A Phase 1/2 Multi-center Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Subjects With Relapsed/Refractory Large B-Cell Lymphoma
Phase: PHASE1
Conditions: Relapsed/Refractory Large B-cell Lymphoma
Sponsor: Kite, A Gilead Company



A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2
0 7 J u ne 2 0 2 2
P R O T O C O L S Y N O P SI S
Title:
A P hase 1/ 2 M ultice nter 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 C o m bi nati o n wit h Ut o mil u ma b i n 
S u bjects wit h Rela pse d/ Refract or y Lar ge B-cell L y m p h o ma
I n dic ati o n:
F or t he treat me nt of a d ult s u bjects wit h rela pse d/refract or y lar ge 
B-cell l y m p h o ma
St u d y Desi g n: 
T his is a P hase 1/ 2, o pe n-la bel, m ultice nter 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 c o m bi nati o n wit h 
ut o mil u ma b a d mi nistrati o n i n s u bjects wit h rela pse d/refract or y lar ge 
B-cell l y m p h o ma. T he trial will be se parate d i nt o 2 disti nct p hases 
desi g nate d as P hase 1 a n d P hase 2.
D uri n g P hase 1, u p t o 3 6 s u bjects wit h refract or y lar ge B-cell 
l y m p h o ma will be e nr olle d i n a 3 + 3 desi g n i n u p t o 6 of 1 0 p ossi ble 
c o h orts t o e val uate t he safet y of a xica bta ge ne cil ole ucel a n d 
ut o mil u ma b c o m bi nati o n re gi me ns. A xica bta ge ne cil ole ucel will be 
a d mi nistere d as a si n gle d ose, a n d ut o mil u ma b will be a d mi nistere d 
at escalati n g d oses.  S u bjects will be e nr olle d a n d treate d o ne at a 
ti me d uri n g t he P hase 1 p orti o n of t he st u d y. S u bject treat me nt wit h 
a xica bta ge ne cil ole ucel will be sta g gere d b y at least 2 wee ks. T he 
P hase 1 c o h orts a n d ut o mil u ma b re gi me ns a d mi nistere d are o utli ne d 
i n t he f oll o wi n g ta ble.
D ose Le vel *
C o h ort
First Ut o mil u m a b 
A d mi nistr ati o n
1
Da y 1
1 0 m g
1 A
Da y 2 1
2
Da y 1
3 0 m g
2 A
Da y 2 1
3
Da y 1
1 0 0 m g
3 A
Da y 2 1
4
Da y 1
2 0 0 m g
4 A
Da y 2 1
5
Da y 1
4 0 0 m g
5 A
Da y 2 1
* Ut o mil u ma b d oses re prese nt t otal d oses ( 1 0 m g, 3 0 m g, 1 0 0 m g, 2 0 0 m g, a n d 4 0 0 m g) 
a n d will be a d mi nistere d Q 4 W f or 6 m o nt hs or u ntil pr o gressi ve disease ( P D), w hic he ver 
c o mes first.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3
0 7 J u ne 2 0 2 2
A safet y re vie w tea m ( S R T) t hat is i nter nal t o t he st u d y s p o ns or a n d 
at least o ne P hase 1 i n vesti gat or will re vie w safet y data after all 
s u bjects i n eac h P hase 1 c o h ort ha ve ha d t he o p p ort u nit y t o 
c o m plete t he d ose-li miti n g t o xicities ( D L T) wi n d o w. T he S R T will 
ma ke rec o m me n dati o ns o n f urt her st u d y c o n d uct of P hase 1 a n d 
pr o gressi o n t o P hase 2 as de picte d i n Fi g ure 5  a n d o utli ne d i n 
Secti o n 9. 1 0 .
I n P hase 2, a p pr o xi matel y 2 4 s u bjects will be e nr olle d t o recei ve 
treat me nt wit h a xica bta ge ne cil ole ucel a n d ut o mil u ma b base d o n t he 
d ose/re gi me n selecte d t o m o ve f or war d fr o m t he P hase 1 p orti o n of 
t he st u d y as rec o m me n de d b y t he S R T. 
I n de pe n de nt of t he c o h ort or p hase of t he st u d y, eac h s u bject will 
pr ocee d t hr o u g h t he f oll o wi n g st u d y peri o ds: 

Scree ni n g

E nr oll me nt/ Le u ka p heresis 

Bri d gi n g t hera p y; if a p plica ble 

C o n diti o ni n g c he m ot hera p y 

I n vesti gati o nal pr o d uct treat me nt (a xica bta ge ne cil ole ucel a n d 
ut o mil u ma b)

P ost-treat me nt assess me nt

L o n g-ter m f oll o w- u p ( L T F U)
F or st u d y re q uire me nt details assi g ne d t o eac h st u d y peri o d, refer t o 
t he sc he d ule of assess me nts ( S O As) a n d Secti o n 7 .
A st u d y sc he ma is pr o vi de d i n Fi g ure 1 .
St u d y O bjecti ves: 
Pri mar y o bjecti ve:

T he pri mar y o bjecti ve of P hase 1 is t o e val uate t he safet y of 
a xica bta ge ne cil ole ucel i n c o m bi nati o n wit h ut o mil u ma b a n d t o 
i de ntif y t he m ost a p pr o priate d ose a n d ti mi n g of ut o mil u ma b t o 
carr y f or war d i nt o P hase 2.

T he pri mar y o bjecti ve of P hase 2 is t o e val uate t he efficac y of 
a xica bta ge ne cil ole ucel a n d ut o mil u ma b, as meas ure d b y 
c o m plete res p o nse ( C R) rate, i n s u bjects wit h rela pse d/refract or y 
lar ge B-cell l y m p h o ma.
Sec o n dar y o bjecti ves:

Sec o n dar y o bjecti ves f or P hase 1 a n d P hase 2 will i ncl u de 
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 ut o mil u ma b, a d diti o nal efficac y e n d p oi nts, a n d le vels of 
a xica bta ge ne cil ole ucel i n bl o o d ( p har mac o ki netics [ P K]) a n d 
le vels of c yt o ki nes i n ser u m.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4
0 7 J u ne 2 0 2 2
H y p ot hesis:
N o f or mal h y p ot hesis will be teste d i n t he st u d y. T he P hase 2 
p orti o n of t he st u d y is desi g ne d t o esti mate t he tr ue C R rate i n 
s u bjects wit h rela pse d/refract or y lar ge B-cell l y m p h o ma treate d wit h 
a xica bta ge ne cil ole ucel f oll o we d b y ut o mil u ma b.
Pri m ar y E n d p oi nts:

P hase 1: I nci de nce of a d verse e ve nts defi ne d as D L Ts

P hase 2: C o m plete res p o nse rate per t he L u ga n o Classificati o n 
{ C hes o n 2 0 1 4 }, (refer t o A p pe n di x 2 ), as deter mi ne d b y st u d y 
i n vesti gat ors
Sec o n d ar y 
E n d p oi nt(s):
P hase 1 a n d P hase 2:

O bjecti ve res p o nse rate ( C R + partial res p o nse [ P R]) per t he 
L u ga n o Classificati o n { C hes o n 2 0 1 4 }, as deter m i ne d b y st u d y 
i n vesti gat ors

D urati o n of res p o nse 

Pr o gressi o n-free S ur vi val per t he L u ga n o Classificati o n { C hes o n 
2 0 1 4 }, as deter m i ne d b y st u d y i n vesti gat ors 

O verall s ur vi val ( O S)

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 

P K: Le vels of a xica bta ge ne cil ole ucel i n bl o o d  

P har mac o d y na mics: Le vels of c yt o ki nes i n ser u m  
S a m ple Size: 
A p pr o xi matel y 3 t o 6 0 s u bjects
P hase 1: a p pr o xi matel y 3 t o 3 6 s u bjects 
P hase 2: a p pr o xi matel y 2 4 s u bjects 
St u d y Eli gi bilit y: 
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:
C o n diti o ni n g c he m ot hera p y treat me nt: 

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 5 0 0 m g/ m 2/ da y a n d fl u dara bi ne 
3 0 m g/ m 2/ da y will be a d mi nistere d x 3 da ys pri or t o 
a xica bta ge ne cil ole ucel i nf usi o n. Refer t o Secti o n 6  f or 
c he m ot hera p y treat me nt details.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5
0 7 J u ne 2 0 2 2
Bri d gi n g t hera p y peri o d, if a p plica ble:

N o n-c he m ot hera p y bri d gi n g t hera p y will be a d mi nistere d at t he 
discreti o n of t he i n vesti gat or.  F or s u bjects recei vi n g bri d gi n g 
t hera p y, refer t o Secti o n 6  f or bri d gi n g t hera p y details.
I n vesti gati o nal pr o d uct(s):

A xica bta ge ne cil ole ucel treat me nt c o nsists of a si n gle i nf usi o n of 
c hi meric a nti ge n rece pt or (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.  Refer t o Secti o n 6  a n d Sectio n 7. 8  f or 
treat me nt details. 

Ut o mil u ma b treat me nt c o nsists of a n i ntra ve n o us i nf usi o n 
starte d o n eit her st u d y Da y 1 or st u d y Da y 2 1 a n d c o nti n ui n g 
Q 4 W f or 6 m o nt hs or u ntil P D, w hic he ver c o mes first. I n t he 
P hase 1 p orti o n of t he st u d y, t he d oses of ut o mil u ma b 
a d mi nistere d will be 1 0 m g, 3 0 m g, 1 0 0 m g, 2 0 0 m g, a n d 
4 0 0 m g. 
A d diti o nal a xica bta ge ne cil ole ucel a n d ut o mil u ma b re gi me ns ma y 
be e x pl ore d i n P hase 1 at t he rec o m me n dati o n of t he S R T. 
T he a xica bta ge ne cil ole ucel a n d ut o mil u ma b treat me nt i n P hase 2 
will f oll o w t he d osi n g re gi me n wit h t he best o verall be nefit/ris k 
pr ofile teste d i n P hase 1 as deter mi ne d b y t he safet y re vie w tea m 
(see Fi g ure 5 ). 
S u bjects w h o recei ve a xica bta ge ne cil ole ucel treat me nt, w hic h 
c o nsists of 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 o n Da y 0 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 ( ma xi m u m 2 x 1 0 8 a nti- C D 1 9 C A R T 
cells) a n d at least o ne d ose of ut o mil u ma b, will be c o nsi dere d 
e val ua ble i n t he efficac y set.
Pr oce d ures:
As o utli ne d i n t he sc he d ule of assess me nts ( 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 
a n d me dical hist or y, i ncl u di n g 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.
S u bjects will als o u n der g o bl o o d dra ws f or t he f oll o wi n g:

L ocal e val uati o n: c o m plete bl o o d c o u nt ( C B C), c he mistr y 
pa nels, C-reacti ve pr otei n, a n d pre g na nc y test (if a p plica ble).

Ce ntral e val uati o n: C B C wit h differe ntial, P K assess me nts 
( ut o mil u ma b a n d a xica bta ge ne cil ole ucel), p har mac o d y na mic 
assess me nt (c yt o ki nes), ut o mil u ma b a nti- dr u g a nti b o dies 
( A D A), re plicati o n-c o m pete nt retr o vir us ( R C R), a n d l y m p h oc yte 
s u bsets ( B-cell rec o ver y).  

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7
0 7 J u ne 2 0 2 2
Fi g ure 1.
St u d y Sc he m a ( P h ase 1 a n d P h ase 2)
1   
N o n-c he m ot hera p y bri d gi n g t hera p y will be a d mi nistere d at t he discreti o n of t he i n vesti gat or.  F or s u bjects recei vi n g bri d gi n g t hera p y, refer t o Secti o n 6. 1. 2  f or 
bri d gi n g t hera p y details.
2   
A xica bta ge ne cil ole ucel is a d mi nistere d after 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 5 0 0 m g/ m 2/ da y a n d fl u dara bi ne 3 0 m g/ m2/ da y, 
a d mi nistere d x 3 da ys.  Refer t o Secti o n 6  f or c he m othera p y treat me nt details.
3   
A xica bta ge ne cil ole ucel treat me nt c o nsists of 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 o n Da y 0 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 ( ma xi m u m 2 x 1 0 8 a nti- C D 1 9 C A R T cells). 
4   
Ut o mil u ma b treat me nt c o nsists of a n i ntra ve n o us i nf usi o n starte d o n Da y 1 or Da y 2 1 a n d c o nti n ui n g Q 4 wee ks f or 6 m o nt hs or u ntil P D, w hic he ver c o mes first.   T he 
S R T will ma ke rec o m me n dati o ns o n f urt her st u d y c o n d uct of P hase 1.  A d diti o nal a xica bta ge ne cil ole ucel a n d ut o mil u ma b re gi me ns ma y be e x pl ore d i n P hase 1. 
5   
After t he e n d of K T E- C 1 9- 1 1 1, s u bjects w h o recei ve d a n i nf usi o n of a xica bta ge ne cil ole ucel a n d ut o mil u ma b 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 o n g-ter m F oll o w- u p st u d y, K T- U S- 9 8 2- 5 9 6 8.
Ut o mil u ma b treat me nt i n P hase 2 will f oll o w t he d osi n g re gi me n fr o m P hase 1 a gree d u p o n b y t he st u d y s p o ns ors a n d t he S R T.
A b bre viati o ns: I P, i n vesti gati o nal pr o d uct.
Scree ni n g
E nr oll me nt/ Le u ka p heresis
C o n diti o ni n g C he m ot hera p y 2
I P A d mi nistrati o n Peri o d 
I P Treat me nt Peri o d 
A xica bta ge ne Cil ole ucel 
Treat me nt 3
( Da y 0)
S u bjects will recei ve 
a xica bta ge ne cil ole ucel i n 
a healt hcare 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. 
I P Treat me nt Peri o d 
Ut o mil u ma b Treat me nt 4
( Da y 1 or Da y 2 1, Q 4 Wee ks)
P hase 1: Ut o mil u ma b will be 
a d mi nistere d i n u p t o 6 of 1 0 
c o h orts t o i de ntif y best d ose 
f or P hase 2
P hase 2: Ut o mil u ma b will be 
a d mi nistere d acc or di n g t o 
res ults of P hase 1 
P ost-treat me nt Assess me nt 
L o n g-ter m F oll o w- u p Peri o d 5
Bri d gi n g T hera p y (if a p plica ble) 1
 
 
 
 
 
 
 

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8
0 7 J u ne 2 0 2 2
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
T A B L E O F C O N T E N T S................................................................................................................................................ 8
LI S T O F T A B L E S........................................................................................................................................................ 1 0
LI S T O F FI G U R E S ...................................................................................................................................................... 1 0
LI S T O F A B B R E VI A TI O N S....................................................................................................................................... 1 1
1.   
O BJ E C TI V E S....................................................................................................................................................... 1 4
1. 1.  
Pri mar y O bjecti ve.................................................................................................................................... 1 4
1. 2.  
Sec o n dar y O bjecti ve(s) ........................................................................................................................... 1 4
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 5
2. 1.   
Disease Bac k gr o u n d................................................................................................................................ 1 5
2. 2.   
A xica bta ge ne Cil ole ucel.......................................................................................................................... 1 5
2. 3.  
Pri or A nti- C D 1 9 C A R T-cell St u d y Desi g n............................................................................................ 1 6
2. 4.   
Ut o mil u ma b............................................................................................................................................. 1 6
2. 4. 1.  
S u m mar y of Cli nical St u dies f or Ut o mil u ma b...................................................................... 1 7
2. 5.  
Rati o nale f or C o m bi nati o n T hera p y........................................................................................................ 1 8
3.  
S T U D Y D E SI G N................................................................................................................................................. 2 2
3. 1.   
Ge neral St u d y Desi g n.............................................................................................................................. 2 2
3. 2.   
D osi n g Rati o nale..................................................................................................................................... 2 4
3. 2. 1.  
Rati o nale f or C o n diti o ni n g C he m ot hera p y ........................................................................... 2 4
3. 2. 2.  
Rati o nale f or A xica bta ge ne Cil ole ucel D ose ........................................................................ 2 5
3. 2. 3.  
Rati o nale f or Ut o mil u ma b D ose............................................................................................ 2 5
3. 3.  
Partici pati n g Sites.................................................................................................................................... 2 6
3. 4.   
N u m ber of S u bjects................................................................................................................................. 2 6
3. 5.  
Re place me nt of S u bjects ......................................................................................................................... 2 7
3. 6.  
St u d y D urati o n......................................................................................................................................... 2 7
3. 6. 1.  
St u d y D urati o n f or I n di vi d ual S u bjects................................................................................. 2 7
3. 6. 2.  
C o m pleti o n of St u d y.............................................................................................................. 2 7
3. 6. 3.  
L o n g-ter m F oll o w- u p ............................................................................................................ 2 7
4.  
S U BJ E C T I D E N TI FI C A TI O N A S SI G N M E N T ................................................................................................. 2 8
5.  
S U BJ E C T E LI GI BI LI T Y..................................................................................................................................... 2 9
5. 1.  
I ncl usi o n Criteria..................................................................................................................................... 2 9
5. 2.  
E xcl usi o n Criteria.................................................................................................................................... 3 1
6.  
P R O T O C O L T R E A T M E N T................................................................................................................................ 3 4
6. 1.  
St u d y Treat me nt ...................................................................................................................................... 3 4
6. 1. 1.  
Le u ka p heresis........................................................................................................................ 3 4
6. 1. 2.  
Bri d gi n g T hera p y................................................................................................................... 3 4
6. 1. 3.  
C o n diti o ni n g C he m ot hera p y ................................................................................................. 3 5
6. 1. 4.   
A xica bta ge ne Cil ole ucel........................................................................................................ 3 5
6. 1. 5.   
Ut o mil u ma b........................................................................................................................... 3 6
6. 1. 6.  
C o nc o mita nt T hera p y............................................................................................................ 3 7
6. 1. 7.  
E xcl u de d Me dicati o ns........................................................................................................... 3 8
6. 1. 8.  
S u bse q ue nt T hera p y .............................................................................................................. 3 9
6. 1. 9.   
A xica bta ge ne Cil ole ucel T o xicit y Ma na ge me nt................................................................... 3 9
C CI

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9
0 7 J u ne 2 0 2 2
6. 1. 1 0.   
Ut o mil u ma b T o xicit y Ma na ge me nt ...................................................................................... 3 9
7.  
S T U D Y P R O C E D U R E S...................................................................................................................................... 4 0
7. 1.  
I nf or me d C o nse nt.................................................................................................................................... 4 0
7. 2.  
Scree ni n g................................................................................................................................................. 4 0
7. 2. 1.  
Rescree ni n g ........................................................................................................................... 4 1
7. 3.   
De m o gra p hic Data................................................................................................................................... 4 1
7. 4.   
Me dical a n d Treat me nt Hist or y............................................................................................................... 4 1
7. 5.  
P h ysical E xa m, Vital Si g ns, a n d Perf or ma nce Stat us ............................................................................. 4 1
7. 5. 1.  
Car diac F u ncti o n ................................................................................................................... 4 2
7. 6.   
Ne ur ol o gical E xa mi nati o n....................................................................................................................... 4 2
7. 7.   
Disease Assess me nt................................................................................................................................. 4 2
7. 7. 1.  
I ma gi n g.................................................................................................................................. 4 3
7. 7. 2.   
Deter mi nati o n of B o ne Marr o w I n v ol ve me nt....................................................................... 4 3
7. 8.  
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.............. 4 4
7. 8. 1.  
Le u ka p heresis........................................................................................................................ 4 4
7. 8. 2.  
C o n diti o ni n g C he m ot hera p y Peri o d...................................................................................... 4 4
7. 8. 3.  
I n vesti gati o nal Pr o d uct Treat me nt Peri o d............................................................................. 4 7
7. 9.  
La b orat or y ............................................................................................................................................... 5 1
7. 9. 1.  
L ocal La b A nal ysis................................................................................................................ 5 1
7. 9. 2.  
Ce ntral La b orat or y A nal yses................................................................................................. 5 2
7. 1 0.  
P ost-treat me nt Assess me nt Peri o d .......................................................................................................... 5 6
7. 1 1.  
L o n g-ter m F oll o w- u p Peri o d................................................................................................................... 5 6
8.  
S U BJ E C T WI T H D R A W A L................................................................................................................................ 6 6
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
8. 3.  
I nstr ucti o ns f or F oll o w- u p a n d Data t o Be C ollecte d f or S u bjects Wit h dra w n Fr o m 
Treat me nt/ St u d y...................................................................................................................................... 6 7
9.  
S A F E T Y R E P O R TI N G........................................................................................................................................ 6 8
9. 1.   
A d verse E ve nts........................................................................................................................................ 6 8
9. 2.  
Re p orti n g of A Es..................................................................................................................................... 6 8
9. 2. 1.  
Re p orti n g A b n or mal La b orat or y Fi n di n gs............................................................................ 7 0
9. 2. 2.   
A b n or mal Li ver F u ncti o n Tests ( H y’s La w): Dr u g-i n d uce d Li ver I nj ur y............................ 7 0
9. 2. 3.   
A Es of S pecial I nterest (I m me diatel y Re p orta ble t o t he S p o ns or)........................................ 7 0
9. 3.   
Defi niti o n of Seri o us A d verse E ve nts..................................................................................................... 7 1
9. 4.  
Re p orti n g of S A Es................................................................................................................................... 7 1
9. 5.  
Re p orti n g Deat hs..................................................................................................................................... 7 3
9. 6.   
Dia g n osis vers us Si g ns a n d S y m pt o ms................................................................................................... 7 3
9. 7.  
Pre g na nc y a n d Lactati o n ......................................................................................................................... 7 3
9. 8.   
H os pitalizati o n a n d Pr ol o n ge d H os pitalizati o n....................................................................................... 7 5
9. 9.   
A b n or mal Vital Si g n Val ues ................................................................................................................... 7 5
9. 1 0.  
Safet y Re vie w Tea m a n d D ose-li miti n g T o xicit y................................................................................... 7 5
1 0. 
S T A TI S TI C A L C O N SI D E R A TI O N S................................................................................................................. 7 8
1 0. 1.   
H y p ot hesis............................................................................................................................................... 7 8
1 0. 2.  
St u d y E n d p oi nts....................................................................................................................................... 7 8
1 0. 2. 1.  
Pri mar y E n d p oi nts................................................................................................................. 7 8
1 0. 2. 2.  
Sec o n dar y E n d p oi nts............................................................................................................. 7 8
1 0. 3.  
Sa m ple Size C o nsi derati o ns.................................................................................................................... 7 9
1 0. 4.  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. 4. 1.  
Safet y I nteri m A nal ysis......................................................................................................... 8 0
C CI

