or 
NALT
Both
Event
Date of the first time SD 
was established up to and 
including Day 150 
assessment 
ASCT while in an 
axicabtagene-ciloleucel 
induced response 
Axicabtagene 
ciloleucel
Censored
ASCT Date
Remain event-free after 
ASCT 
SOC
Censored
Last evaluable disease 
assessment date
Remain event-free without 
ASCT
Both
Censored
Last evaluable disease 
assessment date
Disease progression or 
death after ASCT 
SOC
Event*
Death or PD Date**
Death without documented 
prior event
Both
Event*
Death Date***
Withdrawal of consent or 
lost to follow-up prior to 
documented event
Both
Censored
Date of last evaluable 
disease assessment prior to 
data cutoff for analysis
Note: NALT  next anti lymphoma therapy, it is defined the same as subsequent new lymphoma therapy
Note: For subjects without evaluable disease assessment or any EFS event at the time of analysis, their EFS will be censored at 
the date of the randomization. Day 150 disease assessment includes any disease assessment up through the protocol specified 
window (+/ 14 days; up through Day 164).
* if the progression, NALT, or death occurs after more than one missed disease assessment, this will be censored.
** if the progression, NALT, or death occurs after more than one missed disease assessment, the censor time will be at the last 
evaluable disease assessment prior to the observed progression, NALT, or death.
Table 6.
(Sensitivity Analysis 4):  subjects in the axicabtagene ciloleucel arm 
who undergo ASCT while in axicabtagene induced response are 
imputed to have an EFS event at the time of ASCT
Circumstance
Treatment Arm
Event / Censored
Date of Event / Censoring
ASCT while in an 
axicabtagene-ciloleucel 
induced response 
Axicabtagene 
ciloleucel
Event
ASCT Date
For all other circumstances, follow the same derivation rule as the primary analysis of EFS.


Axicabtagene ciloleucel: KTE-C19
Kite Pharma, Inc.
Statistical Analysis Plan
KTE-C19-107 (ZUMA-7) Study
CONFIDENTIAL
Page 48
15 June 2020
Appendix 3.
Derivation of Last Date Known to Be Alive
The last date known to be alive will be derived by obtaining the maximum complete date among 
the following data modules:

Start date and stop date of AE (including targeted AE)

Start date and stop date of concomitant medication

Start date and stop date of subsequent new lymphoma therapy

Subsequent SCT date

Leukapheresis dates

Conditioning chemotherapy administration dates

SOC therapy administration dates

HDT administration dates

Axicabtagene ciloleucel infusion dates (including retreatment)

SCT dates

Computed tomography (CT) scan dates

Positron emission tomography (PET) scan dates

Clinical symptoms of lymphoma assessment dates

Target lesion assessment

Non-target lesion assessment

New lesion assessment

Disease response assessment

Long-term follow-up subject status date where status  ”alive”

End of treatment disposition where status is not equal to death, lost to follow-up

End of post-treatment assessment period where status is not equal to death, lost to follow-up

End of study data where end of study reason is not equal to death, lost to follow-up