A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined With MOR00208 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma
Sponsor: MorphoSys AG

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Page 1 of 110 
 
 
CLINICAL STUDY PROTOCOL 
 
 
 
AMENDMENT NO. 5 
 
A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the 
Safety and Efficacy of Lenalidomide Combined with MOR00208 in Patients 
with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) 
Brief Description of 
Study: 
Open-label study to evaluate the safety and clinical efficacy of 
lenalidomide combined with MOR00208 in adult patients with 
R-R DLBCL (L-MIND) 
Study Type: 
Phase II 
Sponsor: 
MorphoSys AG 
Sponsor's Address: 
Semmelweisstr. 7 
82152 Planegg 
Germany 
Study Protocol Number: 
MOR208C203 
IND No.: 
EudraCT No.: 
114,856 
2014-004688-19 
Date of Protocol: 
18 March 2015 
Amendment No. 5: 
Final v8.0, 24 February 2021  
 
 
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 No unpublished information in 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 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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SIGNATURES 
Amendment No. 5: 
Final v8.0, 24 February 2021 
 
Approved/Authorised By: 
 
 
 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 3 of 110 
Country Coordinating Investigator’s Signature (in countries where 
required) 
 
 
 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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Signature of Principal Investigator 
 
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 co-investigator(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. 
Investigator: 
 
 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 5 of 110 
Contact Details of Key Study Personnel 
Sponsor's Clinical 
Programme Leader 
Sponsor’s Clinical Project 
Manager 
Contact for Serious 
Adverse Events (SAEs): 
Medical Monitor 
(24/7 Medical Coverage) 
 
 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 6 of 110 
PROTOCOL SYNOPSIS 
Title of Study 
A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the 
Safety and Efficacy of Lenalidomide Combined with MOR00208 in 
Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-
R DLBCL) 
 
Investigational Drugs 
MOR00208 (an Fc-engineered, humanised, monoclonal antibody 
targeting the B-cell surface antigen CD19) and Lenalidomide (LEN: 
Revlimid®) 
 
Protocol Number 
MOR208C203 
IND Number 
114,856 
EudraCT Number 
2014-004688-19 
Sponsor and CRO 
Sponsor: 
MorphoSys AG 
Semmelweisstr. 7 
82152 Planegg 
Germany 
 
 
 
 
 
 
Study Phase 
Phase II 
Background/Study 
Purpose and Rationale  
Diffuse large B-cell lymphoma (DLBCL) represents approximately 40% 
of all non-Hodgkin lymphomas (NHLs), with a rate of incidence which 
continues to increase and a median age at diagnosis of 64 years.  
 
The addition of the CD20 monoclonal antibody (mAb) rituximab (RTX) 
to standard CHOP (cyclophosphamide, doxorubicin, vincristine, and 
prednisone) chemotherapy (R-CHOP) has been shown to improve the 
outcome compared with CHOP alone in untreated patients with DLBCL. 
Despite advances in first-line treatment, 30–40% of such patients relapse. 
Patients progressing or relapsing after first-line treatment may be offered 
salvage chemotherapy followed by high-dose chemotherapy (HDC) with, 
if the disease is still chemosensitive, autologous stem-cell transplantation 
(ASCT). Several second-line combination therapies are used with variable 
success. However, a substantial percentage of patients will either fail to 
respond to salvage therapy and subsequently not be eligible for ASCT, or 
will progress after ASCT.  
 
Additionally, the use of HDC with stem cell support in patients with R-R 
DLBCL may not be appropriate for those with comorbidities or advanced 
age, restricting the benefit of this aggressive approach to a relatively small 
fraction of patients. 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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R-CHOP-like regimens have become standard first-line treatment in 
patients with DLBCL. Those patients who have received prior RTX are 
less likely to respond to RTX-containing salvage treatment and therefore 
effective and well-tolerated new treatment modalities with manageable 
toxicities are needed to ameliorate prognosis in R-R DLBCL. Rational 
combinations of effective compounds have been shown to be active and 
often lead to better clinical outcomes in DLBCL than single-agent therapy. 
 
The B-lymphocyte lineage specific surface antigen CD19 is the earliest 
and most broadly expressed of the selective B-cell markers, and is highly 
expressed in the tumour cells of most patients with B-cell NHL. Because 
of this expression pattern, a CD19 antibody may have clinical utility as a 
new therapeutic approach to NHL treatment.  
 
MOR00208 is an Fc-engineered, humanised, mAb with significantly 
enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), 
antibody-dependent cell-mediated phagocytosis (ADCP) and direct 
cytotoxic effects (apoptosis) compared with the parental murine antibody. 
 
Monotherapy with MOR00208 has shown preliminary signs of clinical 
efficacy and acceptable toxicity in a phase I study in R-R chronic 
lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) and a 
phase IIa study in R-R NHL. Additionally, MOR00208 is currently being 
studied as single-agent therapy in a phase IIa study in R-R B-cell acute 
lymphoblastic leukaemia (B-ALL). 
 
Lenalidomide (LEN) belongs to a class of immunomodulating agents 
(immunomodulatory drugs [IMiDs®]), which have demonstrated direct 
tumouricidal 
and 
immunomodulatory 
actions. 
LEN 
has 
both 
antiproliferative and antiangiogenic activities, modulating the tumour cell 
microenvironment and stimulating the activity of effector cells such as 
cytotoxic T-cells and natural killer (NK) cells. LEN demonstrated 
manageable toxicity when administered as monotherapy and in 
combination, as well as a synergistic effect with RTX, administered alone 
or as a part of an immunochemotherapeutic regimen. 
 
Preclinical data suggest that the combination of LEN with MOR00208 
may increase NK cell-mediated ADCC, making this combination of 
interest for further study in patients with R-R DLBCL. This patient 
population is particularly relevant for the current study as they can usually 
achieve a rapid and complete lymphoma regression with second-line 
therapy, but invariably experience relapse, which is the principal 
unfavourable prognostic factor. 
 
Combining two agents with probable synergistic mechanisms of action 
and acceptable safety profiles could potentially contribute to significantly 
prolonging time to progression, and possibly overall survival (OS), in this 
patient population. Therefore, this open label, single-arm, prospective 
phase II study is designed to confirm the activity of MOR00208 combined 
with LEN in patients with R-R DLBCL who have had at least one, but no 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Page 8 of 110 
more than three prior systemic regimens and who are not eligible for HDC 
with ASCT at the time of study entry. 
 
Study Objectives (Key 
Primary and Secondary) 
PRIMARY OBJECTIVE: 
To determine the activity of a combination of LEN with MOR00208 in 
terms of objective response rate (ORR = complete response [CR] + partial 
response [PR]) in adult patients with R-R DLBCL. 
 
SECONDARY OBJECTIVES: 
1. To determine the disease control rate (DCR = CR + PR + 
stable disease [SD])  
2. To determine the duration of response (DoR)  
3. To determine the activity of a combination of LEN with 
MOR00208 in terms of progression-free survival (PFS) 
4. To determine the overall survival (OS)  
5. To determine time to progression (TTP) 
6. To determine the time to next treatment (TTNT)  
7. To determine the safety of LEN combined with MOR00208 
assessed according to the frequency and severity of adverse 
events (AEs) 
8. To assess the potential immunogenicity of MOR00208 
9. To assess the pharmacokinetics (PK) of MOR00208 
10. To make a preliminary evaluation of ORR, DCR, DoR, PFS, 
OS, TTP and TTNT in patients treated with a combination of 
LEN plus MOR00208 in cohorts with a “low risk”, “low-
intermediate”, “high-intermediate” and “high” International 
Prognostic Index (IPI) 
11. To compare each patient’s TTP on LEN plus MOR00208 with 
the TTP of their most recent prior therapy 
12. To correlate efficacy parameters with certain biomarkers 
(e.g., baseline tumour CD19 expression level, peripheral NK 
cell 
count, 
constitutional 
FcγRIIIa 
and 
FcγRIIa 
polymorphism status). 
 