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 0
0 7 J u ne 2 0 2 2
1 0. 5.   
A nal ysis S u bsets...................................................................................................................................... 8 0
1 0. 6.  
Pla n ne d Met h o d of A nal ysis ................................................................................................................... 8 1
1 0. 6. 1.  
C o m plete Res p o nse Rate....................................................................................................... 8 1
1 0. 6. 2.   
O bjecti ve Res p o nse Rate....................................................................................................... 8 1
1 0. 6. 3.   
D urati o n of Res p o nse............................................................................................................ 8 1
1 0. 6. 4.  
Pr o gressi o n-free S ur vi val...................................................................................................... 8 1
1 0. 6. 5.   
O verall S ur vi val..................................................................................................................... 8 1
1 0. 6. 6.  
Safet y..................................................................................................................................... 8 2
1 0. 6. 7.  
L o n g-ter m Data A nal ysis ...................................................................................................... 8 2
1 1. 
R E G U L A T O R Y O B LI G A TI O N S....................................................................................................................... 8 3
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 3
1 1. 2.  
S u bject C o nfi de ntialit y............................................................................................................................ 8 3
1 1. 3.  I n vesti gat or Si g nat or y O bli gati o ns.......................................................................................................... 8 4
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 5
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 VI N G............................................................................................ 8 6
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...................................................................................... 8 7
1 5. 
P U B LI C A TI O N ................................................................................................................................................... 8 8
1 6. 
R E F E R E N C E S..................................................................................................................................................... 8 9
A D DI N E N. R E F LI S T.......................................................................................................................................... 8 9
1 7. 
A P P E N DI C E S...................................................................................................................................................... 9 2
A p pe n di x 1.  
S p o ns or a n d I n vesti gat or Si g nat ure Pa ge................................................................................ 9 3
A p pe n di x 2.  
L u ga n o Classificati o n { C hes o n 2 0 1 4 }.................................................................................... 9 4
A p pe n di x 3.  
C hil d beari n g P ote ntial a n d Birt h C o ntr ol................................................................................ 9 8
LI S T O F T A B L E S
Ta ble 1.  
Cli nical E x perie nce wit h Ut o mil u ma b.................................................................................... 1 8
Ta ble 2.   
Ut o mil u ma b Re gi me ns............................................................................................................ 2 3
Ta ble 3.  
Bri d gi n g T hera p y Re gi me ns.................................................................................................... 3 4
Ta ble 4.  
L ocal La b orat or y Para meters................................................................................................... 5 2
Ta ble 5.  
Sc he d ule of Assess me nts C o h ort 1, 2, 3, 4, 5 a n d P hase 2 (as a p plica ble) 
Ut o mil u ma b A d mi nistrati o n Starti n g o n Da y 1 ...................................................................... 5 8
Ta ble 6.  
Sc he d ule of Assess me nts C o h ort 1 A, 2 A, 3 A, 4 A, 5 A a n d P hase 2 (as a p plica ble) 
Ut o mil u ma b A d mi nistrati o n Starti n g o n Da y 2 1 .................................................................... 6 1
Ta ble 7.  
L o n g-ter m F oll o w- u p Assess me nts......................................................................................... 6 4
Ta ble 8.  
E xact C o nfi de nce I nter vals ( 9 5 % a n d 8 0 %) C orres p o n di n g t o O bser ve d C R Rate 
F oll o wi n g Treat me nt of 2 7 S u bjects wit h A xica bta ge ne Cil ole ucel a n d Ut o mil u ma b........... 8 0
LI S T O F FI G U R E S
Fi g ure 1.  
St u d y Sc he ma ( P hase 1 a n d P hase 2)........................................................................................ 7
Fi g ure 2.  
E x pa nsi o n of C A R T Cells was Ass ociate d wit h O bjecti ve Res p o nse a n d 
Ne ur ol o gic E ve nts ................................................................................................................... 1 9
Fi g ure 3.  
P ost-i nf usi o n Ki netics of C A R T Cells i n t he Bl o o d............................................................... 2 0
Fi g ure 4.   
U pre g ulati o n of 4- 1 B B o n C A R T Cells After I nf usi o n ......................................................... 2 1
Fi g ure 5.  
St u d y Desi g n O ver vie w........................................................................................................... 2 3

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 1
0 7 J u ne 2 0 2 2
LI S T O F A B B R E VI A TI O N S
A B C
Acti vate d B cell
A D A
A nti- dr u g a nti b o d y
A E
A d verse e ve nt
AI C D
Acti vati o n i n d uce d cell deat h
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
B P
Bl o o d press ure
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 eff
Efficaci o us c o nce ntrati o n
CI
C o nfi de nce I nter val
C L L
C hr o nic l y m p h oc ytic le u ke mia
C M V
C yt o me gal o vir us
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 O
C o ntract Researc h Or ga nizati o n
C R P
C-reacti ve pr otei n
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 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
DI LI
Dr u g-i n d uce d li ver i nj ur y
D L B C L
Diff use lar ge B-cell l y m p h o ma
D L T
D ose-li miti n g t o xicit y
D O R
D urati o n of res p o nse
D O R R
D urati o n retreat me nt res p o nse
E B V
E pstei n- Barr vir us
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
F A S
F ull a nal ysis set
F D A
F o o d a n d Dr u g A d mi nistrati o n
F L
F ollic ular l y m p h o ma
G C B
Ger mi nal ce nter B cell

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 2
0 7 J u ne 2 0 2 2
G C P
G o o d Cli nical Practice
G M- C S F
Gra n ul oc yte macr o p ha ge-c ol o n y sti m ulati n g fact or
H E E N T
Hea d, e ye, ear, n ose, a n d t hr oat
H G B C L
Hi g h- gra de B-cell l y m p h o ma
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
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 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 U
I nte nsi ve care u nit
I D
I de ntificati o n
I F
I nterfer 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 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
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 A b
M o n ocl o nal a nti b o d y
M A P
Mit o ge n acti vate d pr otei n 
M C P
M o n oc yte c he m oattracta nt pr otei n
MI P
Macr o p ha ge i nfla m mat or y pr otei n
mI T T
M o difie d i nte nt-t o-treat
M RI
Ma g netic res o na nce i ma gi n g
Na b
Ne utralizi n g a nti b o d y
N CI
Nati o nal Ca ncer I nstit ute
N E
Ne ur ol o gic e ve nt
N F- k B
N uclear fact or ka p pa-li g ht-c hai n-e n ha ncer of acti vate d 
B cells
N H L
N o n- H o d g ki n l y m p h o ma
N K
Nat ural killer
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
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

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 3
0 7 J u ne 2 0 2 2
P F S
Pr o gressi o n-free s ur vi val
P K
P har mac o ki netics
P R
Partial res p o nse
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
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 T
Safet y re vie w tea m
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 GI
T u m or gr o wt h i n hi biti o n
T L S
T u m or l ysis s y n dr o me
T N F
T u m or necr osis fact or 
U L N
U p per li mit of n or mal
W B C
W hite bl o o d cell

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 5
0 7 J u ne 2 0 2 2
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
2. 1.   
Dise ase B ac k gr o u n d
N o n- H o d g ki n l y m p h o ma ( N H L) is a heter o ge ne o us gr o u p of ca ncers ori gi nati n g i n B 
l y m p h oc ytes, T l y m p h oc ytes, or nat ural killer ( N K) cells.  I n t he U nite d States, B-cell 
l y m p h o mas re prese nt 8 0 % t o 8 5 % of cases re p orte d. I n 2 0 1 8, it is esti mate d t hat t here will be 
a p pr o xi matel y 7 4, 6 8 0 ne w cases of N H L a n d o ver 1 9, 0 0 0 deat hs relate d t o t he disease.  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 t y pe of ca ncer 
a m o n g me n a n d w o me n a n d acc o u nts f or 4. 3 % of all ne w ca ncer cases a n d 3 % of deat hs relate d 
t o ca ncer {N o o ne 2 0 1 7 }.
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 % of N H L cases.  T here are a p pr o xi matel y 2 2, 0 0 0 ne w dia g n oses of D L B C L i n 
t he U nite d States eac h year.  I n t he past 2 deca des, pr o gress has bee n ma de i n u n dersta n di n g t he 
bi ol o gical heter o ge neit y of D L B C L a n d i n i m pr o vi n g s ur vi val wit h c o m bi nati o ns of 
c he m ot hera p y a n d i m m u n ot hera p y.  T he a d diti o n of rit u xi ma b i nt o c o m bi nati o n t hera pies f or 
D L B C L has greatl y i m pr o ve d patie nt o utc o mes.  H o we ver, patie nts wit h c he m ot hera p y-
refract or y D L B C L still ha ve a partic ularl y dire pr o g n osis {Fl o wers 2 0 1 0 }.
S C H O L A R- 1, a lar ge m ultice nter, patie nt-le vel retr os pecti ve st u d y, e xa mi ne d o utc o mes of 
refract or y D L B C L usi n g p o ole d data fr o m 2 ra n d o mize d P hase 3 cli nical trials ( L y m p h o ma 
Aca de mic Researc h Or ga nizati o n- C O R A L a n d Ca na dia n Ca ncer Trials Gr o u p L Y. 1 2) a n d 
2 o bser vati o nal c o h orts ( M D A n ders o n Ca ncer Ce nter a n d U ni versit y of I o wa/ Ma y o Cli nic 
L y m p h o ma S pecialize d Pr o gra m of Researc h E xcelle nce).  F or t he st u d y, refract or y D L B C L was 
defi ne d as pr o gressi ve disease or sta ble disease as t he best res p o nse at a n y p oi nt d uri n g 
c he m ot hera p y ( > 4 c ycles of first-li ne or 2 c ycles of later-li ne t hera p y) or rela pse d ≤ 1 2 m o nt hs 
of a ut ol o g o us ste m cell tra ns pla ntati o n ( A S C T).  T he st u d y hi g hli g hte d t he p o or pr o g n osis of 
patie nts affecte d wit h refract or y D L B C L, fi n di n g a n o bjecti ve res p o nse rate ( O R R) t o t he ne xt 
li ne of t hera p y of 2 6 % (c o m plete res p o nse [ C R], 7 %) a n d a me dia n o verall s ur vi val ( O S) of o nl y 
6. 3 m o nt hs { Cr u m p 2 0 1 7 }.
2. 2.   
A xic a bt a ge ne Cil ole ucel
A xica bta ge ne cil ole ucel is a C D 1 9- directe d ge neticall y m o difie d a ut ol o g o us T-cell 
i m m u n ot hera p y.  F or t his t hera p y, a patie nt’s T cells are ge neticall y m o difie d t o pr o d uce a 
c hi meric a nti ge n rece pt or ( C A R) pr otei n, all o wi n g t he T cells t o i de ntif y a n d eli mi nate C D 1 9-
e x pressi n g n or mal a n d mali g na nt cells. C D 1 9 is e x presse d b y m ost B-cell mali g na ncies 
{ Le o nar d 2 0 0 1 , Olej nicza k 2 0 0 6 , R o dri g uez 1 9 9 4 , Uc k u n 1 9 8 8 } as well as n or ma l B 
l y m p h oc ytes i n peri p heral bl o o d a n d s plee n, b ut n ot b y gra n ul oc ytes, m o n oc ytes, platelets, 
er yt hr oc ytes, a n d T l y m p h oc ytes { Uc k u n 1 9 8 8 }. Briefl y, t he a nti- C D 1 9 C A R tra ns ge ne 
c o m prises t he f oll o wi n g ke y d o mai ns: 1) a n e xtracell ular a nti- h u ma n C D 1 9 si n gle-c hai n varia ble 
re gi o n fra g me nt (sc F v) deri ve d fr o m t he m o n ocl o nal a nti b o d y F M C 6 3; 2) t he tra ns me m bra ne c o-
sti m ulat or y d o mai n C D 2 8; a n d 3) t he c yt o plas mic p orti o n of h u ma n C D 3ζ t hat i ncl u des t he 
si g nali n g d o mai ns {Nic h ols o n 1 9 9 7 }. F oll o wi n g C A R e n ga ge me nt wit h C D 1 9 +  tar get cells, t he 

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 6
0 7 J u ne 2 0 2 2
c o-sti m ulat or y d o mai ns acti vate a d o w nstrea m si g nali n g casca de t hat lea ds t o T-cell acti vati o n, 
pr oliferati o n, a n d ac q uisiti o n of effect or f u ncti o n.
O n 1 8 Oct o ber 2 0 1 7, t he F o o d a n d Dr u g A d mi nistrati o n ( F D A) a p pr o ve d a xica bta ge ne 
cil ole ucel f or t he treat me nt of a d ult patie nts wit h rela pse d or refract or y lar ge B-cell l y m p h o ma 
after 2 or m ore li nes of s yste mic t hera p y, i ncl u di n g D L B C L n ot ot her wise s pecifie d, pri mar y 
me diasti nal lar ge B-cell l y m p h o ma, hi g h- gra de B-cell l y m p h o ma ( H G B C L), a n d D L B C L arisi n g 
fr o m f ollic ular l y m p h o ma ( F L) {Y E S C A R T A 2 0 1 7 }.
F D A a p pr o val was base d o n Z U M A- 1, a si n gle-ar m m ultice nter trial of 1 0 8 a d ult s u bjects wit h 
rela pse d or refract or y a g gressi ve lar ge B-cell N H L.  Of t he 1 0 1 s u bjects e val uate d f or efficac y, 
t he O R R was 7 2 %, wit h a C R rate of 5 1 %.  T he me dia n d urati o n of res p o nse ( D O R) was l o n ger 
i n s u bjects wit h a best o verall res p o nse of C R c o m pare d wit h t h ose w h o ac hie ve d a best o verall 
res p o nse of partial res p o nse ( P R) ( n ot esti ma ble vs 2. 1 m o nt hs, res pecti vel y) {Y E S C A R T A 
2 0 1 7 } . T he m ost c o m m o n Gra de 3 or hi g her a d verse e ve nts ( A Es; i nci de nce of ≥ 1 0 %) were 
fe ver, c yt o ki ne release s y n dr o me ( C R S), e nce p hal o pat h y, i nfecti o ns ( pat h o ge n u ns pecifie d), 
h y p ote nsi o n, a n d h y p o xia.  Seri o us a d verse reacti o ns occ urre d i n 5 2 % of s u bjects a n d i ncl u de d, 
b ut were n ot li mite d t o, e nce p hal o pat h y, fe ver, fe brile ne utr o pe nia, a n d seri o us i nfecti o ns.  Fatal 
cases of C R S a n d ne ur ol o gic t o xicit y occ urre d. F D A a p pr o ve d a xica bta ge ne cil ole ucel wit h a 
Ris k E val uati o n a n d Miti gati o n Strate g y { Y E S C A R T A 2 0 1 7 }.
T he d ose of a xica bta ge ne cil ole ucel is a si n gle i ntra ve n o us (I V) i nf usi o n wit h a tar get of 
2 x 1 0 6 C A R- p ositi ve via ble T cells per k g b o d y wei g ht ( ma xi m u m 2 x 1 08 cells), prece de d b y 
c ycl o p h os p ha mi de a n d fl u dara bi ne l y m p h o de pleti n g c he m ot hera p y { Y E S C A R T A 2 0 1 7 }.  
A d diti o nal details re gar di n g t he mec ha nis m of acti o n a n d cli nical res ults of a xica bta ge ne 
cil ole ucel ca n be f o u n d i n t he m ost c urre nt versi o n of t he a xica bta ge ne cil ole ucel I n vesti gat or’s 
Br oc h ure (I B).
2. 3.  
Pri or A nti- C D 1 9 C A R T-cell St u d y Desi g n
T he desi g n a n d rati o nale of t his st u d y is i n part deri ve d fr o m pri or e x perie nce wit h a xica bta ge ne 
cil ole ucel o n ot her Kite P har ma, I nc., ( hereafter referre d t o as Kite or Kite P har ma) s p o ns ore d 
st u dies, i ncl u di n g Z U M A- 1, a n d o n a si n gle-ce nter st u d y c o n d ucte d at t he Nati o nal Ca ncer 
I nstit ute ( N CI). See 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 details.
2. 4.   
Ut o mil u m a b
T he i n d uci ble c o-sti m ulat or y rece pt or 4- 1 B B ( C D 1 3 7 or t u m or necr osis fact or [ T N F] 
s u perfa mil y 9) is a critical me diat or of i m m u ne res p o nses, a n d it is e x presse d o n s u bsets of 
acti vate d i m m u ne cells, i ncl u di n g T cells { Wa n g 2 0 0 9 }.  Its l i ga n d, 4- 1 B B L, is e x presse d o n 
acti vate d a nti ge n- prese nti n g cells, a n d t hr o u g h 4- 1 B B e n ga ge me nt, it tri g gers d o w nstrea m 
i ntracell ular si g nali n g t hr o u g h t he n uclear fact or ka p pa-li g ht-c hai n-e n ha ncer of acti vate d B cells 
( N F- k B) a n d mit o ge n acti vate d pr otei n ( M A P) ki nase pat h wa ys t hat pr o m ote cell ular 
pr oliferati o n, s ur vi val, a n d c yt o ki ne pr o d ucti o n { Cr oft 2 0 0 9 }.  F or t hese rea s o ns, 4- 1 B B is a n 
attracti ve i m m u n ot hera p y tar get.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 7
0 7 J u ne 2 0 2 2
Ut o mil u ma b (c o m pa n y c o de: P F- 0 5 0 8 2 5 6 6) is a hi g hl y selecti ve, f ull y h u ma n 4- 1 B B I g G 2 
m o n ocl o nal a nti b o d y ( m A b) t hat bi n ds as a n a g o nist t o t he h u ma n 4- 1 B B wit h na n o m olar 
affi nit y.  I n precli nical st u dies, ut o mil u ma b acti vate d t he N F- k B pat h wa y a n d i n d uce d 
d o w nstrea m c yt o ki ne pr o d ucti o n i n e n gi neere d cell li nes a n d pri mar y l y m p h oc ytes.  I n a d diti o n, 
ut o mil u ma b pr o m ote d h u ma n le u k oc yte pr oliferati o n i n a m o del of h u ma n peri p heral bl o o d 
m o n o n uclear cell ( P B M C) e n graft me nt a n d i n hi bite d t u m or gr o wt h i n xe n o graft t u m or m o dels i n 
w hic h h u ma n P B M C ha d bee n c o-e n grafte d.  Ut o mil u ma b ma y, t heref ore, e n ha nce t he i m m u ne 
res p o nse a gai nst t u m ors {Fis her 2 0 1 2 } (refer t o P F 0 5 0 8 2 5 6 6 I B).
2. 4. 1.  
S u m m ar y of Cli nic al St u dies f or Ut o mil u m a b 
Cli nical e x perie nce t o date wit h ut o mil u ma b is s u m marize d i n Ta ble 1 .  As of J ul y 2 0 1 7, 
P F- 0 5 0 8 2 5 6 6 has bee n a d mi nistere d t o a t otal of 3 9 0 s u bjects. St u d y B 1 6 4 1 0 0 1 is a P hase 1 
o pe n-la bel, m ultice nter, d ose escalati o n st u d y of P F- 0 5 0 8 2 5 6 6 as a si n gle a ge nt ( P orti o n A) i n 
s u bjects wit h rela pse d s oli d t u m ors or rela pse d or refract or y B-cell l y m p h o ma or i n c o m bi nati o n 
wit h rit u xi ma b ( P orti o n B) i n s u bjects wit h rela pse d or refract or y C D 2 0 p ositi ve N H L (refer t o 
P F- 0 5 0 8 2 5 6 6 I B) { G o pal 2 0 1 5 , Se gal 2 0 1 8 }.  P F- 5 0 8 2 5 6 6 d oses ra n ge d fr o m 0. 0 0 6 m g/ k g t o 
1 0 m g/ k g a d mi nistere d i ntra ve n o usl y (I V) o nce e ver y 2 8 da ys.  T he re gi me n was well t olerate d 
wit h t he m ost fre q ue ntl y o bser ve d treat me nt-relate d, treat me nt-e mer ge nt a d verse e ve nt ( T E A E) 
i n P orti o n A bei n g fati g ue ( 1 4. 0 %).  Treat me nt-relate d T E A Es were m ostl y Gra de 1 or Gra de 2 
wit h o nl y 4 Gra de 3/ 4 A Es re p orte d (c olitis, diarr hea, fati g ue, h y per bilir u bi ne mia, a n d 
h y p o natre mia).  T he m ost fre q ue ntl y o bser ve d treat me nt-relate d T E A Es i n P orti o n B wit h 
6 6 s u bjects were i nf usi o n-relate d reacti o n ( 2 1. 2 %) a n d fati g ue ( 1 9. 7 %).  All of t he i nf usi o n 
reacti o ns were ass ociate d wit h rit u xi ma b i nf usi o n. P F- 0 5 0 8 2 5 6 6-relate d T E A Es were eit her 
Gra de 1 or Gra de 2 i n se verit y.  Gra de 3/ 4 A Es were re p orte d i n 6 s u bjects i n c o m bi nati o n wit h 
rit u xi ma b o nl y: i nf usi o n-relate d reacti o n a n d ne utr o pe nia ( 2 s u bjects eac h) a n d decrease d 
l y m p h oc yte a n d ne utr o p hil c o u nts ( 1 s u bject eac h).  T here were n o d ose-li miti n g t o xicities 
(D L Ts ). P F- 0 5 0 8 2 5 6 6 is n o w c o nsi dere d t o be safe u p t o d oses of 1 0 m g/ k g, e q ui vale nt t o 
a p pr o xi matel y 7 0 0 m g i n a 7 0- k g s u bject, as a m o n ot hera p y or i n c o m bi nati o n wit h rit u xi ma b 
( 3 7 5 m g/ m2).  T h us, t he pr o p ose d starti n g d ose of 1 0 m g t otal d ose f or t his pr ot oc ol re n ders a 
mar gi n of safet y of at least 7 0-f ol d relati ve t o hist orical safet y data.  
St u d y B 1 6 4 1 0 0 3 is a P hase 1 o pe n-la bel, m ultice nter, d ose escalati o n st u d y of P F- 0 5 0 8 2 5 6 6 
a d mi nistere d i n c o m bi nati o n wit h pe m br oliz u ma b (a n a nti P D- 1 m A b) i n a d ult s u bjects wit h 
a d va nce d s oli d mali g na ncies.  E nr oll me nt of s u bjects i nt o t he d ose escalati o n p hase of t he st u d y 
is c o m plete, wit h 2 3 s u bjects e nr olle d at P F- 0 5 0 8 2 5 6 6 d oses ra n gi n g fr o m 0. 4 5 m g/ k g t o 
5. 0 m g/ k g a d mi nistere d I V c o nc urre ntl y wit h pe m br oliz u ma b at 2 m g/ k g o nce e ver y 2 1 da ys. 
Treat me nt-relate d T E A Es were m ostl y Gra de 1 or Gra de 2.  T here were o nl y 2 treat me nt-relate d 
( P F- 0 5 0 8 2 5 6 6 a n d pe m br oliz u ma b) Gra de 3 A Es re p orte d i n 2 s u bjects: a dre nal i ns ufficie nc y 
( n o e vi de nce of ass ociate d h y p o p h ysitis) a n d h y p o kale mia ( 1 s u bject eac h).  N o Gra de 4 or 
Gra de 5 treat me nt-relate d A Es were o bser ve d.  T his c o m bi nati o n was well t olerate d w he n t he 
ma xi m u m a d mi nistere d d ose of P F- 0 5 0 8 2 5 6 6 was 5 m g/ k g f or t his c o m bi nati o n, r o u g hl y 3 5 0 m g 
i n a 7 0- k g s u bject, a n d was dee me d well t olerate d wit h n o D L Ts o bser ve d i n t he st u d y.  Ot her 
c o m bi nati o n strate gies are als o u n der i n vesti gati o n as s h o w n i n Ta ble 1 .

