Clinical trial NCT01685008
Conditions: Non-Hodgkin Lymphoma
Keywords: NHL CD19 MOR208 MOR00208 Xmab5574 B-Cell Non-Hodgkin´s Lymphoma Fc-optimized Anti-CD19 Antibody Tafasitamab
Sponsor: MorphoSys AG
Start date: 2013-04-23; Completion date: 2022-04-06
Enrollment: 92 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multicenter study to characterize the safety and efficacy of the human anti-CD19 antibody MOR00208 in adult patients with relapsed/refractory non-Hodgkin's lymphoma (NHL) who have received at least 1 prior therapy containing rituximab (at least once).

Detailed description:
The study enrols patients from four different NHL subtypes: follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) and other indolent NHL (iNHL). The study will employ a two-stage design where the decision to further enrol any NHL subtype in stage 2 will depend on best responses after two or three cycles in stage 1.

Arms: arm 1: intravenous Infusion of MOR00208, Fc-Optimized Anti-CD19 Antibody
Interventions: intervention 1: MOR00208 (formerly Xmab 5574)
Intervention descriptions: intervention 1: None

Protocol documents:
Prot_000.pdf: 
Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 1 of 84 
 
 
CLINICAL STUDY PROTOCOL 
AMENDMENT NO. 5 
 
A Phase IIa, Open-Label, Multicenter Study of Single-Agent MOR00208, an 
Fc-Optimized Anti-CD19 Antibody, in Patients with Relapsed or Refractory 
B-Cell Non-Hodgkin’s Lymphoma 
Brief Description of Study 
Open-label study to evaluate the preliminary efficacy and 
safety of MOR00208 in adult patients with refractory or 
relapsed non-Hodgkin’s lymphoma (NHL) 
Study Type: 
Phase IIa 
Sponsor: 
MorphoSys AG 
Sponsor's Address: 
Semmelweisstr. 7 
D-82152 Planegg 
GERMANY 
Study Protocol Number: 
MOR208C201 
IND No.: 
EudraCT No.: 
114,856 
2012-002659-41 
Date of Protocol: 
Final v2.0, 31 Aug 2012  
Amendment No. 1: 
Final v3.0, 07 Jan 2013 
Amendment No. 2: 
Final v4.0, 02 Oct 2013 
Amendment No. 3: 
Final v5.0, 15 Apr 2014 
Amendment No. 4: 
Final v6.0, 19 Sep 2017 
Amendment No. 5: 
Final v7.0, 26 May 2020 
 
Confidentiality Statement 
This confidential document is the property of MorphoSys AG. No unpublished information in 
this document may be disclosed without prior written approval of MorphoSys AG. 


Product Name: MOR00208
Date:26May 2020
Protocol Amendment 5, Final v7.0
Protocol Number: MOR20 gC20 1
IND Number: I14,g56
EudraCT Number: 2012-002659 -41
SIGNATURES
Amendment No. 5: 
Final v7.0,26Way 2020
Protocol Amendment No. 4: prepared and Approved/Authorized By:
Signature:
Signature:
MorphoSys AG
Confidential
Page 2 of 84


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 3 of 84 
 
Coordinating Investigator’s Signature 
 
I have read the entire clinical study protocol. I agree that this protocol version contains all 
the information required to conduct this study. 
Investigator: 
Signature: 
 
Date: 
 
 
 
 
(DD, MMM, YYYY) 
Printed Name: 
 
 
 
 
 
 
 
Address: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 4 of 84 
 
Signature of Principal Investigator, Coinvestigator, or 
Subinvestigator 
 
I have read the entire clinical study protocol. I agree that this protocol version contains all 
the information required to conduct this study. I agree to conduct the study as outlined in the 
study protocol and to comply with all the terms and conditions set out therein. I confirm that 
I will conduct the study in accordance with ICH GCP guidelines and the principles which 
have their origin in the Declaration of Helsinki, copies of both documents have been given 
to me by the sponsor, I will also ensure that coinvestigator(s) and other relevant members of 
my staff have access to copies of this protocol, the ICH GCP guidelines and the Declaration 
of Helsinki to enable them to work in accordance with the provisions of these documents. 
Signature: 
 
Date: 
 
 
 
 
(DD, MMM, YYYY) 
Printed Name: 
 
 
 
 
 
 
 
Address: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 5 of 84 
Contact Details of Key Study Personnel 
Sponsor Clinical Program 
Leader 
Telephone: 
Fax: 
 
Mobile: 
E-mail: 
 
Sponsor Clinical Project 
Manager 
Clinical Trial Leader 
Telephone: 
Fax: 
Mobile: 
E-mail: 
Contact for Serious Adverse 
Events (SAEs): 
 
 
 
 
 
Medical Monitor 
(24/7 Medical Coverage) 
 
 
 
 
 
 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 6 of 84 
CRO Project Manager 
 
 
 
 
 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 7 of 84 
1 
PROTOCOL SYNOPSIS 
Title of Study 
A Phase IIa, Open-Label, Multicenter Study of Single-Agent MOR00208, 
an Fc-Optimized Anti-CD19 Antibody, in Patients with Relapsed or 
Refractory B-Cell Non-Hodgkin’s Lymphoma 
Investigational Drug 
MOR00208 (an Fc-engineered humanized monoclonal antibody targeting 
the B-cell surface antigen CD19) 
Protocol Number 
MOR208C201 
IND Number 
114,856 
EudraCT Number 
2012-002659-41 
Sponsor and CRO 
Sponsor: 
MorphoSys AG 
Semmelweisstr. 7 
D-82152 Planegg 
Germany 
 
Clinical Research Organization (CRO): 
 
 
Study Phase 
Phase IIa 
Background  
Introduction of rituximab into first-line non-Hodgkin’s lymphoma (NHL) 
regimens in recent years has improved cure rate in several NHL subtypes 
by at least 10%. Despite extensive use of rituximab across a range of NHL 
subtypes in combination with chemotherapy, as a single agent, or as 
maintenance therapy, there is still a high unmet medical need for patients 
with refractory or relapsed NHL (eg, mantle cell lymphoma [MCL], 
diffuse large B-cell lymphoma [DLBCL] and follicular lymphoma [FL]). 
The B-lymphocyte lineage specific surface antigen CD19 is the earliest 
and broadest of the selective B-cell markers, which is highly expressed in 
most patients with B-cell NHL. Because of this expression pattern, an 
anti-CD19 antibody may have clinical utility as a new therapeutic 
approach to NHL treatment. MOR00208 is an Fc-engineered humanized 
monoclonal antibody with significantly enhanced antibody-dependent 
cell-mediated cytotoxicity (ADCC), antibody-dependent cell-mediated 
phagocytosis (ADPC) and direct cytotoxic effects (apoptosis).  
Preliminary data from a currently ongoing Phase I study in adult patients 
with relapsed/refractory 
CLL/SLL 
demonstrated 
that 
8 
weekly 
administrations of MOR00208 are safe and well-tolerated, with a 
recommended biological dose of 12 mg/kg. The most common study
drug-related adverse events (AEs) reported so far are infusion-related 
reactions, leukopenia/neutropenia, and thrombocytopenia. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 8 of 84 
Study Purpose/Rationale Non-Hodgkin’s lymphoma accounts for approximately 5% of all new 
cancer cases. Non-Hodgkin’s lymphoma is a heterogeneous group of 
lymphoproliferative malignancies which are in 90% of cases derived of B 
cells. Diffuse large B-cell lymphoma, an aggressive B-cell lymphoma, 
accounts for one-third of NHL. After standard treatment with the 
anti-CD20 antibody rituximab in combination with CHOP chemotherapy 
(cyclophosphamide, doxorubicin, vincristin, prednisone) still 30% to 40% 
of DLBCL patients are relapsed or refractory, requiring further treatment. 
Mantle cell lymphoma, like DLBCL, is an aggressive form of NHL but is 
far less responsive to treatment than DLBCL.  
Follicular lymphoma, an indolent B-cell lymphoma, accounts for 22% of 
NHL. Even if the overall response rate is high, standard therapy is rarely 
curative and nearly all patients will relapse. There is no standard-of-care 
treatment available for patients with advanced FL. 
The purpose of this study is to evaluate the preliminary efficacy and safety 
of MOR00208 in adult patients with relapsed or refractory NHL. 
Study Objectives (Key 
Primary and Secondary) 
PRIMARY OBJECTIVE: 
1. To assess the antitumor activity of single-agent MOR00208 in adult 
patients with relapsed or refractory NHL who have received at least 
one prior therapy containing rituximab as one of the treatments. 
SECONDARY OBJECTIVES: 
1. To evaluate the duration of response 
2. To establish safety and tolerability of MOR00208 
3. To assess the potential immunogenicity of MOR00208 
4. To evaluate the pharmacokinetics and pharmacodynamics of 
MOR00208 in patients with relapsed or refractory NHL 
Study Endpoints (Key 
Primary and Secondary) 
PRIMARY ENDPOINT: 
1. Overall response rate (ORR) (complete remission [CR] + partial 
remission [PR]), assessed as per the 2007 International Working 
Group (IWG) response criteria (see Section 17.4) 
SECONDARY ENDPOINTS: 
1. Stable disease (SD), duration of response (DoR), time to progression 
(TTP), and progression-free survival (PFS) 
2. Incidence and severity of AEs 
3. Number and proportion of patients who potentially develop 
anti-MOR00208 antibodies and semiquantitative (anti-MOR00208 
antibody titer determination of confirmed positive samples) 
anti-MOR00208 antibody assessments 
4. Pharmacokinetics (apparent maximum serum concentration [Cmax], 
time to maximum serum concentration [tmax], apparent trough serum 
concentration before dosing [Cpd], area under the serum concentration 
versus time curve from time 0 to the time t of the last quantifiable 
concentration [AUC0-t], area under the serum concentration versus 
time curve from time 0 to infinity (extrapolated) [AUC0-∞], apparent 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 9 of 84 
terminal rate constant [λZ], apparent terminal half-life [t½], total body 
clearance [CL], volume of distribution during the terminal phase 
[Vz]), parameters determined using non-compartmental data analysis) 
5. Absolute and percentage change from baseline in measurements of B, 
T- and natural killer (NK) cell populations 
6. Evaluation of AEs and ORR stratified by baseline CD19 expression 
on malignant lymphoma cells 
7. Evaluation of AEs and ORR stratified by (FcγR)IIIa and FcγRIIa 
polymorphism 
Design and Methodology This is a Phase IIa open-label, multicenter safety and efficacy study that 
will enrol approximately 40 to 120 adult patients with refractory or 
relapsed NHL who have received at least one prior therapy. The study will 
enrol different NHL subtypes: FL, DLBCL, MCL and other indolent NHL 
(marginal zone lymphoma [MZL], mucosa-associated lymphoid tissue 
lymphoma [MALT], etc). Efficacy will be determined with the ORR,
which will be evaluated by using the revised IWG criteria (Cheson 
response criteria) and will be defined as the proportion of patients with 
CR and PR (CR+PR). 
The study will employ a two-stage design and may be stopped for futility 
(lack of efficacy) for any NHL subtype, thus potentially reducing the 
number of patients exposed to ineffective treatment. 
Stage 1 – At least ten patients per NHL subtype (in total a minimum of 
40 patients) will be enrolled to receive MOR00208 12 mg/kg IV weekly 
infusions for 8 weeks. After 8 and 12 weeks of dosing (for patients having 
had at least SD at Week 8), patients will be evaluated to determine if it is 
futile to continue testing patients of a subtype. If in stage 1 fewer than 2 
patients per NHL subtype have a best response of PR or better, then the 
subtype cohort will be stopped for futility. In other words, no more 
patients of that subtype will be enrolled in the next stage. If at least 2 
patients per NHL subtype have a response of PR or better, then this cohort 
will progress to Stage 2.  
Regardless of futility decisions, any patients with a response of at least SD 
will qualify for further 4 weeks of dosing. 
Stage 2 – An additional 20 patients will be enrolled for each NHL subtype 
cohort demonstrating a response of PR or better in 2 patients in Stage 1. 
After 8 weeks, the ORR per cohort will be evaluated.  
All patients with a response of at least SD will qualify for further 4 weeks 
of dosing. 
Maintenance treatment – Patients with an ongoing response of at least 
PR at the end of Cycle 3 (regardless of Stage 1 or 2) may receive further 
study drug until progression.
Population 
Adult patients with refractory or relapsed B-cell NHL who have received 
at least 1 completed cycle of combination therapy with rituximab + 
chemotherapy OR at least 4 weekly administrations of rituximab as 
monotherapy. 
1) FL 
2) DLBCL 
3) MCL  
4) Other indolent NHL


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 10 of 84 
Key Inclusion / Exclusion 
Criteria 
INCLUSION CRITERIA:
1. Patients are male or female ≥ 18 years of age. 
2. Patients have a histologically-confirmed diagnosis according to the 
Revised European American lymphoma/World Health Organization 
(REAL/WHO) classification, of the following B-cell lymphomas: 
a. FL 
b. Other indolent NHL (eg, MZL/MALT) 
c. DLBCL 
d. MCL  
NOTE: For transformed lymphomas, the subtype at 
screening (not at initial diagnosis) is relevant for the 
assignment to the respective subtype. 
3. Patients’ NHL must have progressed after at least one prior 
rituximab-containing regimen. 
4. Patients have at least one site of measurable disease by magnetic 
resonance imaging (MRI) or computed tomography (CT) scan defined 
as at least one lesion that measures at least 1.5 × 1.5 cm,
Exception: 
For patients with MCL only, patients with nonmeasurable disease but 
evaluable 
sites 
(bone 
marrow, 
spleen, 
peripheral 
blood, 
gastrointestinal tract) can be enrolled. 
5. Patients who have previously received an autologous stem cell 
transplantation must be at least 4 weeks post-transplant before study 
drug administration and must have exhibited a full haematological 
recovery. 
6. Patients must have discontinued previous monoclonal antibody 
therapy (except rituximab) or radioimmunotherapy administration for 
at least 60 days before study drug administration. 
7. Patients should be off rituximab for at least 14 days before the 
screening visit and be confirmed to have either no response or have
disease progression after rituximab treatment. 
8. Patients with DLBCL had a positive [18F]fluorodeoxyglucose-positron 
emission tomography (FDG-PET) scan at baseline (Cheson response 
criteria). 
9. Patients have a life expectancy of > 3 months. 
10. Patients must have an Eastern Cooperative Oncology Group (ECOG) 
performance status of < 3. 
11. Patients must meet the following laboratory criteria at screening: 
a. Absolute neutrophil count (ANC) ≥ 1.0 × 109/L  
b. Platelet count ≥ 75 × 109/L without previous transfusion within 
10 days of first study drug administration 
c. Haemoglobin ≥ 8.0 g/dL (may have been transfused) 
d. Serum creatinine < 2.0 x upper limit of normal (ULN) 
e. Total bilirubin ≤ 2.0 × ULN  
f. Alanine transaminase (ALT) and aspartate aminotransferase 
(AST) ≤ 2.5 × ULN. 
12. If a female of childbearing potential, a negative pregnancy test must 
be confirmed before enrolment and use of double-barrier 
contraception, oral contraceptive plus barrier contraceptive must be 
used during the study and for 3 months after the last dose, or 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 11 of 84 
confirmation of having undergone clinically documented total 
hysterectomy and/or oophorectomy, tubal ligation. 
13. If a male, an effective barrier method of contraception must be used 
during the study and for 3 months after the last dose if the patient is 
sexually active with a female of childbearing potential. 
14. The patients are able to comply with all study-related procedures, 
medication use, and evaluations. 
15. The patients are able to understand and give written informed consent 
and comply with the study protocol. 
 
EXCLUSION CRITERIA: 
1. Previous treatment with cytotoxic chemotherapy, immunotherapy, 
radiotherapy or other lymphoma-specific therapy within 14 days 
before the screening visit or patient has not recovered from side 
effects of previous lymphoma-specific therapy. 
2. Treatment with a systemic investigational agent within 28 days before 
the screening visit. 
3. Previous treatment with an anti-CD19 antibody or fragments.  
4. Previous allogenic stem cell transplantation. 
5. Known or suspected hypersensitivity to the excipients contained in 
the study drug formulation. 
6. Clinically significant cardiovascular disease or cardiac insufficiency 
(New 
York 
Heart 
Association 
[NYHA] 
classes III-IV), 
cardiomyopathy, preexisting clinically significant arrhythmia, acute 
myocardial infarction within 3 months of enrolment, angina pectoris 
within 3 months of enrolment. 
7. Patients with positive hepatitis serology (see also Section 9.5.2). 
Hepatitis B (HBV): Patients with positive serology for HBV, defined 
as positivity for hepatitis B surface antigen (HBsAg) or total anti-
hepatitis B core antibody (anti-HBc). Patients positive for anti-HBc 
may 
be 
included 
if 
HBV 
DNA 
is 
not 
detectable. 
Hepatitis C (HCV): Patients with positive HCV serology (defined as 
positive for anti-HCV antibody [anti-HCV]) unless HCV-ribonucleic 
acid (RNA) is confirmed negative. 
8. History of human immunodeficiency virus (HIV) infection. 
9. Any active systemic infection (viral, fungal, or bacterial) requiring 
active parenteral antibiotic therapy within 4 weeks of study drug 
administration. 
10. Current treatment with immunosuppressive agents other than 
prescribed corticosteroids (not more than 10-mg prednisone 
equivalent). 
11. Major surgery or radiation therapy within 4 weeks before first study 
drug administration. 
12. Systemic diseases (cardiovascular, renal, hepatic, etc.) that would 
prevent study treatment in the investigator’s opinion. 
13. History or clinical evidence of central nervous system (CNS), 
meningeal, or epidural disease, including brain metastasis. 
14. Active treatment/chemotherapy for another primary malignancy 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 12 of 84 
within the past 5 years (except for ductal breast cancer in situ, 
non-melanoma skin cancer, prostate cancer not requiring treatment, 
and cervical carcinoma in situ). 
15. Pregnancy or breastfeeding in women and women of childbearing 
potential not using an acceptable method of birth control. 
16. History of noncompliance to medical regimens or patients who are 
considered potentially unreliable and/or not cooperative.
Sample Size, Planned 
Total Number of Study 
Sites and Locations 
The study will enrol patients in two stages. Enrolment to the stages will be 
consecutive. 
The primary objective of the study is to assess the antitumor activity as 
measured by ORR after two cycles of treatment with MOR00208 (two 
28-day cycles). A two-stage design is used to minimize exposure of NHL 
subtypes not showing responsiveness to MOR00208. No formal sample 
size estimations for determination of futility were computed for Stage 1. 
The number of patients to be used in this stage was determined to be the 
minimum number needed to adequately determine futility in any specific 
NHL subtype. 
The entire study will enrol between 40 to 120 patients, dependent upon 
patient response in each subtype in Stage 1. 
Stage 1: Approximately 40 patients, a similar number of patients will be 
enrolled per NHL subtype: 
 
FL: at least 10 patients 
 
DLBCL: 
at least 10 patients 
 
MCL: 
at least 10 patients 
 
other indolent NHL: at least 10 patients 
Observing less than 2 responses (at least PR) in stage 1 in any NHL 
subtype will be the criterion for discontinuing evaluation of MOR00208 in 
that NHL subtype. If the study drug is effective with a true ORR of 30%, 
the probability to stop for futility after the first stage for a specific NHL 
subtype, is only 14.9%. 
Stage 2: For those NHL subtypes with 2 or more responders, an 
additional approximately 20 patients will be enrolled for a total of 30 
patients per subtype. Assuming that the true ORR of any NHL type is 
30% and that the number of responses actually observed in the study 
corresponds to the expected number of responses (9 responses), N=30 
would yield a lower limit of the 95% confidence interval for the ORR of 
14.7%. 
Up to a maximum of approximately 80 additional patients, a similar 
number of patients will be enrolled per “responding” NHL subtype. Some 
of the cohorts may have been stopped for futility after Stage 1: 
 
FL: at least 20 
patients 
 
DLBCL: 
at least 20 patients 
 
MCL: 
at least 20 patients 
 
other indolent NHL: at least 20 patients 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 13 of 84 
Approximately 25 to 30 centres in the United States of America and 
Europe are planned. 
Investigational Drug(s) 
(Name, Description) 
MOR00208
Dose, Route of 
Administration, 
Treatment Regimen 
MOR00208 dose: 12 mg/kg
Patients will receive up to 2 cycles for a total of 8 infusions: each 28-day 
cycle will consist of a MOR00208 infusion on Day 1, Day 8, Day 15 and 
Day 22 of the cycle. Premedication will be administered for the first 
3 infusions. 
Patients with a response of at least SD on Day 28 of Cycle 2 will qualify 
for a further cycle (Cycle 3) of MOR00208 with infusions on Day 1, Day 
8, Day 15 and Day 22 of that cycle. 
Patients who have an ongoing response of at least PR may be eligible for 
continued treatment every two weeks or monthly, until disease 
progression.  
Supply, Preparation and 
Administration 
MOR00208 DP is a lyophilisate supplied in single-use 20-mL glass vials. 
Each vial contains 200 mg of MOR00208 for reconstitution with 5 mL 
water for injection (WFI). Reconstitution yields 40 mg/mL MOR00208 in 
25 mM sodium citrate, 200 mM trehalose and 0.02% (w/v) polysorbate 
20 at pH 6.0. Each product vial is intended to deliver 5 mL of drug 
solution or 200 mg of MOR00208. MOR00208 will be diluted into a 
250 mL infusion bag containing 0.9% sodium chloride for injection. 
MOR00208 will be administered via IV infusion using an in-line filter in 
all cases. 
Visit Schedule and 
Assessments 
Refer to Schedule of Assessments in Section 10. 
Efficacy Assessments 
Response will be determined using the revised IWG response criteria for 
malignant lymphoma (Cheson response criteria), evaluated in terms of 
ORR (CR + PR), stable disease (SD), DoR, TTP, and PFS. Response rates 
will also be determined using CT scan. 
Pharmacodynamics will be assessed by measuring B-, T- and NK cell 
populations; for patients with a CR, bone marrow histology will be 
performed. 
Special Safety 
Assessments 
Physical 
examination, 
vital 
signs, 
electrocardiograms 
(ECGs), 
haematological and biochemical tests and number and severity of AEs. 
Laboratory and AE toxicities will be graded according to National Cancer 
Institute (NCI) Common Terminology Criteria for Adverse Events 
(CTCAE), version 4.0.  
Pharmacokinetics 
Cmax, tmax, Cpd (trough level before dosing), AUC0-t, AUC0-∞, λZ, t½, CL, 
and Vz; parameters determined using non-compartmental data analysis
Biomarker Assessments 
Expression levels of CD19 on B cells; FcγRIIa and FcγRIIIa genotyping; 
CD16 expression on NK cells; B-, T- and NK cell counts, ADCC capacity
Immunogenicity 
Assessments 
1.
Number of patients with confirmed positive anti-MOR00208 
antibodies  
2.
MOR00208 antibody titer of confirmed positive samples


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 14 of 84 
Statistical Methods and 
Data Analysis  
The primary efficacy endpoint will be ORR as determined by using 
revised IWG response criteria for malignant lymphoma. The final ORR 
for each subtype will be the rate of patients who met the criteria of PR or 
CR at the end of either the second or third cycle or during a response 
assessment in the follow-up period (best response). Patients with PD after 
Day 28 of the second cycle will be discontinued and classified as 
nonresponders. Those with SD after Day 28 of the second cycle will be 
allowed to continue treatment into a third cycle.  
 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 15 of 84 
2 
TABLE OF CONTENTS 
2.1 Overall Table of Contents 
1 
PROTOCOL SYNOPSIS ............................................................................................................... 7 
2 
TABLE OF CONTENTS ............................................................................................................. 15 
2.1 
Overall Table of Contents .................................................................................................. 15 
2.2 
List of Tables ...................................................................................................................... 18 
2.3 
List of Figures ..................................................................................................................... 18 
3 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ........................................... 20 
4 
BACKGROUND ........................................................................................................................... 23 
4.1 
Overview of Non-Hodgkin’s Lymphoma ......................................................................... 23 
4.2 
Overview of MOR00208 .................................................................................................... 23 
4.2.1 
Clinical Experience with MOR00208 ..................................................................... 24 
4.2.2 
Safety of MOR00208 .............................................................................................. 25 
5 
STUDY PURPOSE/RATIONALE .............................................................................................. 26 
6 
OBJECTIVES ............................................................................................................................... 27 
6.1 
Primary Objective .............................................................................................................. 27 
6.2 
Secondary Objectives ......................................................................................................... 27 
7 
STUDY DESIGN .......................................................................................................................... 27 
7.1 
Overall Study Design and Investigational Plan ............................................................... 27 
7.2 
Study Timeframe ................................................................................................................ 28 
7.3 
Study Endpoints ................................................................................................................. 28 
8 
POPULATION ............................................................................................................................. 28 
8.1 
Inclusion Criteria ............................................................................................................... 29 
8.2 
Exclusion Criteria .............................................................................................................. 30 
8.3 
Definition of Woman of Childbearing Potential .............................................................. 31 
8.4 
Procedures for Enrolment ................................................................................................. 31 
9 
TREATMENT .............................................................................................................................. 33 
9.1 
Patient Numbering ............................................................................................................. 33 
9.2 
Investigational Medicinal Products .................................................................................. 34 
9.2.1 
Instructions for Prescribing and Taking the Study Drug ......................................... 34 
9.2.2 
Treatment ................................................................................................................ 34 
9.3 
Treatment Arms ................................................................................................................. 35 
9.4 
Treatment Blinding ............................................................................................................ 35 
9.5 
Treating the Patient ........................................................................................................... 35 
9.5.1 
Management of Infusion Reactions ......................................................................... 35 
9.5.2 
Management of Patients with Positive Hepatitis B Serology .................................. 37 
9.6 
Management of Treatment-Related Toxicities ................................................................ 37 
9.7 
Safety-related Criteria for the Initiation of Each New Cycle of Therapy ..................... 38 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 16 of 84 
9.8 
Prior and Concomitant Therapy ...................................................................................... 38 
9.9 
Treatment Compliance ...................................................................................................... 39 
9.10 Treatment Postponement .................................................................................................. 39 
9.11 End of Treatment and Study Drug Discontinuation ....................................................... 39 
9.11.1 End of Treatment ..................................................................................................... 39 
9.11.2 Study Drug Discontinuation .................................................................................... 40 
9.12 Study or Site Termination ................................................................................................. 41 
10 VISIT SCHEDULE AND ASSESSMENTS ............................................................................... 41 
10.1 Screening Evaluations ........................................................................................................ 45 
10.2 Main Treatment Phase (Cycles 1-3).................................................................................. 46 
10.3 Follow-up Phase until Follow-up Visit 12 ........................................................................ 48 
10.4 MOR00208 Treatment and Study Procedures after Follow-up  Visit 12 ...................... 49 
10.5 End of Study Visit .............................................................................................................. 50 
10.6 Efficacy ................................................................................................................................ 51 
10.7 Pharmacokinetic Assessments ........................................................................................... 52 
10.8 Safety Assessments ............................................................................................................. 53 
10.8.1 Adverse Events ........................................................................................................ 53 
10.8.2 Physical Examination .............................................................................................. 55 
10.8.3 Vital Signs ............................................................................................................... 55 
10.8.4 Laboratory Evaluations ........................................................................................... 56 
10.8.5 Electrocardiogram ................................................................................................... 59 
10.9 Other Variables .................................................................................................................. 59 
10.9.1 Demographic Data ................................................................................................... 59 
10.9.2 Relevant Medical History and Current Medical Conditions ................................... 59 
10.9.3 Prior and Concomitant Medication and Examinations ............................................ 60 
10.9.4 Immune Cells .......................................................................................................... 60 
10.9.5 Immunogenicity....................................................................................................... 60 
10.9.6 B Cells ..................................................................................................................... 60 
10.9.7 Genotyping .............................................................................................................. 60 
11 SAFETY MONITORING ............................................................................................................ 61 
11.1 Adverse Event and Serious Adverse Event Recording and Reporting ......................... 61 
11.2 Pregnancies ......................................................................................................................... 62 
11.3 Data Monitoring Board ..................................................................................................... 63 
12 PROTOCOL AMENDMENTS AND OTHER CHANGES IN STUDY CONDUCT ............ 63 
12.1 Protocol Amendments ........................................................................................................ 63 
12.2 Other Changes in Study Conduct ..................................................................................... 63 
13 DATA HANDLING AND ARCHIVING ................................................................................... 63 
13.1 Completing and Signing Case Report Forms .................................................................. 63 
13.2 Clinical Data Management ................................................................................................ 64 
13.3 Archiving and Filing .......................................................................................................... 64 


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14 STATISTICAL METHODS AND PLANNED ANALYSIS ..................................................... 64 
14.1 Populations for Analysis .................................................................................................... 64 
14.2 Patient Characteristics ....................................................................................................... 65 
14.3 Immunogenicity Analysis .................................................................................................. 65 
14.4 Primary Objective .............................................................................................................. 65 
14.5 Secondary Objectives ......................................................................................................... 66 
14.5.1 Secondary Efficacy Variables and Analyses ........................................................... 66 
14.6 Pharmacokinetic Analysis ................................................................................................. 66 
14.7 Safety Analysis .................................................................................................................... 67 
14.7.1 Adverse Events ........................................................................................................ 67 
14.7.2 Clinical Laboratory Evaluations .............................................................................. 67 
14.7.3 Physical Examination .............................................................................................. 68 
14.7.4 Vital Signs ............................................................................................................... 68 
14.7.5 Electrocardiograms .................................................................................................. 68 
14.8 Biomarkers .......................................................................................................................... 69 
14.9 Sample Size Determination ............................................................................................... 69 
14.10 Significance Level ............................................................................................................... 70 
14.11 Procedures for Missing, Unused, and Spurious Data ..................................................... 70 
14.12 Rules for Excluding Patients from Analysis .................................................................... 70 
14.13 Procedures for Reporting Deviations from Original Statistical Plan ............................ 70 
15 SPECIAL REQUIREMENTS AND PROCEDURES ............................................................... 70 
15.1 Institutional Review ........................................................................................................... 70 
15.2 Ethical Considerations ....................................................................................................... 71 
15.2.1 Regulatory and Ethical Compliance ........................................................................ 71 
15.2.2 Responsibilities of the Investigator and IRB/IEC ................................................... 71 
15.3 Investigator’s Responsibilities ........................................................................................... 71 
15.3.1 Overall Responsibilities .......................................................................................... 71 
15.3.2 Patient Informed Consent ........................................................................................ 72 
15.3.3 Direct Access to Source Data/Documents ............................................................... 72 
15.3.4 Confidentiality Regarding Study Patients ............................................................... 72 
15.3.5 Relevant Protocol Noncompliances ........................................................................ 73 
15.4 Study Monitoring ............................................................................................................... 73 
15.5 Audit and Inspection .......................................................................................................... 73 
15.6 Insurance ............................................................................................................................. 74 
15.7 Study Report and Publication Policy................................................................................ 74 
16 REFERENCES ............................................................................................................................. 75 
17 APPENDICES............................................................................................................................... 76 
17.1 Information on Investigational and Registered Products ............................................... 76 
17.2 Normal Limits for Vital Signs, Weight, Height, and Electrocardiogram Intervals ..... 77 
17.3 New York Heart Association Functional Classification.................................................. 79 


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17.4 Response Criteria ............................................................................................................... 81 
17.5 ECOG Performance Status ............................................................................................... 82 
17.6 Equivalent Doses for Corticosteroids ............................................................................... 83 
17.7 List of Indolent B-cell Lymphomas .................................................................................. 84 
 
2.2 List of Tables 
Table 1 
Definition of an Infusion Reaction ............................................................................... 35 
Table 2 
Schedule of Assessments .............................................................................................. 42 
Table 3 
Laboratory Evaluations ................................................................................................ 57 
Table 4 
Pre-dose Limits for Laboratory Parameters .................................................................. 58 
Table 5 
Criteria For Normal Limits For Vital Signs, Height, And Weight ............................... 77 
Table 6 
Criteria For Normal Limits For Electrocardiograms .................................................... 77 
Table 7 
Criteria For NYHA Functional Classification .............................................................. 79 
Table 8 
Response Criteria .......................................................................................................... 81 
Table 9 
ECOG Performance Status Grades ............................................................................... 82 
 