Study Endpoints (Key 
Primary and Secondary) 
PRIMARY ENDPOINT: 
1. ORR, defined as the proportion of complete and partial 
responders (ORR = CR + PR) 
 
SECONDARY ENDPOINTS:  
2. DCR, DoR, PFS, OS, TTP and TTNT  
3. Incidence and severity of AEs 
4. Determination and characterisation of a potential anti-
MOR00208 antibody formation 
5. PK analysis of MOR00208 
6. Absolute and percentage change from baseline in 
measurements of B-, T- and NK cell populations 
7. Analysis of exploratory and diagnostic biomarkers (e.g., 
CD19, CD20, BCL2, and BCL6 expression, CD16 expression 
on NK cells, ADCC capacity), gene expression profiling for 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 9 of 110 
cell of origin subtyping and evaluation of AEs and ORR 
stratified by FcγRIIIa and FcγRIIa polymorphism) are 
planned to be investigated during the course of the study. 
 
Design and 
Methodology/Patient 
Population 
This is a single-arm, multicentre, open-label, phase II study of LEN 
combined with MOR00208 in adult patients with DLBCL who have 
relapsed after or are refractory to at least one, but no more than three prior 
systemic therapies and who are not candidates for HDC and ASCT, and 
are thus considered to have exhausted their therapeutic options for 
demonstrable clinical benefit. One prior therapy line must have included 
a CD20-targeted therapy (e.g., RTX). 
 
Histological confirmation of the diagnosis of DLBCL will be performed 
by a central pathologist, retrospectively after enrolment. Objective disease 
response assessments will be made by central radiology and clinical 
reviewers. Details will be provided in an imaging charter, outlining 
functions and processes. 
 
This study will consist of two parts, which will be performed sequentially, 
where the first part (safety run-in) will conclude with an evaluation of the 
safety data after six patients have completed the first cycle of treatment. 
The second part will commence pending the outcome of this evaluation. 
 
Approximately 80 patients will be enrolled in the study. 
 
Key Inclusion/Exclusion 
Criteria 
INCLUSION CRITERIA: 
Diagnosis/Study Population 
1. 
Age >18 years 
2. 
Histologically confirmed diagnosis of DLBCL not otherwise 
specified (NOS); T cell/histiocyte rich large B-cell lymphoma 
(THRLBCL); Epstein-Barr virus (EBV) positive DLBCL of 
the elderly (EBV-positive DLBCL), Grade 3b Follicular 
Lymphoma, Composite lymphoma with a DLBCL component 
with a subsequent DLBCL relapse, according to the Revised 
European American Lymphoma/World Health Organization 
(REAL/WHO) classification. Additionally, patients with the 
evidence of histological transformation to DLBCL from an 
earlier diagnosis of low grade lymphoma (i.e., an indolent 
pathology such as follicular lymphoma, marginal zone 
lymphoma, chronic lymphocytic leukaemia) into DLBCL 
with a subsequent DLBCL relapse are also eligible. 
3. 
Fresh tumour tissue for central pathology review and 
correlative studies must be provided as an adjunct to 
participation in this study. Should it not be possible to obtain 
a fresh tumour tissue sample from the patient, archival paraffin 
embedded tumour tissue acquired ≤3 years prior to screening 
for this protocol must be available for this purpose. 
4. 
Patients must have: 
a) relapsed and/or refractory disease as defined in the 
protocol (Section 5.1.15.1.1) 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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b) at least one bidimensionally measurable disease site. The 
lesion must have a greatest transverse diameter of 
≥1.5 cm and greatest perpendicular diameter of ≥1.0 cm 
at baseline. The lesion must be positive on PET scan (for 
definition see Juweid et al., 2007) 
c) received at least one, but no more than three previous 
systemic regimens for the treatment of DLBCL and one 
therapy line must have included a CD20-targeted therapy 
(e.g., RTX) 
d) an Eastern Cooperative Oncology Group (ECOG) 
performance status of 0 to 2 
5. 
Patients not considered in the opinion of the investigator 
eligible, or patients unwilling to undergo intensive salvage 
therapy including ASCT because of, but not limited to, 
advanced age, comorbidities, impossibility or, refusal to 
perform ASCT. Documentation of the reason for a patient’s 
ineligibility must be provided in the patient’s source data. 
 
Laboratory Values 
6. 
Patients must meet the following laboratory criteria at 
screening: 
a) absolute neutrophil count (ANC) ≥1.5 × 109/L (unless 
secondary to bone marrow involvement by DLBCL as 
demonstrated by recent bone marrow aspiration and bone 
marrow biopsy) 
b) platelet count ≥90 × 109/L (unless secondary to bone 
marrow involvement by DLBCL as demonstrated by 
recent bone marrow aspiration and bone marrow biopsy) 
c) total serum bilirubin ≤2.5 × upper limit of normal (ULN) 
unless secondary to Gilbert’s syndrome or documented 
liver involvement by lymphoma. Patients with Gilbert’s 
syndrome 
or 
documented 
liver 
involvement 
by 
lymphoma may be included if their total bilirubin is 
≤5 × ULN (see exclusion criterion 5g) 
d) alanine transaminase (ALT), aspartate aminotransferase 
(AST) and alkaline phosphatase (AP) ≤3 × ULN or 
<5 × ULN in cases of documented liver involvement 
e) serum creatinine clearance must be ≥60 mL/minute either 
measured or calculated using a standard Cockcroft and 
Gault formula (Cockroft and Gault, 1976; see 
Appendix_A) 
 
General Provisions 
7. 
Females of childbearing potential (FCBP) must: 
a) not be pregnant as confirmed by a negative serum 
pregnancy test at screening and a medically supervised 
urine pregnancy test prior to starting study therapy 
b) refrain from breastfeeding and donating blood or oocytes 
during the course of the study and for 3 months after the 
last dose of study medication. Restrictions concerning 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 11 of 110 
blood donation apply as well to females who are not of 
childbearing potential 
c) agree to ongoing pregnancy testing during the course of 
the study, and after study therapy has ended. This applies 
even if the patient practices complete and continued 
sexual abstinence 
d) commit to continued abstinence from heterosexual 
intercourse if it is in accordance with her lifestyle (which 
must be reviewed on a monthly basis) or agree to use and 
be able to comply with the use of effective contraception 
without interruption during the study and for 3 months 
after the last dose of study medication 
8. 
Males must use an effective barrier method of contraception 
without interruption, refrain from donating blood or sperm 
during the study participation and for 3 months after the last 
dose of study medication if the patient is sexually active with 
a FCBP 
9. 
In the opinion of the investigator, the patients must: 
a) be able and willing to receive adequate prophylaxis 
and/or therapy for thromboembolic events  
b) be able to understand, give written informed consent, and 
comply with all study-related procedures, medication use, 
and evaluations  
c) not have a history of noncompliance in relation to medical 
regimens or be considered potentially unreliable and/or 
uncooperative 
d) be able to understand the reason for complying with the 
special conditions of the pregnancy prevention risk 
management plan and give written acknowledgement of 
this. 
 