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 8
0 7 J u ne 2 0 2 2
T a ble 1.
Cli nic al E x perie nce wit h Ut o mil u m a b
S u bjects
Pr ot oc ol 
Title
Pl a n ne d 
Tre ate d 
St at us
B 1 6 4 1 0 0 1
A P hase 1 St u d y of P F 0 5 0 8 2 5 6 6 as a Si n gle A ge nt 
i n Patie nts wit h A d va nce d Ca ncer a n d i n 
C o m bi nati o n wit h Rit u xi ma b i n Patie nts wit h N o n-
H o d g ki n's L y m p h o ma ( N H L)
7 2- 1 6 1 
1 8 0 
O n g oi n g
B 1 6 4 1 0 0 3
A P hase 1 St u d y of t he 4- 1 B B A g o nist P F- 0 5 0 8 2 5 6 6 
i n C o m bi nati o n Wit h t he P D- 1 I n hi bit or M K- 3 4 7 5 i n 
Patie nts wit h A d va nce d S oli d T u m ors
4 5- 7 5 
2 3 
C o m plete d
B 1 6 4 1 0 0 4
A P hase 1 b St u d y of P F- 0 5 0 8 2 5 6 6 i n C o m bi nati o n 
Wit h M o ga m uliz u ma b ( K W- 0 7 6 1) i n Patie nts Wit h 
A d va nce d S oli d T u m ors
7 0 
2 4 
Ter mi nate d
B 9 9 9 1 0 0 4
A P hase 1 b/ 2 O pe n- La bel St u d y t o E val uate Safet y, 
Cli nical Acti vit y, P har mac o ki netics a n d 
P har mac o d y na mics of A vel u ma b ( M S B 0 0 1 0 7 1 8 C) 
i n C o m bi nati o n wit h Ot her Ca ncer I m m u n ot hera pies 
i n Patie nts wit h A d va nce d Mali g na ncies ( A vel u ma b 
I B versi o n 7, 3 1 Marc h 2 0 1 7)
3 1 7 
1 5 3 
O n g oi n g
B 0 6 0 1 0 0 2
A P hase 1 O pe n La bel, D ose Escalati o n St u d y of P F-
0 4 5 1 8 6 0 0 as a Si n gle A ge nt a n d i n C o m bi nati o n wit h 
P F- 0 5 0 8 2 5 6 6 i n Patie nts wit h Selecte d L ocall y 
A d va nce d or Metastatic Carci n o mas ( P F- 0 4 5 1 8 6 0 0 
I B Dece m ber 2 0 1 6)
1 9 0 
1 0 
O n g oi n g
A b bre viati o ns: I B, I n vesti gat or’s Br oc h ure.
2. 5.   
R ati o n ale f or C o m bi n ati o n T her a p y 
Pre vi o us cli nical trial e x perie nce wit h a xica bta ge ne cil ole ucel i n t he sa me patie nt p o p ulati o n 
( Z U M A- 1) de m o nstrate d a n O R R of 8 2 % a n d a C R rate of 5 8 % at t he u p date d a nal ysis after 
me dia n f oll o w- u p of 1 5. 4 m o nt hs { Neela p u 2 0 1 7 b }.  O n g oi n g re s p o nses were see n i n 4 2 % of 
s u bjects, of w hic h 4 0 % were i n C R. A m o n g t he 5 8 % of s u bjects w h o were n ot i n o n g oi n g 
res p o nse at t he 1 2- m o nt h f oll o w- u p, 1 8 % of s u bjects de m o nstrate d pri mar y resista nce t o t hera p y 
( di d n ot ac hie ve P R or C R), a n d 4 0 % of s u bjects ac hie ve d a n o bjecti ve res p o nse a n d later 
pr o gresse d or die d { Neela p u 2 0 1 7a }.  P ossi ble mec ha nis ms of resista nce t o a xica bta ge ne 
cil ole ucel are h y p ot hesize d t o be s u b o pti mal C A R T-cell e x pa nsi o n { Neela p u 2 0 1 7 b }, a n 
e xcl usi o nar y t u m or micr oe n vir o n me nt { R ossi 2 0 1 8 }, a n d C D 1 9 tar get a nti ge n l oss { Neela p u 
2 0 1 7a }.  
F urt her, it was als o o bser ve d i n Z U M A- 1 t hat 2 3/ 6 0 s u bjects wit h eit her a P R ( 1 1/ 3 5) or sta ble 
disease ( S D) ( 1 2/ 2 5) at t he first t u m or assess me nt ( 1 m o nt h after a xica bta ge ne cil ole ucel 
a d mi nistrati o n) s u bse q ue ntl y ac hie ve d C R u p t o 1 5 m o nt hs after i nf usi o n wit h o ut a d diti o nal 
t hera p y {Neela p u 2 0 1 7a }.  I n a d diti o n, pea k e x pa nsi o n a n d area u n der t he c ur ve 0- 2 8 d (A U C 0- 2 8 d) 
are ass ociate d wit h res p o nse { Neela p u 2 0 1 7 b } ( Fi g ure 2 ).  T heref ore, c o m bi nati o n strate gies t hat 
eit her i ncrease pr oliferati o n, e x pa nsi o n, a n d persiste nce of C A R T cells or pre ve nt acti vati o n-
i n d uce d cell deat h ( AI C D) of C A R T cells ma y i m pr o ve cli nical o utc o mes see n wit h a nti- C D 1 9 
C A R T-cell t hera p y.  

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 1 9
0 7 J u ne 2 0 2 2
Fi g ure 2.
E x p a nsi o n of C A R T Cells w as Ass oci ate d wit h O bjecti ve Res p o nse 
a n d Ne ur ol o gic E ve nts
A b bre viati o ns: O R R, o bjecti ve res p o nse rate; N E, ne ur ol o gic e ve nt; C R S, c yt o ki ne release s y n dr o me; A U C, area u n der t he 
c ur ve; C A R, c hi meric a nti ge n rece pt or.
C A R A U C defi ne d as c u m ulati ve le vels of C A R + cells/ µ L of bl o o d o ver t he first 2 8 da ys after  a xica bta ge ne cil ole ucel 
a d mi nistrati o n.   
P val ues are calc ulate d b y Wilc o x o n ra n k s u m test. 
Strate gies t hat ma y e n ha nce t he e n graft me nt of C A R T cells are c urre ntl y bei n g e x pl ore d i n t he 
cli nical setti n g.  Z U M A- 6 is a P hase 1/ 2 st u d y e xa mi ni n g a xica bta ge ne cil ole ucel i n c o m bi nati o n 
wit h atez oliz u ma b (a n a nti P D- L 1 m A b) i n refract or y D L B C L ( N C T 0 2 9 2 6 8 3 3).  Pr o gra m me d 
cell deat h pr otei n 1 ( P D- 1) is a n acti vati o n/e x ha usti o n mar ker of c yt ol ytic T cells a n d is 
u pre g ulate d o n t he s urface of C A R T cells d uri n g i n vitr o e x p os ure t o C D 1 9-e x pressi n g tar get 
cells {B ot 2 0 1 5 }.  F urt her, i n s u bje cts treate d wit h a nti- C D 1 9 C A R T cells, P D- 1 is u pre g ulate d 
o n C A R T cells after i nf usi o n { Perez 2 0 1 5 }.  Base d o n t he k n o w n bi ol o g y of P D- 1, u pre g ulati o n 
c o ul d p ossi bl y lea d t o i n hi biti o n of cell di visi o n, c yt ol ytic acti vit y, a n d e x ha usti o n of i nf use d 
C A R T cells { Keir 2 0 0 8 }.  T here f ore, it was h y p ot hesize d t hat disr u pti o n of t he P D- 1/ P D- L 1 
T-cell re g ulat or y a xis c o ul d e n ha nce t he c yt ol ytic ca pacit y of t he i nf use d C A R T cells a n d 
a u g me nt a nti- C D 1 9 C A R T-cell e n graft me nt. 
T he P hase 1 p orti o n of Z U M A- 6 wit h a xica bta ge ne cil ole ucel i n c o m bi nati o n wit h atez oliz u ma b 
has bee n c o m plete d wit h a ma na gea ble safet y pr ofile. T here were n o Gra de 5 e ve nts, a n d t he 
m ost c o m m o n Gra de 3/ 4 T E A Es were a ne mia 7 ( 7 8 %), e nce p hal o pat h y 5 ( 5 6 %), ne utr o pe nia 4 
( 4 4 %), h y p o natre mia 3 ( 3 3 %), p yre xia 3 ( 3 3 %), a n d t hr o m b oc yt o pe nia 3 ( 3 3 %).  O verall, t here 
was n o e vi de nce of w orse ni n g or rec urre nt A Es c o nsiste nt wit h C R S, ne ur ol o gic e ve nts ( N E), or 
ot her C A R T-cell-relate d t o xicities f oll o wi n g atez oliz u ma b a d mi nistrati o n { L oc ke 2 0 1 7 }.
After  atez oliz u ma b i nf usi o n, ki netics of C A R T cells s u g gest t hat atez oliz u ma b ma y i ncrease 
o verall C A R T-cell A U C wit h o ut i ncreasi n g t o xicit y or c ha n gi n g t he safet y pr ofile ( Fi g ure 3 ) 
{ L oc ke 2 0 1 7 }.  Ate z oliz u mab a d mi nistrati o n o n Da y 1 at 1, 2 0 0 m g is c urre ntl y bei n g utilize d i n 
t he P hase 2 c o h ort e x pa nsi o n p orti o n of t he st u d y. 
 
 
   
 
 
 
   
 
 
 
   
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
  
 
 
 
 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 0
0 7 J u ne 2 0 2 2
Fi g ure 3.
P ost-i nf usi o n Ki netics of C A R T Cells i n t he Bl o o d
B L, baseli ne; C A R, c hi meric a nti ge n rece pt or; D, da y; D L B C L, diff use lar ge B cell l y m p h o ma; M o n, m o nt h; W k, wee k.
S oli d li nes dis pla y me dia n val ues. Das he d li nes dis pla y t he i nter q uartile ( Q 1, Q 3) ra n ge. A nal ysis was n ot a vaila ble f or 1 patie nt.
Si milar t o P D- 1, 4- 1 B B e x pressi o n is u pre g ulate d o n a nti- C D 1 9 C A R T cells t hat are acti vate d 
(Fi g ure 4 ).  I ntracell ular si g nali n g d o w nstrea m of 4- 1 B B e n ga ge me nt is k n o w n t o e n ha nce T-
-cell pr oliferati o n a n d effect or f u ncti o n {S h uf or d 1 9 9 7 }, u pre g ulate  a nti-a p o pt otic pr otei ns 
{ H urta d o 1 9 9 7 }, a n d pr o m ot e s ur vi val a n d ce ll c ycle pr o gressi o n {Lee 2 0 0 3 } a n d pla ys a criti cal 
r ole i n t he f or mati o n of i m m u n ol o gical me m or y {Lee 2 0 0 2 }.  T h us, a g o nis m of 4- 1 B B o n 
e n gi neere d a nti- C D 1 9 C A R T cells mi g ht e n ha nce a nti-t u m or acti vit y of a xica bta ge ne cil ole ucel 
via t he f oll o wi n g mec ha nis ms:  ( 1) i ncreasi n g t he via bilit y of a nti- C D 1 9 C A R T cells t hr o u g h 
u pre g ulati o n of a nti-a p o pt otic pr otei ns, ( 2) e n ha nci n g a nti- C D 1 9 C A R T-cell e x pa nsi o n a n d 
pr oliferati o n, a n d 3) c o ntri b uti n g t o t he T-cell i m m u ne res p o nse.  It is, t heref ore, p ossi ble t hat 
c o nc o mita nt 4- 1 B B e n ga ge me nt c o ul d pre ve nt pri mar y a n d sec o n dar y resista nce, s u p p ort a n d 
s ustai n c o n versi o n of P R/ S D t o C R, a n d p ossi bl y pre ve nt earl y rela pse.
O ne p ossi ble c o ncer n is t hat e n ha nce d C A R T-cell e n graft me nt a n d acti vit y ma y lea d t o 
i ncrease d t o xicit y.  T o miti gate t his ris k, a starti n g ut o mil u ma b t otal d ose of 1 0 m g per d osi n g 
c ycle has bee n c h ose n. T his d ose has bee n dee me d t o be safe as a b ot h a si n gle a ge nt a n d i n 
c o m bi nati o n wit h rit u xi ma b.  F urt her details o n ut o mil u ma b d osi n g rati o nale are gi ve n i n 
Secti o n 3. 2. 3 .
 
 
  
 
 
 
 
    
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 2
0 7 J u ne 2 0 2 2
3.  
S T U D Y D E SI G N
3. 1.   
Ge ner al St u d y Desi g n
T his is a P hase 1/ 2, o pe n-la bel, m ultice nter 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 c o m bi nati o n wit h ut o mil u ma b a d mi nistrati o n i n s u bjects wit h 
rela pse d/refract or y lar ge B-cell l y m p h o ma.  T he trial will be se parate d i nt o 2 disti nct p hases 
desi g nate d as P hase 1 a n d P hase 2.
D uri n g P hase 1, u p t o 3 6 s u bjects wit h rela pse d/refract or y lar ge B-cell l y m p h o ma will be 
e nr olle d i n a 3 + 3 desi g n i n u p t o 6 of 1 0 c o h orts t o e val uate t he safet y of a xica bta ge ne cil ole ucel 
a n d ut o mil u ma b treat me nt re gi me ns.  A xica bta ge ne cil ole ucel will be a d mi nistere d as a si n gle 
d ose, a n d ut o mil u ma b will be a d mi nistere d at escalati n g d oses.  S u bjects will be e nr olle d a n d 
treate d o ne at a ti me d uri n g t he P hase 1 p orti o n of t he st u d y.  S u bject treat me nt wit h 
a xica bta ge ne cil ole ucel will be sta g gere d b y at least 2 wee ks. 
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 o n Da y 0. Ut o mil u ma b will be gi n at a fi xe d d ose of 1 0 m g o n Da y 1 i n C o h ort 1 
(Fi g ure 5 ).  A n i nter nal safet y re view tea m ( S R T), c o m prisi n g t he st u d y s p o ns or a n d at least o ne 
P hase 1 i n vesti gat or, will re vie w safet y data after all s u bjects i n C o h ort 1 c o m plete t he D L T 
wi n d o w ( 2 8 da ys after t he last s u bject i n a c o h ort recei ve d t he first ut o mil u ma b i nf usi o n).  If 
C o h ort 1 passes D L T criteria (see Secti o n 9. 1 0 ), t he n t he st u d y will pr ocee d t o C o h ort 2.  If 
C o h ort 1 d oes n ot pass D L T criteria (see Secti o n 9. 1 0 ), t he n t he st u d y will pr ocee d t o C o h ort 1 A, 
w hic h will e x pl ore t he sa me fi xe d d ose of ut o mil u ma b ( 1 0 m g) a d mi nistere d o n Da y 2 1.  T he 
S R T will ma ke rec o m me n dati o ns o n f urt her st u d y c o n d uct of P hase 1, i ncl u di n g d ose escalati o n 
t o C o h ort 2 A ( 3 0 m g), or e x pl ori n g a d diti o nal d osi n g a n d/ or ti mi n g of ut o mil u ma b 
a d mi nistrati o n as nee de d.  T he sa me r ules will a p pl y t o C o h ort 2, C o h ort 3, C o h ort 4, a n d 
C o h ort 5.  Refer t o Fi g ure 5  a n d Secti o n 9. 1 0 .  
At t he c o ncl usi o n of eac h S R T safet y re vie w meeti n g, t he S R T will ma ke rec o m me n dati o ns o n 
f urt her st u d y c o n d ucts o utli ne d i n Secti o n 9. 1 0 .

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 3
0 7 J u ne 2 0 2 2
Fi g ure 5.
St u d y Desi g n O ver vie w
*   
Ut o mil u ma b will be a d mi nistere d at t otal d oses of 1 0 m g, 3 0 m g, 1 0 0 m g, 2 0 0 m g, a n d 4 0 0 m g Q 4 W f or 6 m o nt hs u nless 
t here is disease pr o gressi o n.
A b bre viati o ns: D L T, d ose-li miti n g t o xicit y.
T he P hase 1 C o h orts a n d ut o mil u ma b re gi me ns a d mi nistere d are o utli ne d i n Ta ble 2 .
T a ble 2.
Ut o mil u m a b Re gi me ns
D ose Le vel *
C o h ort
First Ut o mil u m a b A d mi nistr ati o n
1
Da y 1
1 0 m g
1 A
Da y 2 1
2
Da y 1
3 0 m g
2 A
Da y 2 1
3
Da y 1
1 0 0 m g
3 A
Da y 2 1
4
Da y 1
2 0 0 m g
4 A
Da y 2 1
5
Da y 1
4 0 0 m g
5 A
Da y 2 1
*   
Ut o mil u ma b t otal d oses of 1 0 m g, 3 0 m g, 1 0 0 m g, 2 0 0 m g, a n d 4 0 0 m g will be a d mi nistere d Q 4 W f or 6 m o nt hs or u ntil 
pr o gressi ve disease ( P D), w hic he ver c o mes first.  T he S R T will ma ke rec o m me n dati o ns o n f urt her st u d y c o n d uct of P hase 1.  
 
 
 
 
 
   
 
 
 
 
 
    
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
  
 
  
 
  
 
   
      
 
 
 
 
 
 
 
  
 

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 4
0 7 J u ne 2 0 2 2
I n P hase 2, u p t o 2 4 s u bjects will be e nr olle d t o recei ve a xica bta ge ne cil ole ucel a n d ut o mil u ma b 
base d o n t he d ose a n d sc he d ule selecte d t o m o ve f or war d fr o m t he P hase 1 p orti o n of t he st u d y 
as rec o m me n de d b y t he S R T.
I n de pe n de nt of t he c o h ort or p hase of t he st u d y, eac h s u bject will pr ocee d t hr o u g h t he f oll o wi n g 
st u d y peri o ds:

Scree ni n g 

E nr oll me nt/ Le u ka p heresis 

Bri d gi n g t hera p y, if a p plica ble 

C o n diti o ni n g c he m ot hera p y 

I n vesti gati o nal pr o d uct (I P) treat me nt (a xica bta ge ne cil ole ucel a n d ut o mil u ma b)

P ost-treat me nt assess me nt

L o n g-ter m F oll o w- u p ( L T F U)
T he S R T will a d diti o nall y meet o n at least 1 occasi o n d uri n g t he P hase 2 p orti o n of t he st u d y 
after 6 s u bjects ha ve c o m plete d t heir 1- m o nt h disease assess me nt.  T he S R T will re vie w safet y 
a n d efficac y data a n d 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 be nefit/ris k rati o.  Refer t o Secti o n 9. 1 0 .
F or st u d y re q uire me nt  details assi g ne d t o eac h st u d y peri o d, refer t o t he sc he d ule of assess me nts 
( S O As) i n Secti o n 7 .
A st u d y sc he ma is descri be d i n Fi g ure 1 .
3. 2.   
D osi n g R ati o n ale
3. 2. 1.   
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 orrelate 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 pecifi call 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 precli nical m o dels, 
w hic h de m o nstrate t hat t he de pt h a n d d urati o n of l y m p h o de pleti o n c orrelates 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 c o n diti o ni 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) are b ot h gi ve n f or 
3 c o nsec uti ve da ys.  T his c o m bi nati o n has bee n st u die d i n s u bjects wit h B-cell mali g na ncies a n d 
was t olerate d b y t his p o p ulati o n { O' Brie n 2 0 0 1 }.  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 treat me nt was als o use d i n t he Z U M A- 1 trial { Neela p u 2 0 1 7 b }. 

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 5
0 7 J u ne 2 0 2 2
3. 2. 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 Z U M A- 1 as o utli ne d i n t he a xica bta ge ne cil ole ucel 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 0 8  a nti- C D 1 9 C A R T cells will be a d mi nistere d. 
3. 2. 3.   
R ati o n ale f or Ut o mil u m a b D ose
Ut o mil u ma b ( P F- 0 5 0 8 2 5 6 6) s h o we d a fa v ora ble t o xicit y pr ofile i n all cli nical testi n g c o n d ucte d 
t h us far (Ta ble 1 ; refer t o Secti o n 2. 4. 1 ).  Si n gle-a gent ut o mil u ma b or i n c o m bi nati o n wit h 
rit u xi ma b was f o u n d t o be safe wit h n o D L Ts u p t o 1 0 m g/ k g Q 4 W i n st u d y B 1 6 4 1 0 0 1, a d ose 
e q ui vale nt t o 7 0 0 m g i n a 7 0- k g s u bject, a n d t he M T D was esti mate d t o be at least 1 0 m g/ k g 
Q 4 W.  Treat me nt-relate d, treat me nt-e mer ge nt a d verse e ve nts were m ostl y Gra de 1 or - 2 wit h 
o nl y f o ur Gra de 3/ 4 A Es re p orte d (c olitis, diarr hea, fati g ue, h y per bilir u bi ne mia, a n d 
h y p o natre mia), Gra de 3/ 4 c olitis a n d diarr hea were o bser ve d i n t he sa me patie nt.  N o Gra de 5 
treat me nt-relate d A Es were o bser ve d.
S u bse q ue ntl y, preli mi nar y p o p ulati o n P K a nal ysis was c o n d ucte d usi n g data fr o m 6 8 s u bjects 
( n = 4 1 i n P orti o n A a n d n = 2 7 fr o m P orti o n B) fr o m st u d y B 1 6 4 1 0 0 1, w hic h i n dicate d t hat t he 
e x p os ure at d ose le vels hi g her t ha n 0. 1 2 m g/ k g ( ~ 8 m g i n 7 0- k g s u bject) was a b o ve t he ass u me d 
efficaci o us c o nce ntrati o n ( Ceff, 1 7 3 0 n g/ m L) wit h b ot h o nce e ver y 3 wee ks ( Q 3 W) a n d Q 4 W 
sc he d ule.  Briefl y, efficaci o us c o nce ntrati o n ( Ceff) was esti mate d usi n g t he mea n dr u g ser u m 
c o nce ntrati o n of 1 1. 5 n M ( 1 7 3 0 n g/ m L) fr o m t he bi o mar ker, s ol u ble C D 1 3 7 (s C D 1 3 7), a n d 
t u m or gr o wt h i n hi biti o n ( T GI) st u dies usi n g a s urr o gate a nti b o d y ( Ma B 9 3 7 1), w hic h has a 
si milar affi nit y t o m o use 4- 1 B B ( K D = 1 2 n M) c o m pare d wit h t hat of P F- 0 5 0 8 2 5 6 6 t o h u ma n 4-
1 B B.  F or t he bi o mar ker s C D 1 3 7, E C 5 0 was esti mate d t o be 1 1 n M ( 1 6 5 0 n g/ m L) usi n g t he 
i n direct -res p o nse E ma x m o del. F or T GI, a c o m plete res p o nse was ac hie ve d at 0. 2 m g/ k g 
( 1 2 n M), w hic h was c o nsiste nt wit h t he E C 5 0 of 1 1 n M esti mate d fr o m t he bi o mar ker data.  
He nce, a mea n dr u g ser u m c o nce ntrati o n of 1 1. 5 n M ( 1 7 3 0 n g/ m L) fr o m t he bi o mar ker a n d T GI 
st u dies was use d f or h u ma n si n gle-a ge nt efficaci o us c o nce ntrati o n/ d ose pr ojecti o n.  Lastl y, b o d y 
wei g ht acc o u nte d f or o nl y a s mall perce nta ge ( ~ < 7 %) of t he i nter-i n di vi d ual varia bilit y i n ser u m 
P F- 0 5 0 8 2 5 6 6 e x p os ure, a n d als o si m ulati o ns i n dicate d t hat P F- 0 5 0 8 2 5 6 6 e x p os ure was si milar 
bet wee n b o d y wei g ht- base d a n d fi xe d d osi n g re gi me ns.  
 