2.3 List of Figures 
Not applicable 


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Product Name: MOR00208 
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3 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
ADCC 
Antibody-dependent cell-mediated cytotoxicity 
ADCP 
Antibody-dependent cell-mediated phagocytosis 
ADR 
Adverse drug reaction 
AE 
Adverse event 
ALC 
Absolute lymphocyte count 
ALL 
Acute lymphoblastic leukaemia 
ALT 
Alanine transaminase 
ANC 
Absolute neutrophil count 
aPTT 
Activated partial thromboplastin time 
AST 
Aspartate aminotransferase 
AUC0-t 
Area under the serum concentration versus time curve from time 0 to the time t of 
the last quantifiable concentration 
AUC0- 
Area under the serum concentration versus time curve from time 0 to infinity 
(extrapolated) 
β-HCG 
Beta-human chorionic gonadotropin 
bpm 
Beats per minute (heart rate) 
CBC 
Complete blood count 
CD19 
Cluster of differentiation 19 
CL 
Total body clearance 
CLL 
Chronic lymphocytic leukaemia 
Cmax 
Apparent maximum serum concentration 
Cpd 
Apparent trough serum concentration before dosing 
CML 
Chronic myeloid leukaemia 
CNS 
Central nervous system  
CR 
Complete remission 
CRi 
Incomplete count recovery 
CRO 
Clinical Research Organization 
CT 
Computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
DLBCL 
Diffuse large B-cell lymphoma 
DLT 
Dose-limiting toxicity 
DNA 
Deoxyribonucleic acid 
DoR 
Duration of response 
ECG 
Electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
Electronic Case Report Form 
EDTA 
Ethylenediamine tetraacetic acid 
EMA 
European Medicines Agency  
EOS 
End of Study 
FcγR 
Fc gamma receptors 
FDA 
Food and Drug Administration 
FDG-PET 
[18F]fluorodeoxyglucose-positron emission tomography 
FL 
Follicular lymphoma 
GCP 
Good Clinical Practice 
GGT 
Gamma-glutamyltransferase 
GLP 
Good Laboratory Practice 
anti-HBc 
Anti-hepatitis B core antibody 
HBsAb 
Hepatitis B surface antibody 


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HBsAg 
Hepatitis B surface antigen 
HBV 
Hepatitis B virus 
HCL 
Hairy cell leukaemia 
HCV 
Hepatitis C virus 
HIV 
Human immunodeficiency virus 
HR 
Heart rate 
IB 
Investigator’s Brochure 
ICH 
International Conference on Harmonisation 
ID 
Identification 
IEC 
Independent Ethics Committee 
IRB 
Institutional/Independent Review Board 
IV 
Intravenous 
IWG 
International Working Group 
IWRS 
Interactive web response system 
Z 
Apparent terminal rate constant 
LLQ 
Lower limit of quantification 
mAb 
Monoclonal antibody 
MALT 
Mucosa-associated lymphoid tissue lymphoma 
MCL 
Mantle cell lymphoma 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRI 
Magnetic resonance imaging 
MTD 
Maximum tolerated dose 
MZL 
Marginal zone lymphoma 
NCI 
National Cancer Institute 
NHL 
Non-Hodgkin’s lymphoma 
NK 
Natural killer 
NYHA 
New York Heart Association 
ORR 
Overall response rate (complete remission + partial remission) 
PEI 
Paul-Ehrlich-Institut 
PET 
Positron emission tomography 
PFS 
Progression-free survival 
PML 
Progressive multifocal leukoencephalopathy 
po 
Per oral 
POC 
Proof-of-concept 
PR 
Partial remission 
PR (ECG) 
PR interval 
PT 
Prothrombin time 
PVC 
Polyvinyl chloride 
QRS 
QRS interval 
QT 
QT interval 
QTc 
QT interval corrected 
RBC 
Red blood cell 
REAL/WHO 
Revised European American Lymphoma/World Health Organization 
RNA 
Ribonucleic acid 
rpm 
Respirations per minute (respiration rate) 
RR (ECG) 
RR interval 
SAE 
Serious adverse event 
SCID 
Severe combined immunodeficiency 
SD 
Stable disease  
SLL 
Small lymphocytic lymphoma 


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SOP 
Standard Operating Procedure 
SUSAR 
Suspected unexpected serious adverse reaction 
t1/2 
Apparent terminal half-life 
tmax 
Time to maximum serum concentration 
TNF-α 
Tumour necrosis factor alpha 
TTP 
Time to progression 
ULN 
Upper limit of normal 
US 
United States 
USP 
United States Pharmacopoeia 
Vz 
Volume of distribution during the terminal phase 
WBC 
White blood cell 
WFI 
Water for Injection 
WHO-DDE 
World Health Organization–Drug Dictionary Enhanced 
WOCBP 
Woman of childbearing potential 
 


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4 
BACKGROUND 
 
4.1 Overview of Non-Hodgkin’s Lymphoma 
Non-Hodgkin’s lymphoma (NHL) accounts for approximately 5% of all new cancer cases. 
Non-Hodgkin’s lymphoma is a heterogeneous group of lymphoproliferative malignancies and 
is in 90% of cases derived of B cells. 
Diffuse large B-cell lymphoma (DLBCL), an aggressive B-cell lymphoma, accounts for 
one-third of NHL, and after standard treatment with the anti-CD20 antibody rituximab with the 
chemotherapy CHOP (cyclophosphamide, doxorubicin, vincristin and prednisone) 30% to 40% 
of patients are still relapsed or refractory, requiring further treatment. Mantle cell lymphoma 
(MCL), like DLBCL, is an aggressive NHL but is far less responsive to treatment than 
DLBCL.  
Follicular lymphoma (FL), an indolent B-cell lymphoma, accounts for 22% of NHL. Even if 
the overall response rate is high, standard therapy is rarely curative and nearly all patients will 
relapse. There is no standard-of-care treatment available for patients with advanced FL. 
Therapy with a monoclonal antibody would have the potential to improve response rates and 
overall survival without increasing haematologic toxicity. 
This is supported by initial data from other anti-CD19 monoclonal antibodies (MDX-1342 and 
SAR3419) and the bispecific antibody blinatumomab (Viardot, 2011), MDX-1342 a 
glycoengineered fully human anti-CD19 Ab (Camacho, 2009), SAR3419 a humanized IgG1 
conjugated with DM4 (a cytotoxic maytansinoid derivate) (Coiffier, 2011) published 
preliminary data from their Phase I studies indicating that a CD19 is a valid target and that an 
anti-CD19 therapy has potential clinical benefit. No significant myelosuppression was reported 
from these trials.  
4.2 Overview of MOR00208 
MOR00208 (synonym: XmAb®5574), an Fc engineered mAb that binds to the human B-cell 
surface antigen CD19, is being developed for the treatment of CD19+ lymphoid malignancies. 
The engineered antibody possesses variable modes of significantly increased tumor 
cytotoxicity relative to the parent, nonengineered, murine 4G7 anti-CD19 antibody. The 
increase in binding of MOR00208 Fc to Fc gamma receptors (FcγR) due to engineered 
mutations significantly enhances in vitro ADCC, ADCP, and direct cytotoxic effects 
(apoptosis) on tumor relative to the unmodified antibody. MOR00208 has not been shown to 
mediate complement-dependent cytotoxicity.  
In preclinical studies, MOR00208 has demonstrated to significantly enhance in vitro ADCC, 
ADCP, and direct cytotoxic effects (apoptosis) on CD19+ tumor cell line spanning a broad 
range of human lymphomas and leukaemias (Burkitt’s lymphoma, chronic lymphocytic 
leukaemia [CLL], hairy cell leukaemia [HCL], CD19+ chronic myeloid leukaemia [CML], 
DLBCL, and acute lymphoblastic leukaemia [ALL]) expressing different levels of CD19 
antigen (15000 to 105000 molecules/cell). Similar effects were also noted on freshly isolated 
patient CLL or ALL cells and are also expected to translate to primary NHL cells since the 
expression range reported for ALL and CLL B cells covers the respective range observed for 


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NHL B cells (Ginaldi et al., 1998; Olejniczak et al., 2006). In vivo, MOR00208 has also shown 
a superior efficacy compared with its nonengineered version as demonstrate in xenograft 
models of human lymphoma inducing a significant reduction of tumor growth and increased 
survival. 
Tissue cross-reactivity studies have shown that the pattern and distribution of MOR00208 
binding to cynomolgus monkey tissues closely parallels that of human tissues. Flow cytometry 
experiments with MOR00208 show binding to human and cynomolgus monkey B cells. 
However, similar results were not observed with B cells of other common laboratory species 
(rat, mouse, rabbit and dog). Therefore, the range of pharmacology studies was restricted to 
human and cynomolgus monkey cell-based in vitro systems, CD19+ human B-cell tumor 
xenograft models in severe combined immunodeficiency (SCID) mice, and to cynomolgus 
monkeys in vivo. In cynomolgus monkeys, in vivo B-lymphocyte depletion in peripheral 
blood, bone marrow, spleen and in inguinal lymph nodes, the anticipated response to 
MOR00208, was observed. Cynomolgus monkeys were judged to be the only relevant 
common laboratory species for toxicity studies. 
The results of studies evaluating the pharmacokinetics, pharmacodynamics and toxicity of 
MOR00208 are provided in the Investigator’s Brochure (IB). The findings in preclinical 
toxicology studies were limited to the expected pharmacologic effects of MOR00208 and no 
unanticipated toxicity was observed. These studies include a nonclinical toxicology study 
conducted in cynomolgus monkeys to support the use of MOR00208 in human clinical trials. 
The supporting Good Laboratory Practice (GLP)-compliant, multiple-dose toxicology study 
involved four administrations of MOR00208 over an 8-week time period. Other than the 
expected dose-related decreases in B-lymphocyte level and in cellularity of spleen tissues, 
there were no MOR00208-related changes identified in clinical observations, food 
consumption, body weight, electrocardiography, ophthalmology, urinalysis, coagulation, serum 
chemistry, and gross anatomic pathology at doses up to 50 mg/kg. In addition, GLP-compliant 
tissue cross-reactivity studies were performed on normal tissue panels from human and 
cynomolgus monkey donors. No specific staining to structures other than the expected 
mononuclear leukocytes, lymphocytes and haematopoietic precursor cells was observed. 
Study XmAb®5574-01, a Phase I study in patients with CLL/SLL, was the first study of 
XmAb®5574/MOR00208 in humans. The preliminary results of Study XmAb®5574-01 
showed an acceptable safety profile as well as preliminary activity. One dose-limiting 
toxicity (DLT) of Grade 4 neutropenia lasting at least 7 days was observed during 
Study XmAb®5574-01 in one patient at the maximum-administered dose (12 mg/kg) out of 
16 patients treated at this dose level. 
Because the major pharmacologic effect of MOR00208 is B-cell depletion, investigators 
should be vigilant for adverse events (AEs) associated with the clinical use of B-cell depleting 
anti-CD20 mAbs as similar effects might be observed with MOR00208. 
4.2.1 
Clinical Experience with MOR00208 
A Phase I study of MOR00208 (XmAb®5574-01) in adult patients with relapsed/refractory 
CLL/SLL was the first study of XmAb®5574/MOR00208 in humans. During the course of this 
study, 27 patients were treated in dose cohorts from 0.3 mg/kg to 12 mg/kg (n=16) 
intravenously on a weekly schedule for 8 weeks, with an extra dose administered on Day 4. 
Patients enroled in the expansion phase of Cohort 6 (12 mg/kg) received an additional 


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4 monthly doses of MOR00208 after completing the initial 2 cycles of therapy if there was no 
evidence of disease progression or intolerable drug-related toxicity. 
The preliminary antitumor activity of MOR00208 observed in this Phase I study is encouraging 
and provides support for additional studies. Twenty of 23 patients (87%) with evaluable data in 
the clinical database had a reduction in their absolute lymphocyte count (ALC; range 2% to 
99%), with 17 of 20 (85%) having reductions of >50% from their baseline values. Lymph node 
size reduction (range 4% to 89%) as assessed by CT scans were observed in 13 of 18 (72%) of 
patients to date. While the number of patients in this Phase I study is limited to draw definitive 
conclusions, there appeared to be a dose response relationship with greater reductions in ALCs 
and nodal size reduction in the higher dose cohorts. 
The maximum-tolerated dose (MTD) was not established, since only one DLT occurred. 
Therefore the selected dose (12 mg/kg) from study XmAb®5574-01 will be used in this clinical 
trial. 
4.2.2 
Safety of MOR00208 
MOR00208 provides a novel mechanism of action that may add to the care of NHL. Based on 
the available data from the completed clinical study of MOR00208 (Study XmAb®5574-01), 
nonclinical studies and experiments, and literature data on CD19, the sponsor is of the opinion 
that the potential benefit of MOR00208 outweighs the potential risks. It is expected that the 
potential risks will be adequately controlled by the design of this trial (eg, by the inclusion and 
exclusion criteria) and by frequent monitoring of potential adverse drug reactions throughout 
the entire study. Based on the preliminary results of the clinical study of MOR00208 in patients 
with CLL/SLL, anticipated possible risks associated with administration of MOR00208 include 
the following:  
One DLT of Grade 4 neutropenia (normal absolute neutrophil count [ANC] at baseline) lasting 
at least 7 days was observed at the maximum-administered dose of 12 mg/kg. 
As of 11 May 2012, 5 serious adverse events (SAEs) have been reported in 5 patients; 2 were 
considered possibly related to the study drug. One related SAE of febrile neutropenia (Grade 3) 
occurred in the same patient who experienced the DLT. The second related SAE of tumor lysis 
syndrome (Grade 3) occurred after the first dose of study drug. The other 3 SAEs were 
assessed as unrelated by the investigator and included rash (Grade 1), pneumococcal 
pneumonia (Grade 3), and sinusitis/acute bilateral otitis media (Grade 3).  
The most frequent AE was infusion-related reaction in trial XmAb®5574-01, which occurred in 
12 of 21 (57.1%) patients, despite premedication with antihistamine, acetaminophen and 
corticosteroids as mandated for the first 3 infusions of MOR00208. All infusion reactions 
occurred during the patient’s first infusion (typically within the first 15 minutes of the start of 
infusion), as has been described with other B-cell depleting monoclonal antibody therapies in 
this patient population. Infusion reaction was more frequent in the higher dose cohorts, 
although infusion reaction did occur in at least one patient in every cohort. The infusion 
reactions were all Grade 1 or Grade 2 in severity. All patients were able to complete their dose 
after pausing of the infusion and symptomatic treatment, some with a reduction in the infusion 
rate. 


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Leukopenia and neutropenia has been observed in 14% and 24% of patients, respectively, with 
one patient experiencing Grade 4 neutropenia. Thrombocytopenia has also been reported at a 
frequency of 14% in patients. 
Since a major pharmacologic effect of MOR00208 is B-cell depletion, risks associated with the 
use of approved anti-CD20 B-cell depleting therapeutics based on their labeling should be 
considered. These anticipated possible risks include the following: B-cell depletion, absolute 
lymphocyte 
reduction, 
infusion 
reactions, 
tumor 
lysis 
syndrome, 
neutropenia/thrombocytopenia, 
hepatitis 
B 
reactivation, 
progressive 
multifocal 
leukoencephalopathy, mucocutaneous reactions and infections. 
Anticipated possible risks associated with administration of MOR00208 are described in detail 
in the IB for MOR00208. 
5 
STUDY PURPOSE/RATIONALE 
MOR00208 has enhanced cytotoxicity against CD19+ tumors in both in vitro and in vivo, and 
it is expected to provide potent recruitment of immune effector cells as a result of the Fc 
engineering. MOR00208 is being developed for the treatment of CD19+ lymphoid 
malignancies. CLL, NHL, HCL and B-precursor ALL represent tumor types that have been 
well characterized in regard to expression of the CD19 antigen. 
Introduction of rituximab into first-line NHL regimens in the recent years has improved cure 
rate in several NHL subtypes by at least 10%. Despite extensive use of rituximab across a 
range of NHL subtypes in combination with chemotherapy, as a single agent, or as 
maintenance therapy, there is still a high unmet medical need for patients with refractory or 
relapsed NHL (eg, MCL, DLBCL, and FL). (van Oers, 2011; Rummel, 2010; Parekh, 2011) 
The B-lymphocyte lineage-specific surface antigen CD19 is the earliest and broadest of the 
selective B-cell markers, which is highly expressed on the malignant cells in most patients with 
B-cell NHL. Because of this expression pattern, an anti-CD19 antibody may have clinical 
utility as a new therapeutic approach to NHL treatment. MOR00208 is an Fc-engineered mAb 
with significantly enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-
dependent cell-mediated phagocytosis (ADPC), and direct cytotoxic effects (apoptosis) on the 
tumor relative to the unmodified antibody. 
Several mAbs targeting CD19 are currently being evaluated in early-phase clinical trials, 
demonstrating preliminary efficacy. Data from the Phase I trial in patients with 
relapsed/refractory 
CLL/SLL 
(study 
XmAb®5574-01) 
demonstrate 
that 
MOR00208/XmAb®5574 is well-tolerated and has potential clinical benefit. With an enhanced 
cytotoxicity and safety/tolerability profile, MOR00208 has the potential to be an effective 
therapy for patients with CD19-expressing B-cell malignancies. The purpose of this study is to 
evaluate the efficacy and safety of MOR00208 in adult patients with relapsed or refractory 
NHL. 
 


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6 
OBJECTIVES 
6.1 Primary Objective 
 To assess the antitumor activity of single-agent MOR00208 in adult patients with relapsed 
or refractory NHL who have received at least 1 prior therapy containing rituximab as one 
of the treatments. 
 
6.2 Secondary Objectives 
 To evaluate the duration of response 
 To establish safety and tolerability of MOR00208 
 To assess the potential immunogenicity of MOR00208 
 To evaluate the pharmacokinetics and pharmacodynamics of MOR00208 in patients with 
relapsed or refractory NHL 
 
7 
STUDY DESIGN 
7.1 Overall Study Design and Investigational Plan 
This is a Phase IIa open-label, multicenter safety and efficacy study of MOR00208, that will 
enrol approximately 40 to 120 adult patients with refractory or relapsed NHL who have 
received at least 1 prior therapy containing rituximab. 
The study will enrol patients from four different NHL subtypes: FL, DLBCL, MCL and other 
indolent NHL (MZL, MALT, etc.). 
The study will employ a two-stage design where the decision to further enrol any NHL subtype 
in Stage 2 will depend on best responses after 2 or 3 cycles in Stage 1. 
Stage 1 – At least ten patients per NHL subtype (a minimum of 40 patients in total) will be 
enrolled to receive MOR00208 12 mg/kg weekly for 8 weeks. After 8 and 12 weeks (the latter 
applicable only for patients with at least SD after 8 weeks) of dosing, patients will be evaluated 
for response. If in Stage 1 fewer than 2 patients per NHL subtype have a best response of PR or 
better, then continued enrolment in that cohort will be stopped for futility. If at least 2 patients 
per NHL subtype have a best response of PR or better, then additional patients will be enrolled 
into Stage 2 for that subtype cohort.  
Any patients with a response of at least stable disease (SD) in Stage 1 will qualify for a further 
4 weeks of dosing. 
Stage 2 – At least an additional 20 patients will be enrolled for each NHL cohort demonstrating 
a response in Stage 1. After 8 weeks, the ORR will be evaluated for each NHL cohort. 
Any patients with a response of at least stable disease (SD) in Stage 2 will qualify for a further 
4 weeks of dosing. 


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Maintenance treatment - Patients with an ongoing response of at least PR at the end of Cycle 3 
(regardless of Stage 1 or 2) may receive further study drug until progression (please see 
Sections 10.3 and 10.4). Eligible patients will receive a dose of 12 mg/kg MOR00208 either 
monthly or every second week. 
The decision on patient eligibility and dosing frequency for this maintenance treatment will be 
taken jointly on a case-by-case base by the concerned investigator and the sponsor.    
 
7.2 Study Timeframe 
Each patient will participate in the active phases of the study for a minimum of 8 weeks and a 
maximum of 12 weeks. Patients in maintenance will be treated until progression. The 
anticipated overall time frame of the study will be 30 months or longer, depending on response 
in maintenance, until all patients have completed the end of study visit. 
 
7.3 Study Endpoints 
Primary endpoint: 
1. Overall response rate (CR+PR), assessed as per the 2007 International Working Group 
(IWG) response criteria  
Secondary endpoints: 
1. Stable disease (SD), duration of response (DoR), time to progression (TTP), and 
progression-free survival (PFS) 
2. Incidence and severity of AEs 
3. Number and proportion of patients who potentially develop anti-MOR00208 antibodies and 
semiquantitative (anti-MOR00208 antibody titer determination of confirmed positive 
samples) anti-MOR00208 antibody assessments 
4. Pharmacokinetics (Cmax, tmax, Cpd [apparent trough serum concentration before dosing], 
AUC0-t, AUC0-∞, λZ, t½, CL, Vz) 
5. Absolute and percentage change from baseline in measurements of B-, T- and NK cell 
populations 
6. Evaluation of AEs and ORR stratified by baseline CD19 expression on malignant 
lymphoma cells 
7. Evaluation of AEs and ORR stratified by FcγRIIIa and FcγRIIa polymorphism 
 
8 
POPULATION 
The study population will consist of adult patients with relapsed or refractory B-cell NHL who 
have received at least 1 completed cycle of combination therapy with rituximab + 
chemotherapy or at least 4 weekly administrations of rituximab as monotherapy. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
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The planned sample size is at least 40 patients in Stage 1 (at least 10 patients per NHL subtype) 
and up to a maximum of 80 additional patients in Stage 2 (approximately 20 patients enrolled 
to each NHL subtype that continues to enrol into Stage 2). The entire study will enrol between 
40 to approximately 120 patients, depending on decision to stop enrolment for futility. 
The investigator or his/her designee must ensure that only patients who meet the following 
inclusion and exclusion criteria are offered enrolment into the study: 
8.1 Inclusion Criteria 
1. Patients are male or female ≥ 18 years of age. 
2. Patients have a histologically confirmed diagnosis according to the Revised European 
American lymphoma/World Health Organization (REAL/WHO) classification, of the 
following B-cell lymphomas:  
a. FL 
b. Other indolent NHL (eg, MZL/MALT) (see section 17.7) 
c. DLBCL 
d. MCL  
NOTE: For transformed lymphomas, the subtype at screening (not at initial diagnosis) 
is relevant for the assignment to the respective subtype. 
3. Patients’ NHL must have progressed after at least 1 prior rituximab-containing regimen. 
4. Patients have at least one site of measurable disease by magnetic resonance imaging (MRI) 
or computed tomography (CT) scan defined as at least one lesion that measures at least 
1.5 × 1.5 cm, 
Exception: 
For patients with MCL only, patients with nonmeasurable disease but evaluable sites (bone 
marrow, spleen, peripheral blood, gastrointestinal tract) can be enrolled. 
5. Patients who have previously received an autologous stem cell transplantation must be at 
least 4 weeks post-transplant before study drug administration and must have exhibited a 
full haematological recovery. 
6. Patients must have discontinued previous monoclonal antibody therapy (except rituximab) 
or radioimmunotherapy administration for at least 60 days before study drug 
administration. 
7. Patients should be off rituximab for at least 14 days before the screening visit and be 
confirmed to have either no response or have disease progression after rituximab treatment. 
8. Patients with DLBCL had a positive [18F]fluorodeoxyglucose-positron emission 
tomography (FDG-PET) scan at baseline (Cheson 2007 response criteria). 
9. Patients have a life expectancy of > 3 months. 
10. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 
< 3. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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11. Patients must meet the following laboratory criteria at screening: 
a. Absolute neutrophil count (ANC) ≥ 1.0 × 109/L 
b. Platelet count ≥ 75 × 109/L without previous transfusion within 10 days of first study 
drug administration 
c. Hemoglobin ≥ 8.0 g/dL (may have been transfused) 
d. Serum creatinine < 2.0 x upper limit of normal (ULN) 
e. Total bilirubin ≤ 2.0 × ULN 
f. Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN 
12. If a female of childbearing potential, a negative pregnancy test must be confirmed before 
enrolment and use of double-barrier contraception, oral contraceptive plus barrier 
contraceptive must be used during the study and for 3 months after the last dose, or 
confirmation of having undergone clinically documented total hysterectomy and/or 
oophorectomy, tubal ligation. 
13. If a male, an effective barrier method of contraception must be used during the study and 
for 3 months after the last dose if the patient is sexually active with a female of 
childbearing potential. 
14. The patients are able to comply with all study-related procedures, medication use, and 
evaluations. 
15. The patients are able to understand and give written informed consent and comply with the 
study protocol. 
 
8.2 Exclusion Criteria 
1. Previous treatment with cytotoxic chemotherapy, immunotherapy, radiotherapy or other 
lymphoma-specific therapy within 14 days before the screening visit or patient has not 
recovered from side effects of previous lymphoma-specific therapy. 
2. Treatment with a systemic investigational agent within 28 days before the screening visit.  
3. Previous treatment with an anti-CD19 antibody or fragments. 
4. Previous allogeneic stem cell transplantation. 
5. Known or suspected hypersensitivity to the excipients contained in the study drug 
formulation. 
6. Clinically significant cardiovascular disease or cardiac insufficiency (New York Heart 
Association [NYHA] classes III-IV), cardiomyopathy, preexisting clinically significant 
arrhythmia, acute myocardial infarction within 3 months of enrolment, angina pectoris 
within 3 months of enrolment. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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7. Patients 
with 
positive 
hepatitis 
serology 
(see 
also 
Section 
9.5.2).  
Hepatitis B (HBV): Patients with positive serology for HBV defined as positivity for 
hepatitis B surface antigen (HBsAg) or total anti-hepatitis B core antibody (anti-HBc). 
Patients positive for anti-HBc may be included if HBV DNA is not detectable.  
Hepatitis C (HCV): Patients positive HCV serology (defined as positive for anti-HCV 
antibody [anti-HCV]) unless HCV-ribonucleic acid (RNA) is confirmed negative. 
8. History of human immunodeficiency virus (HIV) infection. 
9. Any active systemic infection (viral, fungal, or bacterial) requiring active parenteral 
antibiotic therapy within 4 weeks of study drug administration. 
10. Current treatment with immunosuppressive agents other than prescribed corticosteroids 
(not more than 10-mg prednisone equivalent). 
11. Major surgery or radiation therapy within 4 weeks before first study drug administration. 
12. Systemic diseases (cardiovascular, renal, hepatic, etc.) that would prevent study treatment 
in the investigator’s opinion. 
13. History or clinical evidence of central nervous system (CNS), meningeal, or epidural 
disease, including brain metastasis. 
14. Active treatment/chemotherapy for another primary malignancy within the past 5 years 
(except for ductal breast cancer in situ, non-melanoma skin cancer, prostate cancer not 
requiring treatment, and cervical carcinoma in situ). 
15. Pregnancy or breastfeeding in women and women of childbearing potential not using an 
acceptable method of birth control. 
16. History of noncompliance to medical regimens or patients who are considered potentially 
unreliable and/or not cooperative. 
8.3 Definition of Woman of Childbearing Potential 
A female patient or a female partner of a male patient is considered to have childbearing 
potential unless she meets at least 1 of the following criteria: 
 Age at least 50 years and naturally amenorrhoeic for at least 1 year (amenorrhoea 
following cancer therapy does not rule out childbearing potential) 
 Premature ovarian failure confirmed by a gynaecologist 
 Previous bilateral salpingo-oophorectomy, or hysterectomy 
 XY genotype, Turner syndrome, uterine agenesis 
 
8.4 Procedures for Enrolment 
A fully signed informed consent must be available before the start of screening activities.  
Patients who are able to understand the study but unable to read or write may be consented in 
accordance with the local legislation, e.g. written confirmation by a witness. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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Enrolment to treatment will be performed after all inclusion and exclusion criteria have been 
confirmed and the patient is found to be eligible.  
Patients can be re-screened once if since the last visit (either screening or baseline visit) at least 
four weeks have elapsed. 
In cases of re-screening, patients need to be reconsented and a new patient number will 
be assigned. 
Re-screening procedures 
Patients can be re-screened at the discretion of the investigator under certain circumstances. 
Re-screening is restricted to one attempt per patient and may be performed only if one of the 
following criteria is met: 
 If the inclusion of a patient who has already consented and who met all the inclusion 
and has met none of the exclusion criteria is delayed due to an unexpected change in 
the patient’s personal situation (e.g. family issues), 
 If a patient previously failed to be eligible due to any event (e.g. planned surgery) that 
has since been resolved, 
 If the allowed concomitant medication doses have stabilized, 
 If laboratory values that prevented the inclusion of a patient based on the first screening 
attempt have changed to satisfy the inclusion and exclusion criteria outlined in the 
currently valid study protocol,  
 If a patient who previously failed screening becomes eligible for the study, based on a 
change in the inclusion and exclusion criteria following a protocol amendment. 
 If a patient failed screening due to non-progressed/non-relapsed disease at the time of 
screening and later is clinically diagnosed as having progressed/relapsed. 
 
NOTE:  A patient should only be re-screened if there is a clear indication that the patient may 
be eligible according to the currently valid study protocol.   
In these cases, if previous screening activities were discontinued and enrollment did not occur, 
the following procedure should be implemented: 
 the patient must sign and date a new Informed Consent Form as part of the screening 
procedure, 
 the patient will receive a new unique inclusion/identification number and, in case of 
eligibility, a new unique number via the IWRS, 
 a new Case Report Form (CRF) will be completed, 
 the patient will be documented as re-screened in the source documents, and 
 recording of medical histories, physical examinations, prior NHL treatments, adverse 
events, and concurrent medications will be transcribed from the previously used to the 
new CRF if the conditions and medications still apply to the current status of the 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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re-screened patient as documented in the source documents. All screening procedures 
must be completed again. 
A re-screened patient can be enrolled if all current inclusion criteria are met and none of the 
exclusion criteria are met.  
9 
TREATMENT 
Each investigator is responsible for ensuring that deliveries of study drug and other study 
materials from the sponsor via delegated depot are correctly received, recorded, handled and 
stored safely and properly in accordance with all applicable regulatory guidelines, and used in 
accordance with this protocol. The investigator can delegate these tasks to a dedicated 
pharmacist or another person (according to the national laws and regulations). Drug 
accountability forms will be kept by the site during the study and will be checked during 
monitoring visits. 
For the first 5 patients in the study (irrespective of the subgroup) the first study drug infusion 
will be administered as in-patients (ie, these patients will remain in the hospital overnight for 
the first infusion). Whether subsequent patients will have to stay overnight will then be decided 
by the sponsor after consultation with the investigators concerned. 
All study drug containers – ie, outer packing and vial - (opened, unopened, or empty) must be 
returned to the sponsor/sponsor’s designee and will be destroyed by the sponsor or 
representative after the study and overall drug accountability has been completed by the 
sponsor or representative.  
Opened or empty vials should only be returned if this is not in violation of local guidances or 
SOPs. 
A list of study drug and other materials that have been returned or destroyed must be prepared 
and signed by the principal investigator or designee. If there are any discrepancies, an 
explanation for these should also be provided. 
The IB for MOR00208 or other safety documents for study drugs will be supplied to the study 
sites. 
9.1 Patient Numbering 
This is an open-label study. Patients will not be randomized. 
For each patient screened, the investigator or designee will log into the Interactive Web 
Response System (IWRS) and will enter the age at time of consent and the gender. The IWRS 
will allocate the next available screening identification (ID) number, ensuring that screening ID 
numbers are assigned sequentially per center. These numbers (7 digits) are made up of the 
country code (2 letters) (eg, PL, DE), the site number (2 digits) (01, 02), and a 3-digit number 
(001, 002) given to each patient in sequence as they are screened at site. Leading zeros will be 
used for the site and 3-digit number part of the ID number to ensure a consistent length of 
7 digits. The investigator will enter the information (ie, age at time of consent and the 
associated screening ID number) into the confidential patient identification list. The patient 
will be identified by the previously assigned screening ID number throughout the study. No 
additional patient number will be used. For numbering of patients who were re-screened, 
please see Section 8.4.  