EXCLUSION CRITERIA: 
Exclusionary Diagnosis 
1. Patients who have: 
a) any other histological type of lymphoma including 
primary mediastinal (thymic) large B-cell (PMBL) or 
Burkitt lymphoma 
b) primary refractory DLBCL (see Section 5.1.1 for 
definitions) 
c) a history of "double/triple hit" genetics DLBCL 
characterised by simultaneous detection of MYC with 
BCL2 
and/or 
BCL6 
translocation(s) 
defined 
by 
fluorescence in situ hybridisation. MYC, BCL2, BCL6 
testing prior to study enrolment is not required 
 
Exclusionary Previous and Current Treatment 
2. Patients who have, within 14 days prior to Day 1 dosing: 
a) 
not discontinued CD20-targeted therapy, chemotherapy, 
radiotherapy, investigational anticancer therapy or other 
lymphoma-specific therapy 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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Page 12 of 110 
b) 
undergone major surgery or suffered from significant 
traumatic injury 
c) 
received live vaccines (see Section 6.7 for details) 
d) required parenteral antimicrobial therapy for active, 
intercurrent infections 
3. Patients who: 
a) have, in the opinion of the investigator, not recovered 
sufficiently from the adverse toxic effects of prior 
therapies 
b) were previously treated with CD19-targeted therapy or 
IMiDs® (e.g., thalidomide, LEN) 
c) have a history of hypersensitivity to compounds of similar 
biological or chemical composition to MOR00208, 
IMiDs® and/or the excipients contained in the study drug 
formulations 
d) have undergone ASCT within the period ≤ 3 months prior 
to signing the informed consent form. Patients who have 
a more distant history of ASCT must exhibit full 
haematological recovery before enrolment into the study  
e) have 
undergone 
previous 
allogenic 
stem 
cell 
transplantation 
f) have a history of deep venous thrombosis/embolism, 
threatening thromboembolism or known thrombophilia or 
are at high risk for a thromboembolic event in the opinion 
of the investigator and who are not willing/able to take 
venous thromboembolic event prophylaxis during the 
entire treatment period 
g) concurrently use other anticancer or experimental 
treatments 
 
Exclusionary Patient’s Medical History 
4. Prior history of malignancies other than DLBCL, unless the 
patient has been free of the disease for ≥5 years prior to 
screening. Exceptions to the ≥5 year time limit include a 
history of the following: 
a) basal cell carcinoma of the skin 
b) squamous cell carcinoma of the skin 
c) carcinoma in situ of the cervix 
d) carcinoma in situ of the breast 
e) carcinoma in situ of the bladder 
f) incidental histological finding of prostate cancer 
(Tumour/Node/Metastasis [TNM] stage of T1a or T1b) 
5. Patients with: 
a) positive hepatitis B and/or C serology (see Section 
7.2.13.2 for details) 
b) known seropositivity for or history of active viral 
infection with human immunodeficiency virus (HIV) 
c) CNS lymphoma involvement – present or past medical 
history 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 13 of 110 
d) history or evidence of clinically significant 
cardiovascular, CNS and/or other systemic disease that 
would in the investigator’s opinion preclude 
participation in the study or compromise the patient’s 
ability to give informed consent 
e) history or evidence of rare hereditary problems of 
galactose intolerance, the Lapp lactase deficiency or 
glucose-galactose malabsorption 
f) gastrointestinal abnormalities including the inability to 
take oral medication, requiring intravenous alimentation, 
or prior surgical procedure affecting absorption 
g) history or evidence of severe hepatic impairment (total 
serum bilirubin > 3mg/dL), jaundice unless secondary to 
Gilbert’s syndrome or documented liver involvement by 
lymphoma (see inclusion criterion 6c) 
 
Investigational Drug(s) 
(Name, Description)  
MOR00208 and LEN (Revlimid®) 
Dose, Route of 
Administration, 
Treatment Regimen 
Treatment consisting of LEN and MOR00208 combination will be 
administered up to twelve 28-day cycles at specified dose levels, as 
scheduled, until disease progression, unacceptable toxicity, or 
discontinuation for any other reason, whichever comes first.  
 
MOR00208 Dose: 12 mg/kg 
For the first three cycles of the study, each cycle (Cycles 1-3) will consist 
of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the 
cycle. Additionally a loading dose will be administered on Day 4 of Cycle 
1.  
Thereafter MOR00208 will be administered on a bi-weekly (every 
fourteen days) basis with infusions on Days 1 and 15 of each 28-day cycle 
until disease progression, or unacceptable toxicity, or discontinuation for 
any other reason, whichever comes first. 
 
 
LEN: 
Patients will self-administer a starting dose of 25 mg oral LEN daily on 
Days 1–21 of each cycle. Treatment with LEN may be modified in a de-
escalating fashion or discontinued based upon clinical and laboratory 
findings. Detailed dose modification guidelines to manage haematologic 
and/or other toxicities are provided in the relevant sections of the protocol. 
 
LEN can be given for up to a total of 12 cycles. MOR00208 can be 
administered until disease progression, or unacceptable toxicity, or 
discontinuation for any other reason, whichever comes first. 
 
It is up to the investigator to decide according to the individual risk/benefit 
ratio if the patient should continue further MOR00208 therapy in the case 
of disease progression. 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 14 of 110 
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 of 
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 200 mg 
of MOR00208 in 5 ml of reconstituted solution. MOR00208 will be 
diluted into a 250 mL infusion bag containing 0.9% (w/v) sodium chloride 
for injection.  
 
LEN will be sourced from commercially available drug suppliers 
(Revlimid®). 
 
Efficacy Assessments 
Disease response assessments will be made according to the revised 
response criteria for malignant lymphoma based on the guidelines of the 
International Working Group (IWG, as reported by Cheson et al. (2007) 
and will be based on a central review (radiological + clinical) of the 
disease assessments. Efficacy will be evaluated in terms of ORR, DCR, 
DoR, PFS, OS, TTP and TTNT. Results of local disease response 
assessments will also be available. 
 
Safety Assessments 
The safety and tolerability of study drug treatments will be evaluated by 
means of AE reports (number and severity), performance status, physical 
examinations, 12-lead resting electrocardiograms (ECGs), and laboratory 
safety evaluations. 
 
Laboratory and AE toxicities will be graded according to National Cancer 
Institute (NCI) Common Terminology Criteria for Adverse Events 
(CTCAE), version 4.0. 
 
Pharmacokinetics 
The PK of MOR00208 will be investigated during the course of the study. 
 
Biomarker Assessments  Blood and tumour specimens for the analysis of exploratory biomarkers 
will be collected throughout the study and will be characterised for 
markers which are important in the mechanism of action of, or could 
predict response to, the study drugs. Exploratory and diagnostic 
biomarkers (e.g., CD19, CD20, BCL2, BCL6), CD16 expression on NK 
cells, B-, T- and NK cell counts, ADCC capacity and gene expression 
profiling for cell of origin subtyping are planned to be investigated during 
the course of the study. 
 
Statistical Methods and 
Data Analysis 
The primary purpose of this study is to evaluate the clinical efficacy of 
oral LEN combined with MOR00208 administered by IV infusion in 
patients with R-R DLBCL. No formal statistical hypothesis testing will be 
performed. 
 
For the sample size determination it is assumed that the combination 
treatment could improve the ORR from a value of 20% (corresponding to 
monotherapy) to one of 35% which is achievable under combination 
treatment. Sample size estimation using a one-sample exact binomial test 
with a two-sided significance level of 5% and a power of 85% delivers a 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 15 of 110 
sample size of 73 patients. According to this scenario an observed ORR 
of 32% would lead to a statistically significant study outcome. Allowing 
for a drop-out rate of 10% the total required sample size comes to 
approximately 80 patients. 
 