F or t his st u d y, ut o mil u ma b was a d mi nistere d o n Da y 1 f oll o wi n g a xica bta ge ne cil ole ucel 
a d mi nistrati o n i n li g ht of pre-e xisti n g a n d i nter nal data, w hic h s h o ws u pre g ulati o n of 4- 1 B B at 
1 8 h o urs after C A R T-cell tar get e n ga ge me nt/acti vati o n ( Fi g ure 4  a n d data o n file).  I n t he e ve nt 
t hat a n y of t he d ose le vel/c o h ort wit h Da y 1 ut o mil u ma b a d mi nistrati o n fails t o pass t he D L T 
criteria, Da y 2 1 a d mi nistrati o n of ut o mil u ma b will be e x pl ore d.  Da y 2 1 a d mi nistrati o n of 
ut o mil u ma b was c h ose n beca use b y t his ti me, t he maj orit y of s u bjects will ha ve passe d t he 
wi n d o w f or ac ute a xica bta ge ne cil ole ucel-relate d t o xicities a n d pea k C A R T-cell e x pa nsi o n.  
C CI

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 6
0 7 J u ne 2 0 2 2
T he starti n g d ose of 1 0 m g (t otal d ose) is 7 0-f ol d less t ha n w hat has bee n s h o w n t o be safe as 
m o n ot hera p y or i n c o m bi nati o n wit h rit u xi ma b ( 1 0 m g/ k g = 7 0 0 m g i n a 7 0- k g s u bject).  T he 
1 0- m g t otal d ose was c h ose n t o e ns ure safet y of s u bjects o n t his st u d y beca use t he effect of 
ut o mil u ma b acti vit y o n a xica bta ge ne cil ole ucel is u n k n o w n.  
At t he d ose escalati o n S R T re vie w of t he Z U M A- 1 1, data f or c o h orts 1- 3, n o D L Ts were 
o bser ve d.  W orst gra de C R S a n d N E were gra de 2.  N o ut o mil u ma b d ose dela ys d ue t o t o xicit y 
were see n i n all 3 c o h orts.  Gra de 3/ 4 treat me nt relate d, treat me nt-e mer ge nt a d verse e ve nts 
( T E A Es) were m ostl y c yt o pe nias: a ne mia ( 4 4 %), ne utr o pe nia ( 4 4 %), l y m p h o pe nia ( 3 3 %) a n d 
w hite bl o o d cell c o u nt decrease d ( 3 3 %).  T here was n o tre n d of i ncreasi n g gra de a n d/ or rate of 
c yt o pe nia wit h i ncreasi n g d ose of ut o mil u ma b.  N o treat me nt-relate d Gr 5 A Es were o bser ve d.  
F urt her, a tre n d was o bser ve d bet wee n pea k a n d c u m ulati ve le vels ( A U C 0- 2 8 d) of a nti- C D 1 9 C A R 
T-cells a n d ut o mil u ma b e x p os ure.  Me dia n C A R T-cell pea k le vels were f o u n d t o be 2. 2 ti mes 
hi g her ( 3 0 m g ut o mil u ma b c o h ort) a n d 4. 7 ti mes hi g her ( 1 0 0 m g ut o mil u ma b c o h ort) relati ve t o 
Z U M A- 1 P hase 2 C o h ort 1.  
I n t his sa me c o h ort of patie nts, pea k le vels of I L- 2 a n d I F N-γ i n ser u m i ncrease i n a d ose-
de pe n de nt ma n ner wit h ut o mil u ma b e x p os ure, p ote ntiall y de m o nstrati n g e n ha nce d T 1 T cell 
acti vit y.  M yel oi d ass ociate d c yt o ki nes a n d c he m o ki nes, pre vi o usl y ass ociate d wit h C R S a n d 
ne ur ol o gic t o xicit y ( Neela p u, N EJ M 2 0 1 7) s h o we d n o e vi de nce of ut o mil u ma b d ose- de pe n de nt 
i ncreases c o m me ns urate wit h t he lac k of i ncrease d t o xicit y relati ve t o Z U M A- 1 P hase 2 
C o h ort 1.
T he p har mac o ki netic a n d p har mac o d y na mic res ults o bser ve d i n t he first t hree c o h orts of 
Z U M A- 1 1, c o m bi ne d wit h t he cli nical o utc o me res ults s u g gest t hat a n i ncrease d d ose of 
ut oli m u ma b c o ul d f urt her e n ha nce C A R T-cell pr oliferati o n a n d acti vit y lea di n g t o a n e n ha nce d 
C R rate a n d d ura bilit y of res p o nse wit h acce pta ble safet y pr ofile.  It is ac k n o wle d ge d t hat t hese 
le vels of ut o mil u ma b are s u bsta ntiall y hi g her t ha n t he d ose ra n ge deter mi ne d f or a de q uate 
e x p os ure a n d tar get m o d ulati o n i n pre vi o us st u dies of ut o mil u ma b { Se gal 2 0 1 8 }.  H o we ver, t he  
s u per- p h ysi ol o gic le vels of T cells i n d uce d b y C A R- T cell e x pa nsi o n i n t ur n s u g gest hi g her 
le vels of i n d uce d 4- 1 B B rece pt or c o nce ntrati o n i n setti n g of a xi-cel c o m pare d t o t he p h ysi ol o gic 
le vels see n i n pre vi o us ut o mil u ma b st u dies.  T heref ore, t he P K, P D data, a n d ut o mil u ma b d ose 
le vels deter mi ne d fr o m pre vi o us st u dies li kel y are n ot a p plica ble i n t he setti n g of a xi-cel a n d 
hi g her d oses of ut o mil u ma b ma y be nee de d t o ac hie ve ma xi m u m 4- 1 B B rece pt or occ u pa nc y f or 
ma xi m u m a g o nist acti vit y. 
3. 3.  
P artici p ati n g Sites
A p pr o xi matel y 8 ce nters l ocate d i n N ort h A merica 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 re gi o ns, c o u ntries, or sites ma y be a d de d as necessar y .
3. 4.   
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 u p 
t o 6 0 s u bjects will be e nr olle d i nt o t his st u d y as defi ne d bel o w:

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 7
0 7 J u ne 2 0 2 2

P hase 1: a p pr o xi matel y 3 t o 3 6 s u bjects

P hase 2: a p pr o xi matel y 2 4 s u bjects 
3. 5.   
Re pl ace me nt of S u bjects
S u bjects will be re place d a n d c o nti n ue t o be e nr olle d u ntil t he s pecifie d n u m ber of s u bjects are 
attai ne d i n t he D L T e val ua ble ( P hase 1) a n d m o difie d i nte nt-t o-treat (mI T T ) sets ( P hase 2).  See 
Secti o n 1 0  f or a d ditio nal i nf or mati o n. S u bjects w h o recei ve bet wee n 1. 0 a n d 2. 4 x 1 0 6 a nti- C D 1 9 
C A R T cells/ k g or a flat d ose of 2. 0 x 1 0 8 a nti- C D 1 9 C A R T cells f or s u bjects > 1 0 0 k g a n d w h o 
recei ve at least 1 d ose of ut o mil u ma b will be c o nsi dere d e val ua ble i n t he efficac y a nal ysis. 
S u bjects w h o ha ve n ot recei ve d a n a xica bta ge ne cil ole ucel cell d ose i n t his ra n ge or ha ve n ot 
recei ve d at least 1 d ose of ut o mil u ma b will be retai ne d i n t he a nal yses of dis p ositi o n a n d safet y, 
w here a p pr o priate ( Secti o n 1 0. 5 ).
3. 6.  
St u d y D ur ati o n
3. 6. 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, 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 a n d s ur vi val, a n d if a p plica ble, ti mi n g of tra nsiti o n t o t he 
se parate L T F U st u d y, K T- U S- 9 8 2- 5 9 6 8 ( disc usse d i n Secti o n 3. 6. 3 ).  
3. 6. 2.   
C o m pleti o n of St u d y
C o m pleti o n of t he st u d y is defi ne d as t he ti me at w hic h t he last s u bject c o m pletes 6 m o nt hs of 
assess me nts. T he e n d- of-st u d y f or eac h s u bject is defi ne d as t he last visit o n t his st u d y, or w he n a 
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.  
3. 6. 3.  
L o n g-ter m F oll o w- u p
T he s u bjects w h o recei ve d a n i nf usi o n of a xica bta ge ne cil ole ucel will be pr o vi de d t he 
o p p ort u nit y t o tra nsiti o n t o a se parate L T F U st u d y, K T- U S- 9 8 2- 5 9 6 8, w here t he y will be 
m o nit ore d f or occ urre nce of late- o nset tar gete d A Es/ S A Es s us pecte d t o be p ossi bl y relate d t o 
a xica bta ge ne cil ole ucel as defi ne d i n K T- U S- 9 8 2- 5 9 6 8, prese nce of re plicati o n-c o m pete nt 
retr o vir us ( R C R) a n d/ or i nserti o nal m uta ge nesis f or u p t o 1 5 years fr o m t he ti me of a xica bta ge ne 
cil ole ucel i nf usi o n (als o refer t o Secti o n 7. 1 1 ).
F or eac h s u bject, t he fi nal visit o n t his st u d y ma y be c o m bi ne d wit h t he s u bject’s first visit o n t he 
L T F U st u d y.  T he ti mi n g of t he s u bject’s fi nal visit/first L T F U st u d y visit will de pe n d u p o n t he 
ti mi n g of t he c ollecti o n of all of t he s u bject’s data t hat are re q uire d f or t he pla n ne d a nal ysis f or 
t his st u d y.  I n K T- U S- 9 8 2- 5 9 6 8, 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 T F U ti me p oi nts i n t his st u d y.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 8
0 7 J u ne 2 0 2 2
4.  
S U B J E C T I D E N TI FI C A TI O N A S SI G N M E N T
Eac h s u bject w h o e nters t he scree ni n g peri o d, w hic h starts w he n t he s u bject si g ns t he i nf or me d 
c o nse nt f or m  (I C F), will recei ve a u ni q ue s u bject i de ntificati o n (I D) n u m ber.  T his 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.  T he s u bject I D n u m ber will ne ver be c ha n ge d e ve n if t he s u bject is 
rescree ne d.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 2 9
0 7 J u ne 2 0 2 2
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 
{ S wer dl o w 2 0 1 6 }:
a)
D L B C L n ot ot her wise s pecifie d (acti vate d B cell/ ger mi nal ce nter B cell [A B C/ G C B ]) 
b)
H G B C 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
c)
D L B C L arisi n g fr o m F L
d)
T-cell/ histi oc yte ric h lar ge B-cell l y m p h o ma
e)
D L B C L ass ociate d wit h c hr o nic i nfla m mati o n
f)
Pri mar y c uta ne o us D L B C L, le g t y pe
g)
E pstei n- Barr vir us ( E B V) + D L B C L 
1 0 2) 
C he m ot hera p y-refract or y disease, defi ne d as o ne or m ore of t he f oll o wi n g:
a)
N o res p o nse t o first-li ne t hera p y ( pri mar y refract or y disease); s u bjects w h o are 
i nt olera nt t o first-li ne s yste mic c he m ot hera p y are e xcl u de d
i)
Pr o gressi ve disease ( P D) as best res p o nse t o first-li ne t hera p y
ii)
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) wit h S D d urati o n n o l o n ger t ha n 6 m o nt hs fr o m last d ose of t hera p y
b)
N o res p o nse t o sec o n d- or greater-li nes of t hera p y
i)
P D as best res p o nse t o m ost rece nt t hera p y re gi me n 
ii)
S D as best res p o nse after at least 2 c ycles of last li ne of t hera p y wit h S D d urati o n 
n o l o n ger t ha n 6 m o nt hs fr o m last d ose of t hera p y 
O R
c)
Refract or y p ost- A S C T
i)
Disease pr o gressi o n or rela pse d ≤ 1 2 m o nt hs after A S C T ( m ust ha ve bi o ps y 
pr o ve n rec urre nce i n rela pse d s u bjects)
ii) If sal va ge t hera p y is gi ve n p ost- A S C T, t he s u bject m ust ha ve ha d n o res p o nse t o 
or rela pse d after t he last li ne of t hera p y 
O R

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
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A me n d me nt 5
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d)
Rela pse d or refract or y L B C L i ncl u di n g D L B C L, T F L, a n d H G B C L after 2 li nes of 
s yste mic t hera p y t hat is defi ne d b y a n d ali g ns wit h c urre ntl y a p pr o ve d i n dicati o n:
i) 
Rela pse d disease after 2 li nes of s yste mic t hera p y
O R
ii)
Best res p o nse t hat is less t ha n a C R t o sec o n d li ne s yste mic t hera p y
1 0 3) 
At least 1 meas ura ble lesi o n acc or di n g t o t he L u ga n o Classificati o n { C hes o n 2 0 1 4 }.  
Lesi o ns t hat ha ve bee n pre vi o usl y irra diate d will be c o nsi dere d meas ura ble o nl y if 
pr o gressi o n has bee n d oc u me nte d f oll o wi n g c o m pleti o n of ra diati o n t hera p y.
1 0 4) 
S u bjects m ust ha ve recei ve d a de q uate pri or t hera p y, i ncl u di n g at a mi ni m u m: 
a)
A nti- C D 2 0 m A b 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
b)
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 5) 
N o ra di o gra p hic  e vi de nce, s us pici o n, a n d/ or hist or y of ce ntral ner v o us s yste m ( C N S) 
i n v ol ve me nt of l y m p h o ma
1 0 6) 
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 t hera p y at t he ti me t he s u bject is pla n ne d f or le u ka p heresis. 
1 0 7) 
T o xicities d ue t o pri or t hera p y m ust be sta ble a n d rec o vere d t o ≤ Gra de 1 (e xce pt f or 
cli nicall y n o n-si g nifica nt t o xicities, s uc h as al o pecia).
1 0 8) 
A ge 1 8 or ol der
1 0 9) 
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 of 0 or 1
1 1 0) 
A bs ol ute ne utr o p hil c o u nt ( A N C) ≥ 1, 0 0 0/ μ L
1 1 1) 
Platelet c o u nt ≥ 7 5, 0 0 0/ μ L
1 1 2) 
A bs ol ute l y m p h oc yte c o u nt ≥ 1 0 0/ μ L
1 1 3) 
A de q uate 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)
Creati ni ne cleara nce (as esti mate d b y C oc kcr oft Ga ult) ≥ 6 0 m L/ mi n
b)
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) 
c)
T otal bilir u bi n ≤ 1. 5 m g/ d L, e xce pt i n s u bjects wit h Gil bert’s s y n dr o me
d)
Car diac ejecti o n fracti o n ≥ 5 0 % a n d n o e vi de nce of pericar dial eff usi o n wit hi n 
1 8 0 da ys pr o vi de d t he s u bject di d n ot recei ve a n a nt hrac ycli ne- base d treat me nt or 
e x perie nce a car diac e ve nt or c ha n ge i n perf or ma nce stat us 

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
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e)
N o cli nicall y si g nifica nt ple ural eff usi o n
f)
Baseli ne o x y ge n sat urati o n > 9 2 % o n r o o m air 
1 1 4) 
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 ol o gicall y pr o ve n pri mar y me diasti nal B-cell l y m p h o ma (P M B C L )  
2 0 2) 
Hist or y of Ric hter’s tra nsf or mati o n of c hr o nic l y m p h oc ytic le u ke mia (C L L ) 
2 0 3) 
Pri or C A R t hera p y or ot her ge neticall y m o difie d T-cell t hera p y
2 0 4) 
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 5) 
Prese nce or s us pici o n 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 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 a n d 
after c o ns ultati o n wit h t he s p o ns or’s me dical m o nit or  
2 0 6) 
Hist or y of h u ma n i m m u n o deficie nc y vir us  (HI V ) i nfecti o n or ac ute or c hr o nic acti ve 
he patitis B or C i nfecti o n.  S u bjects wit h hist or y of he patitis i nfecti o n m ust ha ve cleare d 
t heir i nfecti o n as deter mi ne d b y sta n dar d ser ol o gical a n d ge netic testi n g per c urre nt 
I nfecti o us Diseases S ociet y of A merica (I D S A) g ui deli nes or a p plica ble c o u ntr y g ui deli nes.
2 0 7) 
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 0 8) 
S u bjects wit h detecta ble cere br os pi nal fl ui d ( C S F)  mali g na nt cells, brai n metastases, or a 
hist or y of C N S l y m p h o ma
2 0 9) 
Hist or y or prese nce of 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 0) 
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 1) 
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, 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 2) 
Re q uire me nt f or ur ge nt t hera p y d ue t o t u m or mass effects (e g, bl o o d vessel c o m pressi o n, 
b o wel o bstr ucti o n, or tra ns m ural gastric i n v ol ve me nt)
2 1 3) 
Pri mar y i m m u n o deficie nc y 

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3 2
0 7 J u ne 2 0 2 2
2 1 4) 
Hist or y of a ut oi m m u ne disease (e g, Cr o h n’s, r he u mat oi d art hritis, s yste mic l u p us) 
res ulti n g i n e n d or ga n i nj ur y or re q uiri n g s yste mic i m m u n os u p pressi o n/s yste mic disease 
m o dif yi n g a ge nts wit hi n t he last 2 years.  S u bjects wit h a hist or y of a ut oi m m u ne-relate d 
h y p ot h yr oi dis m o n a sta ble d ose of t h yr oi d re place me nt h or m o ne a n d s u bjects wit h 
c o ntr olle d t y pe 1 dia betes mellit us o n a sta ble i ns uli n re gi me n ma y be eli gi ble f or t his 
st u d y
2 1 5) 
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 1 6) 
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 1 7) 
Hist or y of se vere i m me diate h y perse nsiti vit y reacti o n t o a n y of t he a ge nts use d i n t his 
st u d y 
2 1 8) 
Li ve vacci ne ≤ 6 wee ks pri or t o pla n ne d start of c o n diti o ni n g c he m ot hera p y
2 1 9) 
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 t he pre parati ve c he m ot hera p y o n t he fet us or i nfa nt.  
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.
2 2 0) 
S u bjects of b ot h ge n ders 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 t hr o u g h 9 0 da ys after t he last d ose of ut o mil u ma b a n d at least 6 m o nt hs after t he 
c o m pleti o n of c o n diti o ni n g c he m ot hera p y
2 2 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 i n sit u (e g, cer vi x, bla d der, 
breast) or l o w- gra de ( Gleas o n ≤ 6) pr ostate ca ncer or s ur veilla nce wit h o ut a n y pla ns f or 
treat me nt, u nless disease-free f or a least 3 years 
2 2 2) 
A S C T wit hi n 6 wee ks of pla n ne d e nr oll me nt 
2 2 3) 
Pri or or ga n tra ns pla ntati o n i ncl u di n g pri or all o ge neic ste m cell tra ns pla nt  ( S C T) 
2 2 4) 
Pri or C D 1 9 tar gete d t hera p y wit h t he e xce pti o n of s u bjects w h o recei ve d a xica bta ge ne 
cil ole ucel i n t his st u d y a n d are eli gi ble f or retreat me nt 
2 2 5) 
Use of a n y sta n dar d or e x peri me ntal a nti-ca ncer t hera p y wit hi n 2 wee ks pri or t o 
e nr oll me nt, i ncl u di n g c yt ore d ucti ve t hera p y a n d ra di ot hera p y, i m m u n ot hera p y, or 
c yt o ki ne t hera p y (e xce pt f or er yt hr o p oieti n) 
2 2 6) 
Pri or treat me nt wit h P D- L 1 i n hi bit or, P D- 1 i n hi bit or, a nti- C T L A 4, a nti- C D 1 3 7 ( 4- 1 B B), 
a nti- O X 4 0 or ot her i m m u ne c hec k p oi nt bl oc ka de or acti vat or t hera p y

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3 3
0 7 J u ne 2 0 2 2
2 2 7) 
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 [I F] a n d i nterle u ki n- 2 [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 ut o mil u ma b d ose
2 2 8) 
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. 
2 2 9)
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
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
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6.  
P R O T O C O L T R E A T M E N T
6. 1.  
St u d y Tre at me nt
6. 1. 1.  
Le u k a p heresis
Le u ka p heresis refers t o pr oce d ure f or c ollecti n g P B M Cs t hat are 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.
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 s p o ns or’s 
ma n ufact uri n g facilit y as descri be d i n t he I n vesti gati o nal Pr o d uct Ma n ual (I P M). 
Le u ka p heresis ma y be re peate d i n case of ma n ufact uri n g fail ure(s).
6. 1. 2.  
Bri d gi n g T her a p y
At t he discreti o n of t he i n vesti gat or, n o n-c he m ot hera p y 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 or baseli ne assess me nts (e g, b ul k y disease or 
ra pi dl y pr o gressi n g disease).  Bri d gi n g t hera p y re gi me ns are o utli ne d i n Ta ble 3 .  Bri d gi n g 
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. Sites s h o ul 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 d mi nistrati o n, a n d 
t o xicit y ma na ge me nt of bri d gi n g t hera p y. 
T a ble 3.
Bri d gi n g T her a p y Re gi me ns
T y pe 
T her a p y Re gi me ns a 
Ti mi n g a n d W as h o ut Re q uire me nts 
C ortic oster oi d
De xa met has o ne at a d ose of 2 0 
m g 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 ose ca n be a dj uste d f or 
a ge/c o m or bi dities or per l ocal or 
i nstit uti o nal g ui deli nes
Ma y be a d mi nistere d after e nr oll me nt/le u ka p heresis 
a n d m ust be c o m plete d pri or t o t he start of 
c o n diti o ni n g c he m ot hera p y
N ote:  P E T- C T,  c he mistr y pa nel, a n d C B C wit h 
differe ntial m ust be re peate d pri or t o start of 
c o n diti o ni n g c he m ot hera p y t o c o nfir m eli gi bilit y t o 
pr ocee d 
H D M P +
Rit u xi ma b
{ Castr o 2 0 0 9 }
1 gra m/ m 2 of hi g h d ose 
met h yl pre d nis ol o ne ( H D M P) 
f or 3 da ys i n c o m bi nati o n wit h 
rit u xi ma b at 3 7 5 m g/ m2 wee kl y 
f or 3 wee ks
Ma y be a d mi nistere d after e nr oll me nt/le u ka p heresis 
a n d c o m plete d at least 7 da ys pri or t o t he start of 
c o n diti o ni n g c he m ot hera p y
N ote : P E T- C T,  c he mistr y pa nel, a n d C B C wit h 
differe ntial m ust be re peate d pri or t o start of 
c o n diti o ni n g c he m ot hera p y t o c o nfir m eli gi bilit y t o 
pr ocee d
A b bre viati o ns: 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; C B C, c o m plete bl o o d c o u nt.
a
Bri d gi n g t hera p y re gi me n ma y be c h ose n at t he discreti o n of t he i n vesti gat or.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
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A me n d me nt 5
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6. 1. 3.   
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 refers t o c ycl o p h os p ha mi de a n d fl u dara bi ne 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.
C o n diti o ni n g c he m ot 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 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. 1. 3. 1.  
C ycl o p h os p ha mi de
C ycl o p h os p ha mi de is a nitr o ge n m ustar d- deri vati ve t hat acts as a n 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 a n d has 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.  
Refer t o t he m ost rece nt versi o n of t he pac ka ge i nsert f or s pecific details s urr o u n di n g t he 
a d mi nistrati o n of c ycl o p h os p ha mi de.
6. 1. 3. 2.  
Fl u dara bi ne
Fl u dara bi ne p h os p hate ( hereafter, fl u dara bi ne) 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.
Refer t o t he m ost rece nt versi o n of t he pac ka ge i nsert f or s pecific details s urr o u n di n g t he 
a d mi nistrati o n of fl u dara bi ne.
6. 1. 3. 3.   
Mes na
Mes na is a det o xif yi n g a ge nt use d t o i n hi bit 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. 
Mes na 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 m ost rece nt versi o n of 
t he pac ka ge i nsert f or s pecific details s urr o u n di n g t he a d mi nistrati o n of mes na.
6. 1. 4.   
A xic a bt a ge ne Cil ole ucel 
A xica bta ge ne cil ole ucel is a n I P f or t his st u d y. 
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 
sli g htl y cl o u d y a n d crea m t o yell o w c ol or.  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 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 t hat via ble 

A xica bta ge ne Cil ole ucel
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li ve a ut ol o g o us cells are a d mi nistere d t o t he s u bject.  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.  T he pr o d uct is la belle d per l ocal 
re g ulati o ns wit h t he s u bject’s u ni q ue s u bject I D n u m ber assi g ne d at t he ti me of scree ni n g.  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.  T he pr o d uct 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 D 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. 1. 5.   
Ut o mil u m a b
6. 1. 5. 1.  
F or m ulati o n, Pac ka gi n g, a n d Ha n dli n g 
Ut o mil u ma b dr u g pr o d uct will be s u p plie d i n clear glass vials at a 2 5 m g/ m L ( 1 2 5 m g/ vial) 
c o nce ntrati o n as sterile s ol uti o n f or I V a d mi nistrati o n a n d la bele d as o pe n s u p plies.  See t he I P M 
f or a d diti o nal i nf or mati o n.
6. 1. 5. 2.   
D osa ge, A d mi nistrati o n, a n d C o m plia nce 
Ut o mil u ma b will be a d mi nistere d as a n I V i nf usi o n o nce e ver y f o ur wee ks ( ± 2  da ys) starti n g o n 
eit her Da y 1 or Da y 2 1 ( de pe n di n g o n c o h ort).  T he starti n g d ose of ut o mil u ma b will be 1 0 m g.
As wit h a n y a nti b o d y, aller gic reacti o ns t o d ose a d mi nistrati o n are p ossi ble.  T heref ore, 
a p pr o priate dr u gs a n d me dical e q ui p me nt t o treat aller gic or a na p h ylactic reacti o ns m ust be 
i m me diatel y a vaila ble, a n d st u d y pers o n nel m ust be trai ne d t o rec o g nize a n d treat aller gic a n d 
a na p h ylactic reacti o ns.  S u bjects s h o ul d be i nstr ucte d t o re p ort a n y dela ye d reacti o ns t o t he 
i n vesti gat or i m me diatel y.  Fr o m cli nical trial e x perie nce, o nl y occasi o nal mil d, i nf usi o n-relate d 
reacti o ns ha ve bee n o bser ve d, w hic h di d n ot re q uire t he usa ge of a n y c o nc o mita nt me dicati o ns or 
pre me dicati o ns.  
T he e xact d urati o n of i nf usi o n s h o ul d be rec or de d i n b ot h s o urces d oc u me nt a n d case re p ort 
f or ms ( C R Fs).  T he i nf usi o n rate s h o ul d be re d uce d or i nterr u pte d i n t he case of s y m pt o ms of 
i nf usi o n reacti o n, a n d s y m pt o matic treat me nt s h o ul d be a d mi nistere d.  T he i nf usi o n ma y be 