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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Informed consent must be obtained before any study procedures are carried out. 
 
9.2 Investigational Medicinal Products 
9.2.1 
Instructions for Prescribing and Taking the Study Drug 
Detailed descriptions concerning correct storage conditions, handling, solution preparation, and 
administration will be provided in a drug preparation manual for MOR00208. 
MOR00208 DP is a white to yellowish lyophilisate for reconstitution with 5 mL water for 
injection (WFI), supplied in single-use 20 mL glass vials. The solution after reconstitution is 
colorless to slightly yellow and essentially free of foreign particles; it may contain few white to 
whitish product-related particles. Reconstitution with 5 mL WFI yields approximately 5.4 mL 
of drug product that contains 40 mg/mL of MOR00208, 25 mM sodium citrate, 200 mM 
trehalose and 0.02% (w/v) polysorbate 20 at pH 6.0. Each product vial is intended to deliver 
5 mL of drug solution or 200 mg of MOR00208. Each vial of MOR00208 is packaged in a 
single drug product box. 
MOR00208 DP must be stored under refrigeration at 2°C to 8°C in an appropriately locked 
room accessible only to the pharmacist(s), the investigator, or a duly designated person.  
For administration, MOR00208 will be diluted into a 250 mL infusion bag containing 0.9% 
sodium chloride for injection. MOR00208 DP and commercially available 0.9% sodium 
chloride saline for injection will be provided to investigational sites by the sponsor or delegated 
depot.  
The individual MOR00208 infusion will be prepared and administered at the study site, 
according to directions of the sponsor, which will be provided in a drug preparation manual. In 
general, a vial of MOR00208 must be used as soon as possible after reconstitution with WFI; 
any solution remaining in the vial has to be discarded. After dilution for infusion, 
administration of MOR00208 should take place as soon as possible. Maximum allowed storage 
times and conditions will be detailed in the drug preparation manual. 
For the first infusion, IV infusion should be started with an infusion rate of 70mL/h for the first 
30 minutes and then subsequently increased to a rate of 125mL/h; the total infusion duration 
should ideally not exceed 2.5 hours. All subsequent MOR00208 infusions will be administered 
IV at a constant rate over a 2-hour period. In all cases an in-line filter has to be used. 
MOR00208 infusion should NOT be administered as an IV push or bolus. 
Resuscitation equipment should be readily available. 
9.2.2 
Treatment 
The dose of MOR00208 will be 12 mg/kg, which was established in study XmAb®5574-01. 
For all patients, weight measurements are to be performed at each visit (except Day 2 of Cycle 
1) and the values are to be entered into the eCRF recording the day of the actual measurement.  
Measurements can be done up to 24 hours before study drug administration. The weight 
obtained at at each visit before study drug administration should be used to calculate the study 
drug dose for the respective visit.  


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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Only in exceptional cases, e.g. due to logistical issues, the weight obtained at the previous visit 
can be used (provided that there is no obvious change of +/- 10% compared with the previous 
visit).  
9.3 Treatment Arms 
Not applicable. This is a single-arm study. 
 
9.4 Treatment Blinding 
Blinding does not apply since the study will be open label. 
9.5 Treating the Patient 
9.5.1 
Management of Infusion Reactions 
Infusion reactions will be defined according to the NCI-CTCAE, Version 4.0 definition of 
infusion-related reaction and cytokine release syndrome. 
Table 1 
Definition of an Infusion Reaction 
NCI-CTCAE Version 4.0, Select Criteria: Infusion-Related Reaction and Cytokine 
Release Syndrome 
Adverse 
Event 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Infusion-related 
reaction 
Mild transient 
reaction; infusion 
interruption not 
indicated; 
intervention not 
indicated 
Therapy or infusion 
interruption indicated but 
responds promptly to 
symptomatic treatment (eg, 
antihistamines, NSAIDS, 
narcotics, IV fluids); 
prophylactic medications 
indicated for ≤24 hrs
Prolonged (eg, not rapidly 
responsive to symptomatic 
medication, brief interruption of 
infusion, or both); recurrence of 
symptoms following initial 
improvement; hospitalization 
indicated for clinical sequelae 
Life-threatening 
consequences; 
urgent 
intervention 
indicated 
Cytokine release 
syndrome 
Mild reaction; 
infusion interruption 
not indicated; 
intervention not 
indicated 
Therapy or infusion 
interruption indicated but 
responds promptly to 
symptomatic treatment (eg, 
antihistamines, NSAIDS, 
narcotics, IV fluids); 
prophylactic medications 
indicated for ≤24 hours 
Prolonged (ie, not rapidly 
responsive to symptomatic 
medication and/or brief 
interruption of infusion); 
recurrence of symptoms 
following initial improvement; 
hospitalization indicated for other 
clinical sequelae (eg, renal 
impairment, pulmonary 
infiltrates)
Life-threatening; 
consequences; 
pressor or 
ventilatory 
support indicated 
REMARK:  An acute infusion reaction may occur with an agent that causes cytokine release (eg, monoclonal antibodies or 
other biological agents). Signs and symptoms usually develop during or shortly after drug infusion and generally resolve 
completely within 24 hours of completion of infusion. Signs/symptoms may include: Allergic reaction/hypersensitivity 
(including drug fever); Arthralgia (joint pain); Bronchospasm; Cough; Dizziness; Dyspnea (shortness of breath); Fatigue 
(asthenia, lethargy, malaise); Headache; Hypertension; Hypotension; Myalgia (muscle pain); Nausea; Pruritis/itching; 
Rash/desquamation; Rigors/chills; Sweating (diaphoresis); Tachycardia; Tumor pain (onset or exacerbation of tumor pain due 
to treatment); Urticaria (hives, welts, wheals); Vomiting 
 
During Cycle 1, premedication including antipyretics (eg, acetaminophen 500-650 mg PO or 
IV or equivalent), histamine H1 receptor blockers (eg, diphenhydramine 25 to 50 mg IV or 
equivalent), and glucocorticosteroids (methylprednisolone 80 to 120 mg IV or equivalent; 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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please refer to Table 17.6) should be given for the first 3 infusions. In medically justified cases, 
the investigator may use other doses and/or formulations if this is documented thoroughly in 
the eCRF and the source data.  
Premedication for patients who do not experience any infusion reactions during the first 
3 infusions will be optional for subsequent infusions at the discretion of the investigator. 
Otherwise, the premedication should be continued for subsequent administrations of 
MOR00208. In case of development of rigor or chills treatment with meperidine is allowed. 
Grade 1 or 2 infusion reactions 
If a patient presents with Grade 1 or Grade 2 infusion reactions: 
 Infusion should be stopped immediately 
 The patient should receive appropriate further treatment with an antihistamine and/or 
paracetamol or methylprednisolone (or equivalent) if clinically indicated. 
 Once symptoms are resolved or reduced to “mild” by investigator assessment the 
infusion can be continued at an infusion rate of 50%. If after one hour, the patient’s 
symptoms do not return and vital signs are stable, the infusion rate may be increased 
every 30 minutes as tolerated to the baseline rate. 
If a patient who developed infusion reactions (Grade 1 or 2) receives further infusions, then 
premedication should be given before all subsequent infusions of MOR00208. 
Grade 3 infusion reactions 
If a patient presents with Grade 3 infusion reactions: 
 Infusion should be stopped immediately  
 The patient must receive appropriate treatment with an antihistamine and/or 
paracetamol or methylprednisolone (or equivalent) and, if necessary, further 
medications (ie, epinephrine, bronchodilator). 
 Obtain blood sample for cytokine analysis during the event and approximately 24 hours 
later. 
 Only after complete resolution of all symptoms (less than Grade 1) and after having 
received appropriate prophylactic medication(s) above may the infusion be resumed at 
an infusion rate of 25%. If, after one hour, the patient’s symptoms do not return and 
vital signs are stable, the infusion rate may be increased to a maximum of 50%. 
 If, after resumption of infusion, symptoms have returned (irrespective of Grade), 
infusion must be stopped immediately and the infusion tubing should be disconnected 
from the patient. Patient should not receive further study drug. 
Grade 4 infusion reactions 
If a patient presents with Grade 4 infusion reactions: 
 Infusion should be stopped immediately and the infusion tubing should be disconnected 
from the patient. 


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Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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 Patient should receive appropriate treatment with an antihistamine and/or paracetamol 
or methylprednisolone (or equivalent) and, if necessary, further medications (ie, 
epinephrine, bronchodilator). 
 Obtain blood sample for cytokine analysis during the event and approximately 24 hours 
later. 
 Patient must not receive further study drug. 
9.5.2 
Management of Patients with Positive Hepatitis B Serology 
All patients will be screened for hepatitis B before dosing. Patients with a positive test for anti-
HBc can only be included if HBV-DNA is not detected. In these patients, HBV-DNA should 
be assessed at regular intervals during treatment (see Table 2).  
If HBV-DNA becomes detectable during treatment, patients should be prophylactically treated 
and followed-up for potential hepatitis B reactivation as per local practice or guideline for anti-
CD20 antibodies like rituximab. 
For ongoing patients (ie, either in treatment, follow-up, or maintenance) who were included 
before anti-HBc measurement was introduced with this amendment, anti-HBc should be 
measured at least once (see Table 2) unless a patient’s anti-HBc status is known from within 
6 months prior to screening. If anti-HBc is positive and HBV-DNA from within 6 months 
before screening is not known, then HBV-DNA should be measured. If HBV-DNA is positive, 
then patients can only stay in the study if they were assessed by a physician experienced in the 
treatment of hepatitis B and pre-emptive treatment was initiated if deemed appropriate and/or 
according to local practice/guideline. 
9.6 Management of Treatment-Related Toxicities 
If a patient develops a study drug-related Grade 3 or 4 toxicity and the toxicity has not resolved 
to Grade 1 or to at least the baseline grade (if the condition was pre-existing at screening) at the 
day of the next scheduled administration, study drug administration for that visit will be 
postponed.  
If treatment needs to be postponed for more than 15 days for the same study drug-related 
toxicity, the patient’s treatment should be permanently discontinued. Patients who discontinue 
before end of Cycle 2 proceed with the EOS visit. Patients who have had at least SD at the end 
of Cycle 2 and have not progressed should continue with the first follow-up visit in the study 
(see Section 9.10 and 10.3). 
If based on medical judgment, the treating physician considers a laboratory parameter change 
or adverse event not to be a study drug-related toxicity, but to represent natural fluctuation or 
progression of the underlying disease, it is up to the physician’s discretion and assessment of 
the individual risk/benefit ratio to determine whether the patient should be dosed (see 
Section 10.8.4). The decision and rationale behind the decision should be documented in the 
source data.  


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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9.7 Safety-related Criteria for the Initiation of Each New Cycle of 
Therapy 
Patients can only enter the next treatment cycle if the following criteria are met. If at least one 
criterion is not met (unless this is due to the fluctuation/progression of the underlying disease 
or infiltration of the bone marrow by the NHL; see Section 9.6), the beginning of the cycle will 
be postponed until resolution to Grade 1 or at least the baseline value (for pre-existing 
conditions at screening). If a cycle has to be postponed for more than 15 days for the same 
persisting study drug-related toxicity then the patient will be withdrawn from the study (see 
Section 9.11.2).  
1. ANC ≥ 1.0 x 109/L   
2. Platelet count ≥ 75 × 109/L  
3. Haemoglobin ≥ 8.0 g/dL (may have been transfused) 
4. Serum creatinine < 2.0 × upper limit of normal (ULN) 
5. Total bilirubin ≤ 2.0 × ULN  
6. Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN 
7. No study treatment-related Grade 3 or 4 toxicity in CNS, cardiovascular, infections or 
gastrointestinal system organ class (as per CTC 4.0 classification) 
9.8 Prior and Concomitant Therapy 
Any prior, concomitant, or procedural medications or therapy given to or taken by the patient 
within 1 month before the study and up to the first follow-up visit must be recorded in the 
source document and the eCRF along with the indication and dosage. However, information 
should be provided on any previous NHL-specific therapies since the time point of the first 
diagnosis of NHL. The generic or the trade name may be recorded. Other than the study drug, 
patients should not receive any other NHL-specific therapy during the study. The patient 
should not receive any investigational agent other than MOR00208 during the participation in 
the study. 
Noninvestigational medications needed to treat concomitant medical conditions may be 
continued during the study. Prophylactic antibiotics/antifungals are allowed at the discretion of 
the investigator. Any other medication for treatment of symptoms of NHL or concurrent 
diseases is allowed and can be prescribed at the discretion of the investigator. However, the 
medical monitor should be contacted to discuss the use of any NHL-related therapies before 
those therapies are started. 
However, treatments that might potentially interfere with the study drugs should be avoided 
and (with the exception of treatments required in emergency situations) should be approved by 
the medical monitor before administration. 
The investigator should instruct the patient not to take any additional medications (including 
over-the-counter-products) during the study without prior consultation. All medications 
(including over-the-counter medications) administered after the patient has signed the informed 
consent must be listed on the concomitant medications form in the eCRF. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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All respective treatments given during the treatment period until the first follow-up visit should 
be recorded in the eCRF as concomitant medication. Starting from the first follow-up visit, 
only anti-cancer treatments and, in case of an AE, other relevant concomitant medications 
(according to the discretion of the investigator) should be entered. 
9.9 Treatment Compliance 
Patients will receive MOR00208 under the direct supervision of study personnel. Each 
administration volume or dose will be checked and the vial/outer package code and volume or 
dose per administration will be recorded in each patient’s eCRF as well as in the source data. 
Drug accountability will be checked by the field monitor during site visits and at the 
completion of the trial. 
 
9.10 Treatment Postponement 
Study drug administration may be postponed for medical reasons (see Section 9.6) or other 
reasons (eg, social reasons, weather circumstances). In case of a postponement in study drug 
administration, the treatment should be restarted as early as possible and continue with the 
postponed visit. The allowed window for each treatment visit is ± 1 day, outside this window a 
one-time postponement for up to 7 days is allowed. However, the period between two drug 
administrations should always be at least 5 days. If not, then the administration on the 
following visit should be skipped.  
Should treatment be postponed for more than 15 days due to the same treatment-related 
toxicity, then the treatment should be permanently discontinued. Patients who discontinue 
before end of Cycle 2 proceed with the EOS visit. Patients who have had at least SD at the end 
of Cycle 2 and have not progressed should continue with the first follow-up visit in the study as 
defined in Section 10.3.  
Further or longer postponements, especially during the maintenance treatment, can be allowed 
by the sponsor in close collaboration with the investigator if this is justified by the previous 
response to the treatment and the current medical condition of the patient. 
 
9.11 End of Treatment and Study Drug Discontinuation 
9.11.1 End of Treatment 
Patients may voluntarily withdraw from the study or be dropped from it at the discretion of the 
investigator at any time. In addition, the investigator should discontinue study drug if he or she 
thinks that continuation would be detrimental to the patient´s well-being. 
If such withdrawal occurs, or if the patient fails to return for visits, the investigator must 
determine the primary reason for a patient´s premature withdrawal from the study and record 
the information on the electronic Case Report Form (eCRF). If the reason for withdrawal is an 
AE, monitoring will continue until the outcome is evident. The specific event or test result(s) 
must be recorded in the eCRF. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 40 of 84 
Patients may be withdrawn from the study prematurely for one of the following reasons: 
 Adverse event(s) 
 Abnormal laboratory value(s) 
 Abnormal test procedure result(s) 
 Protocol violation 
 Subject withdrawal of consent 
 Loss to follow-up 
 Administrative problems 
 New cancer therapy 
 Disease progression 
 Death 
 Withdrawal of a patient at the specific request of the sponsor. 
The sponsor must be notified within 24 hours if a patient is withdrawn from the study. 
Patients who withdraw or discontinue before having received study drug on Cycle 2 Day 22 
will only be replaced if the reason for withdrawal/discontinuation was not lack of efficacy. 
Patients will not be replaced after they have received treatment for Cycle 2 Day 22, regardless 
of the reason of withdrawal or discontinuation. 
Patients who are withdrawn for any reason may not re-enter this clinical study at any time. 
 
9.11.2 Study Drug Discontinuation 
Study drug must be discontinued for a given patient if the investigator determines that 
continuing it would result in a significant safety risk for the patient. 
Patients who discontinue study before completing the second cycle and response assessment 
should be scheduled for a visit as soon as possible, at which time all of the assessments listed 
for the End of Study visit should be performed. At a minimum, all patients who discontinue 
study treatment, including those who refuse to return for a final visit, will be contacted for 
safety evaluations during the first 4 weeks following the last dose of study drug. 
Patients who discontinue study drug should be considered withdrawn from the study after the 
final visit assessments are performed or when it becomes clear that the patient will not return 
for these assessments. The last day of study drug administration should be entered into the 
eCRF and the reason for discontinuing study drug should be given. Patients lost to follow-up 
should be recorded as such in the eCRF. Treatment after study drug discontinuation is at the 
discretion of the investigator. 
 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date:26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 41 of 84 
9.12 Study or Site Termination 
The investigator and the sponsor both reserve the right to terminate the study at any time at a 
given clinical study center. The sponsor also reserves the right to terminate the entire study or 
temporarily interrupt enrolment and/or dosing of already enrolled patients for further 
evaluation, eg, if during ongoing evaluation of the risk/benefit ratio the sponsor decides that the 
risks outweigh the benefits of MOR00208.  
Stopping criteria for this study will include, but not be limited to: 
1. 
Two or more patients within the first six patients enrolled experience unexpected Grade 
4 or 5 toxicities of the same or related Adverse Event terms according to CTC and these 
events are assessed as being related to MOR00208 by the investigator or the sponsor. 
2. 
≥ 30% of patients following the initial six enrolled experience unexpected Grade 4 or 5 
toxicities of the same or related Adverse Event terms according to CTC and these 
events are assessed as being related to MOR00208 by the investigator or the sponsor. 
 
Should a termination of a given clinical study center or the whole study be necessary then the 
procedures will be arranged on an individual study basis after review and consultation by all 
involved parties. In terminating the study, the sponsor and the investigator will ensure that 
adequate consideration is given to the protection of the patients’ interests. Institutional Review 
Boards (IRBs)/IECs and competent authorities will be notified of premature termination in 
accordance with applicable regulatory requirements. 
 
10 VISIT SCHEDULE AND ASSESSMENTS 
Table 2 lists all of the assessments, and indicates with an “X” the visits at which these 
assessments are performed. All data obtained from these assessments must be supported in the 
patient´s source documentation. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 42 of 84 
Table 2 
Schedule of Assessments 
 
 
 
Evaluation or Procedure 
Screening 
Cycle 1 (28 days) 
Cycle 2 (28 days) 
 
Cycle 3 (if response is at least 
SD)  
(2 weeks ± 1 day 
after Cycle 2 Day 22 ) 
Follow-up 
Maintenance 
Treatment 
Visits 
beyond 
Follow-up 
Visit 1220 
 
EOS 
Visit 
Day 
-21 to -1 Day 1 Day 2 8 ± 1 
day 
15 ± 1 
day 
22  ± 
1 day 
1  ± 1 
day 
8  ± 
1 
day
15  ± 
1 day 
22  ± 
1 
day 
28 ± 4 
days  
1  ± 
1 
day 
8  ± 
1 
day 
15  ± 
1 
day 
22  
± 1 
day
28 ± 4 
days  
1st 
Follow-
up  
+ 4 
weeks 
± 2 days 
Follow-up 
Visits 
2 - 121 
+ 4 
weeks  
± 2 
days 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
X2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demography 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history (incl. prior 
NHL treatments) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Staging 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ECOG 
X 
X 
 
 
X 
 
X 
 
X 
 
 
X 
 
X 
 
 
X 
X 
 
X 
Determination of CD19 on 
tumor cells (bone marrow) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Determination of CD19 on 
tumor cells (tumor 
biopsy/aspirate)3 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study drug administration 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
 
 
 
X20 
 
Premedication 
 
X 
 
X 
X 
X4 
X4 
X4 
X4 
X4 
 
X4 
X4 
X4 
X4 
 
 
 
 
 
“Emergency laboratory” 
 
X19 
 
X19 
X19 
X19 
X19
X19
X19 
X19
 
X19 
X19 
X19 
X19 
 
 
 
 
 
Haematology 
X 
X2 
X 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X 
X2 
X2 
X2 
X2 
X 
X 
X 
X 
X 
Serum chemistry 
X 
X2 
X 
X2 
X2 
X2 
X2 
X2 
X2 
X2 
X 
X2 
X2 
X2 
X2 
X 
X 
X 
X 
X 
Coagulation 
X 
X2 
 
 
 
 
X2 
 
 
 
 
X2 
 
 
 
 
X 
X 
 
X 
Pharmacokinetics 
 
X5 
 
X6 
X6 
X6 
 
X6 
 
X6 
X 
 
X6 
 
X6 
X 
X 
X7 
 
 
Urinalysis 
X 
X2 
 
 
 
 
X2 
 
 
 
 
X2 
 
 
 
 
X 
X 
 
X 
β-HCG pregnancy test 
(WOCBP) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X22 
X22 
 
X 
Urine pregnancy test 
(WOCBP) 
 
X2 
 
 
 
 
X2 
 
 
 
 
X2 
 
 
 
 
X22 
X22 
X 
 
Serology (Hepatitis B and C) 
X 
 
 
 
 
X21 
 
 
 
 
X21 
 
 
 
 
X21 
X21 
X21 
X21 
 
B-, T- and NK cell flow 
cytometry 
 
X2 
 
X2 
X2 
X2 
X2 
 
X2 
 
X 
X2 
 
X2 
 
X 
 
 
 
X 
CD16 expression on NK cells 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Anti-MOR00208 antibodies 
 
X2 
 
 
 
 
X2 
 
 
 
 
X2 
 
 
 
 
X 
X18 
 
 
FcγR polymorphism (mucosal 
cheek swab) 
 
X2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 43 of 84 
Table 2 
Schedule of Assessments 
 
 
 
Evaluation or Procedure 
Screening 
Cycle 1 (28 days) 
Cycle 2 (28 days) 
 
Cycle 3 (if response is at least 
SD)  
(2 weeks ± 1 day 
after Cycle 2 Day 22 ) 
Follow-up 
Maintenance 
Treatment 
Visits 
beyond 
Follow-up 
Visit 1220 
 
EOS 
Visit 
Day 
-21 to -1 Day 1 Day 2 8 ± 1 
day 
15 ± 1 
day 
22  ± 
1 day 
1  ± 1 
day 
8  ± 
1 
day
15  ± 
1 day 
22  ± 
1 
day 
28 ± 4 
days  
1  ± 
1 
day 
8  ± 
1 
day 
15  ± 
1 
day 
22  
± 1 
day
28 ± 4 
days  
1st 
Follow-
up  
+ 4 
weeks 
± 2 days 
Follow-up 
Visits 
2 - 121 
+ 4 
weeks  
± 2 
days 
ADCC assessment 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Tumor biopsy (cytogenetics)3 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Serum immunoglobulin levels 
 
X2 
 
 
 
X2 
 
 
 
X2 
 
 
 
 
X2 
 
X 
X 
 
X 
Bone marrow aspiration & 
biopsy 
X9 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
X10 
 
X10, 8 
 
 
Body weight 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Physical examination 
X11 
X2  
 
 
 
X 
 
 
 
 
X12 
 
 
 
 
X12 
X12 
X12 
X 
X 
Vital signs 
X 
X13 
X 
X13 
X13 
X13 
X13 
X13 
X13 
X13
X 
X13 X13
X13 
X13 
X 
X 
X 
X 
X 
ECG 
X 
X14 
 
 
 
 
 
X14 
 
X14
 
 
X14
 
X14 
 
 
 
 
X 
AE assessment 
 
 
---------------continuous--------------- 
Baseline disease and response 
assessment (CT/PET)15 
 
X2, 17
 
 
 
 
 
 
 
 
X17 
 
 
 
 
X17 
 
X8, 17 
 
 
Additional Radiological 
evaluation16 
 
X17 
 
 
 
 
 
 
 
 
X17 
 
 
 
 
X17 
 
X8,17 
 
 
Previous/Concomitant 
medication 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 44 of 84 
Abbreviations:  ADCC = antibody-dependent cell-mediated cytotoxicity; AE = adverse event; β-HCG = beta-human chorionic gonadotropin; C2D22 = Cycle 2 Day 22; 
CT = computed tomography; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; EOS = End of Study; FU= Follow-up; PET = positron emission 
tomography; SD = stable disease; WOCBP = woman of childbearing potential.  
1 The second  and third  FU Visit should be scheduled 6 weeks ± 1 weeks following the previous visit, the fourth to sixth FU Visit should be scheduled 3 months ± 2 weeks 
following the previous visit, further FU Visits should then be scheduled every 6 months.  
2 Before study drug administration. 
 3Tumor biopsy/aspirates should be obtained if malignant lymph nodes are easily accessible. 
4 Premedication for patients who do not experience infusion reactions during the first 3 infusions will be optional at the discretion of the investigator for subsequent infusions. 
5 The PK sample will be taken before study drug administration; at the end of the infusion; and 1 hour, 4 hours, and 24 hours after end of first MOR00208 infusion. The sample 
taken on Day 2 (ie, 24 hours after end of first infusion) belongs formally to Day 1. 
6 The PK sample will be taken before study drug administration and 1 hour after the end of MOR00208 infusion. 
7 The PK sample will be taken at second and third follow-up visit only. 
8 Not performed at third FU (no response assessment). 
9 Results from bone marrow examination done within 4 weeks before screening are acceptable, if the patient’s disease has been stable since then. In this case, obtaining bone 
marrow samples for the sole purpose of CD19 expression does not need to be repeated. 
10 Bone marrow examinations should only be repeated if response at last bone marrow examination was not CR. 
11 Including body height at screening only. Physical examination includes palpable tumor assessment, general appearance, skin, head, eyes, ears, nose, throat, lungs, breasts and 
axillae (if applicable including bi-dimensional measurement of cervical, supraclavicular, axillary and inguinal lymph nodes), cardiovascular system, back and spine, abdomen (if 
applicable including spleen size below the costal margin), extremities, infusion site, lymph nodes, and neurological examination. 
12 Physical examination will be used for response assessment. 
13 Immediately before infusion; 15, 30, and 60 minutes during infusion; at end of infusion; and every hour for two hours after completion of infusion. 
14 Performed 1 hour ± 10 minutes post dose. Additionally, for Cycle 1 Day 1 predose; 12-lead ECG recording should include determination of heart rate and RR, PR, QRS, QT, and 
QTc intervals. The 12-lead ECG will be recorded after 5 minutes of rest in a supine position. 
15 For all patients neck/chest/abdomen/pelvis CT is required. PET should also be performed for response assessment if tumor was PET avid at baseline. 
16 Radiographic examinations in addition to the neck/chest/abdomen/pelvis CT/PET evaluations are to be done, as appropriate. (For MRI, please see Section 10.6.) Follow-up 
radiographic examinations will be performed at the end of Cycle 2, Cycle 3, and at the second and subsequent follow-up visits for any procedures performed at baseline visit. 
17 Radiographic evaluations may be performed up to 3 days before the scheduled visit during Cycle 1-3 and within +/- 4 days of the planned visit during follow-up. If a patient 
discontinues from the study before a response assessment, an evaluation will occur approximately one month after the patient discontinues from the study. CT/PET examinations 
that were done up to 3 weeks before Cycle 1 Day 1 may be used as a patient’s baseline assessment. (For MRI, please see Section 10.6.) 
18 Anti-MOR00208 sample will be taken at third follow-up visit only. 
19 Sample to be taken and evaluated before study drug administration. 
20  Maintenance treatment for patients with at least ongoing PR will be administered either every second week or monthly until progression. The treatment frequency during the 
follow up period should be maintained. Before administration, blood parameters (hematology, serum chemistry, urine pregnancy test) should be evaluated in local laboratory 
according to local guidelines/practice for the administration of monoclonal antibodies. Vital signs should be measured every hour or according to local practice with anti-CD20 
antibodies. 
21 Hepatitic C serology only to be done at screening. HBV-DNA only to be measured during treatment and follow-up if total anti-HBc was positive. If HBV-DNA is positive, 
please see Section 9.5.2. Anti-HBc should be measured if an anti-Hbc status from during the study or within 6 months prior to screening is not known. 
22 Only urine pregnancy test is to be done if the regular follow-up visit coincides with the maintenance treatment visit. Otherwise, serum pregnancy test should be done.