All data will be summarised using appropriate statistics (counts/ 
percentages for discrete variables, mean, median, standard deviation, 
minimum, maximum, number of valid observations for continuous 
variables) for tabulation purposes. For specific variables, p-values and 
95% confidence limits will be presented. 
 
Overall baseline and demographic data will be summarised using 
appropriate statistics. Patient disposition and status at the end of the study 
will be tabulated presenting the number of patients and frequencies. 
General medical history and history of DLBCL, including prior cancer 
therapies, will be tabulated using coding systems (e.g., MedDRA, WHO-
DDE), where appropriate. 
 
PRIMARY OBJECTIVE: 
 
Primary efficacy endpoint: Objective response rate (ORR) 
The ORR will be the percentage of patients who have met the ORR 
definition up until progression based on the central (independent) 
radiological and clinical evaluations. The denominator for calculating the 
rate will be based upon the total number of patients in the full analysis set 
(FAS) population. As a sensitivity analysis, patients without any post-
baseline assessment of response will be included in the denominator for 
ORR calculation. Number of patients being a responder and the respective 
rates, as well as 95% confidence limits, will be presented. 
 
SECONDARY OBJECTIVES: 
 
Disease control rate (DCR) 
The DCR will be evaluated like ORR. 
 
Duration of response (DoR) and Time to next treatment (TTNT) 
Response duration by the local assessment and by the central radiological 
+ clinical assessments will be tabulated with descriptive statistics. Time to 
next treatment will be descriptively analysed. 
 
Progression-free survival (PFS), overall survival (OS) and time to 
progression (TTP) 
Kaplan-Meier methodology will be used to evaluate median survival, 
presenting corresponding statistical parameters and 95% confidence limits 
and Kaplan-Meier survival curves. 
 
Incidence and severity of adverse events 
MedDRA coded adverse events will be used to show the incidence of all 
AEs by specific organ class (SOC), preferred term (PT), relationship to 
treatment, severity and seriousness. An AE summary table will present the 

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number of events, number of patients and the percentage of patients 
having treatment-emergent AEs (TEAEs), serious AEs, adverse drug 
reactions, and TEAEs that led to study discontinuation. 
AE frequency tables will display event and patient counts/frequency by 
MedDRA SOC and PT, distinguishing also by severity/toxicity, 
relationship to study drug, seriousness and outcome. 
 
Concomitant medications taken, starting on the day of the screening visit 
and through the followup- period, will be coded using appropriate coding 
systems and tabulated by each code system. 
 
Extent of exposure, clinical laboratory assessments, vital sign 
measurements, physical examination and results of ECGs will be 
summarised with appropriate descriptive statistics. 
 
Immunogenicity 
The absolute number and percentage of patients who develop anti-
MOR00208 antibodies, and the results of semi-quantitative anti-
MOR00208 antibody titre determinations of confirmed positive samples 
assessments, will be tabulated. 
 
Pharmacokinetics 
Appropriate PK parameters for MOR00208 will be computed based on 
non-compartmental data analysis and summarised using descriptive 
statistics. Mean concentrations will be visualised by figures. 
 
Biomarkers 
Blood and protein biomarkers which are important in the mechanism of 
action of, or could predict response to, the study drugs will be 
descriptively tabulated, presenting absolute and change to baseline values, 
if applicable. 
 
 

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Protocol Number: MOR208C203 
Date: 24 February 2021 
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TABLE OF CONTENTS 
Overall Table of Contents 
PROTOCOL SYNOPSIS ........................................................................................................................ 6 
TABLE OF CONTENTS ....................................................................................................................... 17 
Overall Table of Contents ..............................................................................................................17 
List of Tables ...................................................................................................................................20 
List of Figures .................................................................................................................................20 
LIST OF ABBREVIATIONS ................................................................................................................ 21 
1 
INTRODUCTION ................................................................................................................ 25 
1.1 
Overview of Non-Hodgkin Lymphomas.............................................................................25 
1.2 
Treatment of DLBCL...........................................................................................................25 
1.3 
Lenalidomide in Haematological Malignancies .................................................................26 
 
LEN as a Single Agent in Relapsed DLBCL .......................................................27 
 
LEN and DLBCL Subtype ...................................................................................27 
 
LEN in Combination with RTX in R-R DLBCL .................................................28 
 
LEN in Combination with R-CHOP or R-ICE in DLBCL...................................28 
1.4 
Overview of MOR00208 ......................................................................................................29 
 
Clinical Experience with MOR00208 ..................................................................30 
1.4.1.1 
Protocol No. XmAb®5574-01 ..............................................................................30 
1.4.1.2 
Ongoing Studies ...................................................................................................32 
 
Safety of MOR00208 ...........................................................................................33 
2 
STUDY PURPOSE/RATIONALE ..................................................................................... 34 
3 
STUDY OBJECTIVES ........................................................................................................ 35 
3.1 
Primary Objective ................................................................................................................35 
3.2 
Secondary Objectives ...........................................................................................................35 
4 
STUDY ENDPOINTS .......................................................................................................... 36 
4.1 
Primary Endpoint: ...............................................................................................................36 
4.2 
Secondary Endpoints: ..........................................................................................................36 
5 
INVESTIGATIONAL PLAN .............................................................................................. 37 
5.1 
Study Design .........................................................................................................................37 
 
Protocol-specific definitions ................................................................................37 
 
Description of study design ..................................................................................37 
5.2 
Safety Run-in ........................................................................................................................39 
5.3 
Study Duration .....................................................................................................................39 
 
Study Conduct ......................................................................................................39 
 
End of Study .........................................................................................................40 
5.4 
Patient Selection Criteria .....................................................................................................40 
 
Inclusion Criteria ..................................................................................................40 

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Exclusion Criteria .................................................................................................42 
 
Definition of Female of Childbearing Potential ...................................................43 
5.5 
Re-screening Procedures .....................................................................................................43 
6 
STUDY TREATMENTS AND CONCOMITANT DRUGS............................................. 44 
6.1 
MOR00208 ............................................................................................................................44 
6.2 
Lenalidomide (LEN) ............................................................................................................46 
6.3 
Treatment with Study Drugs ...............................................................................................46 
6.4 
Pre-Medication for MOR00208 Infusions ..........................................................................47 
6.5 
Patient Monitoring During MOR00208 Infusion ..............................................................47 
6.6 
Criteria for Dose Modifications and Drug Discontinuation .............................................47 
 
Management of MOR00208 Infusion-Related Reactions (IRRs) ........................47 
6.6.1.1 
Grade 2 IRRs ........................................................................................................49 
6.6.1.2 
Grade 3 IRRs ........................................................................................................49 
6.6.1.3 
Grade 4 IRRs ........................................................................................................49 
 
Management of Toxicities ....................................................................................50 
6.6.2.1 
Haematological and Other Toxicities ...................................................................50 
6.6.2.2 
LEN Dose Reduction Guidelines .........................................................................53 
6.6.2.3 
Tumour Flare with LEN .......................................................................................54 
6.6.2.4 
Tumour Lysis Syndrome ......................................................................................54 
6.6.2.5 
Thromboembolism ...............................................................................................54 
6.7 
Prior and Concomitant Therapy ........................................................................................55 
6.8 
Treatment Compliance ........................................................................................................58 
6.9 
Withdrawal from Study Treatment or Study/Site Termination ......................................58 
 
Withdrawal Criteria ..............................................................................................58 
 
Study or Site Termination ....................................................................................60 
7 
VISIT ASSESSMENTS AND PROCEDURES ................................................................. 60 
7.1 
Visit Schedule .......................................................................................................................60 
7.2 
Procedures ............................................................................................................................69 
 