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3 7
0 7 J u ne 2 0 2 2
c o nti n ue d at o ne- half t he pre vi o us rate u p o n i m pr o ve me nt of s y m pt o ms.  If s y m pt o ms persist or 
w orse n, t he i nf usi o n s h o ul d be disc o nti n ue d.  T he st u d y dr u g d ose escalati o n le vels are s h o w n i n 
Ta ble 2 . 
6. 1. 5. 3.   
D ose M o dificati o n
N o re d ucti o n or m o dificati o n of ut o mil u ma b d ose will be all o we d wit hi n eac h c o h ort.  A n y 
t o xicit y ass ociate d or p ossi bl y ass ociate d wit h ut o mil u ma b treat me nt s h o ul d be ma na ge d 
acc or di n g t o ut o mil u ma b I B.  A d diti o nal la b orat or y tests or bi o psies ma y be use d t o deter mi ne a 
p ossi ble i m m u n o ge nic eti ol o g y. 
Ut o mil u ma b ma y be wit h hel d f or u p t o 5 6 da ys.  If ut o mil u ma b has t o be wit h hel d f or > 5 6 da ys 
d ue t o dr u g-relate d e ve nts wit h o ut a p pr o priate res ol uti o n, des pite a p pr o priate ma na ge me nt, t he n 
ut o mil u ma b s h o ul d be disc o nti n ue d.  H o we ver, if, i n t he i n vesti gat or’s j u d g me nt, t he s u bject is 
li kel y t o deri ve be nefit fr o m res u mi n g ut o mil u ma b after a 5 6- da y dela y, ut o mil u ma b ma y be 
restarte d o nl y wit h t he a p pr o val of t he me dical m o nit or.
Ut o mil u ma b d osi n g will be dela ye d f or o n g oi n g Gra de 2 or hi g her C R S or Gra de 2 or hi g her 
N Es.  T he dela ye d d ose will be gi ve n u p o n res ol uti o n of C R S a n d ne ur ol o gic e ve nts t o Gra de 1 
or l o wer. If a d ose is hel d > 1 0 da ys be y o n d t he sc he d ule d a d mi nistrati o n, it will n ot be gi ve n. 
S h o ul d a n ut o mil u ma b d ose be dela ye d ≤ 1 0 da ys, t he re mai ni n g d oses s h o ul d be a d mi nistere d 
e ver y 2 8 da ys ( ± 2 da ys) fr o m t he o nset date of first d ose.  Li ke wise, all pr ot oc ol-re q uire d 
pr oce d ures s h o ul d f oll o w t he sa me sc he d ule, as o utli ne d i n t he S O As be gi n ni n g o n t he o nset date 
of t he first d ose.
6. 1. 6.   
C o nc o mit a nt T her a p y
C o nc o mita nt t hera p y refers t o treat me nt t hat s u bjects recei ve d uri n g t he c o n d uct of t he st u d y.
D uri n g t he c o urse of t he st u d y, i n vesti gat ors ma y prescri be a n y c o nc o mita nt t hera pies dee me d 
necessar y t o pr o vi de a de q uate s u p p orti ve care e xce pt t h ose me dicati o ns liste d i n Secti o n 6. 1. 7 .
All c o nc o mita nt t hera pies, i ncl u di n g me dicati o ns, o ver-t he-c o u nter pr o d ucts, i nt u bati o n, dial ysis, 
o x y ge n, a n d bl o o d pr o d ucts, will be rec or de d.
F or s u bjects w h o recei ve a xica bta ge ne cil ole ucel treat me nt:  

C o nc o mita nt t hera pies will be rec or de d fr o m t he date of t he i nf or me d c o nse nt u ntil 3 0 da ys 
after t he fi nal ut o mil u ma b i nf usi o n or f or 1 2 wee ks after c o m pleti n g treat me nt wit h 
a xica bta ge ne cil ole ucel ( w hic he ver is l o n ger).  

After t he p ost-treat me nt f oll o w- u p, tar gete d c o nc o mita nt t hera pies will be rec or de d f or eit her 
2 4 m o nt hs after a xica bta ge ne cil ole ucel i nf usi o n or u ntil 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.  

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3 8
0 7 J u ne 2 0 2 2
F or s u bjects w h o are e nr olle d, b ut n ot d ose d wit h a xica bta ge ne cil ole ucel, c o nc o mita nt t hera pies 
will be rec or de d fr o m t he date of t he i nf or me d c o nse nt u ntil 3 0 da ys after t he last st u d y-s pecific 
pr oce d ure has occ urre d (e g, le u ka p heresis, c o n diti o ni n g c he m ot hera p y) or u ntil t he i nitiati o n of 
ne w a nti-ca ncer t hera p y, w hic he ver occ urs first.
F or s u bjects w h o are n ot e nr olle d (e g, scree n fail ure), c o nc o mita 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.
S pecific c o nc o mita nt t hera p y 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. 1. 7.  
E xcl u de d Me dic ati o ns
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.
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 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, s uc h as n o nster oi dal a nti-i nfla m mat or y a ge nts, 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 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.  
T hera pe utic d oses of s yste mic a ntic oa g ula nts, s uc h as u nfracti o nate d he pari n a n d l o w- m olec ular 
wei g ht he pari n, s h o ul d be a v oi de d a n yti me s u bjects are at ris k of blee di n g d ue t o 
t hr o m b oc yt o pe nia.
Treat me nts 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 ds ( ot her t ha n t h ose 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, c o ntact t he s p o ns or’s me dical 
m o nit or.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 3 9
0 7 J u ne 2 0 2 2
6. 1. 8.  
S u bse q ue nt T her a p y
S u bse q ue nt t hera p y refers t o treat me nt a d mi nistere d after i n vesti gati o nal treat me nt t hat is 
necessar y t o treat a s u bject’s disease.
S u bse q ue nt t hera p y a d mi nistere d after i n vesti gati o nal treat me nt t hat is necessar y t o treat a 
s u bject’s L B C L, 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, 
ste m cell tra ns pla nt, or ra diati o n t hera p y, will be rec or de d f or all s u bjects d ose d u ntil o ne of t he 
f oll o wi n g ha p pe ns: t he s u bject tra nsiti o ns t o t he K T- U S- 9 8 2- 5 9 6 8 L T F U st u d y, 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.  
F or s u bjects w h o are e nr olle d, b ut d o n ot recei ve i n vesti gati o nal treat me nt i nf usi o n, a n y 
a d diti o nal a nti-ca ncer t hera p y will als o be c ollecte d u ntil t he s u bject c o m pletes t heir partici pati o n 
i n t he c urre nt st u d y, 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, w hic he ver 
occ urs first. 
6. 1. 9.   
A xic a bt a ge ne Cil ole ucel T o xicit y M a n a ge me nt 
T o date, t he f oll o wi n g ris ks ha ve bee n i de ntifie d wit h a xica bta ge ne cil ole ucel: C R S, N Es, 
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 urrent 
a xica bta ge ne cil ole ucel 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. 
6. 1. 1 0.   
Ut o mil u m a b T o xicit y M a n a ge me nt
Refer t o t he c urre nt ut o mil u ma b I B f or details re gar di n g t o xicit y ma na ge me nt g ui da nce.  

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 0
0 7 J u ne 2 0 2 2
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 S O A Ta ble 5 , Ta ble 6 , a n d Ta ble 7  f or a n o utli ne of the pr oce d ures 
re q uire d.  
T he visit sc he d ule is calc ulate d fr o m a xica bta ge ne cil ole ucel i nf usi o n o n Da y 0. 
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 best practices f or 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 partici pates 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 uatel y e x plai ni n g t he st u d y desi g n, 
a ntici pate d be nefits, a n d p ote ntial ris ks.  S u bjects s h o ul d si g n t he m ost c urre nt 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 I C F bef ore 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 m ust 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 m ust be 
si g ne d a n d date d b y b ot h t he s u bject a n d 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, a n d a c o p y of t he I C F will be 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 n of 
t he I R B/I E C-a p pr o ve d I C F if t he ne w versi o n is rele va nt t o t heir partici pati o n.
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 i 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 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 ( S O C) are n ot c o nsi dere d st u d y-s pecific a n d, t heref ore, 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 pr o vi de d t he y occ ur wit hi n 
t he ti me all o wa nce 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, I nc., will assi g n a scree ni n g 
n u m ber t o t he s u bject, as descri be d i n Secti o n 4 .  

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 1
0 7 J u ne 2 0 2 2
See Secti o n 7. 2. 1  f or t he st u d y pr oced ures f or s u bjects w h o rescree n i nt o t he st u d y.  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  a n d w h o c o m mence le u ka p heresis 
will be e nr olle 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 o n t he s u bject scree ni n g 
l o g, a n d t he reas o ns f or faili n g scree ni n g s h o ul d als o be rec or de d.  T he scree ni n g wi n d o w is 
2 8 da ys pri or t o e nr oll me nt.
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. 2. 1.   
Rescree ni n g
S u bjects w h o are u na ble t o c o m plete or meet t he eli gi bilit y criteria d uri n g t he 2 8- da y scree ni n g 
peri o d will be per mitte d t o rescree n o ne ti me.  S u bjects will retai n t he sa me s u bject I D  n u m ber 
assi g ne d at t he ori gi nal scree ni n g.  If rescree ni n g occ urs wit hi n 2 8 da ys of t he si g ni n g of t he 
ori gi nal i nf or me d c o nse nt, it is o nl y necessar y t o perf or m t he pr oce d ure(s)/assess me nt(s) t hat di d 
n ot ori gi nall y meet t he eli gi bilit y criteria; all ot her i nitial scree ni n g pr oce d ures/assess me nts d o 
n ot nee d t o be re peate d.  If rescree ni n g occ urs or le u ka p heresis is dela ye d m ore t ha n 2 8 da ys 
fr o m t he si g ni n g of t he ori gi nal i nf or me d c o nse nt, s u bjects m ust be re-c o nse nte d a n d re peat all 
scree ni n g pr oce d ures/assess me nts.
7. 3.   
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, year 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 a p ossi ble ass ociati o n bet wee n t hese varia bles a n d s u bject safet y a n d 
treat me nt effecti ve ness.
7. 4.   
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 E 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 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. 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.  All fi n di n gs will be rec or de d i n t he C R Fs.
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. 5.  
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.  All p h ysical 
e xa m 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 Es.  
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 scree ni n g a n 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 are m o nit ore d 
d uri n g a n d after st u d y treat me nt a n d as cli nicall y i n dicate d.  

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 2
0 7 J u ne 2 0 2 2
F or t he first i nf usi o n of ut o mil u ma b, t he s u bject’s vital si g ns ( 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) s h o ul d be deter mi ne d wit hi n 6 0 mi n utes 
bef ore t he start of i nf usi o n, d uri n g t he i nf usi o n (e ver y 1 5 [ ± 5] mi n utes), a n d 3 0 ( ± 1 0) mi n utes 
a n d 2 h o urs ( ± 1 5 mi n utes) after t he start of i nf usi o n. F or s u bse q ue nt ut o mil u ma b i nf usi o ns, vital 
si g ns will be c ollecte d wit hi n 6 0 mi n utes bef ore t he start of i nf usi o n, d uri n g t he i nf usi o n if 
cli nicall y i n dicate d or if s y m pt o ms occ urre d i n t he pri or i nf usi o n, a n d 1 h o ur ( ± 1 0 mi n utes) after 
t he start of i nf usi o n.
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. 5. 1.   
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.  E vi de nce of n o pericar dial 
eff usi o n will als o be c o nfir me d per st u d y eli gi bilit y criteria.  B ot h L V E F a n d prese nce of 
pericar dial eff usi o n will be assesse d b y ec h ocar di o gra m ( E C H O) pri or t o e nr oll me nt.  A n E C H O 
t hat was perf or me d after t he s u bject’s last c he m ot hera p y treat me nt ma y als o be use d t o c o nfir m 
eli gi bilit y, pr o vi de d t hat it occ urre d ≤ 2 8 da ys pri or t o si g ni n g t he c o nse nt.
T o esta blis h a baseli ne, a 1 2-lea d electr ocar di o gra m ( E C G) will als o be perf or me d d uri n g t he 
scree ni n g peri o d.
7. 6.   
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, a n d a n y of t he f oll o wi n g a b n or malities will be 
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, a n d 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 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 o n e ver y ot her da y d uri n g t he o bser vati o n peri o d, w hic h 
m ust last a mi ni m u m of 7 da ys.  
S u bjects will be s pecificall y as ke d a b o ut c ha n ges i n ne ur ol o gical stat us si nce t he pre vi o us 
ne ur ol o gical e xa mi nati o n, as n ote d i n t he S O A (see Ta ble 5 , Ta ble 6 , a n d Ta ble 7 ).  
7. 7.   
Dise ase 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 }; refer 
t o A p pe n di x 2 .  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.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 3
0 7 J u ne 2 0 2 2
7. 7. 1.  
I m a gi n g
7. 7. 1. 1.  
I ma gi n g at Baseli ne
Eac h s u bject will u n der g o a scree ni n g brai n ma g netic res o na nce i ma gi n g ( M RI) t o r ule o ut C N S 
metastasis d uri n g t he scree ni n g peri o d of t he st u d y.
T o c o nfir m eli gi bilit y a n d/ or t o esta blis h a baseli ne, 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 E T- C T) sca ns of t he nec k, c hest, a b d o me n, a n d pel vis, 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 at scree ni n g.  P E T- C T perf or me d f oll o wi n g t he 
s u bjects last li ne of t hera p y a n d 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 if wit hi n 2 8 da ys pri or t o e nr oll me nt, a n d n o ot her a nti-ca ncer treat me nt has bee n 
a d mi nistere d.  If P E T- C T is perf or me d > 2 8 da ys pri or t o e nr oll me nt or if s u bject recei ves a n y 
a nti-ca ncer t hera p y bet wee n scree ni n g a n d c o n diti o ni n g c he m ot hera p y, t he P E T- C T sca n m ust 
be re peate d t o esta blis h a ne w baseli ne. P E T- C T s h o ul d be perf or me d as cl ose t o e nr oll me nt as 
p ossi ble.
7. 7. 1. 2.  
P ost-treat me nt Res p o nse Assess me nt
T he first pla n ne d p ost-treat me nt P E T- C T t u m or assess me nt will occ ur at Wee k 4.
P E T- C Ts will c o nti n ue at ti me p oi nts o utli ne d i n t he S O A t hr o u g h M o nt h 2 4 or u ntil disease 
pr o gressi o n, w hic he ver c o mes first.  If t he s u bject’s disease has n ot pr o gresse d b y M o nt h 2 4, 
disease assess me nts will c o nti n ue t o be perf or me d per S O C.  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 
t his re q uires a n u nsc he d ule d visit.
7. 7. 1. 3.  
Res p o nse E val uati o n t o Retreat me nt
F or t he p ur p ose of deter mi ni n g res p o nse t o 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.
7. 7. 2.   
Deter mi n ati o n of B o ne M arr o w I n v ol ve me nt
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 t he start of c o n diti o ni n g c he m ot hera p y.  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 t here is e vi de nce of baseli ne b o ne marr o w i n v ol ve me nt a n d 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  
(I H C).  Refer t o A p pe n di x 2  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 }. 

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 4
0 7 J u ne 2 0 2 2
B o ne marr o w as pirate/ bi o ps y s h o ul d als o be c o nsi dere d t o e val uate he m o p ha g oc ytic 
l y m p h o histi oc yt osis ( H L H) as i n dicate d.  Refer t o t he a xica bta ge ne cil ole ucel I B f or a d diti o nal 
i nf or mati o n.
7. 8.   
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
7. 8. 1.  
Le u k a p heresis 
S u bjects m ust re mai n eli gi ble per t he eli gi bilit y criteria o utli ne d i n Secti o n 5  pri or t o t he start of 
le u ka p heresis. 
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 eli gi bilit y c o nfir mati 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 eli gi bilit y c o nfir mati o n.  
After a s u bject c o m me nces le u ka p heresis, t he s u bject will be c o nsi dere d e nr olle d i nt o t he st u d y.  
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 L) 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 5  a n d Ta ble 6  f or a listi n g of st u d y pr oced ures t o be c o m plete d o n t he 
le u ka p heresis c ollecti o n da y (pri or t o t he start of le u ka p heresis).  L ocal a n d ce ntral la bs ca n be 
c ollecte d o n t he da y pri or t o le u ka p heresis.
7. 8. 2.   
C o n diti o ni n g C he m ot her a p y Peri o d
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.  

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 5
0 7 J u ne 2 0 2 2
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 c o nsi dere d t o be dia g n oses of e xcl usi o n a n d, t h us, re q uire 
a d oc u me nte d w or k u p t o de m o nstrate t hat all ot her p ossi ble dia g n oses are r ule d o ut. 
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 w he n 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 7. 8. 2. 1 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.
7. 8. 2. 1.  
Criteria Pri or t o C o n diti o ni n g C he m ot hera 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 7. 8. 3. 1. 1 . 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 c o u nt ( 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/ µ L, ra pi dl y 
i ncreasi n g W B C, or differe ntial wit h hi g h perce nta ge of se g me nts/ 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, e ye, ear, n ose, a n d t hr oat ( H E E N T) a n d 
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).  

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).

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 6
0 7 J u ne 2 0 2 2

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 ol y merase c hai n reacti o n [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.
After 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.
7. 8. 2. 2.  
C o n diti o ni n g C he m ot hera p y A d mi nistrati o n ( Da y – 5 t hr o u g h Da y – 3 Pri or t o 
A xica bta 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 a n d t hr o u g h Da y – 3, wit h 2 rest da ys ( Da y – 2 a n d Da y – 1) 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 c ycl o p h os p ha mi de a n d fl u dara bi ne will be a d mi nistere d i n 
acc or da nce wit h t he f oll o wi n g 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 6 0 mi n utes ( ± 1 5 mi n utes) f oll o we d b y

Fl u dara bi ne 3 0 m g/ m 2 I V o ver 3 0 mi n utes ( ± 1 5 mi n utes) f oll o we d b y

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 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 c he m ot hera p y a n d t hr o u g h o ut t he 
2 4- h o ur peri o d f oll o wi n g c he m ot hera p y (a p pr o xi matel y 2 L/ 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 5  a n d Ta ble 6  f or a listi n g of st u d y pr oced ures t o be c o m plete d d uri n g 
t he 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
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 7
0 7 J u ne 2 0 2 2
7. 8. 3.  
I n vesti g ati o n al Pr o d uct Tre at me nt Peri o d
7. 8. 3. 1.   
A xica bta ge ne Cil ole ucel Pretreat me nt Criteria 
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 7. 8. 3. 1. 1 . 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/ µ L, ra pi dl y i ncreasi n g W B C, or 
differe ntial wit h hi g h perce nta ge of se g me nts/ 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 a n d 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 i nf usi o n ( 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.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 8
0 7 J u ne 2 0 2 2
After 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.
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 t o re peat c o n diti o ni n g c he m ot hera p y. 
7. 8. 3. 1. 1.  
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
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 hest X-ra y), 
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 vaila 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 uri nar y a nal ysis 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 ])

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.  

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 4 9
0 7 J u ne 2 0 2 2
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 t o 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.  
7. 8. 3. 2.   
A xica bta ge ne Cil ole ucel Pre me dicati 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 n 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.  Alter nati ves t o t he rec o m me n dati o ns bel o w s h o ul d be 
disc usse d wit h t he me dical m o nit or.

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
7. 8. 3. 3.   
A xica bta ge ne Cil ole ucel A d mi nistrati o n Da 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 N Es.  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 N Es 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 N Es > 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.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 0
0 7 J u ne 2 0 2 2
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 nisteri n g 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. 5 ).  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.  
7. 8. 3. 4.   
Ut o mil u ma b A d mi nistrati o n
Ut o mil u ma b treat me nt c o nsists of a n I V i nf usi o n gi ve n e ver y 4 wee ks f or 6 m o nt hs or u ntil 
disease pr o gressi o n, w hic he ver c o mes first. I n t he P hase 1 p orti o n of t he st u d y, t he d oses of 
ut o mil u ma b a d mi nistere d will be 1 0 m g, 3 0 m g, 1 0 0 m g, 2 0 0 m g, a n d 4 0 0 m g be gi n ni n g at 
eit her Da y 1 or Da y 2 1 after a xica bta ge ne cil ole ucel i nf usi o n.  T he S R T will ma ke 
rec o m me n dati o ns o n f urt her st u d y c o n d uct of P hase 1 a n d pr o gressi o n t o P hase 2 as de picte d i n 
Fi g ure 5  a n d o utli ne d i n Secti o n 9. 1 0 .
S u bjects will re mai n i n cli nic f or p ost- ut o mil u ma b o bser vati o n f or at least 2 h o urs after t he e n d 
of t he first i nf usi o n of ut o mil u ma b a n d f or at least 1 h o ur after t he e n d of s u bse q ue nt i nf usi o ns.
F or m ore detaile d i nf or mati o n re gar di n g a d mi nistrati o n, refer t o t he I P M a n d I B.
7. 8. 3. 5.   
A xica bta ge ne Cil ole ucel Retreat me nt 
S u bjects w h o ac hie ve 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 
w hile e nr olle d i n t his st u d y. T he sec o n d c o urse of treat me nt m ust be gi ve n wit hi n 2 4 m o nt hs of 
t he i nitial a xica bta ge ne cil ole ucel i nf usi o n.
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 Wee k 4 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. 

C D 1 9 t u m or e x pressi o n c o nfir me d l ocall y b y bi o ps y after disease pr o gressi o n a n d pri or t o 
retreat me nt.

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, 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 ( 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 ] Gra de ≥ 4) 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.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 1
0 7 J u ne 2 0 2 2

T o xicities relate d t o c o n diti o ni n g c he m ot hera p y (c ycl o p h os p ha mi de a n d fl u dara bi ne), 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 
retreat 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 bject ma y be retreate d if t he 
ori gi nal st u d y eli gi bilit y criteria are met).