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 45 of 84 
10.1 Screening Evaluations 
All patients must have signed and dated the informed consent before initiation of any study-
related evaluation. However, assessments that have been performed before the signing of the 
informed consent and that fall within the screening period window may be used as screening 
assessments only if the assessments were performed as part of the routine standard of care visit 
for the patient. The investigational site must provide a note to file in the patient folder to attest 
to any such occurrence. The screening period lasts for up to 21 days. All patients must satisfy 
all of the inclusion criteria and none of the exclusion criteria listed in Sections 8.1 and 8.2.  
The screening evaluations will include: 
 Demography and ECOG performance status (see the appendix, Section 17.5) 
 Prior and concomitant medication 
 Medical history and physical examination including height, weight, palpable tumor 
assessment, general appearance, skin, head, eyes, ears, nose, throat, lungs, breasts and 
axillae 
(if 
applicable 
including 
bi-dimensional 
measurement 
of 
cervical, 
supraclavicular, axillary and inguinal lymph nodes), cardiovascular system, back and 
spine, abdomen (if applicable including spleen size below costal margin), extremities, 
infusion site, lymph nodes, and basic neurological examination) 
 Staging 
 Blood sampling: 
o Haematology with complete blood count (CBC) with differential and platelet 
count, serum chemistry, and coagulation 
o β-HCG pregnancy test for women of childbearing potential 
o Determination of CD16 expression on NK cells and ADCC assessment (Due to 
the exploratory nature of the ADCC assay, the sponsor may decide at any point 
during the study to terminate these assessments in which case the sites will be 
informed accordingly) 
o Hepatitis B and C screening (please see Section 9.5.2) 
 Urine sampling for urinalysis 
 Bone marrow aspirate and biopsy. Results from bone marrow examination done within 
4 weeks before screening are acceptable, if the patient’s disease has been stable since 
then. The following are included: 
o Histology (to be analysed locally) 
o Determination of CD19 on malignant B cells (to be done through central lab) 
 Tumor aspirate and biopsy, if malignant lymph nodes are easily accessible. The 
following are included: 
o Histology (to be analysed locally) 
o Determination of CD19 on B cells (to be analysed through central lab) 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
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o Cytogenetics (if historical data are not available, to be analysed locally) 
 Vital signs (pulse, blood pressure, temperature and respiratory rate) 
 12-lead ECG 
 
10.2 Main Treatment Phase (Cycles 1-3) 
Only patients fulfilling all inclusion and none of the exclusion criteria should be enrolled. 
The schedule of required procedures for each treatment day is detailed in Table 2. Clinical site 
study days are Days 1, 2, 8, 15, and 22 for Cycle 1 and Days 1, 8, 15, 22, and 28 for Cycle 2. 
Patients qualifying for Cycle 3 will have visits on Days 1, 8, 15, 22, and 28 of this cycle.  
During the first two 28-day cycles, patients will receive a total of 8 infusions: each 28-day 
cycle will consist of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.  
 Patients with a response of at least SD on Cycle 2, Day 28, will qualify for 1 further 
cycle of MOR00208 (infusions on Day 1, Day 8, Day 15 and Day 22 of the 28-day 
cycle). This potential Cycle 3 should start 2 weeks ± 1 day after Cycle 2, Day 22. 
Before dosing, premedication as detailed in Section 9.5 should be administered. 
Clinical assessments, physical examinations and laboratory evaluations (instead of emergency 
lab) may be performed within 24 hours before administration of MOR00208 (except PK and 
anti-MOR00208 antibodies); assessments for Cycle 3 should only be performed if patient 
qualifies for the respective study drug administration: 
 Assessment of AEs and concomitant medication at all visit days (see Section 9.8) 
 Assessment of body weight at all visit days  
 Physical examination including palpable tumor assessment, general appearance, skin, 
head, eyes, ears, nose, throat, lungs, breasts and axillae (if applicable including bi-
dimensional measurement of cervical, supraclavicular, axillary and inguinal lymph 
nodes), cardiovascular system, back and spine, abdomen (if applicable including spleen 
size below the costal margin), extremities, infusion site, lymph nodes and neurological 
examination at Day 1 (predose) and Day 22 of Cycle 1; and Day 28 of Cycles 2 and 3. 
 ECOG performance status (Day 1 and 15 of Cycles 1 to 3) 
 Vital signs (pulse, blood pressure, temperature and respiratory rate): At each treatment 
visit immediately before infusion, 15, 30, 60 minutes (± 5 minutes) after start of 
infusion, at the end of the infusion, and every hour for two hours (± 10 minutes) after 
completion of the infusion. If the infusion is interrupted and/or subsequently restarted, 
vital signs should be assessed every 60 minutes after the first hour until two hours after 
the end of the infusion. Vital signs should be obtained once on Day 2 Cycle 1 and on 
Day 28 of Cycles 2 and 3. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
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Page 47 of 84 
 Baseline disease status on Day 1 of Cycle 1 and response assessment on Day 28 of 
Cycles 2 and 3 should include: 
o Assessment by physical examination 
o CT of neck, chest, abdomen and pelvis on Day 1 of Cycle 1 and Day 28 of 
Cycles 2 and 3 (for MRI, please see Section 10.6). A PET scan should also be 
used for response assessment if CT does not provide a clear readout and if the 
lymphoma is expected to be PET-avid. Results from CT and/or PET 
examination done within 3 weeks before Cycle 1 Day 1 are acceptable to be 
used for baseline. Radiographic examinations can be done up to 3 days before 
the treatment visit. 
o Radiological evaluation in addition to the CT/PET of neck, chest, abdomen and 
pelvis are to be done as appropriate on Day 1 of Cycle 1 and Day 28 of Cycles 2 
and 3 (for MRI, please see Section 10.6). Results from additional radiological 
evaluations done within 3 weeks before Cycle 1 Day 1 are acceptable to be used 
for baseline. Radiographic examinations may be performed up to 3 days before 
the treatment visit. 
o Bone marrow aspiration and biopsy (baseline assessment should be done during 
screening and not on Day 1 of Cycle 1). 
 Laboratory assessments from blood sampling (Day 1 preinfusion assessments will be 
considered baseline assessments): 
o Blood sample for “emergency laboratory” for immediate evaluation before 
study drug administration on all Days 1, 8, 15, 22 of Cycles 1, 2 and 3 (if Cycle 
3 is applicable) if no blood sample from the 24 hours before study drug 
administration is available. 
o Haematology including CBC with differential and platelet count and serum 
chemistry before each infusion of MOR00208 and on Day 2 of Cycle 1 and Day 
28 of Cycles 2 and 3. 
o Coagulation before infusion on Day 1 of Cycles 1 to 3 
o PK samples: 
Cycle 1, Day 1 : before infusion, at the end of infusion (± 10 minutes) and 1 
hour (± 10 minutes), 4 hours (± 10 minutes) and 24 hours (± 1 hour) after end of 
first MOR00208 infusion 
Cycle 1, Days 8, 15 and 22; Cycles 2 and 3, Days 8 and 22: before infusion and 
1 hour after the end of infusion (± 10 minutes) 
Cycles 2 and 3, Day 28 
o B-, T- and NK cell flow cytometry before infusion on Days 1, 8, 15 and 22 of 
Cycle 1 and on Days 1, 15 and 28 of Cycles 2 and 3. 
o Anti-MOR00208 antibodies before infusion on Day 1 of Cycles 1 to 3. 
o Serum immunoglobulin levels before infusion on Day 1 of Cycle 1 and Day 22 
of Cycles 1 to 3. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
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o If anti-HBc is positive: HBV-DNA as per assessment schedule. (Please see also 
Section 9.5.2.) 
 
 Laboratory assessments from urine sampling before infusion (Day 1 preinfusion 
assessments will be considered baseline assessments): 
o Urinalysis on Day 1 of Cycles 1 to 3. 
o Urine pregnancy test in women of childbearing potential on Day 1 of Cycles 1 
to 3. 
 FcγRIIIa and FcγRIIa polymorphism (mucosal cheek swab) before infusion on Day 1, 
Cycle 1 (optional, see Section 10.9.7) 
 12-lead ECG on Day 1 of Cycle 1, and on Days 8 and 22 of Cycles 2 and 3 
10.3 Follow-up Phase until Follow-up Visit 12 
All patients who performed treatment Cycle 3 should have a follow-up visit 4 weeks after end 
of the last treatment cycle (4 weeks ± 2 days after Cycle 3 Day 28). Patients should return for 
further follow-up visits until relapse of the lymphoma or for a maximum of 4 years. The 
second and third follow-up visit should be scheduled 6 weeks ± 1 week following the previous 
visit, the fourth to sixth follow-up visit should be scheduled 3 months ± 2 weeks following the 
previous visit, further follow-up visits should then be scheduled every 6 months. If not 
otherwise indicated, the following assessments should be performed at every follow-up visit: 
 Patients with an ongoing response of at least PR after Cycle 3 may receive maintenance 
treatment with MOR00208 (12 mg/kg either every second week or monthly). Before 
administration, blood parameters (hematology, serum chemistry) should be evaluated in 
the local lab according to local guidelines/practice for the administration of monoclonal 
antibodies. A urine pregnancy test should be performed for women of childbearing 
potential. These lab results will only be captured in the eCRF if the administration visits 
coincide with the planned follow-up visits. 
 Assessment of AEs and concomitant medication (see Section 9.8) 
 Assessment of body weight 
 Physical examination including palpable tumor assessment (general appearance, skin, 
head, eyes, ears, nose, throat, lungs, breasts and axillae (if applicable including bi-
dimensional measurement of cervical, supraclavicular, axillary and inguinal lymph 
nodes), cardiovascular system, back and spine, abdomen (if applicable including spleen 
size below the costal margin), extremities, infusion site, lymph nodes, and neurological 
examination). 
 ECOG performance status 
 Vital signs (pulse, blood pressure, temperature and  respiratory rate) 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 49 of 84 
 Response assessment should be repeated at 2nd, 4th, 5th and all subsequent follow-up 
visits and include: 
o Assessment by physical examination 
o CT of neck, chest, abdomen and pelvis. A PET scan should also be used for 
response assessment if CT does not provide a clear readout and if the lymphoma 
is expected to be PET-avid. Follow-up radiographic evaluations may be 
performed any time ± 4 days of the planned visit. 
o Radiological evaluation in addition to the CT/PET of neck, chest, abdomen and 
pelvis are to be done as appropriate (for MRI, please see Section 10.6). 
Radiological evaluations for response assessment should be performed at least 
for any procedure performed at baseline. 
o Bone marrow aspiration and biopsy (only to be repeated if previous response 
was not CR) 
 Laboratory assessments from blood sampling: 
o Haematology including CBC with differential and platelet count and serum 
chemistry 
o Coagulation 
o PK sample at the 1st, 2nd and 3rd follow-up visit only 
o Anti-MOR00208 antibodies at the 1st and 3rd follow-up visit only 
o Serum immunoglobulin levels 
o β-HCG pregnancy test for women of childbearing potential (only urine 
pregnancy test is to be done if regular follow-up visit coincides with 
maintenance treatment visit; otherwise, serum pregnancy test should be done) 
o If anti-HBc is positive: HBV-DNA as per assessment schedule. (Please see also 
Section 9.5.2.) 
 Laboratory assessments from urine sampling: Urinalysis 
 
10.4  MOR00208 Treatment and Study Procedures after Follow-up  
Visit 12 
Patients who have not progressed after four years of treatment with MOR00208 (ie, after 
Follow-up Visit 12 as described above) may continue receiving the IMP thereafter, until 
progression, based on the decision of the treating physician. The treatment frequency (during 
the follow-up period as described above) should be maintained.  
Prior to each administration of MOR00208, the following assessments should be performed at 
a local laboratory: 
 Assessment of body weight 
 Haematology including CBC with differential and platelet count and serum chemistry 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 50 of 84 
 β-HCG urine pregnancy test for women of childbearing potential (only urine pregnancy 
test is to be done if regular follow-up visit coincides with maintenance treatment visit; 
otherwise, serum pregnancy test should be done) 
 Vital signs (pulse, systolic and diastolic blood pressure, body temperature, and 
respiratory rate) hourly 
 Physical examination 
 If anti-HBc was positive earlier: HBV-DNA should be measured every six months. 
(Please see also Section 9.5.2.) 
Only the data on AEs, SAEs, and concomitant medications will be collected in the study 
database during this period.  
 
10.5 End of Study Visit 
Patients will have their EOS 4 weeks (± 2 days) following:  
 The last administration of MOR00208 in Cycle 2 if the response after 2 cycles was not 
at least SD  
 The visit where a relapse (or disease progression) was diagnosed or decision to stop 
treatment was made in patients qualifying for Cycle 3 of MOR00208  
If patient terminates the study early (ie, before end of Cycle 2), the EOS will be performed on 
the day of termination.  
The assessments that will be performed at the EOS include the following: 
 Assessment of AEs and concomitant medication 
 Assessment of body weight 
 Physical examination including palpable tumor assessment, general appearance, skin, 
head, eyes, ears, nose, throat, lungs, breasts and axillae (if applicable including bi-
dimensional measurement of cervical, supraclavicular, axillary and inguinal lymph 
nodes), cardiovascular system, back and spine, abdomen (if applicable including spleen 
size below costal margin), extremities, infusion site, lymph nodes, and neurological 
examinations 
 ECOG performance status 
 Vital signs (pulse, blood pressure, temperature, respiratory rate) 
 Response assessment includes: 
o Assessment by physical examination 
 Laboratory assessments from blood sampling: 
o Haematology including CBC with differential and platelet count and serum 
chemistry 
o Coagulation 


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o B-, T- and NK cell flow cytometry  
o Serum immunoglobulin levels 
o β-HCG pregnancy test for women of childbearing potential 
 Laboratory assessments from urine sampling: Urinalysis 
 ECG 
Patients who were positive for anti-HBc at screening should be followed up for potential HBV 
reactivation as per local practice (refer to Section 9.5.2). 
 
10.6 Efficacy  
Efficacy will be evaluated in terms of the ORR, SD, DoR, TTP, and PFS. The ORR will be 
evaluated using the revised IWG criteria (Cheson, 2007) and will be defined as the proportion 
of patients with CR and PR (CR+PR).  
The DoR will be the time from first meeting of criteria for response (ie, CR or PR) to first 
documentation of relapse or progression. 
The TTP is defined as the time from study entry (first dosing) until documented lymphoma 
progression or death as a result of lymphoma. Deaths from other causes are censored at the 
time of death. 
PFS is defined as the time from study entry (first dosing) until lymphoma progression or death 
as a result of any cause. 
Response criteria are provided in Section 17.4. 
CT or PET Examination, or Further Radiological Examinations 
CT: For all patients, CT neck/chest/abdomen/pelvis is required as indicated in the schedule of 
assessments at baseline and at all time points when a radiographic response assessment is 
performed. 
PET: For patients with DLBCL and patients known or expected to have PET-avid lymphomas, 
a PET scan should be performed at baseline in addition to the CT scan. At the subsequent 
visits, PET should be done in DLBCL patients or if at baseline the lymphoma was PET-avid, 
but can be omitted if PET definitely would not change the reponse assessment according to the 
clinical judgement of the investigator (eg, CT already shows progressive disease).  
MRI may be used in lieu of CT for subjects with contraindications to administration of contrast 
agents or due to other medical reasons (at the same time windows as CT), or in addition to CT 
at the discretion of the investigator (in this case, MRI may be performed as/when appropriate). 
The method used at baseline should be used throughout the study unless otherwise medically 
indicated. 
Additional radiographic evaluations:  are to be done, as appropriate. Follow-up radiographic 
evaluations will be performed for any procedures performed at baseline visit at the end of 
Cycle 2 and 3 (if applicable) and at the second, fourth and every further follow-up visit. 
Follow-up radiographic evaluations may be performed anytime ± 4 days of the planned visit. If 


Product Name: MOR00208 
Protocol Number: MOR208C201 
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IND Number: 114,856 
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a patient discontinues from the study before any response assessment, if possible a response 
evaluation will occur approximately one month after the patient discontinues from the study. 
CT, PET or additional radiological examinations (eg, MRI) that were done up to 3 weeks 
before Cycle 1 Day 1 may be used as a patient’s baseline assessment at the investigator’s 
discretion. 
Physical Examination 
The response assessment will be supported by the palpation of lymph nodes from the physical 
examination (see Section 10.2) 
Bone Marrow 
At the Screening visit (Baseline), a bone marrow aspirate and a biopsy should be obtained. 
Results from bone marrow examination done within 4 weeks before screening are acceptable if 
the patient’s disease has been stable since then. In this case only available data will be used and 
bone marrow examinations at screening for which this data are not available will not be 
performed. Repeat of marrow aspirates and biopsies should be obtained at Day 28 of Cycles 2 
and 3. Histological examination should be performed and the infiltration by malignant B-cells 
should be evaluated. 
If bone marrow has been obtained within 4 weeks before screening and disease has been stable,  
the bone marrow biopsy does not need to be repeated solely to obtain samples for 
determination of CD19 expression. 
10.7 Pharmacokinetic Assessments 
Concentration-time profiles and pharmacokinetic parameters will be assessed for MOR00208 
from serum samples collected on the following schedules (if not otherwise specified, a 
deviation of 10 minutes from the planned collection time point is acceptable): 
- 
For the first study drug administration (Cycle 1 Day1), serum samples will be collected 
predose and then at the end of infusion and 1 hour, 4 hours and 24 hours (± 1 hour) 
after end of first MOR00208 infusion. 
- 
During Cycle 1 on Days 8, 15 and 22, serum samples will be collected predose for 
trough level determination and then 1 hour after the end of the infusion. 
- 
During Cycle 2 and 3 on Days 8 and 22 of each cycle, serum samples will be collected 
predose for trough level determination and then 1 hour after the end of the infusion. 
- 
During Cycle 2 and 3 on Day 28 
- 
At the 1st, 2nd and 3rd follow-up visit 
Serum samples for pharmacokinetic analysis will be handled and stored as specified in the lab 
manual at the study site until shipment on dry ice to an external analytical laboratory. Per 
sample 2 aliquots (primary and back-up) should be obtained. At the analytical laboratory, the 
samples will also be stored as specified in the lab manual until analysis. Detailed instructions 
for handling of serum samples will be provided in the laboratory-specific documentation. 
Pharmacokinetic sample assessment of MOR00208 will be performed at a specified central 
laboratory.  
 


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10.8 Safety Assessments 
Safety monitoring for all patients enrolled in the study will include laboratory safety 
assessments (haematology, blood chemistry, and urinalysis, coagulation, and anti-MOR00208 
antibodies) and clinical evaluations (physical examinations, vital signs, 12-lead ECG) as 
detailed in the Schedule of Assessments (Section 10) and Section 10.8.4. All AEs and serious 
adverse events (SAEs) will be recorded. 
Laboratory and AE toxicities will be graded according to National Cancer Institute (NCI) 
Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Patients who 
experience any toxicity should be followed until the toxicity has stabilized, the toxicity 
returned to the baseline level, or a new treatment has commenced. 
Safety monitoring is detailed in Section 11. 
10.8.1 Adverse Events 
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical 
subject administered a medicinal product, which does not necessarily have a causal relationship 
to this treatment. 
An AE can therefore be any unfavourable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease temporally associated with the use of a study drug, 
whether or not it is considered related to that study drug.  
Temporally associated means after signing the informed consent form until 30 days after last 
administration of the study drug. 
For screening failure patients only SAEs will be recorded in the eCRF. 
AEs include any clinically significant deterioration of a patient’s medical status after the 
signing of the informed consent form. Also an increase in frequency or intensity of a 
preexisting episodic event or conditions and events resulting from protocol mandated 
procedure (eg, invasive procedures) fall under the definition of AE. In addition, overdoses 
(defined as exceeding planned dose by more than 10%) should be recorded as AEs. 
As far as possible, each AE should be evaluated to determine the following: 
 Relationship to study drug (suspected/not suspected) 
 Duration (start and end date or if continuing at end of study) 
 Intensity: The intensity of all AEs will be graded as mild, moderate, or severe using the 
following definitions: 
o Mild: 
Tolerable 
o Moderate: Interferes with normal activity 
o Severe: 
Incapacitating (causes inability to perform usual activity or work) 


Product Name: MOR00208 
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 Toxicity grade: The toxicity grade of AEs will be graded according to the NCI-CTC 
(CTCAE version 4.0 of May 28, 2009) using the following definitions: 
o Grade 1:  Mild; asymptomatic or mild symptoms; clinical or diagnostic  
 
 
observations only; intervention not indicated. 
o Grade 2: 
Moderate; minimal, local or noninvasive intervention indicated;  
 
 
limiting age-appropriate instrumental activities of daily living (refers to 
 
 
preparing meals, shopping for groceries or clothes, using the telephone, 
 
 
managing money, etc.). 
o Grade 3: 
Severe or medically significant but not immediately life-threatening; 
 
 
hospitalization or prolongation of hospitalization indicated; disabling; 
 
 
limiting self-care activities of daily living. 
o Grade 4: 
Life-threatening consequences; urgent intervention indicated. 
o Grade 5: 
Death related to AE. 
 Outcome 
 Action taken (no action taken; study drug temporarily interrupted; study drug 
permanently discontinued due to this AE; concomitant medication taken; non-drug 
therapy given; hospitalization/prolonged hospitalization) 
 Seriousness: Whether it is serious, where a serious adverse event (SAE) is defined as 
one that: 
o Results in death. 
o Is life-threatening. 
o Requires inpatient hospitalization or prolongation of existing hospitalization 
(hospitalization signifies that the patient was inpatient for at least one overnight 
stay) unless hospitalization is for 
 
Routine treatment or monitoring of the studied indication, not associated 
with deterioration of symptoms related to NHL 
 
Elective or preplanned treatment for a preexisting condition that is 
unrelated to NHL and has not worsened since signing of the informed 
consent 
 
Social reason and respite care in the absence of any deterioration in the 
patient’s general condition 
 
Hospitalization signifies that the patient was in-patient for at least one 
overnight stay. 
o Results in persistent or significant disability or incapacity. 
o Is a congenital anomaly or birth defect. 
o Is medically significant, ie, defined as an event that jeopardizes the patient or 
may require medical intervention to prevent one of the outcomes listed 
previously. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
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NOTE: The term “life-threatening” refers to an event in which the patient was, in the view of 
the reporting investigator, at immediate risk of death at the time of the event; it does not refer 
to an event that hypothetically might have caused death if it were more severe. Medical 
judgment should be exercised in deciding whether an AE is serious in other situations: 
Important AEs that are not immediately life-threatening or do not result in death or 
hospitalization but may jeopardize the patient or may require intervention to prevent one of the 
other outcomes listed in the previous definitions should also be considered serious. 
Unlike routine safety assessments, SAEs and AEs of special interest are monitored 
continuously and have special reporting requirements (see Section 11.1). 
The investigator should determine the causality (relation to the study drug) based on his/her 
clinical experience and on the information given in the IB. The causal relationship of all AEs to 
the study drug will be judged as either suspected or not suspected. A suspected causal 
relationship means at least a reasonable possibility that the event is caused by the study drug. If 
no relationship has been provided by the investigator, the event will be considered as related to 
study drug. 
Information about adverse drug reactions already known about the investigational study drug 
can be found in the IB, or will be communicated in the form of Investigator Notifications. This 
information will be included in the patient informed consent form and should be discussed with 
the patient during the study as needed. 
 
10.8.2 Physical Examination 
A qualified physician (or nurse practitioner or physician’s assistant under the supervision of a 
physician, if permitted by local legislation and medical practice) will conduct physical 
examinations before study drug administration. The physical examination will include an 
assessment for the presence of abnormalities of the following: general appearance, skin, head, 
eyes, ears, nose, throat, lungs, breasts and axillae (if applicable including bi-dimensional 
measurement of cervical, supraclavicular, axillary and inguinal lymph nodes), cardiovascular 
system, back and spine, abdomen (if applicable including spleen size below costal margin), 
extremities, infusion site, lymph nodes, and basic neurological examination (general motor and 
sensory systems, mental status, cranial nerves, and coordination). 
In the event that new and worsening abnormal physical examination findings are encountered 
during the study, these terms are defined as follows: A new abnormal physical examination 
finding is defined as one that occurs when a patient’s normal baseline physical examination 
becomes abnormal post baseline, based on clinical grounds. A worsening abnormal physical 
examination finding is defined as one that occurs when a patient’s abnormal baseline physical 
examination becomes worse post baseline, also based on clinical grounds. Any new findings, 
worsening findings, or both should be recorded as AEs. 
10.8.3 Vital Signs 
Vital signs will be measured at the various pre- and posttreatment time points described in the 
Schedule of Assessments in Table 2. Vital sign parameters include measurements of heart rate, 
systolic and diastolic blood pressures, respiratory rate, and body temperature. Before vital signs 
are measured, the patient should be resting for at least 5 minutes (if possible). The same 


Product Name: MOR00208 
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position will be used each time vital signs are measured for a given patient, and blood pressure 
will be measured from the arm contralateral to the site of study drug administration whenever 
possible. Body temperature should be measured using normal hospital practice. 
The actual time for measurement of vital signs should not deviate more than 10 minutes from 
the planned time but the actual time should be recorded accurately. If the infusion is interrupted 
and/or subsequently restarted, vital signs should be assessed every 60 minutes after the first 
hour until two hours after the end of the infusion. 
10.8.4 Laboratory Evaluations 
Clinical laboratory parameters to be assessed in this study are displayed in Table 3. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
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Table 3 
Laboratory Evaluations 
Evaluation 
Analysis 
Sample Collection 
(approximate amount per 
collection) 
“Emergency laboratory” 
(EDTA blood and serum sample) 
Serum creatinine, haemoglobin, white blood 
cells (WBC), platelets, sodium, potassium, 
AST, ALT, total bilirubin 
Same sample as for chemistry 
and haematology 
 
Haematology 
(EDTA blood) 
WBC with differential, haematocrit, 
hemoglobin, mean corpuscular volume, 
platelet count, red blood cell (RBC) count 
At screening, will include a peripheral 
blood smear. 
5 mL blood 
Serum chemistry 
(Serum sample) 
Alanine aminotransferase (ALT), albumin, 
alkaline phosphatase, amylase, aspartate 
aminotransferase (AST), bicarbonate, 
bilirubin (total), blood urea nitrogen, 
calcium, chloride, creatinine, creatine 
kinase, gamma-glutamyltransferase (GGT), 
glucose, lactate dehydrogenase, lipase, 
phosphorus, potassium, protein (total), 
sodium, uric acid 
10 mL blood 
Coagulation parameters 
(Sodium citrate blood) 
Activated partial thromboplastin time 
(aPTT), prothrombin time (PT) 
3 mL of blood 
Serology parameters 
(Serum sample) 
Hepatitis B: hepatitis B surface antigen 
(HBsAg), hepatitis B core antibody (anti-
HBc) and hepatitis B surface antibody (anti-
HBs). HBV-DNA if anti-HBc positive, 
optional   
Hepatitis C: HCV antibody (HCV RNA 
quantification if anti-HCV-positive) 
Same sample as for chemistry 
(for HBV  
please see also Section 9.5.2) 
Pregnancy test  
(Serum sample) 
β-HCG serum, females of childbearing 
potential only 
Same sample as for chemistry 
Pregnancy test  
(Urine) 
β-HCG urine, females of childbearing 
potential only 
30 mL (midstream urine) 
Urinalysis 
pH, semiquantitative “dipstick” evaluation 
of glucose, protein, bilirubin (optional), 
ketones, leucocytes, RBCs, and microscopic 
evaluation if abnormal findings 
30 mL (midstream urine) 
Serum immunglobulin levels 
IgG, IgM, IgE 
Same sample as for chemistry 
Immune cells (EDTA blood) 
(exploratory assay) 
B-, T- and NK cell population 
(flow cytometry) 
2 mL of blood 
Genotyping 
FcγRIIa and FcγRIIIa polymorphism 
Mucosal cheek swab, 
optional 
Flow cytometry (Heparinized 
blood) (Exploratory assay) 
CD16 expression on NK cells 
8 mL of blood 
Immunogenicity 
(Serum sample) 
Anti-MOR00208 antibodies 
4 mL of blood 
Pharmacokinetics 
(Serum sample) 
MOR00208 
3 mL of blood 
ADCC assessment 
(Heparinized blood) 
(Exploratory assay) 
ADCC with PBMCs 
Same sample as for the CD16 
flow cytometry 
Flow Cytometry (BM+LN) 
CD19 expression, % of total malignant B 
cells 
4 mL aspirate of BM+LN  


Product Name: MOR00208 
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IND Number: 114,856 
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The signed and interpreted laboratory results will be kept as supplemental pages to the patient’s 
eCRF. The laboratory results should be reviewed, dated and signed in a timely manner by the 
investigator. 
With the exception of PK samples (see Section 10.7), anti-MOR00208 antibodies, CD19 and 
CD16 expression, and the ADCC assessment, all clinical laboratory parameters (see Table 3) 
will be analyzed at the local hospital laboratories. All blood samples will be processed and 
handled according to standard laboratory procedures. Anti-MOR00208 antibody assessments, 
the ADCC assessment, CD19 and CD16 expression assessment will be performed at a 
specified laboratory. 
Serum samples will be collected for anti-MOR00208 antibodies and stored at the study site as 
specified in the lab manual until shipment on dry ice to the external analytical laboratory. At 
the analytical laboratory, the samples will also be stored according to the lab manual until 
analysis. Detailed instructions for handling of plasma and serum samples will be provided in 
the laboratory manual. 
For all study drug administrations, the following parameters should be evaluated in a blood 
sample taken within 24 h predose on the day before study drug administration or on the day of 
study drug administration (“emergency laboratory”); if outside the limits described below, 
depending on the individual risk-/benefit ratio of the patient, IMP administration should be 
postponed (see Sections 9.6, 9.7, and 9.10): 
Table 4 
Pre-dose Limits for Laboratory Parameters 
Value 
Subject should only be dosed if the value is: 
ANC 
≥ 1.0 x 109/L  (unless this neutropenia is due to infiltration of 
bone marrow) 
Platelet count 
≥ 75 × 109/L (unless this thrombocytopenia is due to 
infiltration of bone marrow) 
Haemoglobin 
≥ 8 g /dL  (unless anemia is due to infiltration of bone 
marrow) (may have been transfused)  
Serum creatinine 
< 2.0 × upper limit of normal (ULN) 
Total bilirubin 
≤ 2.0 × ULN 
Alanine and aspartate 
transaminase (ALT and 
AST) 
≤ 2.5 × ULN 
Potassium 
< 6.0 mmol/L 
Sodium 
< 155 mmol/L 
Blood (CD16 expression, ADCC) or bone marrow samples and lymph node samples 
(CD19 expression) will be shipped to the external laboratory at room temperature by overnight 
courier for analysis. At the laboratory, samples will be handled as detailed in the respective 
laboratory manuals. 


Product Name: MOR00208 
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IND Number: 114,856 
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EudraCT Number: 2012-002659-41 
 
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Urine will be collected at the various pre- and posttreatment time points described in the 
Schedule of Assessments in Table 2 and analyzed at the local hospital laboratory. In the case of 
any abnormal result, a microscopic urine examination should be conducted. 
A pregnancy test will be performed for women of childbearing potential at various pre- and 
posttreatment time points either by urine pregnancy test or β-HCG test of a serum sample. The 
pregnancy test assay should have a minimum sensitivity of 25 IU/mL. On dosing days, the 
result should be available before study drug administration. 
If an abnormal laboratory value of Grade 4 or an abnormal laboratory value judged to be 
clinically significant that was not present at baseline is not reported as an AE, then the 
investigator should clearly document the rationale for not doing so in the source 
documentation. 
Any abnormal laboratory findings that constitute an AE should be reported as such and should 
be followed up until the outcome is known. Also, additional diagnostic tests may be indicated 
to determine a more precise diagnosis of the patient’s condition (eg, ordering a WBC 
differential count to help characterise a high or low WBC count, or ordering a determination of 
RBC indices to help characterise a low haematocrit). 
Detailed instructions and amounts of blood needed for the respective laboratory measurement, 
as well as details of which local or central laboratory is involved for the respective laboratory 
measurements, will be summarized in site-specific laboratory manuals. 
Blood samples will be obtained for assessment of serum chemistry, haematology, and 
coagulation parameters at the various pre- and posttreatment time points described in the 
Schedule of Assessments in Table 2. The time of blood collection should be documented in the 
eCRF.  
10.8.5 Electrocardiogram 
A standard 12-lead ECG will be obtained at the various pre- and posttreatment time points 
described in the Schedule of Assessments in Table 2. A 12-lead ECG will be recorded after 
5 minutes of rest in a supine position. Heart rate and RR, PR, QRS, and QT intervals will be 
determined. All ECG recordings will be reviewed on an ongoing basis at the investigational 
site. The investigator will evaluate the clinical significance of each value outside the reference 
ranges according to the nature and degree of the observed abnormality. Any new abnormal 
values considered to be clinically significant should be reported as AEs. 
10.9 Other Variables 
10.9.1 Demographic Data 
Demographic variables to be recorded will include age, gender, race, ethnicity, body height, 
and body weight. Weight and height should be measured while the patient is without shoes, but 
dressed. 
10.9.2 Relevant Medical History and Current Medical Conditions 
Relevant medical history and current medical conditions will be recorded until the start of the 
study drug administration. 


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The medical history of NHL should be documented in detail. This should include the date of 
first diagnosis, details on NHL subtype, previous treatments, and best response and duration of 
response to these treatments. Any previous therapy (eg, chemotherapy, immunotherapy, or 
radiation therapy) for the NHL-specific therapy should be recorded in the eCRF. 
Also, examinations leading to the diagnosis of the latest progression of NHL should be 
documented in the patient’s source documents. This may include, for example, results of 
laboratory examinations, imaging results, or clinical symptoms related to the NHL. The 
baseline assessment of the lymphoma should include a staging. 
10.9.3 Prior and Concomitant Medication and Examinations 
All respective treatments given during the treatment period until the first follow-up visit should 
be recorded in the eCRF as concomitant medication. Starting from the first follow-up visit, 
only anti-cancer treatments and, in case of an AE, other relevant concomitant medications 
(according to the discretion of the investigator) should be entered. 
Further examinations that constitute standard measures and are not covered by the protocol are 
left to the discretion of the investigator. However, such examinations performed during the 
study should be documented in the patient’s source documents as well. 
10.9.4 Immune Cells 
For evaluation of the status of the immune system, B-, T- and NK cells in peripheral blood will 
be measured frequently throughout the study (exploratory assay) on sites selected for this assay 
by the sponsor. The absolute and percentage changes from baseline will be evaluated. 
CD16 expression on NK cells in peripheral blood will be evaluated at baseline (exploratory 
assay). 
10.9.5 Immunogenicity 
Number and proportion of patients who develop anti-MOR00208 antibodies will be 
summarized. In addition, summarization of a semiquantitative antibody assessment will be 
based on anti-MOR00208 antibody titres of confirmed positive samples. 
10.9.6 B Cells 
CD19 expression on malignant B cells in bone marrow and/or tumour aspirate (if malignant 
lymph node is easily accessible) will be evaluated at baseline (exploratory assay). The CD19 
expression at baseline will be correlated with safety and response. Tumor and/or lymph node 
aspirates will be evaluated centrally. Biopsies (eg, trephine) to evaluate histology will be done 
locally. 
If a tumour biopsy is available at screening, cytogenetics from malignant cells should be 
obtained if no historical data are available. In case bone marrow is affected, cytogenetics can 
be obtained from these samples.  
10.9.7 Genotyping 
A mucosal cheek swab will be used for DNA analysis of FcγRIIa and FcγRIIIa polymorphism. 
The evaluation will be performed at a specified laboratory. 
Genotyping is optional, it will be only performed if the patient agrees. A patient can participate 
in the study regardless of consent to undergo genotyping.  