Screening followed by Enrolment (Start of IMP) ................................................69 
 
End of Treatment (EOT) Visit .............................................................................70 
 
MOR00208 Administration Despite Disease Progression ...................................70 
 
Safety Follow-up Visit .........................................................................................71 
 
Survival Follow-up ...............................................................................................71 
 
Diagnostic Biopsy ................................................................................................71 
 
Demographic Data/Relevant Medical History and Current Medical 
Conditions/Baseline Stage and Prognostic Classification ....................................72 
 
Vital Signs ............................................................................................................73 
 
Physical Examination (PE) ...................................................................................73 
7.2.9.1 
Full PE ..................................................................................................................73 
7.2.9.2 
Limited PE ...........................................................................................................73 

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7.2.9.3 
Body Weight and Height Measurements..............................................................74 
7.2.9.4 
B-Symptoms .........................................................................................................74 
 
Electrocardiogram ................................................................................................74 
 
Adverse Event Monitoring ...................................................................................74 
 
Monitoring of Second Primary Malignancies ......................................................74 
 
Laboratory Assessments .......................................................................................75 
7.2.13.1 
Safety and Haematology Laboratory Testing .......................................................75 
7.2.13.2 
Hepatitis Virus Serology ......................................................................................78 
7.2.13.3 
Pregnancy Testing ................................................................................................79 
7.2.13.4 
PK Assessments ...................................................................................................79 
7.2.13.5 
Immunogenicity ...................................................................................................80 
7.2.13.6 
Other Laboratory Evaluations ..............................................................................80 
 
Efficacy Assessments ...........................................................................................80 
7.2.14.1 
Tumour Imaging Assessment ...............................................................................81 
7.2.14.2 
Bone Marrow .......................................................................................................82 
8 
SAFETY MONITORING .................................................................................................... 82 
8.1 
Definition of Adverse Events, Serious Adverse Events, Adverse Events of Special 
Interest ..................................................................................................................................83 
8.2 
Adverse Event and Serious Adverse Event Recording and Reporting ...........................85 
8.3 
Pregnancies ...........................................................................................................................87 
9 
DATA HANDLING AND ARCHIVING ........................................................................... 88 
9.1 
Completing and Signing Case Report Forms ....................................................................88 
9.2 
Clinical Data Management ..................................................................................................88 
9.3 
Archiving and Filing ............................................................................................................88 
10 
STATISTICAL METHODS AND PLANNED ANALYSIS............................................. 89 
10.1 Populations for Analysis ......................................................................................................89 
10.2 Primary Endpoint ................................................................................................................89 
10.3 Secondary Endpoints ...........................................................................................................89 
10.4 General Statistical Methods ................................................................................................89 
10.5 Patient Disposition................................................................................................................90 
10.6 Analysis of Efficacy Data .....................................................................................................90 
 
Primary Efficacy Endpoint ORR ..........................................................................90 
 
Secondary Endpoints ............................................................................................91 
10.6.2.1 
Disease Control Rate (DCR) ................................................................................91 
10.6.2.2 
Duration of Response (DoR) and Time to Next Treatment (TTNT) ....................91 
10.6.2.3 
Time to Event Variables: Progression-Free Survival (PFS), Overall 
Survival (OS), and Time to Progression (TTP) ....................................................91 
10.6.2.4 
Immunogenicity Analysis ....................................................................................92 
10.6.2.5 
Pharmacokinetic Analysis ....................................................................................92 
10.6.2.6 
Biomarkers ...........................................................................................................92 
10.7 Analysis of Safety Data ........................................................................................................93 

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Adverse Events .....................................................................................................93 
 
Clinical Laboratory Evaluations ...........................................................................93 
 
Physical Examination, Vital Signs and Electrocardiogram (12-lead ECG) .........93 
10.8 Sample Size Determination .................................................................................................93 
10.9 Safety Run-In ........................................................................................................................94 
11 
SPECIAL REQUIREMENTS AND PROCEDURES ....................................................... 94 
11.1 Charters 94 
11.2 Protocol Amendments and Other Changes in Study Conduct .........................................94 
11.3 Regulatory and Ethical Considerations, Including the Informed Consent Process .......95 
11.4 Quality Control (Study Monitoring)...................................................................................95 
11.5 Quality Assurance ................................................................................................................96 
11.6 Insurance 96 
11.7 Publication Policy .................................................................................................................96 
12 
REFERENCES ..................................................................................................................... 98 
13 
APPENDICES .................................................................................................................... 102 
Appendix A: ..................................................................................................................................103 
Appendix B: ..................................................................................................................................104 
Appendix C: ..................................................................................................................................105 
Appendix D: ..................................................................................................................................106 
Appendix E: ..................................................................................................................................107 
Appendix F: ...................................................................................................................................108 
Appendix G: ..................................................................................................................................109 
 
List of Tables 
(Excluding those in the appendix) 
 
Table 1 
Definition of Infusion-Related Reaction ...................................................................... 48 
Table 2 
Haematological and Other Toxicities ........................................................................... 51 
Table 3 
Other Toxicities Judged to be Related to LEN ............................................................. 52 
Table 4 
LEN Dose Reduction Guidelines ................................................................................. 53 
Table 5 
Schedule of Assessments .............................................................................................. 61 
Table 6 
Laboratory Evaluations ................................................................................................ 77 
 
List of Figures 
Figure 1 Study design ............................................................................................................................. 38 
 

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LIST OF ABBREVIATIONS 
ABC 
Activated B-cell type 
ADCC 
Antibodydependent- cell-mediated cytotoxicity 
ADCP 
Antibody-dependent cell-mediated phagocytosis 
AE 
Adverse event 
ALC 
Absolute lymphocyte count 
ALL 
Acute lymphoblastic leukaemia 
ALT 
Alanine transaminase 
ANC 
Absolute neutrophil count 
Anti-Hbc 
Hepatitis B core antibody 
Anti-HBs 
Hepatitis B surface antibody 
Anti-HCV 
Hepatitis C virus antibody 
AP 
Alkaline phosphatase 
ASCT 
Autologous stem-cell transplantation 
AST 
Aspartate aminotransferase 
B-ALL 
B-cell acute lymphoblastic leukaemia 
BCL-2/6 
B-cell leukaemia/lymphoma protein-2/6 
BEN 
Bendamustine 
bpm 
Beats per minute (heart rate) 
BSC 
Best supportive care 
CBC 
Complete blood count 
CD19 
Cluster of differentiation 19 
CDC 
Complement-dependent cytotoxicity 
CHOP 
Cyclophosphamide, hydroxydaunorubicin (also referred to as doxorubicin or 
adriamycin), and oncovin (vincristine) plus prednisone or prednisolone 
CLL 
Chronic lymphocytic leukaemia 
CML 
Chronic myeloid leukaemia 
CNS 
Central nervous system  
COPD 
Chronic obstructive pulmonary disease 
CR 
Complete response 
CRF 
Case report form 
CRO 
Contract research organisation 
CSF 
Cerebrospinal fluid 
CT 
Computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
DHAP 
Cisplatin, cytarabine, dexamethasone 
DCR 
Disease control rate 
DLBCL 
Diffuse large B-cell lymphoma 
DLT 
Dose-limiting toxicity 
DNA 
Deoxyribonucleic acid 
DoR 
Duration of response 
DP 
Drug product 
ECG 
Electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
Electronic case report form 
EDTA 
Ethylenediaminetetraacetic acid 
EMA 
European Medicines Agency  
EOT 
End of treatment 