S u bject meets a xica bta ge ne cil ole ucel pretreat me nt 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 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 retreat me nt.
T he decisi o n t o retreat s h o ul d be ma de i n c o ns ultati o n wit h t he s p o ns or’s 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 usi n g 
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.  
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.  Res ults were i de ntical i n a se nsiti vit y a nal ysis t hat 
e xcl u de d res p o nses i n 4 s u bjects w h o u n der we nt A S C T f oll o wi n g retreat me nt.    
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 wit h t he e xce pti o n of ut o mil u ma b 
i nf usi o ns.
7. 9.  
L a b or at or y
7. 9. 1.  
L oc al L a b A n al ysis
Assess me nts liste d i n Ta ble 4  will be perf or med at t he l ocal la b orat or y 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 f or f urt her safet y testi n g.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 2
0 7 J u ne 2 0 2 2
T a ble 4.
L oc al L a b or at or y P ar a meters
Ser u m C he mistries
He m at ol o g y
Ot her
Al b u mi n
A L T/ G P T
A L P
A S T/ G O P
Bicar b o nate t otal
Bilir u bi n direct
Bilir u bi n t otal
B U N or urea a 
Calci u m t otal
C hl ori de
Creati ni ne
Creati ni ne cleara nce
Gl uc ose
I n or ga nic P h os p h or us
L D H
Ma g nesi u m t otal
P otassi u m
S o di u m
Uric aci d b 
C B C wit h differe ntial b 
C R P
Ferriti n
Pre g na nc y test c
A b bre viati o ns:  A L P, al kali ne p h os p hatase; A L T, ala ni ne a mi n otra nsferase; A S T, as partate a mi n otra nsferase; B U N, bl o o d urea 
nitr o ge n; C B C, c o m plete bl o o d c o u nt; C R P, C-reacti ve pr otei n; G O P, ser u m gl uta mic- o xal oacetic tra nsa mi nase; G P T, ser u m 
gl uta mic- p yr u vic tra nsa mi nase; L D H, lactate de h y dr o ge nase.
a  
If B U N test ca n n ot be a nal yze d b y t he l ocal la b, urea s h o ul d be a nal yze d. 
b  
Per i nstit uti o nal g ui deli nes.
c   
W o me n of c hil d beari n g p ote ntial o nl y.
7. 9. 2.   
Ce ntr al L a b or at or y A n al yses
Bi o mar ker a nal ysis will be perf or me d o n bl o o d, C S F, a n d t u m or sa m ples t o e val uate 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 i n c o nj u ncti o n wit h ut o mil u ma b. 
Pr o g n ostic mar kers f or a g gressi ve N H L a n d relate d t o t he t u m or i m m u ne e n vir o n me nt ma y als o 
be e val uate d.
Cli nical bi os peci me ns (e g, t u m or tiss ue, b o ne marr o w, c o m plete bl o o d, C S F, or ot her b o dil y 
fl ui ds) will be se nt fr o m cli nical st u d y ce nters t o t he ce ntral la b orat or y f or sa m ple pr ocessi n g, 
accessi o ni n g, a n d distri b uti o n t o s pecialt y la b orat ories or Kite. Sa m ples will be o btai ne d at t he 
ti mes i n dicate d i n t he S O A.  A d diti o nal sa m ples (e g, c o m plete bl o o d, uri ne, C S F, tiss ue) ma y be 
c ollecte d as nee de d f or f urt her safet y testi n g.
A p heresis a n d pr o d uct retai ns are pr o vi de d t o t he ce ntral la b or are st ore d at a Kite s p o ns ore d 
ce ntral la b orat or y.  C o m plete i nstr ucti o ns re gar di n g sa m ple s u b missi o n t o ce ntral la b orat ories are 
pr o vi de d i n t he Ce ntral La b orat or y Ma n ual.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 5
0 7 J u ne 2 0 2 2

Ser u m sa m ples will be assa ye d f or ut o mil u ma b c o nce ntrati o ns wit h t he use of a vali date d 
a nal ytical met h o d.  P K sa m ples are t o be c ollecte d at t he f oll o wi n g ti me p oi nts (i n relati o n t o 
ut o mil u ma b i nf usi o n): 

I nf usi o n 1: pri or t o i nf usi o n; e n d of i nf usi o n; a n d o n Da ys 3, 7, 1 4 ( Wee k 2), a n d 
2 1 ( Wee k 3) f oll o wi n g ut o mil u ma b i nf usi o n

I nf usi o ns 2 a n d 4: pri or t o i nf usi o n; e n d of i nf usi o n; a n d 2 da ys f oll o wi n g ut o mil u ma b 
i nf usi o n 2

At t he p ost-treat me nt f oll o w- u p visit 
7. 9. 2. 3. 2.  
Sa m ple C ollecti o ns f or S u bjects wit h Ut o mil u ma b A d mi nistere d Starti n g o n 
Da y 2 1

A D A sa m ples are t o be c ollecte d at t he f oll o wi n g ti me p oi nts (i n relati o n t o ut o mil u ma b 
i nf usi o n):

I nf usi o n 1 a n d 2: pri or t o i nf usi o n 

At t he p ost-treat me nt f oll o w- u p visit

P K sa m ples are t o be c ollecte d at t he f oll o wi n g ti me p oi nts (i n relati o n t o ut o mil u ma b 
i nf usi o n): 

I nf usi o n 1: pri or t o i nf usi o n, e n d of i nf usi o n, a n d 2 a n d 8 ( Wee k 4) da ys f oll o wi n g t he 
ut o mil u ma b i nf usi o n

I nf usi o ns 2 a n d 4: pri or t o i nf usi o n; e n d of i nf usi o n; a n d 2 da ys f oll o wi n g ut o mil u ma b 
i nf usi o n 2

At t he p ost-treat me nt f oll o w- u p visit 
7. 9. 2. 3. 3.  
Sa m ple C ollecti o ns f or S u bjects i n P hase 2

Ser u m sa m ples will be assa ye d f or t he prese nce of A D As t o ut o mil u ma b wit h t he use of 
vali date d i m m u n oassa ys.  A D A sa m ples are t o be c ollecte d at t he f oll o wi n g ti me p oi nts 
(i n relati o n t o ut o mil u ma b i nf usi o n):

I nf usi o n 1 a n d 2: pri or t o i nf usi o n

At t he p ost-treat me nt f oll o w- u p visit

Ser u m sa m ples will be assa ye d f or ut o mil u ma b c o nce ntrati o ns wit h t he use of a vali date d 
a nal ytical met h o d.  P K sa m ples are t o be c ollecte d at t he f oll o wi n g ti me p oi nts (i n relati o n t o 
ut o mil u ma b i nf usi o n): 

I nf usi o n 1, 2, a n d 4: pri or t o a n d f oll o wi n g t he e n d of i nf usi o n

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 6
0 7 J u ne 2 0 2 2
7. 9. 2. 4.  
Pr o d uct C haracteristics
I n a d diti o n, 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 ba n ke d a n d 
ma y be a nal yze d b y i m m u n o p he n ot y pi n g, q ua ntitati ve p ol y merase c hai n reacti o n  (q P C R), a n d/ or 
ge ne e x pressi o n pr ofili n g.  
 
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. 
7. 9. 2. 5.  
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.  R C R testi n g will occ ur at t he f oll o wi n g 
ti me p oi nts: baseli ne, Wee k 1 2, Wee k 2 0/ 2 3 ( de pe n di n g o n c o h ort), a n d M o nt h 1 2.  T hereafter, 
sa m ples will be c ollecte d yearl 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.  A d diti o nal i nf or mati o n is pr o vi de d i n t he a xica bta ge ne 
cil ole ucel I B. 
7. 1 0.  
P ost-tre at me nt Assess me nt Peri o d
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 a p ost-treat me nt 
f oll o w- u p visit. 
If a s u bject d oes n ot res p o n d t o treat me nt at a n y ti me d uri n g t he st u d y, t he n 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 T F U p orti o n of t he st u d y.  
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.
7. 1 1.  
L o n g-ter m F oll o w- u p Peri o d
All e nr olle d s u bjects will be f oll o we d i n t he L T F U peri o d f or safet y a nal ysis a n d s ur vi val a n d 
disease stat us, if a p plica ble.  S u bjects will be gi n t he L T F U peri o d after c o m pleti o n of t he 
p ost-treat me nt f oll o w- u p visit ( w het her t he y ha ve res p o n de d t o treat me nt or we nt strai g ht t o t he 
p ost-treat me nt f oll o w- u p visit d ue t o disease pr o gressi o n).  S u bjects w h o recei ve d a n i nf usi o n of 
a xica bta ge ne cil ole ucel will be gi ve n t he o p p ort u nit y t o tra nsiti o n t o a se parate L T F U st u d y, K T-
U S- 9 8 2- 5 9 6 8, after pr o vi di n g si g ne d i nf or me d c o nse nt. S u bjects w h o di d n ot res p o n d t o 
treat me nt 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 nti-ca 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 a nti-
ca ncer t hera p y use.  If t he 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, usi n g b ot h t he tele p h o ne a n d eit her mail or e mail t o 
C CI

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 7
0 7 J u ne 2 0 2 2
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 n 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. 
Refer t o t he S O A 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 T F U peri o d.
S u bjects w h o are e nr olle d, b ut di d n ot recei ve t he I P(s) will be f oll o we d o nl y u ntil t he e n d of t his 
st u d y 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: 

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 

Disease assess me nt per pr ot oc ol

A E/ S A Es per Secti o n 9

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 8
0 7 J u ne 2 0 2 2
T a ble 5.
Sc he d ule of Assess me nts C o h ort 1, 2, 3, 4, 5 a n d P h ase 2 ( as a p plic a ble) Ut o mil u m a b A d mi nistr ati o n 
St arti n g o n D a y 1
Pr oce d ures
Scree ni n g
E nr oll me nt/
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 Peri o d
P ost-
tre at me nt 
F oll o w- u p
D a y
Wit hi n 
2 8 d a ys of 
e nr oll me nt 
  
- 5 
- 4 
- 3 
0 
1 
2- 7
Wee k 
2
( 1 4 ± 2 
d a ys)
Wee k 
3
( 2 1 ± 2 
d a ys)
Wee k 
4
( 2 8 ± 3 
d a ys)
Wee k 
8
( ± 1 
wee k)
Wee k 
1 2
( ± 1 
wee k)
Wee k 
1 6
( ± 1 
wee k)
Wee k 
2 0
( ± 1 
wee k)
3 0 d a ys
( ± 1 wee k) 
f oll o wi n g l ast 
ut o mil u m a b 
i nf usi o n 
Ut o mil u m a b I nf usi o n #
# 1
# 2 
# 3 
# 4 
# 5 
# 6
Me dical Hist or y 
X
E C O G Perf or ma nce Stat us
X
1 2-lea d E C G
X
E C H O
X
Brai n M RI
X
Ne ur ol o gical Assess me nt 
X
X 
Q O D 1
P E T- C T/ Disease Assess me nt 2
X
X
X
X
Arc hi val/ Fres h T u m or 3
X
D 5
P ost- Pr o gressi o n Bi o ps y 4
X
P h ysical E xa m
X
X
X 
X 
X 
X
X 
X 
X 
X 
X
X
Vital Si g ns ( B P, H R, O 2 
sat urati o n, R R, Te m perat ure) 5
X
X 
X 
X 
X 
X 
X 1 5
X 
X 
X 
X 1 5
X 1 5
X 1 5
X 1 5
X 1 5
X
Wei g ht (pl us Hei g ht at 
scree ni n g)
X
X
Pre g na nc y Test 6 (ser u m or 
uri ne)
X
X
X
L u m bar P u nct ure 7
X
D 5
X
Bl o o d Dra w f or C he mistr y 
Pa nel
X
X 
X 
X 
X 
X 
X 
X 
X
X 
X 
X 
X 
X
X

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 5 9
0 7 J u ne 2 0 2 2
Pr oce d ures
Scree ni n g
E nr oll me nt/
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 Peri o d
P ost-
tre at me nt 
F oll o w- u p
D a y
Wit hi n 
2 8 d a ys of 
e nr oll ment 
  
- 5 
- 4 
- 3 
0 
1 
2- 7
Wee k 
2
( 1 4 ± 2 
d a ys)
Wee k 
3
( 2 1 ± 2 
d a ys)
Wee k 
4
( 2 8 ± 3 
d a ys)
Wee k 
8
( ± 1 
wee k)
Wee k 
1 2
( ± 1 
wee k)
Wee k 
1 6
( ± 1 
wee k)
Wee k 
2 0
( ± 1 
wee k)
3 0  d a ys
( ± 1 wee k) 
f oll o wi n g l ast 
ut o mil u m a b 
i nf usi o n 
Ut o mil u m a b I nf u si o n #
# 1
# 2 
# 3 
# 4 
# 5 
# 6
Bl o o d Dra w f or C B C 
w/ Differe ntial
X
X 
X 
X 
X 
X 
X 
X 
X
X 
X 
X 
X 
X
X
Bl o o d Dra w f or C R P
X
Bl o o d Dra w f or C yt o ki nes 8, 9
X
X 
X 
D 3, D 7, D 1 4 
X 
X 9
X 9
X 9
Ce ntral C B C w/ Differe ntial 
a n d P B M C 8, 1 0
X
X 
X
D 3, D 7, D 1 0, 
D 1 4
X 
X 1 0
X 1 0
X 
X 
X
X
Bl o o d Dra w f or Ut o mil u ma b 
P K 1 1  
X
D 3, 
D 7
X 
X 
X
X
X
Bl o o d Dra w f or Ut o mil u ma b 
A D A 1 2
X
X
X
Le u ka p heresis 
X
C ycl o p h os p ha mi de/ Fl u dara bi ne
X 
X 
X
A xica bta ge ne Cil ole ucel 
I nf usi o n I V
X
Ut o mil u ma b I nf usi o n I V 1 3
D 1
D 2 9 
D 5 7 
D 8 5 
D 1 1 3 
D 1 4 1
A d verse E ve nts/ C o nc o mita nt 
Me dicati o n
1 4
X
A b bre viati o ns:  C B C, c o m plete bl o o d c o u nt; 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 ute d t o m o gra p h y; S A E, seri o us a d verse 
e ve nt; I P, i n vesti gati o nal pr o d uct; D, da y; I V, i ntra ve n o us; A D A, a nti- dr u g a nti b o d y; C R P, C-reacti ve pr otei n; P K, p har mac o ki netics; 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; M RI, ma g netic res o na nce i ma gi n g; B P, bl o o d press ure; H R, heart rate; R R, res pirati o n rate; Q O D, < defi ne acr o n y m >. 
1   
Assess me nts o n Da y 1, e ver y ot her da y u ntil Da y 7, a n d as cli nicall y i n dicate d t hereafter. 
2  
P E T- C T ( Nec k- C hest- A b d o me n- Pel vis)/ Disease Assess me nt: P E T- C T perf or me d f oll o wi n g t he s u bject’s last li ne of t hera p y a n d pri or t o si g ni n g t he i nf or me d c o nse nt ma y be 
use d f or c o nfir mati o n of eli gi bilit y if wit hi n 2 8 da ys pri or t o e nr oll me nt a n d n o ot her a nti-ca ncer treat me nt has bee n a d mi nistere d.  If P E T- C T is perf or me d > 2 8 da ys pri or t o 
e nr oll me nt or if s u bject recei ves a n y a nti-ca ncer t hera p y bet wee n scree ni n g a n d c o n diti o ni n g c he m ot hera p y, t he P E T- C T sca n m ust be re peate d t o esta blis h a ne w baseli ne. 
P E T- C T will als o be perf or me d at Wee k 4, Wee k 1 2, a n d at t he p ost-treat me nt f oll o w- u p visit.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 6 1
0 7 J u ne 2 0 2 2
T a ble 6.
Sc he d ule of Assess me nts C o h ort 1 A, 2 A, 3 A, 4 A, 5 A a n d P h ase 2 ( as a p plic a ble)
Ut o mil u m a b A d mi nistr ati o n St arti n g o n D a y 2 1
Pr oce d ures
Scree ni n g
E nr oll me nt/
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 Peri o d
P ost-
tre at me nt 
F oll o w- u p
D a y
Wit hi n 2 8 
d a ys of 
e nr oll me nt 
  
- 5 
- 4 
- 3 
0 
1- 7
Week 
2
(14 ± 2 
days)
Week 
3
(21 ± 
2 
days)
Week 
4
(28 ± 
3 
days)
Week 
7
( ±1 
wee k)
Week 
11
( ± 1 
wee k)
Week 
1214
( ± 1 
wee k)
Week 
15
( ± 1 
wee k)
Week 
19 
( ± 1 
wee k)
Week 
23 
( ± 1 
wee k)
3 0 d a ys 
( ± 1 wee k) 
f oll o wi n g l ast 
ut o mil u m a b 
i nf usi o n 
Ut o mil u m a b I nf usi o n #
# 1
# 2 
# 3
# 4 
# 5 
# 6
Me dical Hist or y 
X
E C O G Perf or ma nce Stat us
X
1 2-lea d E C G
X
E C H O
X
Brai n M RI
X
Ne ur ol o gical Assess me nt 
X
X 
Q O D 1
P E T- C T/ Disease Assess me nt 2
X
X
X
X
Arc hi val/ Fres h T u m or 3
X
D 5
P ost- Pr o gressi o n Bi o ps y 4
X
P h ysical E xa m
X
X
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X
X
Vital Si g ns ( B P, H R, O 2 
sat urati o n, R R, Te m perat ure) 5
X
X 
X 
X 
X 
X 
X 
X 
X 1 6
X 
X 1 6
X 1 6
X 
X 1 6
X 1 6
X 1 6
X
Wei g ht (pl us Hei g ht at 
scree ni n g)
X
X
Pre g na nc y Test 6 (ser u m or 
uri ne)
X
X
X
L u m bar P u nct ure 7
X
D 5
X
Bl o o d Dra w f or C he mistr y Pa nel 
X
X 
X 
X 
X 
X 
X 
X 
X 
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 
X 
X 
X 
X 
X 
X 
X 
X
X

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 6 2
0 7 J u ne 2 0 2 2
Pr oce d ures
Scree ni n g
E nr oll me nt/
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 Peri o d
P ost-
tre at me nt 
F oll o w- u p
D a y
W it hi n 2 8 
d a ys of 
e nr oll me nt 
  
- 5 
- 4 
- 3 
0 
1- 7
W eek 
2
(14 ± 2 
days)
W eek 
3
(21 ± 
2 
days)
W eek 
4
(28 ± 
3 
days)
W eek 
7
( ±1 
wee k)
W eek 
11
( ± 1 
wee k)
W eek 
1214
( ± 1 
wee k)
W eek 
15
( ± 1 
wee k)
W eek 
19 
( ± 1 
wee k)
W eek 
23 
( ± 1 
wee k)
3 0 d a ys 
( ± 1 wee k) 
f oll o wi n g l ast 
ut o mil u m a b 
i nf usi o n 
Ut o mil u m a b I nf u si o n #
# 1
# 2 
# 3
# 4 
# 5 
# 6
Bl o o d Dra w f or C R P
X
Bl o o d Dra w f or C yt o ki nes 8, 9
X
X
D 1, D 3, D 7, 
D 1 4
X 9
X 
X 9
X 9
X 9
Ce ntral C B C w/ Differe ntial a n d 
P B M C 8, 1 0
X
X
D 1, D 3, D 7, 
D 1 0, D 1 4
X 1 0
X 
X 1 0
X 1 0
X 
X 
X 
X
X
Bl o o d Dra w f or Ut o mil u ma b 
P K 1 1  
X 1 1
X 
X
X
X
Bl o o d Dra w f or Ut o mil u ma b 
A D A 1 2
X
X
X
Le u ka p heresis 
X
C ycl o p h os p ha mi de/ Fl u dara bi ne
X 
X 
X
A xica bta ge ne Cil ole ucel 
I nf usi o n I V
X
Ut o mil u ma b I nf usi o n I V 1 3
D 2 1
D 4 9 
D 7 7
D 1 0 5 
D 1 3 3 
D 1 6 1
A d verse E ve nts/ C o nc o mita nt 
Me dicati o n
1 5
X
A b bre viati o ns:  C B C, c o m plete bl o o d c o u nt; 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 ute d t o m o gra p h y; S A E, seri o us a d verse 
e ve nt; I P, i n vesti gati o nal pr o d uct; D, da y; I V, i ntra ve n o us; A D A, a nti- dr u g a nti b o d y; C R P, C-reacti ve pr otei n; P K, p har mac o ki netics; 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; M RI, ma g netic res o na nce i ma gi n g; B P, bl o o d press ure; H R, heart rate; R R, res pirati o n rate; Q O D, < defi ne acr o n y m >.
1   
Assess me nts o n Da y 1, e ver y ot her da y u ntil Da y 7, a n d as cli nicall y i n dicate d t hereafter. 
2  
P E T- C T ( Nec k- C hest- A b d o me n- Pel vis)/ Disease Assess me nt: P E T- C T perf or me d f oll o wi n g t he s u bject’s last li ne of t hera p y a n d pri or t o si g ni n g t he i nf or me d c o nse nt ma y be 
use d f or c o nfir mati o n of eli gi bilit y if wit hi n 2 8 da ys pri or t o e nr oll me nt a n d n o ot her a nti-ca ncer treat me nt has bee n a d mi nistere d.  If P E T- C T is perf or me d > 2 8 da ys pri or t o 
e nr oll me nt or if s u bject recei ves a n y a nti-ca ncer t hera p y bet wee n scree ni n g a n d c o n diti o ni n g c he m ot hera p y, t he P E T- C T sca n m ust be re peate d t o esta blis h a ne w baseli ne. 
P E T- C T will als o be perf or me d at Wee k 4, Wee k 1 2, a n d at t he p ost-treat me nt f oll o w- u p visit.
3  
Sites are str o n gl y e nc o ura ge d t o s u b mit arc hi val/fres h t u m or sa m ple: 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 u p t o 2 0 u nstai ne d sli des.  Arc hi ve d a n d 
fres h t u m or sa m ples will be s u b mitte d t o ce ntral la b orat or y after eli gi bilit y has bee n c o nfir me d a n d pri or t o start of c o n diti o ni n g c he m ot hera p y. 
 