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11 SAFETY MONITORING 
The patients will be closely observed and questioned for any kind of AE during the study 
procedures and at follow-up appointments throughout the study period with nonleading 
questioning (eg, “How do you feel?”). AEs also may be detected when they are volunteered by 
the patient during or between study visits or through physical examination, laboratory tests, or 
other assessments. 
Study personnel must remain vigilant for the occurrence of AEs, particularly those that may be 
life-threatening. Personnel who are trained in the acute management of infusion-related 
reactions, cytokine release syndrome, anaphylaxis, and other emergencies and who have access 
to appropriate clinical supplies must be immediately available from start of infusion until no 
less than 30 minutes after dosing. 
All AEs should be treated appropriately. Such treatment may include changes in study drug 
treatment including possible interruption or discontinuation, starting or stopping concomitant 
treatments, changes in the frequency or nature of assessments, hospitalization, or any other 
medically required intervention. Once an AE is detected, it should be followed up, and an 
assessment should be made at each visit (or more frequently, if necessary) of any changes in its 
severity, its suspected relationship to the study drug(s), any of the interventions required to 
treat it, and its outcome. 
11.1 Adverse Event and Serious Adverse Event Recording and 
Reporting 
All AEs (except non-serious AEs for screening failures) that occur after the signing of 
informed consent and up to 30 days after last drug administration will be recorded in the eCRF 
and in the patient’s medical records, whether or not considered by the investigator to be related 
to the study drug. Thereafter only AEs assessed as related should be recorded. All AEs should 
be recorded using acceptable diagnoses, if possible. For screening failure patients the 
non-serious adverse events will not be recorded in the e-CRF but only in the patient’s medical 
records. 
In addition all SAEs will be recorded on the SAE Report Form. Study centres are 
instructed to report all SAEs and AEs of special interest (ie, infusion-related reactions 
and allergic reactions to study drug grade 3 or higher, cytokine release syndrome, 
overdoses) to United Bio Source within 24 hours using the study-specific SAE report 
form. 
Infusion-related reactions and allergic reactions to study drug grade 3 or higher, or cytokine 
release syndrome, which are AEs of special interest in this study, should be reported along with 
their respective symptoms (eg, hives, chill, and fever for infusion reaction). Equally, for 
overdoses the symptoms caused by the overdose should be reported. If an AE has already been 
reported, it is not necessary to report each individual sign and symptom of that AE as a 
separate AE. For example, if myocardial infarction is reported as an AE, there is no need to 
report elevated creatine phosphokinase and abnormal ECG, or other related signs, symptoms, 
or laboratory values as separate AEs. However, if both occurred in isolation and myocardial 
infarction was not diagnosed, then each event would be reported as an AE. 


Product Name: MOR00208 
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IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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All nonserious AEs must be followed up for a final outcome. An outcome of “unknown” is not 
considered to be an acceptable final outcome. An outcome of “not yet resolved” is an 
acceptable final outcome for nonserious AEs at the end of a patient’s participation in a study. 
All SAEs must be followed up for a final outcome until resolution or, if resolution becomes 
unlikely, until stabilization or death. The follow-up for SAEs that are a progression of NHL 
only until the end of a patient’s participation in a study is acceptable. This includes obtaining 
information on recovery and any sequelae and, in case of a fatal outcome, the cause of death. 
Notification of initial or follow-up SAE information (by using the standard SAE form provided 
by the sponsor) must be sent by email to
at the following address:  
 
 
Or via fax to: 
 
 
 
For any safety-related or protocol related questions, please contact the
Medical Monitor (24/7 coverage): 
Europe: 
Medical Monitor 
 
United States: 
Medical Monitor 
 
 
11.2 Pregnancies 
As detailed in the Schedule of Assessments (Table 2) and Section 10.8.4, serum pregnancy 
testing will be carried out at the Screening, Follow-up, and End of Study visits. During the 
treatment period of the study, urine pregnancy testing will be performed locally and can be 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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repeated if required. Any pregnancy that occurs during study participation should be reported 
using a Clinical Trial Pregnancy Form. To ensure patient safety, each pregnancy of a study 
patient or a female partner of a study patient must also be reported within 24 hours of learning 
of its occurrence to 
 
 
Female study patients who become pregnant must be withdrawn from the study. 
A newly diagnosed pregnancy in a patient or female partner of a study patient who has 
received trial medication is not considered an SAE unless it meets any criteria of seriousness or 
it is suspected that the trial medication interacted with a contraceptive method and led to 
pregnancy. If the pregnancy results in clinical consequences/complications in mother or child, 
eg, if the child is born with a birth defect, this should be reported as an SAE of mother or child 
as applicable. 
The pregnancy should be followed up to determine outcome, including spontaneous or 
voluntary termination, details of birth, and the presence or absence of any birth defects or 
congenital abnormalities or maternal and newborn complications. Every infant has to be 
followed up for 2 months after delivery. 
11.3 Data Monitoring Board 
Not applicable. 
 
12 PROTOCOL AMENDMENTS AND OTHER CHANGES IN STUDY 
CONDUCT 
12.1 Protocol Amendments 
Any changes to the protocol will be made in the form of an amendment. 
12.2 Other Changes in Study Conduct 
Changes in the study conduct are not permitted. Any unforeseen changes in the study conduct 
will be recorded in the clinical study report. 
 
13 DATA HANDLING AND ARCHIVING 
13.1 Completing and Signing Case Report Forms 
Electronic CRFs will be used in this study. Data will be entered by trained site personnel, with 
reasons given for any missing data. Any errors should be corrected within the electronic 
system. The audit trail will record all changes made, the date and time of the correction, and 
the person correcting the error. The appropriate electronic signature will be provided. The 
investigator will receive a copy of their eCRF in a readable format after database lock for 
archiving. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
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IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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13.2 Clinical Data Management 
The contract research organization (CRO) will be responsible for the processing and quality 
control of the data according to the CRO’s SOPs. Data management will be carried out by 
CRO. The handling of data, including data quality control, will comply with all applicable 
regulatory guidelines. 
Details for data validation and edit checks will be described in appropriate data management 
documents. Queries will be handled via the eCRF system. Data cleaning will continue until all 
queries are resolved. 
Medical coding will use MedDRA for AEs and the WHO-DDE/drug dictionary enhanced for 
medication. 
13.3 Archiving and Filing 
All study documentation at the investigator site and sponsor site will be archived in accordance 
with International Conference on Harmonisation (ICH) E6 GCP and the sponsor’s quality 
standards and SOPs in the relevant current version. 
 
14 STATISTICAL METHODS AND PLANNED ANALYSIS 
14.1 Populations for Analysis 
The following analysis populations will be defined: 
Intent-to-treat (ITT) Population: Consists of all patients who received at least one dose of 
study drug. Patients without any postbaseline assessment of NHL response will be included as 
nonresponders. 
Safety Population: Consists of all patients who received at least one dose of study drug.  
Pharmacokinetic Population: The Pharmacokinetic Population will consist of all patients 
who have sufficient pharmacokinetic data to characterize the time course of MOR00208 in 
serum for the first study drug administration. 
The Safety Population will be used for safety analysis and to analyze immunogenicity. The ITT 
Population will be used to analyze immunogenicity and the pharmacodynamic endpoints. 
Summaries for the analysis of response will be provided for the ITT Population. 
Pharmacokinetic summaries will be presented for the Pharmacokinetic Population. 
Tabulations of summary statistics, graphical presentations, and statistical analyses will be 
performed using SAS software. 
Continuous, quantitative variable summaries will include the number of patients (N) (with 
nonmissing values), mean, standard deviation, median, minimum, maximum, and first and 
third quartiles. 
Categorical, qualitative variable summaries will include the frequency and percentage of 
patients who are in the particular category. 


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Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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The last preadministration observation will be used as the baseline value for calculating 
postadministration changes from baseline. All data obtained on the eCRF and entered into the 
database will be provided in separate data listings showing individual patient values. The 
planning and reporting of statistical analyses will be carried out as described in the CRO’s 
SOPs. 
14.2 Patient Characteristics 
A table will be provided with the following information: 
 
Number of patients enrolled. 
 
Number of patients included in each analysis population. 
 
Number of patients withdrawn from the study and the reason for withdrawal. 
Demographic information (age, height, weight, and body mass index) will be summarized for 
the Safety and ITT Populations using descriptive statistics. Gender, ethnicity and race will be 
summarized by counts and percentages. 
Medical histories will be summarized by counts and percentages. Concurrent medications will 
be recorded and coded using the WHO Drug Dictionary and grouped by different classes, if 
applicable. 
The NHL-specific medical history will be summarized for the duration of disease, number of 
previous therapies, type of previous therapy, and best response following previous 
NHL-specific therapy. 
14.3 Immunogenicity Analysis 
One of the secondary endpoints will be to evaluate the potential immunogenicity of 
MOR00208 in the Safety Population. This analysis will be based on both absolute (number and 
percentage of patients who develop anti-MOR00208 antibodies) and semi-quantitative 
(anti-MOR00208 antibody titer determination of confirmed positive samples) assessments. 
The number of patients who develop confirmed anti-MOR00208 antibodies will be 
summarized descriptively by means, standard deviations and ranges.  
14.4 Primary Objective 
The primary efficacy endpoint will be ORR as determined by using revised IWG response 
criteria for malignant lymphoma. The final ORR for each subtype will be the rate of patients 
who met the ORR definition at the end of either the second or third cycle or during the 
follow-up period (best response). The denominator for calculating the rate will be based upon 
the total number of patients in the ITT population, thus patients without any postbaseline 
assessment of NHL response will be included as nonresponders. Overall ORR, independent of 
NHL subtype, will also be summarized; 95% CI for ORR for each subtype and over all 
subtypes will be summarized. 
All efficacy analyses will be provided for the ITT Population. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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14.5 Secondary Objectives 
The secondary efficacy variables will be analyzed using the ITT Population. For all safety 
analyses, the Safety Population will be used.  
14.5.1 Secondary Efficacy Variables and Analyses 
The proportion of patients in each subtype with stable disease (SD) will be summarized after 
the second cycle. 
The DoR will be the time from first meeting of criteria for response (ie CR or PR) to first 
documentation of relapse or progression. 
The TTP is defined as the time from study entry (first dosing) until documented lymphoma 
progression or death as a result of lymphoma. Patients not experiencing a progression will be 
censored at the last NHL assessment. Deaths from other causes are censored at the time of 
death. The data will be summarized using Kaplan-Meier estimates. 
Progression-free survival is defined as the time from study entry (first dosing) until lymphoma 
progression or death as a result of any cause. Patients not experiencing a progression or death 
will be censored at the last NHL assessment. The data will be summarized using Kaplan-Meier 
estimates. 
 
14.6 Pharmacokinetic Analysis 
Concentration and pharmacokinetic data will be collected and analyzed for this study. 
The following pharmacokinetic parameters will be computed based on non-compartmental data 
analysis and summarized by means, standard deviations and ranges:  
Cmax 
Maximum serum concentration observed 
tmax 
Time to maximum serum concentration observed 
Cpd 
Apparent trough serum concentration before dosing  
AUC0-t 
Area under the concentration curve. The time curve from time zero (0) to the 
time that the last concentration above the lower limit of quantification (LLQ) is 
observed. 
AUC0- 
Area under the concentration curve. The time curve from time zero (0) to 
infinity (), where infinity is computed from AUC0-t + [Ct/Z)]. Ct is calculated 
from the concentration at the last sampling time at which the sample is above 
LLQ. 
Z 
Apparent terminal rate constant calculated from the regression analysis (slope) 
from the log-transformed measured concentrations on the terminal phase of the 
time-point concentration curve 
t½ 
Apparent terminal half-life calculated from ln(2)/Z 
CL 
Total body clearance calculated for single or multiple doses: dose(s)/AUC0- 
Vz 
Apparent volume of distribution during the terminal phase, calculated from 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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dose/(AUC0-*Z) 
AUC0-, Z, t½, CL and Vz will only be calculated for those patients where a sufficient and 
meaningful number of serum concentration values are available. More detailed information on 
the methodology of PK analysis will be supplied in the statistical analysis plan. 
 
14.7 Safety Analysis 
14.7.1 Adverse Events 
The primary endpoint is the incidence and severity of adverse events (AEs). This endpoint will 
be determined based on the Safety Population. 
Adverse events will be coded according to MedDRA (version 15.1) system organ class (SOC) 
and preferred term. Incidence of all AEs will be summarized by SOC, preferred term, 
relationship to treatment, severity and seriousness. Adverse events will be summarized overall 
and by each NHL subtype. 
An AE summary table will be presented showing the incidence and frequency of treatment 
emergent AEs (TEAEs), SAEs, MOR00208-related TEAEs, MOR00208-related TEAEs by 
severity/toxicity (according to NCI-CTC toxicity criteria), and infusion reactions. The 
incidence refers to the number and percentage of patients and the frequency to the number of 
AEs. Exact 95% confidence intervals for the incidence rates will be included for overall 
population. 
The number and percentage of patients with one or more treatment-emergent AEs will be 
summarised by NHL subtype and by MedDRA system organ class and preferred term. Such 
summaries will be displayed for all TEAEs, TEAEs by maximum severity/toxicity, and TEAEs 
by relationship to study drug. 
The sponsor will describe other AEs of special interest (for the definition please see Section 
11.1), in addition to those reported as SAEs. 
The number and percentage of patients with one or more pretreatment AEs will be summarised 
by NHL subtype and by system organ class and preferred term. 
14.7.2 Clinical Laboratory Evaluations 
The analysis of laboratory parameters will be presented as separated into blood parameters 
(haematology, serum chemistry, endocrinology, coagulation) and urine parameters (urinalysis). 
All data will be listed. 
For haematology and serum chemistry, the laboratory values will be transformed into SI values 
based on SI units to make laboratory parameters comparable between different local 
laboratories. The relevant reference ranges supplied by each laboratory will also be 
transformed into SI reference ranges for each laboratory. 
Descriptive summaries of actual (absolute) values and change-from-baseline values will be 
presented for haematology and serum chemistry for the Safety Population. 
Each abnormal value will be flagged to show whether it is a value below or above the reference 
range. For the assessment of laboratory variables, 5 categories will be used that into account 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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Page 68 of 84 
the investigator’s assessment of clinical relevance: ‘clin. rel., above’, ‘non-clin. rel., above’, 
‘within’, ‘non clin. rel., below’, ‘clin. rel., below’. 
The assessment of laboratory variables will be tabulated by time point for each clinical 
laboratory analyte for the Safety Population (frequency tables). Additionally, for each 
laboratory parameter, shifts in assessments from baseline to all postadministration time points 
will be presented (shift tables). 
If NCI-CTC grades are available for a clinical laboratory analyte, they will be derived 
according to NCI CTCAE, Version 4.0, and used to present additional frequency and shift 
tables based on NCI-CTC grades. 
The assessment of categorical urinalysis variables will be tabulated by time point for each urine 
parameter for the Safety Population (frequency tables). Additionally, for each of these urine 
parameter shifts in assessments from baseline to all postadministration time points will be 
presented (shift tables). 
Laboratory values that are outside the reference range will also be flagged in the data listings, 
along with corresponding reference ranges. 
14.7.3 Physical Examination 
Baseline physical examination will be summarized by body system. New and worsening 
abnormal physical examination findings during the study will be entered as AEs and analyzed 
within the AE tables. 
14.7.4 Vital Signs 
Descriptive summaries of actual values and changes from baseline will be calculated for vital 
signs. These summaries will be presented for the Safety Population at all time points. Each 
abnormal value will be flagged to show whether it is a value below or above the normal limit. 
The normal limits are detailed in the appendix (Section 17.2). 
14.7.5 Electrocardiograms 
Electrocardiogram data will be summarized as change from baseline. The summary ECG 
assessment (categories: “normal; abnormal clinically significant”; “abnormal not clinically 
significant”) will be tabulated by time point for the Safety Population. 
Each abnormal PR (ECG), QRS, and RR interval value will be flagged to show whether it is a 
value below or above the normal limit. The normal limits are detailed in the appendix 
(Section 17.2). 
Summary statistics for all time points will be displayed for QT and both QTc correction 
methods, side-by-side. The Bazett’s corrections method for QTc will be applied as follows: 
 
Bazett’s Correction (QTcb) 
RR
QT
QTc
m
b
sec

 
where: Relative Rate: RR = 60/HR  


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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Also, the number and percentage of patients with QTc values above the normal limit 
(441-480 ms, 481-500 ms, or > 500 ms) and the number and percentage of patients who 
experienced a change > 30 ms or a change > 60 ms will be presented by time point. 
14.8 Biomarkers 
Biomarker assessments will include expression levels of CD19 on malignant B cells, FcγRIIa 
and FcγRIIIa genotyping, CD16 expression on NK cells, and B-, T- and NK cell counts.  
In addition, the ADCC capacity of the patient will be assessed.  
Due to the exploratory nature of these assays, the sponsor may decide at any point during the 
study to terminate these assessments, in which case the sites will be informed accordingly. 
 
14.9 Sample Size Determination 
A two-stage design is used to minimize exposure of NHL subtypes not showing responsiveness 
to MOR00208. No formal sample size estimations for determination of futility were computed 
for Stage 1. The number of patients to be used in this stage was determined to be the minimum 
number needed to adequately determine futility in any specific NHL subtype. The entire study 
will enrol between 40 to 120 patients, dependent upon patient response in each subtype in 
Stage 1. 
Stage 1: Approximately 40 patients, a similar number of patients will be enrolled per NHL 
subtype: 
 FL: 10 patients 
 DLBCL: 10 patients 
 MCL: 10 patients 
 other indolent NHL: 10 patients 
Observing less than 2 responses (at least PR) in 10 patients in any NHL subtype will be the 
criterion for discontinuing evaluation of MOR00208 in that NHL subtype. If the study drug is 
effective with a true ORR of 30%, the probability to stop for futility after the first stage for a 
specific NHL subtype is only 14.9%. 
Stage 2: For those NHL subtypes with 2 or more responders, an additional 20 patients will be 
enrolled for a total of 30 patients per subtype. Assuming that the true ORR of any NHL type is 
30% and that the number of responses actually observed in the study corresponds to the 
expected number of responses (9 responses), N=30 would yield a lower limit of the 95% 
confidence interval for the ORR of 14.7%. Up to a maximum of 80 additional patients, an 
equal number of patients will be enrolled per “responding” NHL subtype. Some of the cohorts 
may have been stopped for futility after Stage 1: 
 FL: 20 patients 
 DLBCL: 20 patients 
 MCL: 20 patients 
 other indolent NHL: 20 patients 
 
Approximately 25 to 30 centres in the United States of America and Europe are planned. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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14.10 Significance Level 
No interference testing will be performed in the study. However, 95% CI of the ORR after 
Stage 2 will be calculated. 
 
14.11 Procedures for Missing, Unused, and Spurious Data 
Missing values will not be substituted by estimated values but will be treated as missing in the 
statistical evaluation. All data from all patients dosed in the study will be included in all 
listings, plots, summary tables, and statistical analyses when appropriate. 
 
14.12 Rules for Excluding Patients from Analysis 
All dosed patients will be included in the analyses unless otherwise specified. The sponsor will 
make any decisions regarding whether any patients will be excluded from the evaluations when 
the protocol noncompliance is considered to have a negative impact on the scientific aspects 
and interpretation of the study results. If the patient has received any MOR00208, all available 
safety data will be used. The reason(s) for any exclusion will be described in the report. 
 
14.13 Procedures for Reporting Deviations from Original Statistical 
Plan 
Details of the analyses to be performed on data from this study will be provided in a separate 
SAP. Any deviations from the statistical analysis outlined in this protocol will be described, 
and reasons for the deviations listed, in the final clinical study report. 
 
15 SPECIAL REQUIREMENTS AND PROCEDURES 
15.1 Institutional Review 
Before starting this study, the protocol (authorized by the sponsor) will be submitted to the 
regulatory bodies/local health authorities (in accordance with local regulations) and to the 
IEC/IRB for evaluation. The protocol will also be signed by the principal investigators before 
submission to the IEC/IRB and to regulatory authorities where applicable. The study will not 
start at the concerned study site before the respective IEC/IRB gives written approval or a 
favourable opinion in accordance with ICH E6 GCP and all applicable regulatory bodies/local 
health authorities give approval or a favourable opinion as required. 
No substantial changes to the final approved (authorized) protocol will be initiated without the 
IEC’s/IRB’s prior written approval or favourable opinion and approval by the regulatory 
bodies/local health authorities of a written amendment, except when necessary to eliminate 
immediate hazards to the patients or when the change involves only logistics or administration. 
The sponsor will authorize and the principal investigator(s) will sign the protocol amendment 
before submission to the IECs/IRBs. Protocol amendments should be submitted to the IEC/IRB 
without delay. Any significant deviation from the protocol when no approved amendment 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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exists will be regarded as a protocol noncompliance, and will be addressed as such during the 
reporting of the study. 
15.2 Ethical Considerations 
15.2.1 Regulatory and Ethical Compliance 
This clinical study was designed and shall be conducted and reported in accordance with the 
protocol, with ICH E6 GCP, with applicable local regulations, and with the ethical principles 
laid down in the current version of the Declaration of Helsinki. 
15.2.2 Responsibilities of the Investigator and IRB/IEC 
The protocol and the proposed patient information/informed consent form must be reviewed 
and approved by a properly constituted IRB/IEC before study start. A signed and dated 
statement that the protocol and informed consent form have been approved by the 
IRB/IEC/Regional Surveillance authority must be given to the sponsor before study initiation. 
Prior to study start, the investigator is required to sign a protocol signature page confirming his 
or her agreement to conduct the study in accordance with these documents and all of the 
instructions and procedures found in this protocol. 
The IRB/IEC must be informed of all substantial subsequent protocol amendments and of 
reportable suspected unexpected serious adverse reactions (SUSARs) and other unexpected 
safety issues occurring during the study that are likely to affect the safety of the patients or the 
conduct of the study. Approval for such changes must be transmitted in writing to the sponsor 
by the investigator. 
The IRB/IEC should be provided with all updates of the IB. Also, written reports should be 
provided to the IRB/IEC annually or more frequently if requested on any change significantly 
affecting the conduct of the study and/or increasing risk to the patients. A final report of study 
outcome, if required, should also be submitted to the IRB/IEC. 
 
15.3 Investigator’s Responsibilities 
15.3.1 Overall Responsibilities 
The investigator is responsible for conducting the study in full accordance with the protocol 
and the current version of the Declaration of Helsinki, the Good Clinical Practice: Consolidated 
Guideline, approved by the ICH, and any applicable national and local laws and regulations. 
Information regarding any investigational centres participating in this study that do not comply 
with these standards will be documented, and noncompliant sites should be excluded. 
The investigator is accountable for the performance of the study (treatment of the patient and 
the documentation). If any responsibilities are delegated, the investigator should maintain a list 
of appropriately qualified persons to whom he or she has delegated significant study-related 
duties. 
A “Delegation of Authority Log” will be filled in and signed by the responsible investigator. In 
accordance with this authority log, study site staff (eg, subinvestigators, nurses) will be 
authorized to perform study-related tasks and to enter specific data into the eCRF. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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The CRO or designee is responsible for IRB/IEC submission, monitoring, biometry, data 
management, pharmacovigilance, and part of project management. The relevant submissions to 
the Competent Authorities are being handled by the sponsor in close cooperation with the 
CRO. 
Most clinical laboratory tests will be done locally. Each investigator will receive detailed 
written instructions on the laboratory samples to be taken and laboratories to be used. 
15.3.2 Patient Informed Consent 
The investigator will obtain a freely given written consent from each patient after an 
appropriate explanation of the aims, methods, anticipated benefits, potential hazards and any 
other aspect of the study that is relevant to the patient's decision to participate. The informed 
consent form must be signed, with name and date and time noted by the patient, before the 
patient is exposed to any study-related procedure, including screening tests for eligibility. 
The investigator will explain that the patients are completely free to refuse to enter the study or 
to withdraw from it at any time, without any consequences for their further care and without 
the need to justify. The investigator or delegate should complete the informed consent section 
of the eCRF for each patient enrolled. 
Each patient will be informed that his or her source records may be reviewed by the study 
monitor, 
a 
quality 
assurance 
auditor, 
a 
health 
authority 
inspector 
(eg, 
FDA, 
Paul-Ehrlich-Institut [PEI]), or other individuals in accordance with applicable regulations, and 
that these persons are bound by confidentiality obligations. The investigator will protect any 
personal information not related to the study and will assure that these persons are bound by 
confidentiality obligations. 
15.3.3 Direct Access to Source Data/Documents 
The monitors, auditors, authorized personnel of the sponsor, health authority inspectors or their 
agents, and authorized members of IECs/IRBs will be given direct access to source data and 
documentation medical charts/records, laboratory results, printouts, videotapes, etc) for source 
data verification, provided that patient confidentiality is maintained in accordance with local 
requirements. 
15.3.4 Confidentiality Regarding Study Patients 
The investigators must assure that the privacy of the patients, including their personal identity 
and all other personal medical information, will be maintained at all times. In eCRFs and other 
documents or image material submitted to the sponsor, patients will not be identified by their 
names but by an identification code (eg, initials and study patient number). 
Personal medical information may be scrutinized for the purpose of verifying data recorded in 
the eCRF. This may be done by the monitor, properly authorized persons on behalf of the 
sponsor, the quality assurance unit, or regulatory authorities. Personal medical information will 
always be treated as confidential. Should the need arise that the investigator forwards a copy of 
personal medical information (ie laboratory report) to the sponsor or delegate, then the 
investigator is responsible for obliterating all patient details revealing their personal identity. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
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IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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15.3.5 Relevant Protocol Noncompliances 
Noncompliances from the protocol should not occur. If noncompliances occur, the investigator 
should promptly inform the medical monitor or the monitor for nonclinical aspects and the 
implication of the deviation must be reviewed and discussed. Any noncompliances must be 
documented, stating the reason and date, the action taken, and the impact on the patient and/or 
the study. The documentation must be kept in the investigator’s study file and the sponsor’s 
file. 
Examples of relevant protocol noncompliances that will be addressed (but are not limited to 
these) are as follows: 
 Patients who enter the study even though they did not satisfy the entry criteria 
 Patients who develop withdrawal criteria during the study 
 Patients who receive the incorrect dose 
 Patients who receive an excluded concomitant treatment (eg, another mAb). 
 Noncompliance with protocol setting that puts the safety of the patient or the scientific 
validity of the study at risk 
 
In case of any major protocol noncompliances, the investigator will decide on the further 
participation of the patient in this study, after having discussed all relevant aspects with the 
medical monitor. The sponsor may, however, request the exclusion of such a patient from 
further participation in the study. 
A list of all included patients with all deviations from the intended study procedures and other 
criteria that may affect the patient's validity for statistical analysis will be prepared upon 
clinical completion of the study. This will then be discussed by a panel consisting of the 
clinical project manager, a medical expert of the sponsor, the data manager, and the study 
biometrician. This panel will decide upon the membership of the patient in the patient 
populations for statistical analysis. 
 
15.4 Study Monitoring 
Study monitoring will be performed in accordance with ICH E6 GCP, the CRO’s SOPs, the 
protocol, and applicable local regulations. 
 
15.5 Audit and Inspection 
According to ICH E6 GCP, the sponsor or regulatory authorities may audit the investigational 
sites. The sponsor’s Quality Assurance Unit, independent of the Clinical Research and 
Development Department, is responsible for auditing the study. The investigator must accept 
such audits by sponsor’s Quality Assurance Unit and ensure access to source documentation. 
The investigator must accept that regulatory authorities may conduct an inspection to verify 
compliance of the study with GCP. If informed that a regulatory inspection will take place, the 
investigator must inform the sponsor without delay. 
 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
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15.6 Insurance 
This study is covered under the sponsor’s Liability Insurance Policy covering damage to 
patients according to applicable legal requirements. A copy of the Certificate of Insurance 
and/or an information leaflet containing essential information about the insurance coverage 
will be provided to the investigator as required by Regulatory Authorities, IRBs or IECs. 
The investigator must inform the patients accordingly and must also point out that the patients 
are allowed to undergo other medical treatment (except in an emergency) only with the 
investigator’s prior approval or to receive additional medication only with the investigator’s 
prior approval. 
 
15.7 Study Report and Publication Policy 
The results of this clinical study will be documented in an integrated clinical study report 
according to ICH E3 Note for Guidance on Structure and Content of Clinical Study Reports, 
which will be signed by the authors, sponsor, and coordinating investigator. Reports will also 
be generated for IEC/IRB review and for regulatory reporting as required. 
Any presentation or publication of data from this study will be intended as a joint publication 
by the investigator(s)/appropriate study centre personnel and appropriate sponsor personnel. 
Authorship will follow the ICMJE Uniform Requirements for Manuscripts Submitted to 
Biomedical Journals and will be defined prior to the first publication. All other investigators, 
coinvestigators, and study coordinators will be listed in an acknowledgement. 
For multicenter studies, it is mandatory that the first publication be based on data from all 
centres, and that data are analyzed and submitted as stipulated in the protocol by a statistician 
assigned by the sponsor. The authors have the final responsibility for the decision to submit 
their manuscript and shall be given full access to the data resulting from the study. The 
coordinating investigator and/or authors shall coordinate any intended publication of study 
results with the sponsor, to enable the sponsor to ensure that results are presented in a 
responsible and coherent manner. The sponsor reserves the right to review all manuscripts and 
abstracts before their submission for publication or presentation. This is not intended to restrict 
or hinder publication or presentation, but is to allow the sponsor to protect the confidentiality 
of information and to provide comments that may not yet available to the investigator. In the 
rare event that such publication would affect the patentability of any invention to which the 
sponsor has rights, the sponsor has the right to request an additional delay to the proposed 
publication of no more than 90 days so as to allow the sponsor to protect its intellectual 
property rights. 
The results of the study may be used by MorphoSys AG for the purposes of national and 
international registration, publication, and information for medical professionals. If necessary, 
the authorities will be notified of the investigators’ names, addresses, qualifications, and extent 
of involvement. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 75 of 84 
16 REFERENCES 
 
Camacho LH, Joyce R, Brown JR, et al. A phase 1, open-label, multi-center, multi-dose, dose-
escalation study of MDX-1342 in patients with CD19-positive refractory/relapsed chronic 
lymphocytic leukemia [abstract 3425]. Blood. 2009;114(22):1330. 
Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. 
J Clin Oncol. 2007;25(5):579-586. 
Coiffier B, Ribrag V, Dupuis J, et al. Phase I/II study of the anti-CD19 maytansinoid 
immunoconjugate SAR3419 administered weekly to patients (pts) with relapsed/refractory 
B-cell non-Hodgkin lymphoma (NHL) [abstract 8017]. J Clin Oncol. 2011;29(suppl). 
Ginaldi L, De Martinis M, Matutes E, Farahat N, Morilla R, Catovsky D. Levels of expression 
of CD19 and CD20 in chronic B cell leukaemias. J Clin Pathol. 1998;51(5):364-369. 
van Oers MH, Kersten MJ. Treatment strategies in advanced stage follicular lymphoma. Best 
Pract Res Clin Haematol. 2011;24(2):187-201.  
Olejniczak SH, Stewart CC, Donohue K, and Czuczman MS. A quantitative exploration of 
surface antigen expression in common B-cell malignancies using flow cytometry: Immunol 
Invest. 2006;35(1):93-114. 
Parekh S, Weniger MA, Wiestner A. New molecular targets in mantle cell lymphoma. Semin 
Cancer Biol. 2011;21(5):335-346. 
Rummel M. Reassessing the standard of care in indolent lymphoma: a clinical update to 
improve clinical practice. J Natl Compr Canc Netw. 2010;8(Suppl 6):S1-14. 
Viardot A, Goebeler M, Noppeney R, et al. Blinatumomab monotherapy shows efficacy in 
patients with relapsed diffuse large B cell lymphoma [poster 1637]. Blood. 2011;118(21). 
 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 76 of 84 
 
17 APPENDICES 
17.1 Information on Investigational and Registered Products 
The Investigator’s Brochure for MOR00208 will be supplied to the study sites. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 77 of 84 
17.2 Normal Limits for Vital Signs, Weight, Height, and Electrocardiogram 
Intervals 
Table 5 
Criteria For Normal Limits For Vital Signs, 
Height, And Weight 
Body Weight, Body Height, 
Vital Signs Parameter 
Normal Limits 
Low 
High 
Systolic BP (mm Hg) 
85 
139 
Diastolic BP (mm Hg) 
60 
89 
Heart rate (bpm) 
60 
100 
Respiration rate (rpm) 
12 
22 
Body temperature (°C) 
36.4C 
37.7C 
Oxygen saturation (%) 
93 
100 
Body weight (kg)a 
41 
113 
Body mass index (kg/m²)b 
18.5 
24.9 
a
Changes in body weight are evaluated by the investigator (without 
taking height into account), because body mass index  is not 
collected on the electronic case report form. 
b 
Body mass index is calculated and analyzed retrospectively by the 
sponsor, at which time height is taken into account. 
 