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ESHAP 
Etoposide, methylprednisone, cytarabine, cisplatin 
FAS 
Full analysis set 
FCBP 
Female(s) of childbearing potential 
FDG 
[18]-Fluordesoxyglucose 
FcγR 
Fc gamma receptor 
FDA 
Food and Drug Administration 
FL(-3) 
Follicular (grade 3) lymphoma 
GCB 
Germinal centre B-cell 
GCP 
Good clinical practice 
G-CSF 
Granulocyte colony-stimulating factor 
GEP 
Gene expression profiling 
GGT 
Gamma-glutamyltransferase 
GLP 
Good laboratory practice 
HbsAg 
Hepatitis B surface antigen 
HBV 
Hepatitis B virus 
HCL 
Hairy cell leukaemia 
HCV 
Hepatitis C virus 
HDC 
High-dose chemotherapy 
HIV 
Human immunodeficiency virus 
IB 
Investigator’s brochure 
ICE 
Ifosfamide, carboplatin, etoposide 
ICF 
Informed consent form 
ICH 
International Conference on Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IEC 
Independent ethics committee 
Ig 
Immunoglobulin 
IHC 
Immunohistochemistry 
IIT 
Investigator initiated trial 
IL-2 
Interleukin-2  
IMiD® 
Immunomodulatory drug 
IMP 
Investigational medicinal product 
IND 
Investigational new drug 
iNHL 
Indolent non-Hodgkin lymphoma 
IPI 
International Prognostic Index 
IRB 
Institutional/independent review board 
IRR 
Infusion-related reaction 
IV 
Intravenous 
IWG 
International Working Group 
LDH 
Lactate dehydrogenase 
LEN 
Lenalidomide 
mAb 
Monoclonal antibody 
MALT 
Mucosa-associated lymphoid tissue lymphoma 
MCL 
Mantle cell lymphoma 
MedDRA 
Medical Dictionary for Regulatory Activities 
MM 
Multiple myeloma 
MRI 
Magnetic resonance imaging 
MTD 
Maximum tolerated dose 
MYC 
v-myc avian myelocytomatosis viral oncogene homolog 
MZL 
Marginal zone lymphoma 

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NCI 
National Cancer Institute 
NHL 
Non-Hodgkin lymphoma 
NK 
Natural killer 
NOAKs 
New oral anticoagulants 
NOS 
Not otherwise specified 
NSAIDs 
Non-steroidal anti-inflammatory drugs  
NYHA 
New York Heart Association 
ORR 
Objective response rate (complete response + partial response) 
OS 
Overall survival 
PD 
Pharmacodynamics 
PE 
Physical examination 
PET 
Positron emission tomography 
PFS 
Progression-free survival 
PK 
Pharmacokinetic 
PLL 
Prolymphocytic leukaemia 
PMBL 
Primary mediastinal (thymic) large B-cell lymphoma 
p.o. 
By mouth 
PPS 
Per-protocol set 
PR 
Partial response 
PR (ECG) 
PR interval 
PT 
Preferred term 
QRS 
QRS interval 
QT 
QT interval 
RBC 
Red blood cell 
R-CHOP 
Rituximab plus cyclophosphamide, hydroxydaunorubicin (also referred to as 
doxorubicin or adriamycin), and oncovin (vincristine) plus prednisone or 
prednisolone  
REAL/WHO 
Revised European American Lymphoma/World Health Organization 
R-EPOCH 
Rituximab plus etoposide, prednisone or prednisolone, oncovin, 
cyclophosphamide, and hydroxydaunorubicin 
R-ICE 
Rituximab plus ifosfamide, carboplatin, etoposide 
RNA 
Ribonucleic acid 
rpm 
Respirations per minute (respiration rate) 
RR (ECG) 
RR interval 
R-R 
Relapsed or refractory 
R-R CLL/SLL 
Relapsed or refractory chronic lymphocytic leukaemia/small lymphocytic 
lymphoma 
R-R DLBCL 
Relapsed or refractory diffuse large B-cell lymphoma 
R-R NHL 
Relapsed or refractory non-Hodgkin lymphoma 
RTX 
Rituximab 
SAE 
Serious adverse event 
SAF 
Safety analysis set 
SAP 
Statistical analysis plan 
SCID 
Severe combined immunodeficiency 
SD 
Stable disease  
SLL 
Small lymphocytic lymphoma 
SOC 
System organ class 
SOP 
Standard operating procedure 
SPC 
Summary of Product Characteristics 

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SPD 
Sum of Product Diameter 
SPM 
Second primary malignancy 
TEAE 
Treatment emergent adverse event 
Th1 
T (thymus) helper cell 1 
TL 
Transformed lymphoma 
TLS 
Tumour Lysis Syndrome 
TFR 
Tumour flare 
TNM 
Tumour/Node/Metastasis 
TTNT 
Time to next treatment 
TTP 
Time to progression 
ULN 
Upper limit of normal 
US 
United States 
VIM 
Etoposide, ifosfamide, methotrexate 
VTE 
Venous thromboembolic event 
WBC 
White blood cell 
WFI 
Water for injection 
WHO-DDE 
World Health Organization–Drug Dictionary Enhanced 
β-HCG 
Beta-human chorionic gonadotropin 

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IND Number: 114,856 
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1 INTRODUCTION 
 
1.1 Overview of Non-Hodgkin Lymphomas 
Non-Hodgkin lymphomas (NHLs) account for approximately 5% of all new cancer cases and 
comprise a heterogeneous group of lymphoproliferative malignancies, which in 90% of cases 
are derived from B-cells. 
 
Diffuse large B-cell lymphoma (DLBCL), the most common high-grade NHL, accounts for 
approximately 40% of NHLs (Armitage and Weisenbuger, 1998; Swerdlow et al., 2008) and 
comprises 60% of all new lymphomas in the elderly population (Thieblemont and Coiffier, 
2007). The median age at the diagnosis of DLBCL is 64 years and the majority of patients present 
with advanced disease. There were an estimated 386,000 new cases of NHL worldwide in 2012, 
including 93,500 new cases in Europe and 70,400 in North America (Ferlay et al., 2014). 
 
DLBCL is a heterogeneous disorder with two major molecular subtypes identified by gene 
expression profiling (GEP): germinal centre B-cell type (GCB) and activated B-cell type (ABC). 
The latter group is often included in non-GCB type in immunohistochemistry (IHC)-based 
algorithms. The ABC (non-GCB subtype) has been associated with worse outcome.  
 
Other NHLs include mantle cell lymphoma (MCL), follicular lymphoma (FL) and other indolent 
NHLs (iNHL) such as marginal zone lymphoma (MZL), mucosa-associated and lymphoid tissue 
lymphoma (MALT). 
 
1.2 Treatment of DLBCL 
DLBCL is considered to be a chemosensitive neoplasm. Originally, CHOP (cyclophosphamide, 
doxorubicin, vincristine, and prednisone) chemotherapy was the standard first-line treatment. 
However the addition of rituximab (RTX) into CHOP-like (R-CHOP-like), anthracycline-based 
regimens has significantly improved the clinical results in patients with DLBCL, becoming the 
standard of care (Feugier et al., 2005; Habermann et al., 2006; Coiffier et al., 2002). 
 
Nevertheless, even with the availability of R-CHOP-like treatment regimens, approximately 30–
40% of patients will ultimately relapse or progress. In patients progressing or relapsing after 
first-line treatment the ultimate therapeutic goal is to be able to offer salvage chemotherapy such 
as DHAP (cisplatin, cytarabine, dexamethasone), VIM (etoposide, ifosfamide, methotrexate), 
ICE (ifosfamide, carboplatin, etoposide), or ESHAP (etoposide, methylprednisone, cytarabine, 
cisplatin), followed by high-dose chemotherapy (HDC) with autologous stem cell transplantation 
(ASCT) if the disease is still chemosensitive. HDC with ASCT is a potentially curative treatment, 
significantly improving disease-free survival and overall survival (OS) in patients with relapsed 
DLBCL (Philip et al., 1995). 
 