. 
C CI

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Kite P har ma, I nc
Cli nical Pr ot oc ol
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A me n d me nt 5
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8  
I n t he e ve nt t his st u d y is ter mi nate d pri or t o t he c o m pleti o n of t he 1 5- year f oll o w u p f or all s u bjects, s u bjects w h o recei ve d a n i nf usi o n of a xica bta ge ne cil ole ucel will be pr o vi de d t he 
o p p ort u nit y t o tra nsiti o n t o a L T F U st u d y ( K T- U S- 9 8 2- 5 9 6 8) after pr o vi di n g si g ne d i nf or me d c o nse nt.  T he s u bject’s fi nal o n-st u d y visit f or t his st u d y ma y be c o m bi ne d wit h t he first 
visit o n t he L T F U st u d y.  T he ti mi n g of t he fi nal o n-st u d y visit/first L T F U st u d y visit will de pe n d o n t he ti mi n g of t he c ollecti o n of all t he s u bject’s data t hat are re q uire d f or t he pla n ne d 
a nal ysis f or t his st u d y.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 6 6
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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 w hile c o nti n ui n g t o partici pate i n t he st u d y.  
T his is referre d t o as partial wit h dra wal of c o nse nt.  Refer t o Secti o n 8. 3  f or i nstr uctio ns o n 
f oll o w- u p a n d data t o be c ollecte d.
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, u n der g o pr oce d ures, a n d c o nti n ue partici pati n g i n st u d y f oll o w- u p.  
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 (refer t o Secti o n 8. 3 ). 
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 P 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 at a n y ti me pri or t o 
st u d y c o m pleti o n.
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 Ps or pr oce d ures i ncl u de a n y of t he f oll o wi n g:

A Es

S u bject re q uest

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 vi n g 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

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Kite P har ma, I nc
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8. 3.  
I nstr ucti o ns f or F oll o w- u p a n d D at a t o Be C ollecte d f or S u bjects Wit h dr a w n 
Fr o m Tre at me nt/ St u d y
If partial wit h dra wal of c o nse nt occ urs ( defi ne d i n Secti o n 8 ), 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 P 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 ( Ta ble 5 , Ta ble 6 , a n d Ta ble 7 ).  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.
If wit h dra wal of f ull c o nse nt occ urs ( defi ne d i n Secti o n 8 ), t he i n vesti gat or is t o disc uss wit h t he 
s u bject t he a p pr o priate pr oce d ures f or wit h dra wal fr o m t he st u d y.  If a s u bject wit h dra ws f ull 
c o nse nt, 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 (e g, deat h 
rec or ds).
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 (e g, f or s u bjects l ost t o f oll o w- u p), 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 retrie ve a ut o ps y re p orts t o c o nfir m stat us of disease at t he ti me of 
deat h, if p ossi ble, per t he l ocal la ws.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
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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, 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 or bl o o d press ure [ B P]) i n a s u bject wit h pre-e xisti n g 
h y perte nsi o n) m ust be pr o vi de d.
A n A E d oes n ot i ncl u de t he f oll o wi n g:

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  

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 

H os pitalizati o n f or st u d y treat me nt i nf usi o ns or st u d y- ma n date d pr oce d ures or h os pitalizati o n 
as a preca uti o nar y meas ure per i nstit uti o nal p olic y  

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 is n ot c o nsi dere d t o be a n A E.  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 as t he pri mar y t u m or 
t y pe (e g, B-cell l y m p h o ma). 
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, it is necessar y t o 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.  If 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 beca use of a n A E, t he n 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 
p ost-treat me nt f oll o w- u p visit of t he S O A. 
9. 2.   
Re p orti n g of A Es
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 e nr oll me nt t hr o u g h 3 0 da ys after c o m pleti n g t he fi nal d ose of 
ut o mil u ma b or 1 2 wee ks after t he a xica bta ge ne cil ole ucel i nf usi o n, w hic he ver is l o n ger.  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 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).  After t hat, o nl y tar gete d A Es will be re p orte d t hr o u g h 2 4 m o nt hs after 

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
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A me n d me nt 5
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a xica bta ge ne cil ole ucel i nf usi o n or disease pr o gressi o n, w hic he ver occ urs first, a n d will be 
rec or de d i n t he e C R F 
Tar gete d A Es i ncl u de ne ur ol o gical e ve nts, he mat ol o gical e ve nts, i nfecti o ns, G V H D, 
a ut oi m m u ne dis or ders, a n d sec o n dar y mali g na ncies.  Sec o n dar y mali g na ncies are defi ne d as t he 
de vel o p me nt of a n y ne w mali g na ncies, wit h t he e xce pti o n of a rela pse of t he pri mar y 
mali g na nc y, occ urri n g after t he a d mi nistrati o n of st u d y treat me nt.
All A Es dee me d relate d t o a xica bta ge ne cil ole ucel i nf usi o n or ut o mil u ma b s h o ul d be rec or de d i n 
t he e C R F a n d re p orte d re gar dless of st u d y peri o d
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)

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 P, 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
T he A E gra di n g scale use d will be t he N CI C T C A E.  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 Ca ncer T hera p y E val uati o n Pr o gra m ( 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 
a xica bta ge ne cil ole ucel I B (as m o difie d fr o m Lee, et al, 2 0 1 4).  T he se verit y of ne ur ol o gic 
t o xicities will be gra de d usi n g t he N CI C T C A E.  T he se verit y of i n di vi d ual si g ns/s y m pt o ms of 
C R S a n d ne ur ol o gic t o xicities will be gra de d acc or di n g t o t he N CI C T C A E f or t h ose 
si g ns/s y m pt o ms t hat are n ot part of t he gra di n g scale.  
I n re vie wi n g A Es, i n vesti gat ors m ust assess w het her t he A E is p ossi bl y relate d t o 
1) a xica bta ge ne cil ole ucel, 2) ut o mil u ma b, 3) c o n diti o ni n g c he m ot hera p y, 4) a n y 
pr ot oc ol-re q uire d st u d y pr oce d ure or treat me nt, 5) disease pr o gressi o n, 6) c o nc urre nt disease, 
7) c o nc o mita nt me dicati o n, or 8) ot her.  
T he relati o ns hi p is i n dicate d b y a “relate d” or “ n ot relate d” res p o nse a n d e ntere d i n t he e C R F.  I n 
assessi n g ca usalit y, t he i n vesti gat or or q ualifie d s u bi n vesti gat or will use cli nical j u d g me nt a n d 
t he f oll o wi n g c o nsi derati o ns:

N ot Relate d: E vi de nce e xists t hat t he A E has a n eti ol o g y ot her t ha n t he I P or st u d y 
pr oce d ure.  F or S A Es, a n alter nati ve ca usalit y m ust be pr o vi de d (e g, disease pr o gressi o n, 
c o nc urre nt disease[s], c o nc o mita nt me dicati o ns, or ot her).

Relate d: T here is reas o na ble p ossi bilit y t hat t he e ve nt ma y ha ve bee n ca use d b y t he I P or as a 
res ult of a st u d y pr oce d ure.

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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.  F or 
A Es/ S A Es, a dia g n osis (if k n o w n) rat her t ha n i n di vi d ual si g ns a n d s y m pt o ms s h o ul d be rec or de d 
o n t he e C R F A E f or m.  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 nifica nt si g ns 
a n d s y m pt o ms will be ca pt ure d i n t he e C R F.
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 a nti-ca ncer 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 or t hat 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 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:

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 
9. 2. 2.   
A b n or m al Li ver F u ncti o n Tests ( H y’s L a w): Dr u g-i n d uce d Li ver I nj ur y
Ele vate d A L T or A S T ( > 3 x U L N), i n c o m bi nati o n wit h eit her a n ele vate d t otal bilir u bi n ( > 2 x 
U L N) or cli nical ja u n dice i n t he a bse nce of c h olestasis or ot her ca uses of h y per bilir u bi ne mia, is 
c o nsi dere d t o be a n i n dicat or of se vere li ver i nj ur y (ie, dr u g-i n d uce d li ver i nj ur y [ DI LI]). 
T heref ore, i n vesti gat ors m ust re p ort t he f oll o wi n g e ve nts as S A Es:

A L T or A S T > 3 x U L N i n c o m bi nati o n wit h t otal bilir u bi n > 2 x U L N ( of w hic h 3 5 % is 
direct bilir u bi n)

A L T or A S T > 3 x U L N i n c o m bi nati o n wit h cli nical ja u n dice
9. 2. 3.   
A Es of S peci al I nterest (I m me di atel y Re p ort a ble t o t he S p o ns or)
I n vesti gat ors m ust re p ort t he f oll o wi n g A Es of s pecial i nterest t o t he s p o ns or n o m ore t ha n 
2 4 h o urs after lear ni n g of t he e ve nt:

DI LI is defi ne d i n Secti o n 9. 2. 2 . A ris k ma na ge me nt pla n ass ociate d wit h ut o mil u ma b 
re q uires t hat a n y DI LI is re p orte d as a n A E u n der e x pe dite d ti meli nes. 

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
A n y DI LI occ urri n g bet wee n t he first i nf usi o n of ut o mil u ma b a n d 3 0 da ys after c o m pleti n g 
t he fi nal d ose of ut o mil u ma b m ust be re p orte d wit hi n 2 4 h o urs. 

C R S e ve nts Gra de 3 or hi g her ( by m o difie d Lee criteri a) 

Ne ur ol o gic e ve nts Gra de 3 or hi g her ( by C T C A E)

All e ve nts of cere bral e de ma 

All e ve nts of he m o p ha g oc ytic l y m p h o histi oc yt osis/ macr o p ha ge acti vati o n s y n dr o me
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 E 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 (ie, a n e ve nt t hat places t he s u bject at i m me diate ris k of deat h); it d oes n ot 
refer t o a n e ve nt t hat h y p ot heticall y mi g ht ha ve ca use d deat h if it were m ore se vere

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.  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.”
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 nte nsi ve care u nit (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.  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 
(e C R F).
9. 4.   
Re p orti n g of S A Es
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 3 0 da ys after c o m pleti n g 

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7 2
0 7 J u ne 2 0 2 2
t he fi nal d ose of ut o mil u ma b or 1 2 wee ks after t he a xica bta ge ne cil ole ucel i nf usi o n, w hic he ver is 
l o n ger.  After t his f oll o w- u p peri o d has bee n c o m plete d, 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, G V H D a n d 
a ut oi m m u ne dis or ders, a n d sec o n dar y mali g na ncies t hat occ ur u p t o 2 4 m o nt hs or u ntil disease 
pr o gressi o n.  After 2 4 m o nt hs, tar gete d S A Es of sec o n dar y mali g na ncies will c o nti n ue t o be 
re p orte d t hr o u g h 1 5 years after a xica bta ge ne cil ole ucel i nf usi o n a n d will be rec or de d i n t he 
e C R F.
S A Es, w hic h t he i n vesti gat or assesses as relate d t o a xica bta ge ne cil ole ucel or ut o mil u ma b, 
i ncl u di n g all deat hs t hat occ ur fr o m si g ni n g of t he scree ni n g I C F s h o ul d be re p orte d re gar dless of 
t he ti me peri o d.  Refer t o Secti o n 9. 5  f or i nstr uctio ns o n re p orti n g deat hs.
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 st u d y-s pecific 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).  
T he f oll o wi n g 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:

All S A Es

Pre g na nc y or lactati o n e x p os ure as defi ne d i n Secti o n 9. 7

A Es of s pecial i nterest as defi ne d i n Secti o n 9. 2. 3
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 se nt via e mail t o t he S A E Re p orti n g mail b o x: 
 
S u bse q ue ntl y, S A Es will be e ntere d i nt o t he e S A E s yste m o nce it bec o mes a vaila ble. 
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 o n t he C R F as A Es or S A Es a n d i n dicate d as bei n g d ue 
t o disease pr o gressi o n.  If t he mali g na nc y has a fatal o utc o me bef ore 2 4 m o nt hs, 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 bei n g 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.  Refer t o Secti o n 9. 5  f or i nstr uctio ns o n re p orti n g deat hs ass ociate d wit h 
t he u n derl yi n g mali g na nc y/ disease pr o gressi o n.
A n y deat h occ urri n g after e nr oll me nt  a n d pri or t o t he p ost-treat me nt f oll o w- u p peri o d , 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 p ost-treat me nt f oll o w- u p peri o d 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, a xica bta ge ne cil ole ucel, ut o mil u ma b, a n d/ or st u d y-re q uire d 
treat me nts (e g, l y m p h o de pleti n g c he m ot hera p y).
P P D

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7 3
0 7 J u ne 2 0 2 2
F oll o wi n g c o m pleti o n of K T E- C 1 9- 1 1 1, 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 P har ma 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 usi n g 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: 
9. 5.   
Re p orti n g De at hs
Deat hs t hat occ ur d uri n g t he pr ot oc ol-s pecifie d A E re p orti n g peri o d ( wit hi n t he 3 0 da ys after 
c o m pleti n g t he fi nal d ose of ut o mil u ma b or 1 2 wee ks after t he a xica bta ge ne cil ole ucel i nf usi o n, 
w hic he ver is l o n ger) t hat are attri b ute d b y t he i n vesti gat or 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 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 i m me diatel y t o t he s p o ns or.  A n y deat h occ urri n g after t he si g ni n g of t he mai n st u d y 
I C F wit hi n t he A E re p orti n g peri o d a n d 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 after t he i n vesti gat or’s k n o wle d ge of t he e ve nt.  A n y deat h occ urri n g 
after t he A E re p orti n g peri o d 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, a xica bta ge ne cil ole ucel i nf usi o n, ut o mil u ma b, a n d/ or st u d y-re q uire d 
treat me nts (e g, l y m p h o de pleti n g c he m ot hera p y).
Deat h is a n o utc o me a n d n ot a disti nct e ve nt.  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.  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 o n (e g, after 
a ut o ps y).  
9. 6.   
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) rat her t ha n i n di vi d ual si g ns a n d s y m pt o ms s h o ul d be rec or de d 
o n t he A E f or m.  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 t he si g ns a n d s y m pt o ms 
c o m prisi n g C R S will be ca pt ure d o n t he C R F A E f or m.  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 of t he A E or S A E. 
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.
9. 7.  
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. 
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 %) t hr o u g h at least 9 0 da ys after 
t he last d ose of ut o mil u ma b or f or at least 6 m o nt hs after a xica bta ge ne cil ole ucel i nf usi o n or 
c o n diti o ni n g c he m ot hera p y d osi n g ( w hic he ver occ urs later).  Male s u bjects are rec o m me n de d t o 
P P D

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7 4
0 7 J u ne 2 0 2 2
n ot fat her a c hil d f or at least 9 0 da ys after t he last d ose of ut o mil u ma b or f or at least 6 m o nt hs 
after c o m pleti o n of a xica bta ge ne cil ole ucel i nf usi o n or c o n diti o ni n g c he m ot hera p y d osi n g 
( w hic he ver occ urs later).  Refer t o A p pe n di x 3  f or a c o mplete list of hi g hl y effecti ve 
c o ntrace pti o n met h o ds.
If a pre g na nc y occ urs i n eit her a fe male s u bject e nr olle d i nt o t he st u d y a n y ti me after 
a xica bta ge ne cil ole ucel i nf usi o n, wit hi n 6 m o nt hs after c o n diti o ni n g c he m ot hera p y, or wit hi n 
9 0 da ys after t he last d ose of ut o mil u ma b, w hic he ver is l o n ger, or i n a fe male part ner of a male 
s u bject wit hi n 6 m o nt hs of a xica bta ge ne cil ole ucel i nf usi o n or c o m pleti n g t he c o n diti o ni n g 
c he m ot hera p y or wit hi n 9 0 da ys after t he last d ose of ut o mil u ma b, w hic he ver is l o n ger, t he 
pre g na nc y m ust be re p orte d usi n g t he Pre g na nc y Re p orti n g F or 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 pre g na nc y e ve nt.
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 or 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.
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 
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 pr ot oc ol-re q uire d t hera pies 
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.
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 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 
 or fa x: 
. 
If a lactati o n case occ urs w hile t he fe male s u bject is ta ki n g pr ot oc ol-re q uire d t hera pies, t he 
lactati o n case s h o ul d be re p orte d t o t he ke y s p o ns or c o ntact 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 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 
lactati o n cases t hat occ ur after t he last d ose of pr ot oc ol-re q uire d t hera pies t hr o u g h 6 m o nt hs.  
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 
 or fa x: 
.
P P D
P P D
P P D
P P D

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7 5
0 7 J u ne 2 0 2 2
9. 8.   
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 of 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. 9.   
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
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 i 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. 1 0.  
S afet y Re vie w Te a m a n d D ose-li miti n g T o xicit y 
T he S R T will be s pecificall y c hartere d t o re vie w safet y data d uri n g P hase 1 of t he st u d y a n d 
ma ke rec o m me n dati o ns o n f urt her st u d y c o n d uct i n P hase 1 a n d pr o gressi o n t o P hase 2 base d o n 
t he i nci de nce of D L Ts a n d re vie w of S A Es.
D ose-li miti n g t o xicit y is defi ne d as t he f oll o wi n g a xica bta ge ne cil ole ucel- or ut o mil u ma b-relate d 
e ve nts wit h a n o nset fr o m i m me diatel y after a n d t hr o u g h 2 8 da ys f oll o wi n g t he first ut o mil u ma b 
i nf usi o n: 

Gra de 4 he mat ol o gic t o xicit y lasti n g m ore t ha n 3 0 da ys (e xce pt l y m p h o pe nia or B-cell 
a plasia)

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7 6
0 7 J u ne 2 0 2 2

All a xica bta ge ne cil ole ucel- or ut o mil u ma b-relate d Gra de 3 n o n- he mat ol o gic t o xicities 
lasti n g f or > 7 da ys a n d all a xica bta ge ne cil ole ucel- or ut o mil u ma b-relate d Gra de 4 
n o n- he mat ol o gic t o xicities re gar dless of d urati o n are c o nsi dere d D L Ts, wit h t he e xce pti o n of 
t he f oll o wi n g, w hic h are n ot c o nsi dere d D L Ts:

A p hasia/ d ys p hasia or c o nf usi o n/c o g niti ve dist ur ba nce, w hic h res ol ves t o at least Gra de 1 
wit hi n 2 wee ks a n d t o at least baseli ne wit hi n 4 wee ks 

Fe ver of a n y gra de

I m me diate I P-relate d h y perse nsiti vit y reacti o ns occ urri n g wit hi n 2 h o urs of cell or 
ut o mil u ma b i nf usi o n t hat are re versi ble t o a Gra de 2 or less wit hi n 2 4 h o urs or 
a d mi nistrati o n wit h sta n dar d t hera p y 

Re nal t o xicit y, w hic h re q uires dial ysis f or ≤ 7 da ys

I nt u bati o n f or air wa y pr otecti o n if ≤ 7 da ys 

T u m or l ysis s y n dr o me ( T L S), i ncl u di n g ass ociate d ma nifestati o ns attri b uta ble t o T L S 
(e g, electr ol yte a b n or malities, re nal f u ncti o n, h y per urice mia)

Gra de 3 tra nsa mi nase, al kali ne p h os p hatase, bilir u bi n or ot her li ver f u ncti o n test 
ele vati o n, pr o vi de d t here is res ol uti o n t o ≤ Gra de 2 wit hi n 1 4 da ys 

Gra de 4 tra nsie nt ser u m he patic e nz y me a b n or malities pr o vi de d t here is res ol uti o n 
t o ≤ Gra de 3 wit hi n < 7 2 h o urs 

Gra de 3 na usea a n d/ or a n ore xia 
C R S will be gra de d acc or di n g t o a m o difie d gra di n g s yste m { Lee 2 0 1 4 } as  descri be d i n t he 
c urre nt a xica bta ge ne cil ole ucel I B.  A Es attri b ute d t o C R S will be ma p pe d t o t he o verall C R S 
gra di n g assess me nt f or t he deter mi nati o n of D L T.  C o nsiste nt wit h n o n- C R S t o xicities, all 
occ urre nces of Gra de 3 C R S of d urati o n > 7 da ys a n d all occ urre nces of Gra de 4 C R S are 
c o nsi dere d D L Ts, ot her t ha n occ urre nces of C R S d ue t o t he e xce pti o ns liste d a b o ve.  
D uri n g P hase 1, a p pr o xi matel y 3 t o 3 6 s u bjects wit h lar ge B-cell l y m p h o ma will be e nr olle d t o 
e val uate t he safet y of a xica bta ge ne cil ole ucel a n d ut o mil u ma b re gi me ns. 
S u bjects i n eac h c o h ort will be e val uate d f or D L Ts wit hi n t he first 2 8 da ys f oll o wi n g t he 
c o m pleti o n of t heir first d ose of ut o mil u ma b.  T he a nal ysis of D L Ts will be base d o n t he 
i nci de nce of D L T a n d o verall safet y pr ofile of t he a xica bta ge ne cil ole ucel a n d ut o mil u ma b 
re gi me n.  If t he s u bject i nci de nce of D L T is 0 of 3 s u bjects, t he st u d y will pr ocee d t o t he ne xt 
c o h ort or if s pecific t o C o h ort 5, t he st u d y ma y pr ocee d t o P hase 2 of t he trial.  T his decisi o n will 
be base d o n o verall be nefit/ris k a n d a vaila ble bi o mar ker data.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7 7
0 7 J u ne 2 0 2 2
H o we ver, if 1 of t he 3 e nr olle d s u bjects wit hi n a n y c o h ort prese nt wit h a pr ot oc ol- defi ne d D L T 
d uri n g P hase 1, t he S R T ma y rec o m me n d e nr olli n g a n a d diti o nal set of 3 s u bjects ( u p t o 
6 s u bjects i n t otal) at t he sa me d ose t hat was a d mi nistere d i n t he first 3 s u bjects i n t hat c o h ort.  I n 
t his sce nari o, pr o gressi o n t o t he ne xt c o h ort or t o P hase 2 of t he st u d y will pr ocee d if 1 of t he 
first 6 s u bjects prese nts wit h a D L T.
If t he s u bject i nci de nce of D L T is ≥ 2/ 6, ot her a xica bta ge ne cil ole ucel a n d ut o mil u ma b re gi me ns, 
i ncl u di n g differe nt d oses of ut o mil u ma b, ma y be e x pl ore d i n c olla b orati o n wit h t he S R T i n a n 
a d diti o nal 3 t o 6 s u bjects ( Fi g ure 5 ).  T he sa me D L T r ules a p pl y as pre vi o usl y descri be d. 
At t he c o ncl usi o n of eac h S R T safet y re vie w meeti n g, t he S R T will ma ke rec o m me n dati o ns o n 
f urt her st u d y c o n d uct.  T he S R T will ma ke a rec o m me n dati o n fr o m a m o n g t he f oll o wi n g: 

E nr oll a d diti o nal s u bjects f or t hat d osi n g c o h ort 

C o nti n ue e val uati o n of a d diti o nal re gi me ns as s pecifie d i n t he st u d y pr ot oc ol 

C ha n ge i n st u d y c o n d uct 

Pr ocee d t o P hase 2 

Ter mi nate st u d y 
A d diti o nal a xica bta ge ne cil ole ucel a n d ut o mil u ma b re gi me ns n ot c urre ntl y s pecifie d i n t he 
pr ot oc ol ma y als o be e x pl ore d i n P hase 1 at t he rec o m me n dati o n of t he S R T, f oll o wi n g a 
pr ot oc ol a me n d me nt.  Lastl y, t he S R T ma y deci de t o halt escalati o n of t he ut o mil u ma b d ose 
le vels at t he ti me of eac h S R T meeti n g after re vie w of t he data, e ve n i n t he a bse nce of D L T, if it 
dee ms n o f urt her be nefit w o ul d be deri ve d wit h hi g her d oses of ut o mil u ma b.
As part of its o versi g ht of t he st u d y, t he S R T will als o meet 1 ti me after 6 s u bjects ha ve bee n 
treate d wit h a xica bta ge ne cil ole ucel a n d ut o mil u ma b i n t he P hase 2 p orti o n of t he st u d y a n d ha ve 
c o m plete d t he Wee k 4 disease assess me nt.  T he S R T will re vie w safet y a n d efficac y data a n d 
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 be nefit/ris k 
rati o.  T he S R T ma y meet m ore ofte n as nee de d.  
F or b ot h P hase 1 a n d P hase 2 p orti o ns of t he st u d y, i n cases w here a c o nse ns us rec o m me n dati o n 
is n ot reac he d b y t he S R T, t he S p o ns or will ser ve as t he fi nal decisi o n- ma ki n g b o d y f or f urt her 
st u d y c o n d uct.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 7 8
0 7 J u ne 2 0 2 2
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
N o f or mal h y p ot hesis will be teste d i n t his st u d y.  T he P hase 2 p orti o n of t he st u d y is desi g ne d t o 
esti mate t he tr ue C R rate i n s u bjects wit h rela pse d/refract or y lar ge B-cell l y m p h o ma treate d wit h 
t he a xica bta ge ne cil ole ucel f oll o we d b y ut o mil u ma b.
1 0. 2.  
St u d y E n d p oi nts
1 0. 2. 1.  
Pri m ar y E n d p oi nts

P hase 1: I nci de nce of A Es defi ne d as D L Ts.

P hase 2: C o m plete res p o nse rate ( C R per 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 t he st u d y i n vesti gat ors.
1 0. 2. 2.  
Sec o n d ar y E n d p oi nts
Sec o n dar y e n d p oi nts are a p plica ble t o b ot h P hase 1 a n d P hase 2:

O bjecti ve res p o nse rate: O bjecti ve res p o nse rate is defi ne d as t he i nci de nce of eit her a C R or 
a P R per L u ga n o Classificati o n { C hes o n 2 0 1 4 } as deter m i ne d b y st u d y i n vesti gat ors.  All 
s u bjects w h o 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 data c ut off 
date will be c o nsi dere d n o n-res p o n ders.

D urati o n of res p o nse: A m o n g s u bjects w h o e x perie nce a n o bjecti ve res p o nse, D O R is 
defi ne d as t he date of t heir first o bjecti ve res p o nse 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 m i ne d b y st u d y i n vesti gat ors, or deat h fr o m a n y ca use. 
Data fr o m t he  retreat me nt peri o d will n ot be i ncl u de d f or a nal ysis.  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 be ce ns ore d at t heir last 
e val ua ble disease assess me nt date, a n d t heir res p o nse will be n ote d as o n g oi n g.  S u bjects 
w h o recei ve a d diti o nal a nti-ca ncer t hera p y i n t he a bse nce of d oc u me nte d pr o gressi o n will be 
ce ns ore d at t he last e val ua ble disease assess me nt pri or t o t he a d diti o nal t hera p y.  S u bjects 
w h o recei ve S C T i n t he a bse nce of d oc u me nte d pr o gressi o n will be ce ns ore d at t he last 
e val ua ble disease assess me nt pri or t o t he date of t he S C T.  A se nsiti vit y a nal ysis will be 
c o n d ucte d i n w hic h disease assess me nts o btai ne d after S C T are i ncl u de d i n t he deri vati o n of 
D O R. 