Table 6 
Criteria For Normal Limits For 
Electrocardiograms 
 
Normal Limits (msec) 
ECG Variable 
Low 
High 
PR interval 
120 
200 
QRS interval 
50 
100 
RR interval 
600 
1000 
QT interval 
(gender not specified) 
- 
440 
QTc intervala 
(gender not specified) 
- 
440 
a No lower boundary will be set for QTc. 
 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 78 of 84 
 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 79 of 84 
17.3 New York Heart Association Functional Classification 
Table 7 
Criteria For NYHA Functional Classification 
NYHA Class 
Criteria 
I 
No symptoms and no limitation in ordinary physical activity; shortness of breath 
when walking, stair climbing, etc. 
II 
Mild symptoms (mild shortness of breath and/or angina pain) and slight limitation 
during ordinary activity 
III 
Marked limitation in activity due to symptoms, even during less-than-ordinary 
activity (eg, walking short distances, approximately > 20 – 100 meters); 
comfortable only at rest 
IV 
Severe limitations; patient experiences symptoms even while at rest, mostly 
bedbound 
Abbreviation: NYHA,  New York Heart Association 
 
 
 
 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 80 of 84 
 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 81 of 84 
17.4 Response Criteria 
The response criteria in this study are those defined in the table below. All of them are based 
on the International Working Group Response Criteria (2007). 
Table 8 
Response Criteria 
Response  
Definition 
Nodal masses 
Spleen, liver 
Bone marrow 
CR 
Disappearance of all 
evidence of disease 
a) FDG-avid or PET 
positive prior to therapy; 
mass of any size 
permitted if PET 
negative 
b) Variable FDG-avid or 
PET negative; regression 
to normal size on CT 
Not palpable, 
nodules 
disappeared 
Infiltrate cleared 
on repeat biopsy; if 
indeterminate by 
morphology, 
immunohisto-
chemistry should 
be negative 
PR 
Regression of 
measurable disease and 
no new sites 
≥ 50% decrease in SPD of 
up to 6 largest dominant 
masses; no increase in size 
on CT 
a) FDG-avid or PET 
positive prior to therapy; 
one or more PET 
positive at previously 
involved site 
b) Variable FDG-avid or 
PET negative; regression 
on CT 
≥ 50% decrease in 
SPD of nodules (for 
single nodule in 
greatest transverse 
diameter); no 
increase in size of 
liver or spleen 
Irrelevant if 
positive prior to 
therapy; cell type 
should be specified 
SD 
Failure to attain CR/PR 
or PD 
a) FDG-avid or PET 
positive prior to therapy; 
PET positive at prior 
sites of disease and no 
new sites on CT or PET 
b) Variable FDG-avid or 
PET negative; no change 
in size of previous 
lesions on CT 
 
 
Relapsed 
disease or 
PD 
Any new lesion or 
increase by ≥ 50% of 
previously involved 
sites from nadir 
Appearance of a new 
lesion(s) > 1.5 cm in any 
axis, ≥ 50% increase in 
SPD of more than one 
node, or ≥ 50% increase 
in longest diameter of a 
previously identified 
node > 1cm in short axis 
Lesions PET positive if 
FDG-avid lymphoma or 
PET positive prior to 
therapy 
> 50% increase 
from nadir in the 
SPD of any 
previous lesions 
New or recurrent 
involvement 
Abbreviations: CR, complete remission; FDG, [18F]fluorodeoxyglucose; PET, positron emission 
tomography; CT, computed tomography; PR, partial remission; SPD, sum of the product of the 
diameters; SD, stable disease; PD, progressive disease 
 
 
 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 82 of 84 
 
17.5 ECOG Performance Status 
Table 9 
ECOG Performance Status Grades 
Grade 
ECOG 
0 
Fully active, able to carry on all pre-disease performance without restriction 
1 
Restricted in physically strenuous activity but ambulatory and able to carry 
out work of a light or sedentary nature, eg, light house work, office work 
2 
Ambulatory and capable of all selfcare but unable to carry out any work 
activities. Up and about more than 50% of waking hours 
3 
Capable of only limited selfcare, confined to bed or chair more than 50% of 
waking hours 
4 
Completely disabled. Cannot carry on any selfcare. Totally confined to bed 
or chair 
5 
Dead 
Published in Am J Clin Oncol:  Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, 
McFadden ET, Carbone PP: Toxicity and Response Criteria of the Eastern Cooperative 
Oncology Group. Am J Clin Oncol 5:649-655, 1982.  
Credit: the Eastern Cooperative Oncology Group, Robert Comis M.D., Group Chair. 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 83 of 84 
 
17.6 Equivalent Doses for Corticosteroids 
 
Name (INN) 
Example 
Equivalent doses for 
80 – 100- 120 mg 
methylprednisolone 
Potency 
Hydrocortisone 
Hydrocortone® 
400 – 500- 600 mg 
1 
Prednisone 
Decortin® 
100 - 125 – 150 mg 
4 
Prednisolone 
Decortin® H 
100 - 125 – 150 mg 
4 
Methylprednisolone 
Urbason® 
80 – 100 – 120  mg 
5 
Dexamethasone 
Fortecortin® 
14- 16 - 20 mg 
30 
 
 
 
 


Product Name: MOR00208 
Protocol Number: MOR208C201 
Date: 26 May 2020 
IND Number: 114,856 
Protocol Amendment 5, Final v7.0 
EudraCT Number: 2012-002659-41 
 
MorphoSys AG 
Confidential 
Page 84 of 84 
 
17.7 List of Indolent B-cell Lymphomas  
Below are listed the indolent lymphomas that can be included in the indolent lymphoma 
subtype. Please note that for FL, gradings 1 and 2 belong to the group of indolent lymphomas 
but will be included in their particular subtype. 
a. Chronic lymphocytic leukemia/small lymphocytic lymphoma  
b. Lymphoplasmacytic lymphoma (Waldenstrom’s macroglobulinemia)  
c. Extranodal marginal zone B-cell lymphoma (MALT lymphoma) 
d. Nodal marginal zone B-cell lymphoma (monocytoid B-cell lymphoma)  
e. Splenic marginal zone lymphoma (splenic lymphoma with villous lymphocytes)  
f. Hairy cell leukemia  

SAP_001.pdf: 
 
AD-ST-33.02 8 April 2011 
 
Statistical Analysis Plan 
Protocol Title: 
A Phase IIa, Open-Label, Multicenter Study of Single Agent 
MOR00208, an Fc-Optimized Anti-CD19 Antibody, in Patients with 
Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma 
Protocol Number: 
MOR208C201 (Version 6.0, including Amendment No. 4, 19 
September 2017) 
Compound: 
MOR00208 
 
Phase: 
IIa 
Sponsor: 
MorphoSys AG 
Semmelweisstr. 7 
82152 Planegg 
Germany 
SAP Author: 
SAP Version: 
Final Version 4.0 
SAP Date: 
03 April 2019 
CONFIDENTIAL 


Protocol: MOR208C201 
 
Page 2 of 55 
Statistical Analysis Plan Final Version 4.0 
 
CONFIDENTIAL 
 
03 April 2019 
AD-ST-33.02 8 April 2011 
DOCUMENT HISTORY 
Version 
Date 
Author 
Description 
Final Version 1.0 
20 Mar 2013 
Final Version 
Final Version 2.0 
7 July 2015 
Final Version 2.0 
Final Version 3.0 
30 November 2018 
Updated to take account of 
protocol amendment 4 
Final Version 4.0 
03 April 2019 
Updated to reflect further changes 
requested by sponsor 
 


Protocol: MOR208C201 
 
Page 3 of 55 
Statistical Analysis Plan Final Version 4.0 
 
CONFIDENTIAL 
 
03 April 2019 
AD-ST-33.02 8 April 2011 
SIGNATURE PAGE AND APPROVALS 
 
 
 
 
Date 
 
 
 
 
Date 
 
 
 
 
Date 
 
 
 
 
Date 
 
 
 
 
Date 
 
 
 
 
Date 


Protocol: MOR208C201 
 
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Statistical Analysis Plan Final Version 4.0 
 
CONFIDENTIAL 
 
03 April 2019 
AD-ST-33.02 8 April 2011 
TABLE OF CONTENTS 
DOCUMENT HISTORY .................................................................................................. 2 
SIGNATURE PAGE AND APPROVALS ...................................................................... 3 
TABLE OF CONTENTS .................................................................................................. 4 
ABBREVIATIONS ............................................................................................................ 7 
1. 
OVERVIEW ......................................................................................................... 10 
2. 
STUDY OBJECTIVES AND ENDPOINTS ..................................................... 11 
2.1 
Study Objectives ........................................................................................ 11 
2.1.1 Primary Objective .......................................................................... 11 
2.1.2 Secondary Objectives .................................................................... 11 
2.2 
Efficacy, Safety and Pharmacokinetic/Pharmacodynamic Endpoints ....... 11 
2.2.1 Primary Endpoint ........................................................................... 11 
2.2.2 Secondary Endpoints ..................................................................... 11 
2.2.3 Pharmacokinetic Assessments ....................................................... 12 
3. 
STUDY METHODS ............................................................................................ 13 
3.1 
Overall Study Design and Plan .................................................................. 13 
3.2 
Selection of Study Population ................................................................... 14 
3.3 
Method of Treatment Assignment and Randomization ............................. 15 
3.4 
Treatment Masking (Blinding) .................................................................. 15 
4. 
ANALYSIS AND REPORTING ........................................................................ 15 
4.1 
Final Analysis ............................................................................................ 16 
4.2 
Final Pharmacokinetic Analysis ................................................................ 16 
5. 
SAMPLE SIZE DETERMINATION ................................................................ 17 
6. 
ANALYSIS POPULATIONS ............................................................................. 18 
7. 
GENERAL ISSUES FOR STATISTICAL ANALYSIS .................................. 18 
7.1 
General Statistical Methodology ............................................................... 18 


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Statistical Analysis Plan Final Version 4.0 
 
CONFIDENTIAL 
 
03 April 2019 
AD-ST-33.02 8 April 2011 
7.2 
Handling of Missing Data for PK Analysis ............................................... 20 
7.3 
Derived and Computed Variables .............................................................. 20 
7.3.1 Previous NHL therapy variables .................................................... 20 
7.3.2 Prognostic variables ....................................................................... 22 
7.3.3 Immunogenicity ............................................................................. 24 
7.3.4 Efficacy .......................................................................................... 24 
7.3.5 Exposure ........................................................................................ 29 
8. 
STUDY PATIENTS AND DEMOGRAPHICS ................................................. 32 
8.1 
Disposition of Patients and Treatment Discontinuation ............................ 32 
8.2 
Protocol Violations and Deviations ........................................................... 34 
8.3 
Demographics and Other Baseline Characteristics .................................... 34 
9. 
EFFICACY ANALYSES .................................................................................... 37 
9.1 
Primary Efficacy Analysis ......................................................................... 37 
9.2 
Secondary Efficacy Analysis ..................................................................... 38 
9.3 
Subgroup analyses ..................................................................................... 40 
9.4 
Other Efficacy Analyses ............................................................................ 41 
10. 
PHARMCOKINETIC AND PHARMACODYNAMIC ANALYSIS ............. 41 
10.1 
Pharmacodynamic Parameters Measured in Blood ................................... 41 
10.2 
Pharmacodynamic Parameters Measured in Bone Marrow and Biopsy ... 42 
10.3 
Pharmacokinetic Analysis ......................................................................... 42 
10.3.1 Bioanalytical Assay of Pharmacokinetic Serum Samples. ............ 42 
10.3.2 Concentration Data ........................................................................ 42 
10.3.3 Pharmacokinetic Parameters estimated ......................................... 43 
11. 
SAFETY AND TOLERABILITY ANALYSES ................................................ 45 
11.1 
Adverse Events .......................................................................................... 45 
11.2 
Clinical Laboratory Evaluations ................................................................ 48 


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Statistical Analysis Plan Final Version 4.0 
 
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03 April 2019 
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11.3 
Vital Signs and Body Weight .................................................................... 49 
11.4 
Electrocardiograms .................................................................................... 50 
11.5 
Physical Examination ................................................................................ 50 
11.6 
Measurement of Exposure ......................................................................... 51 
11.7 
Immunogenicity Analysis .......................................................................... 51 
12. 
CHANGES FROM PLANNED ANALYSIS ..................................................... 51 
13. 
REPORTING CONVENTIONS ........................................................................ 52 
13.1 
General Reporting Conventions ................................................................ 52 
13.2 
Population Summary Conventions ............................................................ 53 
14. 
REFERENCES .................................................................................................... 55 
 


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Statistical Analysis Plan Final Version 4.0 
 
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03 April 2019 
AD-ST-33.02 8 April 2011 
ABBREVIATIONS 
ABBREVIATION 
DEFINITION OR DESCRIPTION 
ADCC 
Antibody-dependent cell-mediated cytotoxicity 
AE 
Adverse Event 
ATC 
Anatomical Therapeutic Chemical 
AUC0-last 
Area under the concentration curve from dose time zero (0) to 
the time the last quantifiable concentration observed. 
BMI 
Body Mass Index 
BSA 
Body Surface Area 
CD16 
Cluster of Differentiation 16 (antigen expressed on malignant 
plasma cells) 
CD19 
Cluster of Differentiation 19 
CL 
Total body clearance calculated for a single dose as a first 
dose 
Cmax 
Maximum serum concentration observed 
Cpd 
Predose serum concentration observed 
CR 
Complete Remission 
CSR 
Clinical Study Report 
CT 
Computer Tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
CV 
Coefficient of Variation 
DLBCL 
Diffuse Large B-Cell Lymphoma 
DoR 
Duration of Response 
ECG 
Electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
Electronic Case Report Form 
EMA 
European Medicines Agency 
FcγR 
Fc gamma receptor 


Protocol: MOR208C201 
 
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Statistical Analysis Plan Final Version 4.0 
 
CONFIDENTIAL 
 
03 April 2019 
AD-ST-33.02 8 April 2011 
FDA 
Food and Drug Administration 
FDG-PET 
[18F]fluorodeoxyglucose-positron emission tomography 
FL 
Follicular Lymphoma 
ICH 
International Conference on Harmonisation 
ITT 
Intent-to-Treat 
IWG 
International Working Group 
Z 
Apparent terminal rate constant 
MALT 
Mucosa-Associated Lymphoid Tissue Lymphoma 
MCL 
Mantle Cell Lymphoma 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRI 
Magnetic Resonance Imaging 
MZL 
Marginal Zone Lymphoma 
NCI-CTC 
National Cancer Institute Common Toxicity Criteria  
NHL 
Non-Hodgkin’s Lymphoma 
NK 
Natural Killer 
ORR 
Overall Response Rate 
PD 
Progressive Disease 
PFS 
Progression-Free Survival 
PK 
Pharmacokinetic 
PR 
Partial Remission 
QTc 
QT-interval for ECG corrected for heart rate 
REAL/WHO 
Revised European American Lymphoma/World Health 
Organization 
RIT 
Radio-immunotherapy 
RT 
Radiotherapy 
SAE 
Serious Adverse Event 
SAP  
Statistical Analysis Plan 
SCT 
Stem cell transplantation 


Protocol: MOR208C201 
 
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Statistical Analysis Plan Final Version 4.0 
 
CONFIDENTIAL 
 
03 April 2019 
AD-ST-33.02 8 April 2011 
SD  
Stable Disease 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
TEAE 
Treatment-emergent Adverse Event 
tmax 
Time to maximum serum concentration observed 
TMF 
Trial Master File 
TTP 
Time to Progression 
t½ 
Apparent terminal half-life 
Vz 
Apparent volume of distribution  
WHO 
World Health Organization 
 


Protocol: MOR208C201 
 
Page 10 of 55 
Statistical Analysis Plan Final Version 4.0 
 
CONFIDENTIAL 
 
03 April 2019 
AD-ST-33.02 8 April 2011 
1. OVERVIEW 
This Statistical Analysis Plan (SAP) describes the planned analysis and reporting of data 
collected from MorphoSys protocol MOR208C201, Amendment 4.0, Version 6.0, dated 
19 September 2017. 
This Phase IIa, open-label, multicenter study is being completed to assess the antitumor activity 
and safety of single agent MOR00208 in adult patients with relapsed or refractory non-
Hodgkin’s lymphoma (NHL) who have received at least one prior therapy containing rituximab 
as one of the treatments. 
The structure and content of this SAP provides sufficient detail to meet the requirements 
identified by the Food and Drug Administration (FDA), European Medicines Agency (EMA), 
and International Council for Harmonization (ICH) of Technical Requirements for Registration 
of Pharmaceuticals for Human Use: Guidance on Statistical Principles in Clinical Trials [1]. All 
work planned and reported from this SAP will follow internationally accepted guidelines, 
published by the American Statistical Association [2] and the Royal Statistical Society [3], for 
statistical practice. 
The planned analysis identified in this SAP may be included in clinical study reports (CSRs), 
regulatory submissions, or future manuscripts. Also, post-hoc exploratory analysis not 
necessarily identified in this SAP may be performed to further examine study data and will not 
require updating the final SAP. Any post-hoc, or unplanned, exploratory analysis performed 
will be clearly identified as such and described in the final CSR. 
The following documents were reviewed in preparation of this SAP: 
• Clinical Research Protocol MOR208C201, Amendment 4; Version 6.0, dated 
19 September 2017. 
• Annotated electronic Case report forms (eCRFs), Version 8 for Protocol MOR208C201, 
dated 10-Sep-2014. 
• ICH Guidance on Statistical Principles for Clinical Trials (E9). 
The reader of this SAP is encouraged to also read the clinical protocol, and other identified 
documents, for details on the planned conduct of this study. Operational aspects related to 
collection and timing of planned clinical assessments are not repeated in this SAP unless 
relevant to the planned analysis. 


Protocol: MOR208C201 
 
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Statistical Analysis Plan Final Version 4.0 
 
CONFIDENTIAL 
 
03 April 2019 
AD-ST-33.02 8 April 2011 
2. STUDY OBJECTIVES AND ENDPOINTS 
2.1 Study Objectives 
2.1.1 Primary Objective 
The primary objectives are 
• To assess the antitumor activity of single agent MOR00208 in adult patients with 
relapsed or refractory NHL who have received at least one prior therapy containing 
rituximab as one of the treatments. 
2.1.2 Secondary Objectives 
• To evaluate the duration of response 
• To establish safety and tolerability of MOR00208 
• To assess the potential immunogenicity of MOR00208 
• To evaluate the pharmacokinetics and pharmacodynamics of MOR00208 in patients 
with relapsed or refractory NHL 
 
2.2 
Efficacy, Safety and Pharmacokinetic/Pharmacodynamic Endpoints  
2.2.1 Primary Endpoint 
The primary efficacy endpoint will be the overall response rate (ORR) based on the revised 
IWG response criteria for malignant lymphoma as assessed by investigator [4]. The ORR for 
each subtype will be the rate of patients who met the criteria of partial remission (PR) or 
complete remission (CR) at the end of either the second or third cycle or during a response 
assessment in the follow-up period. 
2.2.2 Secondary Endpoints 
Secondary endpoints are 
1. Stable disease (SD) rate 
2. Duration of response (DoR) 
3. Time to progression (TTP) 
4. Progression-free survival (PFS) 
5. Incidence and severity of AEs 


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03 April 2019 
AD-ST-33.02 8 April 2011 
6. Number and proportion of patients who potentially develop anti-MOR00208 antibodies and 
semiquantitative (anti-MOR00208 antibody titer determination of confirmed positive 
samples) anti-MOR00208 antibody assessments 
7. Pharmacokinetics (Cmax, tmax, Cpd [apparent trough serum concentration before dosing], 
AUC0-t, λZ, t½) 
8. Absolute and percentage change from baseline in measurements of B-, T- and NK cell 
populations 
9. Evaluation of AEs and ORR stratified by FcγRIIIa and FcγRIIa polymorphism 
10. ORR based on central read 
 
2.2.3 Pharmacokinetic Assessments 
Concentration-time profiles and pharmacokinetic parameters will be assessed as data permit 
from MOR00208 serum samples collected on the following schedules (if not otherwise 
specified, a deviation of 10 minutes from the planned collection time point is acceptable): 
For the first study drug infusion of 12 mg/kg (Cycle 1 Day1), serum samples will be collected 
predose, at the end of infusion, and 1 hour, 4 hours and 24 hours (± 1 hour) after end of first 
MOR00208 infusion.  
During Cycle 1 on Days 8, 15 and 22, serum samples will be collected predose for trough level 
determination and then 1 hour after the end of the infusion. 
During Cycles 2 and 3 on Days 8 and 22 of each cycle, serum samples will be collected 
predose for trough level determination and then 1 hour after the end of the infusion, a sample 
will also be collected on Day 28 ± 4 days. 
At the 1st, 2nd and 3rd follow-up visits (± 2 days), serum samples will be collected. 
The PK samples collected following the first study drug administration through the 24 hours 
sample will be used to characterize PK analysis to the 24 hour sample using actual elapsed 
sampling times with simple calculations and no terminal slope estimation. The other PK 
samples will only be listed and summarized by scheduled sample time except for the Day 28 
samples following the last dose where the 1st, 2nd, and 3rd follow-up samples will be used to 
estimate a patient’s terminal elimination rate. For patients receiving maintenance treatment 
after cycle 3, the FU1, FU2 and FU3 visits will be excluded from PK summary statistics, since 
the concentrations of MOR00208 at the FU1, FU2 and FU3 visits may be influenced by 
additional MOR00208 doses in maintenance treatment. 


Protocol: MOR208C201 
 
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Statistical Analysis Plan Final Version 4.0 
 
CONFIDENTIAL 
 
03 April 2019 
AD-ST-33.02 8 April 2011 
3. STUDY METHODS 
3.1 Overall Study Design and Plan  
This is a Phase IIa open-label, multicenter safety and efficacy study of MOR00208, that will 
enrol approximately 40 to 120 adult patients with refractory or relapsed NHL who have 
received at least 1 prior therapy containing rituximab. 
The study will enrol patients from four different NHL subtypes: FL, DLBCL, MCL and other 
indolent NHL (MZL, MALT, etc). Data from the four subtypes will be presented separately, 
and data will also be presented for FL and other indolent NHL combined, and for all subtypes 
combined. 
The study will employ a two-stage design where the decision to further enrol any NHL subtype 
in Stage 2 will depend on responses after 2 cycles in Stage 1. 
Stage 1: Ten patients per NHL subtype (a minimum of 40 patients in total) will be enrolled to 
receive MOR00208 12 mg/kg weekly for 8 weeks. After 8 weeks of dosing, patients will be 
evaluated for response. If fewer than 2 of 10 patients per NHL subtype have a response of PR 
or better, then continued enrolment in that cohort will be stopped for futility. If at least 2 of 
10 patients per NHL subtype have a response of PR or better, then additional patients will be 
enrolled into Stage 2 for that subtype cohort.  
Any patients with a response of at least stable disease (SD) in Stage 1 will qualify for a further 
4 weeks of dosing. 
Stage 2: An additional 20 patients will be enrolled for each NHL cohort demonstrating a 
response in Stage 1. After 8 weeks, the ORR will be evaluated for each NHL cohort. 
Any patients with a response of at least stable disease (SD) in Stage 2 will qualify for a further 
4 weeks of dosing. 
Patients who withdraw or discontinue before having received study drug on Cycle 2 Day 22 
will only be replaced if the reason for withdrawal/discontinuation was not lack of efficacy. 
Patients will not be replaced after they have received treatment for Cycle 2 Day 22, regardless 
of the reason of withdrawal or discontinuation. 


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03 April 2019 
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3.2 Selection of Study Population 
The study population will consist of adult patients with relapsed or refractory B-cell NHL who 
have received at least one prior therapy containing rituximab. Key inclusion criteria identified 
in the protocol are  
1. Patients are male or female  ≥ 18 years of age. 
2. Patients have a histologically confirmed diagnosis according to the Revised European 
American Lymphoma/World Health Organization (REAL/WHO) classification, of the 
following B-cell lymphomas:  
• Follicular lymphoma (FL)  
• Diffuse large B-cell lymphoma (DLBCL) 
• Mantle cell lymphoma (MCL)  
• Other indolent NHL (eg, marginal zone lymphoma [MZL]/ mucosa-associated 
lymphoid tissue lymphoma [MALT]) 
3. Patients’ NHL must have progressed after at least 1 prior rituximab-containing regimen. 
4. Patients have at least one site of measurable disease by magnetic resonance imaging (MRI) 
or computed tomography (CT) scan defined as at least one lesion that measures at least 
1.5 × 1.5 cm, 
Exception: 
For patients with MCL only, patients with nonmeasurable disease but evaluable sites (bone 
marrow, spleen, peripheral blood, gastrointestinal tract) can be enrolled. 
5. Patients who have previously received an autologous stem cell transplantation must be at 
least 4 weeks post-transplant before study drug administration and must have exhibited a 
full hematological recovery. 
6. Patients must have discontinued previous monoclonal antibody therapy (except rituximab) 
or radioimmunotherapy administration for at least 60 days before study drug administration. 
7. Patients should be off rituximab for at least 14 days before the screening visit and be 
confirmed to have either no response or have disease progression after rituximab treatment. 
8. Patients with DLBCL must have a positive [18F]fluorodeoxyglucose-positron emission 
tomography (FDG-PET) scan at baseline (Cheson 2007 response criteria). 
9. Patients must have a life expectancy of > 3 months. 


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10. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 
< 3. 
11. Patients must meet the following laboratory criteria at screening: 
• Absolute neutrophil count (ANC) ≥ 1.0 × 109/L 
• Platelet count ≥ 75 × 109/L without previous transfusion within 10 days of first study 
drug administration 
• Hemoglobin ≥ 8.0 g/dL (may have been transfused) 
• Serum creatinine < 2.0 x upper limit of normal (ULN) 
• Total bilirubin ≤ 2.0 × ULN 
• Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN 
12. If a female of childbearing potential, a negative pregnancy test must be confirmed before 
enrolment and use of double-barrier contraception, oral contraceptive plus barrier 
contraceptive must be used during the study and for 3 months after the last dose, or 
confirmation of having undergone clinically documented total hysterectomy and/or 
oophorectomy, tubal ligation. 
13. If a male, an effective barrier method of contraception must be used during the study and 
for 3 months after the last dose if the patient is sexually active with a female of childbearing 
potential. 
14. The patients are able to comply with all study-related procedures, medication use, and 
evaluations. 
15. The patients are able to understand and give written informed consent and comply with the 
study protocol. 
3.3 Method of Treatment Assignment and Randomization 
This is a single arm study.  
3.4 Treatment Masking (Blinding)  
This is an open-label study.  
4. ANALYSIS AND REPORTING 
Interim analyses for futility per NHL subtype are the responsibility of the sponsor;


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will not be involved in formal interim analyses (please refer to Section 5 
for further details). Decisions made at interim analysis will be described in the CSR. 
4.1 Final Analysis 
The analyses identified in the protocol and in this SAP will be performed after a database cutoff 
foreseen in July 2015. At that time, all patients will have completed the main treatment period 
(that is, up to 3 cycles of MOR00208 therapy), though some patients will still be receiving 
maintenance treatment and few other patients may be in the follow-up phase (for survival only, 
without maintenance treatment). 
Based on the present SAP, analyses at a later point in time may be conducted, e.g., for 
regulatory interactions, following database lock. 
Further analyses will be done after the last patient has completed the end of study visit, all data 
have been processed and the database has been locked. Those analyses will be used to prepare 
an addendum to the CSR. In addition, no database may be locked or analyses completed until 
this SAP has been approved and signed off by all responsible parties. 
All study results will be made available to MorphoSys AG following database lock and prior to 
completion of the final CSR. 
MorphoSys will perform further exploratory analyses to investigate correlations between 
different biomarker and response variables. 
Any post-hoc, exploratory analyses completed to support planned study analyses, which were 
not identified in this SAP, will be documented and reported in appendices to the CSR, but will 
not necessitate an update of the final SAP. Any results from these unplanned analyses (post-
hoc) will also be clearly identified in the text of the CSR. 
4.2 Final Pharmacokinetic Analysis 
The final PK analysis will be performed on data from the clinical database combined with the 
concentration data from the bioanalytical lab after the database has been locked.  
PK Input Files will be created using SAS® software (version 9.3 or later) from the serum 
concentrations reported by the bioanalytical lab combined with the dosing and sampling 
information from the clinical database after the database has been locked. Actual elapsed time 
from dose to sampling time will be used for all parameter estimation but mean concentration 
data will be presented in tables and figures using scheduled sampling times. Any concentration 
values outside acceptable time windows will be excluded from those summary statistics (see 


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section 10.3.2 for details). For patients receiving maintenance treatment after cycle 3, the FU1, 
FU2 and FU3 visits will be excluded from PK summary statistics, since the concentrations of 
MOR00208 at the FU1, FU2 and FU3 visits may be influenced by additional MOR00208 doses 
in maintenance treatment. 
The PK analysis will be conducted using the Phoenix WinNonlin® version 6.3 or later software 
from Pharsight, Cary, North Carolina. The PK tables, listings, and figures will also be produced 
in SAS. Any PK tables that involve inference testing will be performed by statisticians using 
SAS software. 
The AUC0-last will be produced from the first dose including samples up to the 24-hour post-
infusion sample drawn just before the 2nd infusion. The last dose will provide as many as 4 
samples starting at the sample drawn at Cycle 3 Day 28 and including the 3 follow-up visit 
samples. These samples from the last dose will be used to estimate the terminal elimination rate 
and its associated half-life.  
5. SAMPLE SIZE DETERMINATION 
A two-stage design is used to minimize exposure of NHL subtypes not showing responsiveness 
to MOR00208. No formal sample size estimations for determination of futility were computed 
for Stage 1. The number of patients to be used in this stage was determined to be the minimum 
number needed to adequately determine futility in any specific NHL subtype. The entire study 
will enroll between 40 to 120 patients, dependent upon patient response in each subtype in 
Stage 1. 
Stage 1: Approximately 40 patients, an equal number of patients will be enrolled per NHL 
subtype: 
• FL: 10 patients 
• DLBCL: 10 patients 
• MCL: 10 patients 
• other indolent NHL: 10 patients 
Observing less than two responses (at least PR) in 10 patients in any NHL subtype will be the 
criterion for discontinuing evaluation of MOR00208 in that NHL subtype. If the study drug is 
effective with a true ORR of 30%, the probability to stop for futility after the first stage for a 
specific NHL subtype is only 14.9%. 
Stage 2: For those NHL subtypes with two or more responders, an additional 20 patients will be 


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enrolled for a total of 30 patients per subtype. Assuming that the true ORR of any NHL type is 
30% and that the number of responses actually observed in the study corresponds to the 
expected number of responses (9 responses), N=30 would yield a lower limit of the 95% 
confidence interval for the ORR of 14.7%. Up to a maximum of 80 additional patients, an equal 
number of patients will be enrolled per “responding” NHL subtype. Some of the cohorts may 
have been stopped for futility after Stage 1: 
• FL: 20 patients 
• DLBCL: 20 patients 
• MCL: 20 patients 
• other indolent NHL: 20 patients 
Approximately 25 to 30 centres in the United States of America and Europe are planned. 
6. ANALYSIS POPULATIONS 
The following analysis populations will be defined: 
• Intent-to-treat (ITT) Population: Consists of all patients who received at least one dose of 
study drug. Patients without any post baseline assessment of NHL response will be included 
as non responders. 
• Safety Population: Consists of all patients who received at least one dose of study drug.  
• Pharmacokinetic (PK) Population: The Pharmacokinetic Population will include all patients 
who have at least one quantifiable serum MOR00208 concentration. (PK parameters will be 
calculated as data permit.) 
Please note that the definition of the PK population differs slightly from that in the protocol: 
see section 12. 
7. GENERAL ISSUES FOR STATISTICAL ANALYSIS 
7.1 General Statistical Methodology 
Tables for disposition of patients and study discontinuations (see Section 8.1) will be produced 
for all patients enrolled. The Safety Population will be used for safety analysis and to analyze 
immunogenicity. The ITT Population will be used to analyze pharmacodynamic endpoints. 
Summaries for the analysis of response by investigator and radiology central reader will be 
provided for the ITT Population. Pharmacokinetic summaries will be presented for the 


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Pharmacokinetic Population. 
If not specified otherwise, all statistical summaries will be presented by NHL subtype, for the 
combined subtype of FL and other indolent NHL, and overall. 
Tabulations of summary statistics, graphical presentations, and statistical analyses will be 
performed using SAS software, Version 9.3 or later. 
Continuous, quantitative variable summaries will include the number of patients (N) (with non-
missing values), mean, standard deviation, median, minimum and maximum. Some of the 
descriptive summaries (as specified in the subsequent sections) will additionally include the 
95%-confidence interval for the mean (absolute) change from baseline. The confidence interval 
will be calculated based on the quantiles of the t-distribution assuming normal distribution of 
the data. Moreover, some of the descriptive summaries (as specified in subsequent chapters) 
will include the 95%-confidence interval for the median (absolute or percentage) change from 
baseline. The 95%-confidence interval for the median will be calculated without any 
assumption on the distribution of the data (nonparametric confidence interval). For this 
calculation the SAS option CIQUANTDF in proc UNIVARIATE may be used. 
Categorical, qualitative variable summaries will include the frequency and percentage of 
patients who are in the particular category. 
For time durations in days that need to be converted to months, the number of days will be 
divided by factor 30.4375. For time durations in days that need to be converted to years, the 
number of days will be divided by factor 365.25. 
Unless otherwise specified, Baseline is the last observation before the start of the study 
treatment, which is expected to be the Baseline Visit on Day 1, or Screening or any other 
unscheduled visits before the start of the study drug administration, if Baseline, Day 1 data are 
not available. For data such as CD16 expression on NK cells which is only recorded at 
Screening the Screening value will be the Baseline value, if the Screening value is missing then 
the baseline value will also be missing.  
All data obtained on the eCRF and entered into the database will be provided in separate data 
listings showing individual patient values. The planning and reporting of statistical analyses 
will be carried out as described in the 
SOPs. 
Any patient who withdraws from the study will be analyzed with the data available. Imputation 
of missing values will not be performed, unless specified in the relevant sections of the SAP. 