However, the use of HDC with stem cell support may not be appropriate, especially for patients 
with comorbidities or older age, restricting the benefit of this aggressive approach to a relatively 
small percentage of patients. For the remaining patient population, several second-line 
combination therapies are used with variable success, but the median survival for patients who 

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have relapsed after second-line therapy is less than one year, and the median survival for those 
not responding to second-line therapy is less than 6 months. 
 
Monoclonal antibody (mAb) therapy may have the potential to improve objective response rates 
(ORRs) and OS without increasing haematological toxicity. This is supported by data from 
studies investigating other CD19 mAbs, including MDX-1342, SAR3419 and MEDI-551 
(Ribrag et al., 2014; Matlawska-Wasowska et al., 2013; Younes et al., 2012; Bargou et al., 2008; 
Viardot et al., 2011). 
 
1.3  Lenalidomide in Haematological Malignancies 
Lenalidomide (LEN [Revlimid®]) belongs to the class of pharmaceutical compounds known as 
immunomodulatory drugs (IMiDs®). Although the mechanism(s) of LEN activity remain(s) 
unclear, in vitro and in vivo preclinical studies show that IMiDs® demonstrate a variety of 
biological effects (Haslett et al., 2003; Galustian et al., 2009; Pan et al., 2012; Saloura and Grivas, 
2010; Wiernik, 2013). Specifically, they: 
 inhibit the proliferation and increase the proapoptosis of NHL cells 
 costimulate CD4+ and CD8+ T-cells, thereby enhancing Th1-type cellular immunity. 
IMiDs® may inhibit T-regulatory cells which are known to suppress CD4+ T-cell activity 
in NHL 
o T-cell costimulation leads to interleukin-2 (IL-2) mediated enhanced natural 
killer (NK) effector function leading to enhanced tumour cell recognition and 
killing and increased potential for antibody dependent cell-mediated cytotoxicity 
(ADCC) 
 inhibit regulatory T-cells that are known to suppress CD4+ and CD8+ T-cell activity in 
NHL 
 exert antiangiogenic effects in the tumour microenvironment, and reduce endothelial cell 
migration. 
 
LEN has been approved by multiple health authorities: 
a. for the treatment of patients with transfusion dependent anaemia due to low- or 
intermediate-1-risk myelodysplastic syndrome (MDS) associated with the cytogenetic 
abnormality, deletion 5q, with or without additional cytogenetic abnormalities 
b. for use in combination with dexamethasone for patients with previously treated multiple 
myeloma (MM) based on significant antitumour activity 
c. for the treatment of patients with MCL whose disease has relapsed or progressed after 
two prior therapies including bortezomib. 
 
LEN has also shown activity in R-R chronic lymphocytic leukaemia (CLL)/small lymphocytic 
lymphoma (SLL) (Chanan-Khan et al., 2006). Additionally, LEN is being investigated as a 
treatment for various oncological indications, including MM, NHL and solid tumours. Studies 
have also been conducted in non-oncological indications. 
 

Product Name: MOR00208 
 
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 LEN as a Single Agent in Relapsed DLBCL 
It has been demonstrated that LEN has single-agent activity in R-R DLBCL. Wiernik et al. 
(2008) evaluated the safety and efficacy of 25 mg LEN administered orally, daily, for 52 weeks, 
until disease progression or intolerance as monotherapy in patients with R-R aggressive NHL. 
The primary endpoint was ORR; secondary endpoints included duration of response (DoR), 
progression-free survival (PFS), and safety. Forty-nine patients with a median age of 65 years 
received LEN in this study. The most common histology was DLBCL, established in 53% of 
patients, and patients had received a median of four prior treatment regimens for NHL. The ORR 
was 35% including a 12% complete response (CR)/unconfirmed CR rate. Of patients with stable 
disease (SD) or partial response (PR) at first assessment, 25% improved with continued 
treatment. Estimated median DoR was 6.2 months, and median PFS was 4.0 months. The most 
common grade 4 adverse events (AEs) were neutropenia (8.2%) and thrombocytopenia (8.2%). 
 
Similarly, in a phase II study of LEN in patients with R-R DLBCL, MCL, follicular grade 3 
lymphoma (FL-3), or transformed lymphoma (TL) patients received oral LEN 25 mg on days 1–
21 every 28 days as tolerated or until progression (Witzig et al., 2011). Two hundred and 
seventeen patients were enrolled and received LEN. The ORR was 35% (77/217), with 13% 
(29/217) of patients achieving CRs, 22% (48/217) PRs, and 21% (45/217) with SD. The ORR 
for DLBCL was 28% (30/108). Median PFS for all 217 patients was 3.7 months. For 
77 responders, the median DoR was 10.6 months. The most common AE was myelosuppression, 
with grade 4 neutropenia and thrombocytopenia in 17% and 6% of patients, respectively. 
 
Zinzani et al. (2014) have shown in a retrospective, multicentre study that LEN monotherapy is 
effective and safe for heavily pretreated patients with R-R NHL. The ORR in 64 evaluable 
patients was 42.2% and was similar among patients receiving 10, 15 or 25 mg/day LEN. ORR 
in patients with MCL, DLBCL and FL were 45.5%, 42.1% and 20%, respectively. Mean DoR 
in patients receiving any LEN dose was 10.5 months; 1-year PFS and OS rates were 50.3% and 
82.6%, respectively. 
 
Additionally it has been shown that single agent LEN was active in heavily pretreated patients 
with aggressive, R-R NHL subsequent to a prior ASCT (Vose et al., 2013). 
 
 LEN and DLBCL Subtype 
A retrospective analysis of the outcomes of patients with GCB vs non-GCB DLBCL treated with 
LEN was performed by Hernandez-Ilizaliturri et al. (2011). Forty patients with R-R DLBCL 
were included (24 men; 16 women; median age, 66 years; median of four prior treatments, 
including RTX-containing chemotherapy). Patients were classified as having GCB (n=23) or 
non-GCB (n=17) DLBCL. This analysis showed that patients with R-R DLBCL with a non-GCB 
phenotype had a higher ORR and CR rate and longer PFS when treated with LEN than those 
with a GCB phenotype, despite similarities in terms of disease stage, International Prognostic 
Index (IPI) score, number of prior treatments, and RTX resistance. 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Page 28 of 110 
 LEN in Combination with RTX in R-R DLBCL 
The combination of LEN with RTX has been shown to be active and well tolerated with a 
manageable toxicity profile in heavily pretreated patients with R-R DLBCL. Zinzani et al. (2011) 
conducted a phase II study in heavily pretreated, elderly patients with R-R DLBCL. The 
induction treatment with oral LEN (20 mg/day for 21 days of each 28-day cycle) combined with 
RTX followed by LEN maintenance therapy resulted in a 35% CR rate at a median follow-up of 
16 months. LEN maintenance in responding patients led to continuation of their initial response. 
The most common AEs included neutropenia and thrombocytopenia. 
 