Pr o gressi o n-free s ur vi val: Pr o gressi o n-free s ur vi val ( P F S) is defi ne d as t he ti me fr o m t he 
a xica bta ge ne cil ole ucel i nf usi o n date t o t he 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 }, as deter m i ne d b y st u d y i n vesti gat ors, or deat h fr o m a n y ca use.  
Data fr o m t he retreat me nt peri o d will n ot be i ncl u de d f or a nal ysis.  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 be ce ns ore d at t heir last 
e val ua ble disease assess me nt date.  T he P F S f or s u bjects w h o  u n der g o S C T w hile i n 

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 0
0 7 J u ne 2 0 2 2
A d diti o nal ass u m pti o ns a n d c orres p o n di n g t w o-si de d 9 5 % a n d 8 0 % e xact CIs are pr o vi de d  i n 
Ta ble 8 .
T a ble 8.
E x act C o nfi de nce I nter v als ( 9 5 % a n d 8 0 %) C orres p o n di n g t o 
O bser ve d C R R ate F oll o wi n g Tre at me nt of 2 7 S u bjects wit h 
A xic a bt a ge ne Cil ole ucel a n d Ut o mil u m a b
S u bjects wit h C R 
O bser ve d C R R ate 
9 5 % C o nfi de nce I nter v al 
8 0 % C o nfi de nce I nter v al
1 5
5 6 %
[ 3 5 %, 7 5 %]
[ 4 2 %, 6 9 %]
1 7
6 3 %
[ 4 2 %, 8 1 %]
[ 4 9 %, 7 6 %]
1 9
7 0 %
[ 5 0 %, 8 6 %]
[ 5 6 %, 8 2 %]
2 1
7 8 %
[ 5 8 %, 9 1 %]
[ 6 4 %, 8 8 %]
2 3
8 5 %
[ 6 6 %, 9 6 %]
[ 7 3 %, 9 3 %]
A b bre viati o ns: C R, c o m plete res p o nse. 
1 0. 4.  
I nteri m A n al ysis a n d E arl y St o p pi n g G ui deli nes
F or mal i nteri m a nal yses of efficac y are n ot pla n ne d f or t he earl y trial st o p pi n g p ur p ose.
1 0. 4. 1.  
S afet y I nteri m A n al ysis
A n S R T will be c hartere d t o re vie w safet y d uri n g P hase 1 of t he st u d y o nl y a n d t o ma ke 
rec o m me n dati o ns o n f urt her st u d y c o n d uct i n P hase 1 a n d pr o gressi o n t o P hase 2.
T he S R T will a d diti o nall y meet o n at least o ne occasi o n d uri n g t he P hase 2 p orti o n of t he st u d y 
after 6 s u bjects ha ve c o m plete d t heir 1- m o nt h disease assess me nt.  T he S R T will re vie w safet y 
a n d efficac y data a n d 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 be nefit vs ris k.
1 0. 5.   
A n al ysis S u bsets  
F ull a nal ysis set ( F A S):  T he F A S will c o nsist of all e nr olle d s u bjects a n d will be use d f or 
s u m maries of s u bject dis p ositi o n.
M o difie d i nte nt-t o-treat set ( mI T T): T he mI T T will c o nsist of all s u bjects e nr olle d a n d treate d 
wit h t he tar get d ose of a xica bta ge ne cil ole ucel, 2 x 1 0 6 C A R T cells/ k g (ra n ge 1 x 1 06 t o 2. 4 x 
1 0 6 C A R T cells/ k g), a n d at least 1 d ose of ut o mil u ma b as deter mi ne d u p o n c o m pleti o n of t he 
P hase 1 a n d P hase 2 p orti o ns of t he st u d y.  T his a nal ysis set will be use d f or all efficac y 
a nal yses.
Safet y a nal ysis set: T he safet y a nal ysis set will c o nsist of all s u bjects treate d wit h a n y d ose of 
a xica bta ge ne cil ole ucel.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 1
0 7 J u ne 2 0 2 2
T he D L T e val ua ble set: T he D L T e val ua ble set will c o nsist of all s u bjects i n eac h P hase 1 c o h ort 
w h o are treate d wit h a xica bta ge ne cil ole ucel a n d at least 1 d ose of ut o mil u ma b w h o eit her:

Recei ve d t he tar get a xica bta ge ne cil ole ucel d ose a n d were f oll o we d f or at least 2 8 da ys after 
t he first ut o mil u ma b i nf usi o n

Recei ve d a d ose of a nti- C D 1 9 C A R T cells l o wer t ha n t he tar get f or t hat c o h ort a n d a 
s u bse q ue nt ut o mil u ma b i nf usi o n a n d e x perie nce d a D L T d uri n g t he 2 8- da y, p ost- ut o mil u ma b 
i nf usi o n peri o d
1 0. 6.  
Pl a n ne d Met h o d of A n al ysis
T he pri mar y a nal ysis will be perf or me d w he n t he last treate d s u bject i n t he mI T T set has ha d t he 
o p p ort u nit y t o be e val uate d f or res p o nse 6 m o nt hs after t he Wee k 4 disease assess me nt.  T he 
fi nal a nal ysis will occ ur w he n all s u bjects ha ve c o m plete d t he st u d y.
1 0. 6. 1.   
C o m plete Res p o nse R ate 
T he i nci de nce of c o m plete res p o nse a n d e xact 2-si de d 9 5 % CIs will be ge nerate d.
1 0. 6. 2.   
O bjecti ve Res p o nse R ate
T he i nci de nce of o bjecti ve res p o nse a n d e xact 2-si de d 9 5 % CIs will be ge nerate d.
1 0. 6. 3.   
D ur ati o n of Res p o nse
Ka pla n- Meier esti mates a n d 2-si de d 9 5 % CIs will be ge nerate d f or D O R.  Esti mates of t he 
pr o p orti o n of s u bjects ali ve a n d i n res p o nse at 3- m o nt h i nter vals will be pr o vi de d.
1 0. 6. 4.  
Pr o gressi o n-free S ur vi v al
Ka pla n- Meier esti mates a n d 2-si de d 9 5 % CIs will be ge nerate d f or P F S.  Esti mates of t he 
pr o p orti o n of s u bjects ali ve a n d pr o gressi o n-free at 3- m o nt h i nter vals will be pr o vi de d.
1 0. 6. 5.   
O ver all S ur vi v al
Ka pla n- Meier esti mates a n d 2-si de d 9 5 % CIs will be ge nerate d f or O S.  Esti mates of t he 
pr o p orti o n of s u bjects ali ve at 3- m o nt h i nter vals will be pr o vi de d.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 2
0 7 J u ne 2 0 2 2
1 0. 6. 6.  
S afet y
S u bject i nci de nce rates of 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 t hr o u g h o ut t he c o n d uct of t he st u d y will be ta b ulate d b y preferre d 
ter m a n d s yste m or ga n class.  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 T F U peri o d a n d treat me nt relate d S A Es will be 
pr o vi de d.
1 0. 6. 7.  
L o n g-ter m D at a A n al ysis
All s u bjects will be f oll o we d f or s ur vi val stat us f or u p t o a p pr o xi matel y 1 5 years after recei vi n g 
a xica bta ge ne cil ole ucel. L T F U data a nal ysis will be perf or me d o n s u bjects i n t his st u d y a n d after 
tra nsiti o n t o t he K T- U S- 9 8 2- 5 9 6 8 L T F U st u d y. 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 c ut off f or t he pri mar y a nal ysis.  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
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 3
0 7 J u ne 2 0 2 2
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.  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 S A Es 
( 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 wit hi n all material t hat is 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 D 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 t o l ocal la ws a n d 
re g ulati o ns.
F or re p orti n g of S A Es, s u bjects will be i de ntifie d b y t heir res pecti ve s u bject I D 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
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 4
0 7 J u ne 2 0 2 2
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, I nc., base d o n t he f oll o wi n g criteria:

Is 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 d 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
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 5
0 7 J u ne 2 0 2 2
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 i n vesti gat or’s a gree me nt 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, I nc., 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 re gar di n g eit her 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, I nc., 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 xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 6
0 7 J u ne 2 0 2 2
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 VI N G
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 he i n di vi d uals a ut h orize d t o f ulfill 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 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, t he use of t he C R Fs as s o urce 
d oc u me ntati o n is n ot rec o m me n de d as a r o uti ne practice.
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, healt h 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

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, I nc., 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 if s o urce d oc u me nts 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.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 7
0 7 J u ne 2 0 2 2
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 ntact, 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 m ust als o ass ure 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 a n d 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’s 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, a n d 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 re g ulat or y p olicies.
All data will be c ollecte d i n a n electr o nic 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 t hera pies s h o ul d be i de ntifie d b y tra de na mes.  F or f urt her details s urr o u n di n g 
t he c o m pleti o n of C R Fs, 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
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 8
0 7 J u ne 2 0 2 2
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 K T E- C 1 9- 1 1 1 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 t hat 
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 be 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, 
I nc., f or re vie w a n d a p pr o val.  T he st u d y c o ntract a m o n g t he i nstit uti o n, pri nci pal i n vesti gat or, 
a n d Kite P har ma, I nc., 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
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 8 9
0 7 J u ne 2 0 2 2
1 6.   
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.
B ot A, K oc he n derfer J, Mar dir os A, Perez A, Na vale L, C ha n g R, et al. Bi o mar ker a nal ysis of 
patie nts treate d wit h a nti- C D 1 9 c hi meric a nti ge n rece pt or ( C A R) T cells [ A bstract 
3 0 2 8]. A merica n S ociet y of Cli nical O nc ol o g y ( A S C O) A n n ual Meeti n g; 2 0 1 5 2 9 
Ma y- 0 2 J u ne; C hica g o, I L. 
Castr o J E, Ja mes D F, Sa n d o val- S us J D, Jai n S, B ole J, Rasse nti L, et al. Rit u xi ma b i n 
c o m bi nati o n wit h hi g h- d ose met h yl pre d nis ol o ne f or t he treat me nt of c hr o nic 
l y m p h oc ytic le u ke mia. Le u ke mia 2 0 0 9; 2 3 ( 1 0): 1 7 7 9- 8 9.
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 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. Fi nal Versi o n. 1 5 Se pte m ber.  2 0 1 4.
Cr oft M. T he r ole of T N F s u perfa mil y me m bers i n T-cell f u ncti o n a n d diseases. Nat Re v 
I m m u n ol 2 0 0 9; 9 ( 4): 2 7 1- 8 5.
Cr u m p M, Neela p u S S, Far o o q U, Va n De n Neste E, K ur u villa J, Westi n J, et al. O utc o mes i n 
refract or y diff use lar ge B-cell l y m p h o ma: res ults fr o m t he i nter nati o nal 
S C H O L A R- 1 st u d y. Bl o o d 2 0 1 7; 1 3 0 ( 1 6): 1 8 0 0- 8.
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.
Fis her T S, Ka m persc hr oer C, Oli p ha nt T, L o ve V A, Lira P D, D o y o n nas R, et al. Tar geti n g of 4-
1 B B b y m o n ocl o nal a nti b o d y P F- 0 5 0 8 2 5 6 6 e n ha nces T-cell f u ncti o n a n d 
pr o m otes a nti-t u m or acti vit y. Ca ncer I m m u n ol I m m u n ot her 2 0 1 2; 6 1 ( 1 0): 1 7 2 1-
3 3.
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 Ca ncer J Cli n 2 0 1 0; 6 0 ( 6): 3 9 3- 4 0 8.
Gatti n o ni L, Fi n kelstei n S E, Kle ba n off C A, A nt o n y P A, Pal mer D C, S piess PJ, et al. Re m o val of 
h o me ostatic c yt o ki ne si n ks b y l y m p h o de pleti o n e n ha nces t he efficac y of 
a d o pti vel y tra nsferre d t u m or-s pecific C D 8 + T cells. J E x p Me d 2 0 0 5; 2 0 2 ( 7): 9 0 7-
1 2.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9 0
0 7 J u ne 2 0 2 2
G o pal A K, Bartlett N L, Le v y R, H o u ot R, S mit h S D, Se gal N H, et al. A p hase I st u d y of P F-
0 5 0 8 2 5 6 6 (a nti- 4- 1 B B) + rit u xi ma b i n patie nts wit h C D 2 0 + N H L. J Cli n O nc ol 
2 0 1 5; 3 3 ( 1 5 _s u p pl): 3 0 0 4-.
H urta d o J C, Ki m YJ, K w o n B S. Si g nals t hr o u g h 4- 1 B B are c osti m ulat or y t o pre vi o usl y acti vate d 
s ple nic T cells a n d i n hi bit acti vati o n-i n d uce d cell deat h. J I m m u n ol 1 9 9 7; 1 5 8 
( 6): 2 6 0 0- 9.
Keir M E, B utte MJ, Free ma n GJ, S har pe A H. P D- 1 a n d its li ga n ds i n t olera nce a n d i m m u nit y. 
A n n u Re v I m m u n ol 2 0 0 8; 2 6: 6 7 7- 7 0 4.
Kle ba n off C A, K h o n g H T, A nt o n y P A, Pal mer D C, Restif o N P. Si n ks, s u p press ors a n d a nti ge n 
prese nters: h o w l y m p h o de pleti o n e n ha nces T cell- me diate d t u m or 
i m m u n ot hera p y. Tre n ds I m m u n ol 2 0 0 5; 2 6 ( 2): 1 1 1- 7.
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, et al. 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.
Lee H W, Na m K O, Se o S K, Ki m Y H, Ka n g H, K w o n B S. 4- 1 B B cr oss-li n ki n g e n ha nces t he 
s ur vi val a n d cell c ycle pr o gressi o n of C D 4 T l y m p h oc ytes. Cell I m m u n ol 
2 0 0 3; 2 2 3 ( 2): 1 4 3- 5 0.
Lee H W, Par k SJ, C h oi B K, Ki m H H, Na m K O, K w o n B S. 4- 1 B B pr o m otes t he s ur vi val of 
C D 8 + T l y m p h oc ytes b y i ncreasi n g e x pressi o n of Bcl- x L a n d Bfl- 1. J I m m u n ol 
2 0 0 2; 1 6 9 ( 9): 4 8 8 2- 8.
Le o nar d J P, Sc hatt ner EJ, C ole ma n M. Bi ol o g y a n d ma na ge me nt of ma ntle cell l y m p h o ma. C urr 
O pi n O nc ol 2 0 0 1; 1 3 ( 5): 3 4 2- 7.
L oc ke F L, Westi n J R, Mi kl os D B, Herrara A F, Jac o bs o n C A, Lee J, et al. P hase 1 Res ults fr o m 
Z U M A- 6: A xica bta ge ne Cil ole ucel (a xi-cel; K T E- C 1 9) i n C o m bi nati o n wit h 
Atez oliz u ma b f or t he Treat me nt of Patie nts wit h Refract or y Diff use Lar ge B Cell 
L y m p h o ma ( D L B C L). Bl o o d 2 0 1 7; 1 3 0 ( S u p pl 1): 2 8 2 6-.
Neela p u S S, L oc ke F L, Bartlett N L, Le ka kis LJ, Mi kl os D B, Jac o bse n E D, et al. L o n g- Ter m 
F oll o w- u p Z U M A- 1: A Pi v otal Trial of A xica bta ge ne Cil ole ucel ( A xi- Cel; K T E-
C 1 9) i n Patie nts wit h Refract or y A g gressi ve N o n- H o d g ki n L y m p h o ma ( N H L). 
Bl o o d 2 0 1 7a; 1 3 0 ( S u p pl 1): 5 7 8-.
Neela p u S S, L oc ke F L, Bartlett N L, Le ka kis LJ, Mi kl os D B, Jac o bs o n C A, et al. A xica bta ge ne 
Cil ole ucel C A R T- Cell T hera p y i n Refract or y Lar ge B- Cell L y m p h o ma. N E n gl J 
Me d 2 0 1 7 b; 3 7 7 ( 2 6): 2 5 3 1- 4 4.
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.

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9 1
0 7 J u ne 2 0 2 2
N o o ne A, H o wla der N, Kra pc h o M, Miller D, Brest A, Y u M, et al. S E E R Ca ncer Statistics 
Re vie w, 1 9 7 5- 2 0 1 5. Nati o nal Ca ncer I nstit ute. Bet hes da, M D, 
htt ps://seer.ca ncer. g o v/csr/ 1 9 7 5 _ 2 0 1 5/, base d o n N o ve m ber 2 0 1 7 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 8. 2 0 1 7.
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.
Olej nicza k S H, Ste wart C C, D o n o h ue K, Cz ucz ma n M S. A q ua ntitati ve e x pl orati o n of s urface 
a nti ge n e x pressi o n i n c o m m o n B-cell mali g na ncies usi n g fl o w c yt o metr y. 
I m m u n ol I n vest 2 0 0 6; 3 5 ( 1): 9 3- 1 1 4.
Perez A, Na vale L, R ossi J M, S he n Y- w, Jia n g Y, S her ma n M, et al. P har mac o d y na mic Pr ofile 
a n d Cli nical Res p o nse i n Patie nts wit h B- Cell Mali g na ncies of A nti- C D 1 9 C A R 
T- Cell T hera p y. Bl o o d 2 0 1 5; 1 2 6 ( 2 3): 2 0 4 2.
R o dri g uez J, P u g h W C, R o ma g uera J E, Ca ba nillas F. Pri mar y me diasti nal lar ge cell l y m p h o ma. 
He mat ol o gical O nc ol o g y 1 9 9 4; 1 2 ( 4): 1 7 5- 8 4.
R ossi J M, Gal o n J, T urca n S, Da na n C, L oc ke F L, Neela p u S S, et al. C haracteristics of t he 
pretreat me nt t u m or micr oe n vir o n me nt ma y i nfl ue nce cli nical res p o nse i n patie nts 
wit h refract or y lar ge B cell l y m p h o ma treate d wit h a xica bta ge ne cil ole ucel (a xi-
cel) i n t he pi v otal Z U M A- 1 [ A bstract L B- 0 1 6/ 1 6]. A merica n Ass ociati o n f or 
C nacer Researc h ( A A C R); 2 0 1 8 1 4- 1 8 A pril; C hica g o, Illi n ois. 
Se gal N H, He A R, D oi T, Le v y R, B hatia S, Pis h vaia n MJ, et al. P hase I St u d y of Si n gle- A ge nt 
Ut o mil u ma b ( P F- 0 5 0 8 2 5 6 6), a 4- 1 B B/ C D 1 3 7 A g o nist, i n Patie nts wit h A d va nce d 
Ca ncer. Cli n Ca ncer Res 2 0 1 8; 2 4 ( 8): 1 8 1 6- 2 3.
S h uf or d W W, Kl uss ma n K, Tritc hler D D, L o o D T, C hal u p n y J, Sia da k A W, et al. 4- 1 B B 
c osti m ulat or y si g nals prefere ntiall y i n d uce C D 8 + T cell pr oliferati o n a n d lea d t o 
t he a m plificati o n i n vi v o of c yt ot o xic T cell res p o nses. J E x p Me d 1 9 9 7; 1 8 6 
( 1): 4 7- 5 5.
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.
Uc k u n F M, Jaszcz W, A m br us J L, Fa uci A S, Gajl- Peczals ka K, S o n g C W, et al. Detaile d St u dies 
o n E x pressi o n a n d F u ncti o n of C D 1 9 S urface Deter mi na nt b y Usi n g B 4 3 
M o n ocl o nal A nti b o d y a n d t he Cli nical P ote ntial of A nti- C D 1 9 I m m u n ot o xi ns. 
Bl o o d 1 9 8 8; 7 1 ( 1): 1 3- 2 9.
Wa n g C, Li n G H, Mc P hers o n AJ, Watts T H. I m m u ne re g ulati o n b y 4- 1 B B a n d 4- 1 B B L: 
c o m ple xities a n d c halle n ges. I m m u n ol Re v 2 0 0 9; 2 2 9 ( 1): 1 9 2- 2 1 5.
Y E S C A R T A, Kite P har ma I nc. Y E S C A R T A ® (a xica bta ge ne cil ole ucel) S us pe nsi o n f or 
I ntra ve n o us I nf usi o n. U. S. Prescri bi n g I nf or mati o n. Sa nta M o nica, C A.  2 0 1 7:

A xica bta ge ne Cil ole ucel
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K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9 2
0 7 J u ne 2 0 2 2
1 7.   
A P P E N DI C E S
A p pe n di x 1.  
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 2.  
L u ga n o Classificati o n { C hes o n 2 0 1 4 }
A p pe n di x 3.  
C hil d beari n g P ote ntial a n d Birt h C o ntr ol

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C O N FI D E N TI A L
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A p pe n di x 2.  
L u g a n o Cl assific ati o n { C hes o n 2 0 1 4 }
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 Meta b olic Res p o nse ( C M R) f or  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 E T- C T)- Base 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 fl u or o de o x y gl uc ose ( F D G)-a vi d disease i n b o ne marr o w
C o m plete Ra di ol o gic Res p o nse ( C R R) f or C o m p ute d T o m o gra p h y ( C T )- Base 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

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 m m u n o hist oc he mistr y ne gati ve

A xica bta ge ne Cil ole ucel
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9 5
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P arti al Re missi o n: 
Partial Meta b olic Res p o nse ( P M R) f or P E T- C T- Base 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, 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 ma g netic res o na nce i ma gi n g 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 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 x 5 m m, b ut s maller t ha n n or mal, use t he 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
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
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St a ble Dise ase:
N o Meta b olic Res p o nse ( N M R) f or P E T- C T- Base 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 at t he 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
Sta ble Ra di ol o gic Disease ( S R D) f or C T- Base 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 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
Pr o gressi ve Dise ase:
Pr o gressi ve Meta b olic Disease ( P M D) f or P E T- C T- Base 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 of  4 or 5 wit h a n i ncrease i n i nte nsit y of u pta ke fr o m baseli ne

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 or 
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 

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Pr o gressi ve Ra di ol o gic Disease ( P R D) f or C T- Base 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 all of t he f oll o wi n g:

L Di > 1. 5 c m 

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 na dir

A n i ncrease i n L Di or s h ortest tra ns verse dia meter ( 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 t here is n o 
pri or s ple n o me gal y, t he s ple nic le n gt h 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 pre-e xisti n g n o n meas ure d lesi o ns

Ne w lesi o ns, defi ne d b y a n y of t he f oll o wi n g:

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
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9 8
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A p pe n di x 3.   
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 Trial Facilitati o n Gr o u p ( C T F G) 
{ Cli nical Trials Facilitati o n Gr o u p ( C T F G) 2 0 1 4 }, a s descri be d bel o w. 
A.
Defi niti o n of C hil d be ari n g P ote nti al
A fe male 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 male 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.
B.
Birt h C o ntr ol Met h o ds T h at M a 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 n1 via t he f oll o wi n g f or m of a d mi nistrati o n:

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 1:

Oral

I njecta ble

I m pla nta ble2
1  H or m o nal c o ntrace pti o n ma y be s usce pti ble t o i nteracti o n wit h t he i n vesti gati o nal pr o d uct, w hic h ma y re d uce t he 
efficac y of t he c o ntrace pti o n met h o d.
2  C o ntracepti 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
Kite P har ma, I nc
Cli nical Pr ot oc ol
K T E- C 1 9- 1 1 1 ( Z U M A- 1 1)
A me n d me nt 5
C O N FI D E N TI A L
Pa ge 9 9
0 7 J u ne 2 0 2 2

I ntra uteri ne de vice)2

I ntra uteri ne h or m o ne-releasi n g s yste m2

Bilateral t u bal occl usi o n 2

Vasect o mize d part ner 2 ,3

Se x ual a bsti ne nce 4
C.
U n acce pt a 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, or 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 hea 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.
3  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.
4  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.