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7.2 Handling of Missing Data for PK Analysis 
Missing data can be from patients who drop out and do not complete the study or from serum 
concentration data that are not reported by the bioanalytical lab due to technical issues. 
Handling of both of these situations is described in this section.   
Any patient who withdraws from the study will be evaluated for inclusion in the PK analysis 
based on the PK data available. 
A distinction is made between a missing serum concentration due to failure to deliver the 
sample to the bioanalytical lab for assay, a serum concentration that was not reported by the 
bioanalytical lab due to a failure of the assay or handling, and a matrix concentration that is 
reported as being below limit of quantifiable (BLQ) of the assay. Samples that are reported 
with measurable concentrations are included in the PK analysis. Samples that are reported as 
BLQ are either assigned zero or missing depending on their location in the profile (process 
explained in Section 10.3.2) as this affects the calculation of AUCs. Samples that are either not 
reported or reported as missing will be reported as missing in the analysis. 
7.3 Derived and Computed Variables 
The following derived and computed variables for immunogenicity, efficacy and exposure data 
have been initially identified as important for the statistical analysis.  Additional variables may 
be required. The SAP will not be amended for additional variables that are not related to the 
primary or secondary endpoints. Any additional derived or computed variables will be 
identified and documented in the SAS programs that create the analysis files. If the SAP is not 
amended, further derivations related to primary and secondary target variables will be 
described in the CSR.  
7.3.1 Previous NHL therapy variables 
Previous NHL therapies will be reviewed and assessed by a
medical monitor. 
The review will be conducted in line with the 
SOP-MA-11  on data from the eCRF 
module ‘Previous NHL therapies’ once prior to the analysis. Clarifications on the data may be 
addressed by the
medical monitor to the sites directly using the Remote Data Capture 
portal of the database or via the responsible CRA/CM. The recorded NHL therapies will be 
grouped into lines of therapies taking into account all therapeutic procedures recorded 
(pharmacological treatment, surgery and radiotherapy), the chemotherapy regimens, response 
data and feedback to clarifications by the sites. Induction, consolidation, stem cell collection, 
preparative regimen including transplantation, and maintenance will be considered a single line 


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of therapy. In addition systemic therapies [systemic pharmacology therapy, systemic 
radiotherapy (RT), radio-immunotherapy (RIT), and stem cell transplantation (SCT),)] will be 
identified indicating the type of therapy (chemo, immuno, immune-chemo, SCT, RIT, systemic 
RT). Furthermore rituximab containing regimens will be identified and grouped into subgroups 
(single agent, R-CHOP or R-CHOP-like and other). The outcome of the review will be 
recorded in a table indicating the lines of therapy, the systemic therapies, the types of therapy 
and the rituximab-containing regimens) and will be reviewed by a second medic. Adjudication 
of cases with discrepant assessments will be performed by discussing the case with both medics 
involved. If the assessments remain discrepant the final decision about the case lies with the 
sponsor. The data and outcome of the review and related correspondence will be documented 
and filed in the TMF. 
The following variables will be derived from this assessment: 
• Number of prior lines of therapy  (as continuous variable and as number of patients with 
1, 2, 3, or > 3 prior lines) 
• Number and type of prior systemic therapies  (as continuous variable and as number of 
patients with 1, 2, 3, or > 3 prior therapies) 
• Number (%) of patients with prior rituximab containing regimens, in total and broken 
down as: 
o single agent rituximab 
o R-CHOP or R-CHOP-like (R-CHOP, R-CHOEP, R-CVP, R-GEMOx, R-THP-
COP)  
o Other (purine analog + rituximab, R-bendamustine, R-HyperCVAD, R -ICE, R-
DHAP, R-EPOCH, R-COMP, etc.) 
• Number (%) of patients with previous therapies by type (surgery, local radiation 
therapy, chemotherapy, immunotherapy,  immune-chemotherapy, systemic radiation 
therapy,  stem cell transplantation, or any other previous therapy) 
• Previous NHL Therapies will be coded using the current version of the WHO Drug 
Dictionary Enhanced (WHO-DDE). Surgical and medical procedures will be coded 
using MedDRA. The following variables will be derived from the eCRF directly: 
• Response to last therapy before study inclusion, in categories CR, PR, SD, PD, and 
unknown 
• Response to last rituximab-containing therapy line (broken down into any rituxumab-
containing therapy, rituximab containing monotherapy, and rituximab-containing 


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combination treatments) before study inclusion, in categories CR, PR, SD, PD, and 
unknown 
• Classification of patients as rituximab refractory (no response or response lasting < 6 
months to a prior rituximab-containing therapy; patients will be considered refractory if 
they are refractory to any rituximab-containing regimen, even if they had responded to 
another rituximab-containing regimen)  
• Duration of response to last therapy, as a continuous variable (in months) and as 
number and % (and cumulative number and %) of patients with responses of < 6 
months, 6–12 months, > 12 months, and unknown duration  (if the end date of the 
duration of response to last therapy is not specifically recorded, it will be assumed to be 
the date of screening for the present study) 
7.3.2 Prognostic variables 
Prognostic indices will be calculated for DLBCL patients, MCL patients, and FL patients. No 
prognostic index will be calculated for other indolent NHL patients. Details of the prognostic 
indices used are given below. 
7.3.2.1 Prognostic variables for DLBCL patients 
The International Prognostic Index (IPI) [5] will be calculated for all DLBCL patients. This is 
calculated from the following items: 
• Age older than 60  
• Lactate dehydrogenase level higher than normal  
• ECOG performance status score of 2 or greater 
• Stage III or IV disease  
• More than one involved extranodal disease site  
The IPI gives one point for each of the above characteristics, for a total score ranging from zero 
to five correlating with the following risk groups : 
• Low risk: 0–1 points 
• Low-intermediate risk: 2 points 
• High-intermediate risk: 3 points 
• High risk: 4–5 points 


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The categories above will also be collapsed into low risk (0–2 points) and high risk (3–5 
points). Subgroup analysis according to low risk and high risk IPI scores will be presented for 
DLBCL patients for the outcomes of overall response rate and PFS. 
7.3.2.2 Prognostic variables for MCL patients 
The MCL International Prognostic Index (MIPI) [6] will be calculated for all MCL patients. 
Points are scored for age, ECOG performance status, LDH, and leukocyte count, according to 
the table below, and the scores for each are added to give a total score. 
Points 
Age (years) 
ECOG PS 
LDH/ULN LDH 
WBC, 109/L 
0 
< 50 
0–1 
< 0.67 
< 6,700 
1 
50–69 
- 
0.67–0.99 
6,700–9,999 
2 
60–69 
2–4 
1.00–1.49 
10,000–14,999 
3 
≥ 70 
- 
≥ 1/5 
≥ 15,1000 
The sum of the allotted points correlates with the following risk groups: 
• Low risk: 0–3 points 
• Intermediate risk: 4–5 points 
• High risk: 6–11 points 
The categories above will also be collapsed into low risk (0–3 points) and high risk (> 3 
points). Subgroup analysis according to low risk and high risk MIPI scores will be presented 
for MCL patients for the outcomes of overall response rate, PFS, and OS. 
7.3.2.3 Prognostic variables for FL patients 
The Follicular Lymphoma International Prognostic Index (FLIPI ) [7] will be calculated for all 
FLIPI patients. This is calculated taking into account the following factors: 
• Age > 60 
• Serum LDH > ULN 
• Hgb < 12 g/dl 
• Stage III or IV 
• Number of nodal sites > 4 


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The presence of ≤1, 2, and ≥ 3 factors define low, intermediate, and high risk. 
The categories above will also be collapsed into low risk (0–2 points) and high risk (≥ 3 
points). Subgroup analysis according to low risk and high risk FLIPI scores will be presented 
for FL patients for the outcomes of overall response rate, PFS, and OS. 
7.3.3 Immunogenicity 
Patient has positive anti-MOR00208 antibodies (yes/no/missing) by visit: 
• yes, if a titer is available 
• no, if result is reported as negative 
• missing, if anti-MOR00208 measurement is not available 
Patient has developed positive anti-MOR00208 antibodies during study 
(yes/no/transient/not evaluable/missing):  
• yes, if the patient has at least one positive post-baseline sample containing positive anti-
MOR00208 antibodies including a positive result for the last sample analyzed; baseline 
sample has to be tested negative 
• no, if baseline as well as all post-baseline results are negative 
• transient, if the patient has at least one positive post-baseline sample containing positive 
anti-MOR00208 antibodies but a negative result for the last sample analyzed; baseline 
sample has to be tested negative 
• not evaluable, if the baseline sample of the respective patient was tested positive 
• missing, if no post-baseline anti-MOR00208 measurement is available 
7.3.4 Efficacy 
7.3.4.1 Investigator Assessment 
The Investigator will assess tumor response at specific study visits according to the criteria for 
NHL as defined in Section 17.4 of the study protocol. All of the criteria are based on the 
revised IWG response criteria [4].  
The categories of overall tumor response assessment of  the Investigator are as follows: 
• CR - Complete remission 
• PR - Partial remission 
• SD - Stable disease 


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• PD - Progressive disease 
• Missing (if response assessment is not done) 
In case of progressive disease, the date of progression is given by the Investigator. In case any 
anti-tumor treatments other than MOR00208 are given before end of study (see also section 
8.3), it is regarded as protocol non-compliance. Following a conservative approach, tumor 
assessments of the Investigator after start of other anti-tumor treatment which are non-PD will 
not be taken into account for any of the derived efficacy variables described below, whereas 
assessments of PD will still be taken into account. This ensures that a progression is still 
included in the analysis if an anti-tumor treatment has been started based on clinical 
progression, but the image confirming PD was done at a later time point. A response 
assessment provided by investigator after start of other than protocol indicated anti-tumor 
treatment will, however, not be counted for overall best response. 
Tumor Response categories (Investigator) will be evaluated in terms of absolute and 
percentage frequencies by visit. 
Overall best response (Investigator) will be defined as best response across the following 
time points: end of the second, end of third cycle, during a response assessment in the follow-
up period or at an unscheduled assessment after end of second cycle. 
Overall response rate (ORR) (Investigator) will be evaluated as the rate of patients who met 
the criteria of PR or CR at the end of either the second or third cycle or during a response 
assessment in the follow-up period (i.e. who have an overall best response of PR or CR). 
Overall rate of SD (disease control rate) (Investigator) will be evaluated as the rate of 
patients who met the criteria of PR, CR or SD at the end of either the second or third cycle or 
during a response assessment in the follow-up period (i.e. who have an overall best response of 
PR, CR or SD). 
Duration of response (Investigator): Duration of response will be defined as the time from 
date of first response (CR or PR) until first date that recurrence or progressive disease is 
objectively documented. The duration of response will be calculated in the subgroup of all 
patients showing any response; confirmation of response will not be required. Patients who 
showed a response but did not show PD or recurrence until end of study or before study 
discontinuation (i.e. patients who are at least stable at their last tumor assessment) are 
considered censored at the timepoint of last response assessment. Deaths due to causes other 
than progression of disease are to be reported as SAEs and are censored for duration of 


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response analysis at the date of last tumor assessment before death. The cause of death has to 
be recorded as free text by the Investigator on the eCRF study completion page. If the cause of 
death does not explicitly state whether death is related to progression of disease, a query will be 
raised to ask the investigator to classify the relationship to disease (yes/no). Morphosys Drug 
Safety will assess the causality of the SAE by reviewing the corresponding SAE documents.   
Time to response (Investigator): Time to response will be defined as the time from Cycle 1, 
Day 1 (first administration of study drug) until the date of first response (CR or PR). Patients 
who do not have a response to treatment will be censored at the date of their last tumor 
assessment. 
Time to progression (Investigator): Time to progression is defined as the time from Cycle 1, 
Day 1 (first administration of study drug) until date of first tumor progression (which is entered 
in the tumor assessment module). Patients who do not show any documented progression 
(which is entered in the response assessment module of the eCRF) before the end of study or 
before study discontinuation or before death are considered censored using the last date with a 
tumor assessment as censoring date (irrespective of when the patient died). Deaths due to 
causes other than disease progression are censored. 
Progression-free survival (Investigator): Progression-free survival is defined as the time from 
Cycle 1, Day 1 (first administration of study drug) until date of first tumor progression (which 
is entered in the response assessment module of the eCRF) or date of death from any cause. If 
the patient does not show any documented progression (which is entered in the tumor 
assessment module) before death, the date of progression will be the date of death if death 
occurs within 2 months after the last date with a tumor assessment. If death occurs after 2 
months after the last date with a tumor assessment or the patient did not progress or die until 
end of study or before withdrawal, the patient will be analyzed as censored using the last date 
with a tumor assessment as censoring date. 
7.3.4.2 Central Read 
Additionally a central radiology read of scans will be performed by SYNARC/BioClinica. The 
revised IWG criteria definitions [4] will also be applied. Details of the central read are 
described in the Independent Review Charter, Version 1.0, 01-JUL-2013, provided by 
SYNARC. 
The independent reviewers (two primary radiologists) will be presented with all time points 
sequentially in chronological order, and will provide assessments for each time point. For the 


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overall tumor assessment of the central read a slightly different terminology is used: 
• CR - Complete response 
• PR - Partial response 
• SD - Stable disease 
• PD - Relapsed or progressive disease 
• NE - Non-Evaluable (can be applied if repeated measurements cannot be applied for 
reasons such as inadequate or missing imaging and when progression/relapse cannot be 
assigned for the visit overall response)  
• ND - No Disease (this category is used if there is no tumor and there was no tumor at 
baseline) 
Once the independent reviews for all time points in the course of the study have taken place, all 
time points for a particular patient will be again reviewed together by the two independent 
reviewers in a global patient review over all time points. In their global patient review the two 
independent reviewers will determine: 
• best overall response (defined as best response the subject had since treatment started 
taking into account scheduled and unscheduled visits) 
• date of the best overall response 
• duration of best overall response (calculated by the system as time from first response to 
progression if patient is PD at a specific visit) 
• date when progression/relapse occurred 
Finally, an adjudicator radiologist will perform adjudication, in case there is any discrepancy in 
the global patient review of the two primary radiologists. The adjudicator will review both 
initial readings and will record a new review that will agree with either of the duplicate 
reviews. Thus, the adjudicator will need to agree to the complete reading of one of the primary 
radiologists (all assessments by visit and all variables from corresponding global review). A 
mandatory comment will need to be recorded. The adjudicated reading results will be 
considered as the results for the involved patients.  
There may be rare cases where the two primary radiologists disagree in some of the overall 
assessments by visit, but agree in the global patient review. In these cases no adjudication will 
be performed. Thus for the overall assessment by time point, descriptive tables will be based on 


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the following results: 
• Assessment of the reader the adjudicator agrees with, in case adjudication was 
performed 
• Worst response assessment of the two primary radiologists at each visit in case no 
adjudication was performed 
All other variables described below are only based on the variables from global review which 
are adjudicated in case of discrepancies between the two primary radiologists. The term 
“central reviewer” used below refers to the adjudicator in case adjudication is performed or to 
the primary radiologists (in case global patient review of the two primary radiologists are 
identical and no adjudication is necessary). 
In case any anti-tumor treatments other than MOR00208 are given before end of study (see also 
section 8.3), it is regarded as protocol non-compliance. Following a conservative approach for 
statistical analysis, the following steps will be implemented by
biostatistics: 
tumor assessments of the two primary radiologists after start of other anti-tumor treatment 
which are non-PD will not be taken into account, whereas assessments of PD will still be taken 
into account. Moreover, if the date of best overall response as provided by the adjudicator is 
after start of anti-tumor treatment, the date will be set to missing and the best overall response 
to “not evaluable”. This ensures that a progress is still included in the analysis if an anti-tumor 
treatment has been started based on clinical progression, but the image confirming PD was 
done at a later time point. A response after start of anti-tumor treatment will, however, not be 
counted for best overall response. 
Tumor Response categories (Central Read) will be evaluated in terms of absolute and 
percentage frequencies by visit 
Best overall response (Central Read) will be directly provided by the central reviewer 
(SYNARC uses the terminology best overall response or best response).  
Overall response rate (ORR) (Central Read) will be evaluated as the rate of patients who 
have a best overall response of PR or CR. 
Overall rate of SD (disease control rate) (Central Read) will be evaluated as the rate of 
patients who have a best overall response of PR, CR or SD. 
Duration of best overall response (Central Read):  Duration of best overall response will be 
defined as the time from date of best overall response (as provided by the central reviewer) 
until first date that recurrent or progressive disease is objectively documented. The duration of 


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best overall response will be calculated in the subgroup of all patients showing any response; 
confirmation of response will not be required. Patients who showed a response but did not 
show PD or recurrence until end of study or before withdrawal (according to the central 
reviewer) are considered censored at the timepoint of last response assessment. Deaths without 
documented progression before death (according to the central reviewer) are also considered as 
censored at date of last response assessment. 
Time to response (Central Read): Time to response will be defined as the time from Cycle 1, 
Day 1 (first administration of study drug) until the date of best overall response (as provided by 
the central reviewer) if best overall response is PR or CR. Patients who do not have a response 
to treatment will be censored at the date of their last tumor assessment. 
Time to progression (Central Read): Time to progression is defined as the time from Cycle 1, 
Day 1 (first administration of study drug) until date of progression/relapse (as provided by the 
central reviewer). Patients who do not show any documented progression (according to the 
central reviewer) before the end of study or before withdrawal or before death are considered 
censored using the last date with a tumor assessment as censoring date (irrespectively of when 
the patient died).  
Progression-free survival (Central Read): Progression-free survival is defined as the time 
from Cycle 1, Day 1 (first administration of study drug) until date of progression/relapse (as 
provided by the central reviewer) or date of death from any cause (as given in the eCRF). If the 
patient does not show any documented progression before death (according to the central 
reviewer), the date of progression/death will be the date of death if death occurs within 2 
months after the last date with a tumor assessment. If death occurs after 2 months after the last 
date with a tumor assessment or the patient did not progress or die until end of study or before 
withdrawal, the patient will be analyzed as censored using the last date with a tumor assessment 
as censoring date. 
7.3.5  Exposure 
The following tables show the variables which will be calculated to measure exposure to 
MOR00208. Details regarding study drug administration are only captured from Cycle 1 to 
Cycle 3 in the eCRF. In the maintenance treatment phase, the only information which is 
captured in eCRF at the follow-up visits is whether the patient will continue to receive study 
drug. 


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Variables calculated for each study drug administration (Cycle 1 to Cycle 3) 
Percentage of actual volume administered vs. 
planned volume [%] 
Actual volume administered [mL]/250 mL*100% 
Actual dose administered per kg [mg/kg] 
(Actual volume administered [mL]/250 
mL)*Assigned dose [mg/kg]  
Actual dose administered [mg] 
(Actual volume administered [mL]/250 
mL)*Assigned dose [mg/kg]* Weight[kg] 
Note: The weight obtained at each visit before 
study drug administration should be used to 
calculate the study drug dose for the respective 
visit. 
Only in exceptional cases, e.g. due to logistical 
issues, the weight obtained at the previous visit 
can be used (provided that there is no obvious 
change of ± 10% compared with the previous 
visit).  
Variables calculated on a per-patient basis: 
All of the variables shown in the table below will summarize the exposure from cycle 1 to 
cycle 3, except the first variable “duration of exposure including maintenance treatment” which 
will include maintenance treatment. 


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Duration of exposure including maintenance 
treatment [weeks] 
Time from Cycle 1, Day 1 to date of last study 
treatment (approximated) [weeks] 
Note: This variable can only be approximated as 
the date of last study treatment is not captured in 
the eCRF: 
Date of last study treatment is approximated as 
follows:  
- 
If patient did not receive maintenance 
treatment at all, the date of last study 
treatment is the date of last study 
treatment entered to the study drug 
administration page 
- 
If patient received (or is planned to 
receive) maintenance treatment, the date 
of last study treatment will be 
approximated as the minimum of the two 
following: 
o Date of follow-up visit where the 
question “Will the subject continue 
to receive treatment?” is ticked as 
“NO” for the first time (on the 
response assessment eCRF page) 
o End of study date (from study 
completion page) 
Number of cycles with all infusions completed Number of cycles with all 4 infusions completed  
Total number of infusions administered  
Number of all infusions 
Total number of infusions administered in 
Cycle x  
Number of all infusions in Cycle x 
Total number of infusions with a duration 
> 2.5 h 
Number of infusions with (sum of all periods 
(stop time – start time)) > 150 minutes 


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Total number of infusions with a duration > 2 
h 
Number of infusions with (sum of all periods 
(stop time – start time)) > 120 minutes 
Total number of infusions with a duration of 2 
to 2.5 hours 
Number of infusions with (sum of all periods 
(stop time – start time)) >= 120 minutes,  but 
<=150 min 
Total number of infusions with a duration of 
< 2 hours 
Number of infusions with (sum of all periods 
(stop time – start time)) < 120 minutes 
Total number of infusions administered with 
any modification  
Number of all infusions with any treatment 
modification (infusion rate reduced, infusion rate 
increased, infusion interrupted and restarted, 
infusion stopped) 
Total volume administered [mL] 
Sum of the variable “Actual volume administered 
[mL]” over all infusions 
Average percentage of actual volume 
administered vs. planned volume [%] 
Mean of the variable “Percentage of actual 
volume administered vs. planned volume [%]” 
over all infusions  
Total actual dose administered per kg [mg/kg] 
Sum of the variable “Actual dose administered 
per kg [mg/kg]” over all infusions  
Total actual dose administered [mg] 
Sum of the variable “Actual dose administered 
[mg]” over all infusions  
Average actual dose administered per kg 
[mg/kg] 
Mean of the variable “Actual dose administered 
per kg [mg/kg]” over all infusions  
 
8. STUDY PATIENTS AND DEMOGRAPHICS 
8.1 
Disposition of Patients and Treatment Discontinuation 
The following will be summarized by study population (i.e., NHL subtype) for all patients who 
provided an informed consent for study participation: 


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• Number (%) of patients enrolled (defined as having completed the Informed Consent 
eCRF page) 
• Number (%) of patients screened 
• Number (%) of screen failures including the reasons for being screen failures 
• Number (%) of patients treated (as per IRT information) 
• Number (%) of patients who discontinued in Cycle 1 or Cycle 2 (considering all 
discontinuations during the Cycles including those at the end of Cycle 2, i.e., C2D28), 
including the reason for discontinuation 
• Number of patients who discontinued before completing Cycle 2 including the reason 
for discontinuation 
• Number of patients completing Cycle 2 
• Number of patients completing the first 2 Cycles without proceeding to Cycle 3 (i.e., 
PD or SD at the end of Cycle 2), including the reason for discontinuation 
• Number of patients who completed Cycle 2 and entered Cycle 3 (i.e., patients who 
reached PR, or CR by the end of Cycle 2) 
• Number of patients who discontinued in Cycle 3 (considering all discontinuations that 
happened in Cycle 3 including those at the end of Cycle 3, i.e., C3D28), including the 
reason for discontinuation 
• Number of patients who discontinued in Cycle 1 or 2 or 3 (considering all 
discontinuations that happened during Cycle 1, 2, 3 including those at the end of Cycle 
3, i.e., C3D28), including the reason for discontinuation 
• Number of patients who entered the maintenance treatment phase (i.e., treatment after 
Cycle 3) 
• Number of patients who discontinued during the maintenance treatment phase including 
the reason for discontinuation 
•  
• Number of patients still on treatment (i.e., ongoing at data cut-off; the information will 
be derived from entries in the IRT system) 
• Number (%) of patients screened, and number (%) of screen failures including the 
reason for screen failure. 


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• Number (%) of patients screened, and number (%) of screen failures by center.  
These summaries will be presented for the population of screened patients. The disposition 
summary will additionally be presented for all patients enrolled, including screening failures.  
A listing will be provided indicating in which study stage of the trial individual patients were 
recruited (the listing will be generated based on information in the IRT system). 
 
8.2 Protocol Violations and Deviations  
Protocol violations and deviations will be defined in the document “Handling of Protocol Non-
Compliances”, current version. Protocol non-compliances (PNCs) will be categorized into 
minor, major or critical. The final decision on a PNC category will be taken based on data 
listings during data review meetings. Critical and major PNCs will be listed in the CSR and 
further grouped:  
• PNCs related to subjects not satisfying the study entry criteria 
• PNCs related to subjects who developed treatment discontinuation criteria during the 
study but were not withdrawn 
• PNCs related to subjects receiving the wrong treatment or incorrect dose 
• PNCs related to subjects receiving an excluded concomitant treatment 
• Other critical or major PNCs 
8.3 
Demographics and Other Baseline Characteristics 
Descriptive summaries of the demographic and other baseline characteristics will be completed 
for the populations specified above. 
Descriptive summaries of demographic and other baseline conditions will include: 
• Demographics (age [both as continuous variable and as number of patients aged < 65 
and aged ≥ 65], gender, race, height, weight at screening, body mass index [BMI]) 
• History of NHL (time since first diagnosis [months], NHL subtype, current staging) 
• Medical history 
• Previous NHL therapies (see section 7.3.1) 
• Scores and categories on prognostic indices (see section 7.3.2) 
• ECOG performance status at screening 


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• CD16 expression on NK cells 
• Cytogenetics (tumor biopsy) 
• DNA analysis of FcγR polymorphism (Mucosal cheek swab)  
• Previous and concomitant medication  
Medical History: Medical history will be coded with Medical Dictionary for Regulatory 
Activities (MedDRA Version 20.1). Incidences of findings in medical history will be 
summarized by system organ class (SOC) and preferred term 
Time since first diagnosis of NHL [months]: Time since first diagnosis will be measured from 
date of first diagnosis until Screening Visit. If date of diagnosis is incomplete, time since first 
diagnosis [months] will be calculated based on the latest possible date for date of diagnosis: 
• If the day is missing but the month is complete for date of diagnosis, the date will be 
imputed using day 15 of the month (or the date of screening visit in case this is earlier) 
• If the day and month are missing but the year is complete for date of diagnosis, the date 
will be imputed using June 30 of the year DNA analysis of FcγR polymorphism 
(mucosal cheek swab): The frequency of each genotype will be summarized 
descriptively in a frequency table. 
Prior and Concomitant medication/ therapies: All medications (prior and concomitant) and all 
concomitant non-drug therapies will be listed. Any prior, concomitant, or procedural 
medications or therapy given to or taken by the patient within 1 month before the study and up 
to the first follow-up visit must be recorded in the source document and the eCRF along with 
the indication and dosage.  
Medications will be presented as prior and concomitant medications. 
All medications will be coded using the WHO Drug Dictionary (March 2018). Incidences of 
prior and concomitant  medications will be summarized by ATC level 2 and ATC level 4.  
If the start date of medication is before the start date of study treatment the medication will be 
classified as prior medication.  
Medications applied after start of study treatment will be considered as concomitant 
medication. Medications started before start of study treatment but are ongoing or have a stop 
date after the start of study treatment will be considered twice, as prior and as concomitant 
medications. If the start/stop dates of medication are partially or completely missing a 
medication will be assumed to be concomitant if it cannot be definitely shown that the 
medication was not administered during the treatment or follow-up period. Missing dates will 


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not be replaced.  
Thus, the following approach will be taken for exclusion from concomitant medication because 
of discontinuation before start of treatment: 
• If stop day is missing but month is complete, medication will only be excluded from 
concomitant medication if stop month is before month of treatment start. 
• If stop day and month are missing but year is complete, medication will only be 
excluded from concomitant medication if stop year is before year of treatment start. 
• If stop date is completely missing, medication will not be excluded 
Additionally, concomitant medication will be split into the following two subcategories: (1) 
concomitant medication started before start of study treatment (and continued after start of 
study treatment) and (2) concomitant medication started after start of study treatment. 
Summary tables of concomitant medication will also be prepared within these two 
subcategories. 
Anti-cancer Treatments: Starting from the first follow-up visit, only anti-cancer treatments and, 
in case of an AE, other relevant concomitant medications (according to the discretion of the 
investigator) should be entered to the concomitant medication eCRF module. If a patient 
receives anti-cancer treatment other than MOR00208, it is regarded as protocol non-
compliance. Introduction of new anti-cancer treatment should result in exclusion of the patient 
from further study participation. 
A medical review of the concomitant medication will be performed by
Medical Monitor and approved by MorphoSys Clinical Program Leader before the statistical 
analysis to identify anti-cancer treatments not allowed during study. All anti-cancer treatments 
not allowed during study will be included in the protocol violation/deviation listing and table. 
The effect of anti-cancer treatments on the efficacy endpoints is described in section 7.3.4. 
Previous NHL Therapies: 
Information should be provided separately on any previous NHL-specific therapies since the 
time point of the first diagnosis of NHL. The generic or the trade name or chemo–regimen 
acronym may be recorded. The previous NHL therapies will be reviewed and assessed for 
previous lines of therapy, number of systemic therapies, type of previous therapy and 
rituximab-containing regiments (see section 7.3.1). 


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9. EFFICACY ANALYSES 
All efficacy analyses will be provided for the ITT Population. All efficacy analysis will be done 
using both the central radiology and local (i.e., investigator) assessment. Kaplan-Meier plots 
will be generated for all time-to-event analyses (i.e., for the Time to Progression, Progression-
Free Survival, Duration of Response). 
9.1 Primary Efficacy Analysis 
The primary efficacy endpoint will be ORR as determined by the Investigator by using revised 
IWG response criteria for malignant lymphoma [4]. The final ORR for each subtype will be the 
rate of patients who met the ORR definition at the end of either the second or third cycle or 
during the follow up period (best response) (i.e the ORR will be derived from the variable 
“overall best response”). The denominator for calculating the rate will be based upon the total 
number of patients in the ITT population, thus patients without any post baseline assessment of 
NHL response will be included as non-responders. Overall ORR, independent of NHL subtype, 
will also be summarized. Exact (Clopper-Pearson) 95% CIs for ORR for each subtype and over 
all subtypes will be presented. 
In addition, the tumor response categories will be evaluated by visit. The corresponding 
number of patients in each of the response categories will be summarized in a frequency table 
by visit. In this summary all patients who had discontinued will be analyzed as missing for all 
visits after study discontinuation, also accounting for all patients in the ITT population in the 
denominator. 
ORR will be also calculated and respective results provided based on the central review 
assessment (based on the variable “best overall response”).  
Sensitivity analysis: 
The ORR will be calculated only considering patients who had at least on post-baseline 
response assessment. The analysis will be done using the local (investigator) assessment, and 
also based on the central review assessment. 
Concordance rate: 
The concordance rate in terms of response assessment represents the agreement in the best 
overall response between the central read and investigator assessment. The concordance rate is 
the number of patients that are concordant over the total number of patients assessed, and will 
be calculated across all response categories. A confusion matrix will be generated. The 


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concordance rate is calculated by adding the diagonal counts and dividing by the total number 
of patients assessed. Moreover, the agreement (%) of the investigator assessment with the 
central read in terms of best ORR will be calculated (i.e., the total number of patients with a 
best response of CR or PR by central review divided with the total number of patients with a 
best response of CR or PR by investigator assessment multiplied by 100). 
Patients without any post-baseline response assessment will be considered as not evaluable 
(NE) in both the central read and investigator assessment. Patients who have been evaluated by 
investigator assessment, but not by central review assessment will be excluded from the 
concordance analysis. 
The proportion (%) of patients who had at least one central review among the total number of 
patients who underwent at least one investigator assessment will be calculated. Moreover, the 
proportion (%) of the total number of central reviews among the total number of investigator 
assessments will be derived (i.e., the total number of central reviews across all visits and all 
patients divided with the total number of investigator response assessments across all visits and 
all patients multiplied by 100). The analysis will be conducted using the ITT population. 
9.2 Secondary Efficacy Analysis 
All secondary efficacy analyses will be provided twice, based on the response assessment of 
the Investigator and based on the central review assessment. 
The analysis of ORR as described in section 9.1 will be additionally be stratified by FcγRIIIa 
and FcγRIIa polymorphism. 
FcγR subgroups will comprise the heterozygous population and each different homozygous 
population, as well as the combined heterozygous plus low affinity homozygous FcγR 
populations. Subgroups with fewer than five patients will not be analysed. 
These stratifications will be done for the overall analysis population as well as by NHL 
subtype.  
The overall stable disease rate will be analyzed analogously to the overall response rate as 
described in Sect. 9.1. 
Time to progression and progression-free survival will be analyzed using Kaplan-Meier 
methods. Kaplan-Meier tables for progression-free survival and time to progression will 
contain number of patients, number of patients with an event (non-censored patients), 
percentage of patients with an event, median time [months], 25% and 75% quantile and 95%-


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confidence intervals for median (Brookmeyer and Crowley, 1982). 
Moreover, the percentage of patients having an event until 2, 4, 6, and 12 months together with 
the corresponding 95%-confidence intervals will be retrieved. 
In the main analysis of PFS, only patients with radiologically confirmed progression or death 
within 2 months of the last radiological assessment will be counted as having had a PFS event. 
A sensitivity analysis will also be done in which patients who were withdrawn from the study 
because of disease progression will be included as having a PFS event, even in the absence of 
radiological confirmation of disease progression. 
Duration of response and time to response (Investigator) and duration of best overall response 
and time to response (Central Read) will also be analyzed using Kaplan-Meier estimates for 
median, 25% and 75% quantile. The analysis of duration of response will be restricted to the 
subgroup of responders. Moreover, the percentage of patients having an event after 2, 4, 6, and 
12 months together with the corresponding 95%-confidence intervals will be retrieved from the 
Kaplan Meier curve. 
The analysis of duration of response and time to response will be presented for all responders 
overall.  
Kaplan-Meier plots for time to progression, progression-free survival, time to response, and 
duration of response will be provided. 
Data on tumour lesion size will be presented with descriptive statistics and individual data 
listings. This will include the area of indicator lesions at baseline, the area of indicator lesions 
at nadir, and the difference between those two areas. The data on lesion size will be presented 
separately for the two central reviewers. The area of indicator lesions will be examined as 
follows: 
1. Analysis across all points in time: 
• Absolute values and both absolute and relative changes (from baseline) will be summarized 
for each visit: 
o Separated by NHL subtype 
o For the group of FL patients + other indolent lymphoma patients 
• A graph showing the individual relative changes over time will be generated separately for 
all NHL subtypes and for both central readers. The best overall response of each individual 
will be indicated by colour coding. 
2. Analysis comparing baseline and nadir: 


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• The area of indicator lesions will be reported at baseline and at nadir. The absolute value 
and both the absolute and relative difference between baseline and nadir will be reported 
(separated by NHL subtype, i.e., DLBCL, FL, MCL, other indolent NHL, and for the group 
comprising FL patients + other indolent lymphoma patients). 
• A “waterfall plot” indicating the best change (%) for indicator lesions will be generated 
separately for both central readers. Shading of the bars will indicate the NHL subtype. The 
plot will be produced in the following two versions: 
o Comprising all NHL subtypes (i.e., DLBCL, MCL, FL, and other indolent NHL) 
o Comprising only DLBCL, FL, and other indolent NHL 
 
A listing of total time on study (time from first dose of MOR208 to date of last tumour 
assessment), composed of time to response and duration of response, will be provided. In 
addition, time on study will be tabulated as a continuous variable. No censoring will be applied 
to total time on study. 
All analyses will be provided by NHL subtype, the combined groups of FL and other indolent 
NHL, and overall, if not specified otherwise. 
9.3 Subgroup analyses 
Both ORR and PFS will be evaluated for the following subgroups: 
• ORR and PFS will be presented in subgroups defined by prognostic index scores, 
dichotomised as high risk and low risk as described in section 7.3.2. 
• ORR and PFS will be presented by FcγR subgroups as described above. 
• ORR and PFS will also be presented by duration of response (≤ 12 months or > 12 
months) to previous treatment. 
• ORR and PFS will also be presented by the number of prior therapy lines (as 1, 2, 3, or 
> 3). 
• ORR and PFS will be presented for the category of patients with Follicular lymphoma 
(FL) or other indolent lymphoma (as one group). 
In addition, PFS only will be presented in further subgroups as follows: 
• Baseline ECOG status (0–1 vs. 2 or more) 
• Age group (<65 vs. ≥65) 
• Number of prior therapy lines (as 1, 2, 3, vs >3)  


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• Baseline NK cells number (<100 NK cells/µl vs  ≥  100 NK cells/µl) 
• Baseline NK cells number (<100 NK cells/µl vs. ≥ 100 NK cells/µl): pooled analysis 
across all NHL subtypes (i.e., DLBCL, FL, MCL, other indolent NHL) 
• Baseline NK cells number (<100 NK cells/µl vs. ≥  100 NK cells/µl) split by DLBCL 
and FL+iNHL patients (FL+iNHL patients represent one group). Thus, MCL patients 
will be excluded from the analysis. 
• Baseline CD16 expression (< 60,000 ABCs/NK cell) vs. ≥  60,000 ABCs/NK cell) 
• Baseline CD16 expression (< 60,000 ABCs/NK cell) vs. ≥  60,000 ABCs/NK cell): 
pooled analysis across all NHL subtypes (i.e., DLBCL, FL, MCL, other indolent NHL) 
• Baseline CD16 expression (< 60,000 ABCs/NK cell) vs. ≥  60,000 ABCs/NK cell): split 
by DLBCL and FL+iNHL patients (FL+iNHL patients represent one group). Thus, 
MCL patients will be excluded from the analysis. 
• Rituximab refractoriness (Rituximab-refractory vs. not Rituximab-refractory; see 
definition below) 
• Rituximab refractoriness (Rituximab-refractory vs. not Rituximab-refractory; see 
definition below): pooled analysis across all NHL subtypes (i.e., DLBCL, FL, MCL, 
other indolent NHL) 
• Rituximab refractoriness (Rituximab-refractory vs. not Rituximab-refractory; see 
definition below): pooled analysis across all NHL subtypes excluding MCL (i.e., 
DLBCL, FL, other indolent NHL) 
Rituximab refractoriness is defined as follows: no response (i.e., CR or PR) at all, or relapse 
within 6 months after completion of any rituximab-containing treatment regimen.  
For the PFS subgroup analyses an estimate of the hazard ratio and a corresponding 95% 
confidence interval will be calculated using a Cox proportional hazards model with only one 
covariate in the model. 
9.4 Other Efficacy Analyses 
The ECOG performance status will be summarized categorically in a frequency table by visit. 
10. PHARMCOKINETIC AND PHARMACODYNAMIC ANALYSIS  
10.1 Pharmacodynamic Parameters Measured in Blood 
Actual values and absolute and percent changes from baseline will be summarized descriptively 
by visit for the pharmacodynamic parameters B, T, and NK cell populations. Moreover, 95% 


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confidence intervals will be provided for mean and median changes in summaries of absolute 
changes from baseline and for median changes in summaries of percentage changes from 
baseline. 
10.2 Pharmacodynamic Parameters Measured in Bone Marrow and Biopsy 
At the Screening visit (Baseline), a bone marrow aspirate should be obtained. Results from 
bone marrow examination done within 4 weeks before screening are acceptable if the patient’s 
disease has been stable since then. In this case only available data will be used and bone 
marrow examinations at screening for which this data are not available will not be repeated 
(e.g. for the sole purpose of CD19 expression). 
Repeat of marrow aspirates and biopsies should be obtained at Day 28 of Cycle 2. Histological 
examination should be performed and the infiltration by malignant B-cells should be evaluated. 
Starting end of Cycle 3 and in the course of the follow up bone marrow examinations should 
only be repeated if response at last bone marrow examination was not CR. 
On screening, CD19 expression of tumor cells in bone marrow will be determined by a central 
laboratory. In case CD19 expression on tumor cells can be measured in less than 15% of ITT 
patients the statistical analyses by baseline CD19 expression (as planned in the protocol) will 
not be performed. Data on baseline CD19 expression will only be listed. Other results from 
bone marrow aspiration and biopsy will not be available for statistical analysis.  
10.3 Pharmacokinetic Analysis 
10.3.1 Bioanalytical Assay of Pharmacokinetic Serum Samples. 
MOR00208 concentration values (ng/mL) for each serum sample are to be processed using a 
validated Ligand Binding Assay. A separate bioanalytical phase plan and report will be 
generated that provide details on samples handling and processing, methods used for sample 
analysis, statements on quality control/quality assurance (QC/QA) and results of each 
individual sample analyzed for each patient by the bioanalytical labs. 
All pharmacokinetic sample assessments will be performed at Eurofins ADME Bioanalyses, 
Vergèze, France. 
10.3.2 Concentration Data 
Pharmacokinetic concentration data will be listed as received from the bioanalytical laboratory 
and as used to estimate the PK parameters. The PK concentrations will be summarized based 


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on nominal (scheduled) sampling times. Concentration figures (linear and log y-axis) for each 
patient will be presented, as well as mean concentrations.  
Any concentrations outside allowable windows will be excluded from summary statistics. 
Allowable windows are: 
 ±15 min for the samples at the end of infusion and 1h after the end of infusion, ± 30 min for 
the sample 4h after the end of infusion, and ±2 h for the sample 24 h after the end of infusion. 
In addition, concentrations will be considered outside allowable windows if infusions after the 
first infusion took place outside a ±1 day window within a 28 day cycle. 
Furthermore, PK samples which were analyzed outside the formally validated long-term 
stability will be flagged and excluded from summary statistics. 
For pharmacokinetic parameter estimation, analyte concentrations that are below the limit of 
quantification (BLQ) will be assigned a value of zero when they precede the first quantifiable 
sample. The WinNonlin program automatically does this for the predose sample as it disregards 
any concentrations reported before the first administration of study drug.  
All other BLQ samples will be treated as missing data. 
When 2 or more BLQ sample values occur consecutively, all remaining concentration values 
will be set to missing. 
No linear interpolation for these missing concentration values will be completed. 
10.3.3 Pharmacokinetic Parameters estimated 
Individual PK parameters will be estimated for each patient in the PK population as data 
permits. Pharmacokinetic parameter estimates will be completed using WinNonlin (Pharsight 
Corporation). Descriptive summaries (mean, SD, %CV, median, minimum, and maximum) of 
concentrations at each scheduled time-point and the determined or calculated PK parameters 
will be presented. For patients receiving maintenance treatment after cycle 3, the FU1, FU2 and 
FU3 visits will be excluded from PK summary statistics, since the concentrations of 
MOR00208 at the FU1, FU2 and FU3 visits may be influenced by additional MOR00208 doses 
in maintenance treatment. The categorical variable tmax will only report median, minimum and 
maximum.  
The following PK parameters have been initially identified as important for the analysis of PK. 
Additional PK parameters may be required. The SAP will not be amended for additional PK 


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parameters unless the PK analysis is significantly altered. If the SAP is not amended, any 
additional PK parameters will be described in the CSR.  
The following PK parameters are to be computed for each patient as data permit on samples 
obtained. 
Parameter Units 
Description and Calculation Method 
Parameters Estimated from the First Dose 
Cpd 
µg/mL 
Predose serum concentration observed 
Cmax 
µg/mL 
Maximum serum concentration observed 
Clast 
µg/mL 
Last quantifiable concentration from the First Dose  
tmax 
hr 
Time to maximum serum concentration observed 
AUC0-last 
hr×µg/mL 
Area under the concentration curve from dose time zero (0) to the time the 
last quantifiable concentration is observed.  
Parameters Estimated from the Last Dose 
Z 
1/hr 
Apparent terminal rate constant calculated from the regression analysis slope 
of the log-transformed concentrations included in the terminal phase of the 
concentration-time curve from the last dose 
t½ 
hr 
Apparent terminal half-life calculated as ln(2)/ Z 
 
The parameter estimates dependent upon the regression analysis of the terminal phase (λZ, t½,) 
will only be reported for those patients where a sufficient and meaningful number of serum 
concentration values are available. All possible values will be calculated and listed with a flag 
to indicate inclusion in the summary. Only those values that pass the following criteria will be 
included in the summaries:   
All regression analyses must contain a minimum of 3 concentrations and characterize a 
descending concentration. The estimate of Z from the regression analysis must have a 
correlation coefficient R2 > 0.80 to be accepted. If these conditions fail then λZ and t½, will be 
listed but not reported in the summary table.  


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The parameters λZ and t½ will not be calculated for patients receiving maintenance treatment 
after cycle 3 if they receive any dose after the FU1 visit, since the concentrations of 
MOR00208 at the FU2 and FU3 visits may be influenced by additional MOR00208 doses in 
maintenance treatment and thus not suited to estimate these parameters. However, if patients 
receive maintenance treatment after cycle 3 but have blood samples taken at the FU1, FU2, and 
FU3 visits with no doses administered between them, then those samples may be used for 
estimating these parameters. 
11. SAFETY AND TOLERABILITY ANALYSES 
The analysis of safety assessments in this study will include summaries of the following 
categories of safety and tolerability data collected for each patient: 
• Adverse Events 
• Clinical Laboratory Investigations (Blood Chemistry, Hematology, Coagulation, 
Urinalysis, anti-MOR00208 antibodies) 
• Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate, Body Temperature) 
• Electrocardiogram (ECG) Investigations 
• Physical Examination 
• Measurements of exposure 
11.1 Adverse Events 
The primary safety endpoint is the incidence and severity of adverse events (AEs). This 
endpoint will be determined based on the Safety Population. If not specified otherwise, the 
adverse events summary and overall table will be displayed overall, by each NHL subtype, and 
for the combined group of FL and other indolent NHL. 
All adverse events (AEs) and serious adverse events (SAEs) will be coded using the Medical 
Dictionary for Regulatory Activities (MedDRA), Version 20.1.  
Treatment emergent AEs are defined as AEs occurring or worsening after the start (date and 
time) of the first study treatment and up to 30 days after the last study treatment including all 
treatment cycles (treatment emergent period). However, adverse events occurring or worsening 
later than 30 days after the last treatment are defined as treatment emergent if these are 
considered to be related to the study drug. 
If the start date and time of an AE are partially or completely missing, the AE will be assumed 
to be treatment-emergent if it cannot be definitely shown that the AE did not occur or worsen 


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during the treatment emergent period (worst case approach). Missing dates and times will not 
be replaced.  
Thus, the following approach will be taken: 
• If the start time of an AE is missing but the start date is complete, an AE will only be 
excluded from treatment emergent AEs if start day is before day of first treatment or 
start day is after end day of treatment emergent period. 
• If start time and day are missing but the start month is complete, an AE will only be 
excluded from treatment emergent AEs if start month is before month of first treatment 
or start month is after end month of treatment emergent period or if stop date/time is 
before start of first treatment. 
• If start day and months are missing but the start year is complete, an AE will only be 
excluded from treatment emergent AEs if start year is before year of first treatment or if 
start year is after end year of treatment emergent period or if stop date/time is before 
start of first treatment. 
• If start date is completely missing, an AE will not be excluded from treatment-emergent 
AEs unless the stop date/time is before start of first treatment. 
Time from first treatment to onset of AE [days] will be calculated for complete dates only and 
will be included in listings.  
An AE summary table will be presented showing the incidence and frequency of any 
• Treatment-emergent AEs (TEAEs) 
• Serious Adverse Events (SAEs) 
• Serious Adverse Events (SAEs) related to MOR00208 
• MOR00208-related TEAEs 
• MOR00208-related TEAEs by toxicity (according to NCI-CTC toxicity criteria) 
• MOR00208-related TEAEs by severity  
• Infusion related TEAEs 
• TEAEs leading to any action on MOR00208 
• TEAEs leading to discontinuation of MOR00208 
• TEAEs leading to death 


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The incidence refers to the number and percentage of patient with at least one TEAE of the 
specified type and the frequency to the number of AEs.  
The analyses by toxicity will be based on the NCI-CTC grade (per National Cancer Institute 
Common Toxicity Criteria, version 4.0). If the NCI-CTC grade is not available, this will be 
analyzed as “Missing”.  
Summaries of incidence rates (number and percentage of patients) and frequencies (number of 
AEs) of individual TEAEs by MedDRA System Organ Class (SOC) and Preferred Term will be 
prepared overall and by NHL subtype. Such summaries will be displayed for all  
• TEAEs 
• TEAEs by toxicity according NCT-CTC  
• TEAEs by severity  
• TEAEs suspected to be related to MOR00208 
• TEAEs leading to discontinuation of MOR00208 
• Infusion related TEAEs 
• Cytokine release syndromes 
• Treatment-Emergent Serious Adverse Events 
• TEAEs suspected to be related to MOR00208 
• Serious Adverse Events suspected to be related to MOR00208 (Serious Adverse 
Reactions) 
• TEAEs of toxicity grade 3 or higher 
• MOR00208-related TEAEs of toxicity grade 3 or higher 
• TEAEs of special interest (ie, infusion-related reactions of grade 3 or higher, cytokine 
release syndrome, allergic reaction to MOR00208 of grade 3 or higher and overdoses) 
• Haematological Treatment Emergent Adverse Events 
• Overdoses (defined as exceeding planned dose by more than 10%) 
• Death cases (irrespective of death due to progressive disease or other reason) 
• Pre-treatment AEs (based on all Screened Patients instead of the Safety Population) 
A summary of all TEAEs will also be provided by FcγR polymorphisms.  


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In these summaries each patient will be counted only once within each preferred term to 
calculate the incidences.  
AE listings of all adverse events with the following details will be provided for 
• AEs – details  
• AEs – action taken 
• AEs – coding details 
In the AE listings, AEs that started prior to the administration of any study drug will be flagged 
as pre-treatment AEs. AEs that start 30 days after the last study treatment including all 
treatment cycles will be flagged as post-treatment AEs. 
Special AE summary listing displaying details of the event(s) captured on the eCRF in a 
compact format will be provided for  
• AEs leading to death 
• AEs leading to discontinuation of MOR00208 
• AEs of toxicity grade 3 or higher 
• Infusion related TEAEs 
• Serious Adverse Events 
• Death cases (irrespective of death due to disease progression or other reason) 
Serious adverse event reconciliation will be performed as detailed in the SAE reconciliation 
plan. 
The number and percent of patients with at least one pretreatment AE will be summarized by 
NHL subtype and by system organ class and preferred term. 
11.2 Clinical Laboratory Evaluations 
Safety monitoring for all patients enrolled in the study will include among others laboratory 
assessments: hematology, blood chemistry, and urinalysis, coagulation, and anti-MOR00208 
antibodies. Hematology, serum chemistry, immunoglobulins, coagulation, urinalysis will be 
analyzed by the respective local laboratories of each involved site. Immunogenicity of 
MOR208 will be estimated by a central laboratory (please refer to section 11.7 for details). 
The analysis of laboratory parameters will be presented separated into blood parameters 
(hematology, serum chemistry, immunoglobulin, coagulation) and urine parameters 


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(urinalysis). All data will be listed. 
The blood parameters will be transformed to SI values based on SI units to make laboratory 
parameters comparable between different local laboratories. The relevant reference ranges 
supplied by each laboratory will also be transformed to SI reference ranges for each laboratory. 
The SI reference ranges will be presented in the listings. 
Descriptive summaries of absolute values and changes from baseline will be presented for all 
blood parameters. 
Each abnormal value will be flagged to show whether it is a value below or above the reference 
range. For the assessment of laboratory variables, 5 categories will be used that take into 
account the investigator’s assessment of clinical relevance: ‘clin. sign., above’, ‘non-clin. sign., 
above’, ‘within’, ‘non clin. sign., below’, ‘clin. sign., below’. 
The assessment of laboratory variables will be tabulated by time point for each clinical 
laboratory analyte (frequency tables).  
Additionally, for each laboratory parameter, shifts in assessments from baseline to all post 
administration time points will be presented. 
If NCI-CTC grades are available for a clinical laboratory analyte, these will be derived 
according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) and used 
to present additional frequency and shift tables based on NCI-CTC grades. 
The investigator’s assessment of categorical urinalysis variables (‘normal’, ‘abnormal, not clin. 
sign.’, ‘abnormal clin.sign.’) will be tabulated by time point for each urine parameter 
(frequency tables).  
Additionally, for each of these urine parameter shifts in assessments from baseline to all post-
administration time points will be presented. 
Laboratory values that are outside the reference range will also be flagged in the data listings, 
along with corresponding reference ranges. 
Results of urine microscopy (if available), results of the pregnancy test and screening serology 
results will only be included in listings. 
11.3 Vital Signs and Body Weight 
Descriptive summaries of actual values and changes from baseline will be calculated for vital 
signs (Systolic Blood Pressure, Diastolic Blood Pressure, Body Temperature, Heart Rate and 


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Respiratory Rate) and Body Weight and BMI. These summaries will be presented for all time 
points.  
Each abnormal value will be flagged to show whether it is a value below or above the normal 
limit. The normal limits are detailed in the appendix of the study protocol (Section 17.2 of the 
study protocol). 
11.4 Electrocardiograms 
The summary ECG assessment (categories: <normal; abnormal clinically significant; abnormal 
not clinically significant>) will be tabulated by visit. 
Each abnormal PR, QRS, and RR interval value will be flagged to show whether it is a value 
below or above the normal limit. The normal limits are detailed in the appendix of the study 
protocol (Section 17.2 of the study protocol). 
Descriptive summaries of actual values and changes from baseline will be presented by visit for 
ECG measures of RR interval, PR interval, QRS interval, QT interval, QTc interval (both 
correction methods), and HR (Heart rate).  
The Bazett’s Correction (QTcb) and Fridericia’s Correction (QTcf) for the QTc interval will be 
derived as follows: 
Bazett’s Correction (QTcb) 
RR
QT
QTc
m
b
sec
=
 
Fridericia’s Correction (QTcf) 
3
sec
RR
QT
QTc
m
f =
 
where: Relative Rate: RR = 60 / HR  
  
HR = Heart Rate obtained from the ECG. 
Also, the number and percent of patients with QTc values (for both corrections) above the 
normal limit (451-480 ms, 481-500 ms, or > 500 ms) and the number and percent of patients 
who experienced a change > 30 ms or a change > 60 ms from baseline will be presented by 
visit. 
11.5 Physical Examination 
Baseline physical examination will be summarized by body system. New and worsening 


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abnormal physical examination findings during the study will be entered as AEs and analyzed 
within the AE tables 
11.6 Measurement of Exposure 
Variables which will be calculated to measure exposure to MOR00208 are described in section 
7.3.5. All variables calculated on a per-patient basis for all cycles will be summarized 
descriptively. The number of cycles with all infusions completed will be presented as a 
continuous variable and also in categories of number of patients completing 1, 2, or 3 cycles, 
and the number of patients going into maintenance treatment. 
11.7 Immunogenicity Analysis 
Immunogenicity variables defined in section 7.3.1 will be summarized descriptively. Rates will 
be calculated with respect to all patients in the analysis group who have at least one post-
baseline anti-MOR00208 antibody assessment. Results of semiquantitative antibody 
assessment will be tabulated. 
12. CHANGES FROM PLANNED ANALYSIS 
The PK population was originally defined in the protocol as consisting of all patients who have 
sufficient pharmacokinetic data to characterize the time course of MOR00208 in serum for the 
first study drug administration. This is changed in the SAP to include all patients who have at 
least one quantifiable serum MOR00208 concentration (see section 6). 
The protocol did not specify ORR as a result of central read as an endpoint, but this has now 
been added to the secondary endpoints of the study. 
The protocol specified that “Evaluation of AEs and ORR stratified by baseline CD19 
expression on malignant lymphoma cells” was one of the secondary endpoints. This is no 
longer considered an endpoint  as it has not been possible to measure CD19 expression in 
sufficient cases for such an analysis to be meaningful.


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13. REPORTING CONVENTIONS 
The following reporting conventions will be adopted for the presentation of study data.  
These conventions will enhance the review process and help to standardize presentation 
with common notations. 
13.1 General Reporting Conventions 
• All tables and data listings will be developed in Landscape Orientation, unless 
presented as part of the text in a CSR. 
• Figures will be presented in Landscape Orientation, unless presented as part of the 
text in a CSR. 
• Legends will be used for all figures with more than one variable or item 
displayed. 
• Figures will be in black and white, unless color figures have been identified as 
useful for discriminating presentation in the figure. Lines in figures should be 
wide enough to view the line after being photocopied.  
• Specialized text styles, such as bolding, italics, borders, shading, superscripted 
and subscripted text will not be used in tables, figures, and data listings unless 
they add significant value to the table, figure, or data listing.  
• Only standard keyboard characters should be used in tables and data listings. 
Special characters, such as non-printable control characters, printer specific, or 
font specific characters, will not be used on a table, figure, or data listing.  
Hexadecimal character representations are allowed (e.g., , , ). 
• All titles will be centered on a page.   
• All footnotes will be left justified and the bottom of a page. Footnotes must be 
present on the page where they are first referenced. Footnotes should be used 
sparingly and must add value to the table, figure, or data listing. If more than four 
footnote lines are planned then a cover page may be used to display footnotes. 
• Missing values for both numeric and character variables will be presented as 
blanks in a table or data listing. A zero (0) may be used if appropriate to identify 
when the frequency of a variable is not observed. 
• All date values will be presented as DDMMMYYYY (e.g., 29AUG2001) format. 
A four-digit year is preferred for all dates. 


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• All observed time values will be presented using a 24-hour clock HH:MM:SS 
format (e.g., 01:35:45 or 11:26). Seconds should only be reported if they were 
measured as part of the study.  
• Time durations will be reported in HH:MM:SS notation. The use of decimal 
notation to present (display) time durations should be avoided (e.g. 0.083h = 5m) 
unless it is necessary to show the computation of time differences in a table, 
figure, or data listing, in which case both notations may be used to display the 
time duration.  
• All tables, figure, and data listings will have the name of the program, location 
and a date stamp on the bottom of each output.  
13.2 Population Summary Conventions 
• Population(s) represented on the tables or data listings will be clearly identified in 
the last title of the Table as “Population: <name of population>” and will be 
identical in name to that identified in the protocol or SAP. 
• Consistent terminology will be used to define and identify a population.  Common 
nomenclature may include (a) AllPatients, (b) Safety Population, (c) Evaluable 
Population, (d) Efficacy Evaluable Population and (e) Pharmacokinetic 
Population. 
• Sub-population(s) or special population(s) descriptions will provide sufficient 
detail to ensure comprehension of the population (e.g., ITT Females, Per-Protocol 
Males >60 years of age) used for analysis in a table or figure. 
• Population sizes may be presented for each treatment or dosing category as totals 
in the column header as (N=xxxx), where appropriate.  
• Population sizes shown with summary statistics are the samples sizes (n) of 
subjects with non-missing values.  
• All population summaries for continuous variables will include: N, mean, 
standard deviation, minimum, and maximum. Other summaries (e.g. number 
missing, median, quartiles, 5%, 95% intervals, coefficient of variation (CV) or 
%CV) may be used as appropriate. Median and mean will be presented with one 
more digit than minimum and maximum, standard deviation will be presented 
with two more digits. 
• All percentages are rounded and reported to a single decimal point (xx.x%). 
• Population summaries that include p-values will report the p-value to 
three decimal places with a leading zero (0.001). All p-values reported on default 


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output from statistical software (i.e., SAS® Software) may be reported at the 
default level of precision. P-values <0.001 should be reported as <0.001 not 
0.000. 


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14. REFERENCES 
1. US Federal Register. (1998) International Conference on Harmonization; Guidance on 
Statistical Principles for Clinical Trials. Department of Health and Human Services: 
Food and Drug Administration [Docket No. 97D-0174]. Federal Register Volume 63, 
Number 179, pages 49583-49598. September 16, 1998. 
2. ASA. (1999) Ethical Guidelines for Statistical Practice. Prepared by the Committee on 
Professional Ethics, August 7, 1999.  
3. RSS. (1993) The Royal Statistical Society: Code of Conduct, August 1993.  
4. Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant 
lymphoma. J Clin Oncol. 2007;25(5):579-586 
5. A Predictive Model for Aggressive Non-Hodgkin's Lymphoma. The International Non-
Hodgkin's Lymphoma Prognostic Factors Project. N Engl J Med 1993; 329:987-994 
6. Hoster E, Dreyling M, Klapper W et al. A new prognostic index (MIPI) for patients 
with advanced-stage mantle cell lymphoma. Blood 2008; 111(2):558-565 
7. Solal-Céligny P, Roy  P, Colombat P et al. Follicular Lymphoma International 
Prognostic Index. Blood 2004; 104(5):1258-1265