Wang et al. (2013) assessed the clinical activity of oral LEN and RTX in 45 patients with R-R 
DLBCL (n=32), transformed large cell lymphoma (n=9) or FL-3 (n=4) who had received 
1-4 prior lines of treatment. Patients were given 20 mg oral LEN on Days 1–21 of each 28-day 
cycle, and RTX. The ORR was 33%; median DoR was 10.2 months. Median PFS and OS were 
3.7 and 10.7 months, respectively. Grade 3/4 haematological toxicities included neutropenia 
(53%), lymphopenia (40%), thrombocytopenia (33%), leukopenia (27%) and anaemia (18%). 
 
Ivanov et al. (2014) analysed clinical outcomes in 17 patients with R-R DLBCL treated with 
LEN at a dose of 25 mg/day for 21/28 days and RTX for a maximum of 12 months. The ORR 
was 41.2% with 35.3% of patients achieving a CR, while the median DoR was 26.5 months at a 
median follow-up of 24.9 months. The estimated 24-month OS and PFS rates were 45% and 
38%, respectively. The most common AEs were thrombocytopenia and neutropenia. 
 
 LEN in Combination with R-CHOP or R-ICE in DLBCL  
A phase I study established the maximum tolerated dose (MTD) of LEN that could be combined 
with R-CHOP chemotherapy for adults with newly diagnosed aggressive B-cell NHL 
(Nowakowski et al., 2011). Eligible patients were those with newly diagnosed, untreated CD20-
positive DLBCL or FL-3. Patients received oral LEN on Days 1–10 with standard dose R-CHOP 
administered over 21 days. All patients received pegfilgrastim on Day 2 of the cycle and aspirin 
prophylaxis. The LEN dose levels tested were 15, 20 and 25 mg. Twenty-four patients were 
enrolled. The median age was 65 (range 35–82) years and 54% (13/24) were over 60 years. Three 
patients received 15 mg, 3 received 20 mg and 18 received 25 mg of LEN. No dose-limiting 
toxicity (DLT) was found. LEN dose escalation beyond 25 mg Days 1–10 was not performed 
and LEN 25 mg Days 1–10 was the recommended dose for phase II studies. The incidence of 
grade 4 neutropenia and thrombocytopenia was 67% and 21%, respectively. The incidence of 
febrile neutropenia requiring hospitalisation was 4% and there were no bleeding or toxicity 
related deaths. There were no delays in chemotherapy due to cytopenias. The ORR was 100% 
with a CR rate of 77%. It was shown that the combination of LEN with the R-CHOP regimen 
was safe and effective for the treatment of aggressive lymphomas including DLBCL. In a 
subsequent phase II study, Nowakowski et al. (2015) have not only confirmed their initial 
observation concerning clinical efficacy, but also established that the addition of LEN to R-
CHOP mitigates the negative impact of the non-GCB phenotype on patient outcome. 
 
 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Page 29 of 110 
Additionally, studies conducted by Fondazione Italian Linfomi have shown that combining 
15 mg oral LEN on Days 1–14 of 21-day cycles with standard doses of R-CHOP chemotherapy 
is an effective and safe treatment modality in untreated, elderly patients with DLBCL (Chiapella 
et al., 2013; Vitolo et al., 2014). 
 
Feldman et al. (2014) showed that combining LEN (at doses up to 25 mg daily) with RTX in 
combination with ICE (R-ICE) was associated with promising clinical activity, with no 
additional toxicological burden, in patients with R-R DLBCL. 
 
1.4  Overview of MOR00208 
MOR00208 (synonym: XmAb®5574) is an Fc-engineered mAb that binds to the human B-cell 
surface antigen CD19. MOR00208 possesses significantly increased tumour cytotoxicity when 
compared with the parental, non-engineered, murine 4G7 CD19 antibody. The increased binding 
of MOR00208 to Fc gamma receptors (FcγR), due to the engineered mutations, significantly 
enhances in vitro ADCC, antibody-dependent cell-mediated phagocytosis (ADCP), and its direct 
cytotoxic effects (apoptosis) on the tumour cells compared with the non-engineered parental 
murine antibody. MOR00208 has not been shown to mediate complement-dependent 
cytotoxicity (CDC). 
 
More specifically, in preclinical studies, MOR00208 has been shown to significantly enhance in 
vitro ADCC, ADCP, and direct cytotoxic effects (apoptosis) on CD19+ tumour cell lines 
spanning a broad range of human lymphomas and leukaemias (Burkitt lymphoma, CLL, hairy 
cell leukaemia [HCL], CD19+ chronic myeloid leukaemia [CML], DLBCL and acute 
lymphoblastic leukaemia [ALL]), expressing levels of CD19 antigen ranging from 15,000 to 
105,000 molecules/cell. Similar effects were also noted in relation to 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 range observed for NHL B-cells (Ginaldi et al., 
1998; Olejniczak et al., 2006). MOR00208 has also shown superior efficacy to its non-
engineered parental antibody in relation to its ability to induce a marked reduction in tumour 
growth, inhibit tumour growth rate and increase survival in vivo in xenograft models of human 
lymphoma in severe combined immunodeficiency (SCID) mice (Investigator’s Brochure [IB]). 
 
The pharmacodynamic (PD) interactions of MOR00208 in combination with two standard-of-
care drugs fludarabine and bendamustine (BEN), and one investigational drug, LEN used in the 
treatment of patients with CLL and NHL, were investigated in a human intravenous (IV) 
lymphoma model in SCID mice (see IB). In this orthotopic model for disseminated B-cell 
malignancies, the median survival was superior for all of the groups receiving MOR00208 
combination therapy (with fludarabine, BEN or lenalidomide) when compared with the groups 
receiving MOR00208 monotherapy. The LEN xenograft study showed a clear potentiation of 
the efficacy benefit of MOR00208 (3 mg/kg) and LEN (100/200 mg/kg) combination therapy 
compared with the respective monotherapies (1.5 x increase in median lifespan). 
 
Tissue cross-reactivity studies have shown that the pattern and distribution of MOR00208 
binding to cynomolgus monkey tissues closely parallels those of human tissues. Flow cytometry 
experiments show MOR00208 binding to human and cynomolgus monkey B-cells, but not to the 
B-cells of other common laboratory species (such as rat, mouse, rabbit and dog). Therefore, 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 30 of 110 
pharmacology studies were restricted to human and cynomolgus monkey cell-based in vitro 
systems, CD19+ human B-cell tumour xenograft models in SCID mice, and cynomolgus 
monkeys in vivo. In in vivo studies in cynomolgus monkeys, MOR00208 was shown to induce 
B-lymphocyte depletion in peripheral blood, bone marrow, spleen and inguinal lymph nodes. 
Cynomolgus monkeys were also judged to be the only relevant common laboratory species for 
toxicity studies. 
 
The results of studies evaluating the pharmacokinetics (PK), PD and toxicity of MOR00208 in 
cynomolgus monkeys, are provided in the IB. The findings in four preclinical studies were 
limited to the expected pharmacological effects of MOR00208, with no reports of unanticipated 
toxicity. 
 
The four studies, all conducted in cynomolgus monkeys included: a 26-week single 10.0 mg/kg 
dose, PK, PD and toxicity study; a 28-day single IV dose, dose-ranging (0.3, 1.0 and 3.0 mg/kg) 
PK/PD study; a 29-day, single-dose (3.0 mg/kg) study comparing MOR00208 with two other 
CD19 antibodies with different Fc regions; and an 8-week toxicity study in which MOR00208 
was administered IV every 2 weeks at a dose of 2.0, 10.0 or 50.0 mg/kg for 8 consecutive weeks 
with a 90-day recovery period. The aim of the latter Good Laboratory Practice (GLP)-compliant, 
multiple-dose toxicology study was to support the use of MOR00208 in human clinical studies. 
Other than the expected dose-related decreases in B-lymphocyte levels and cellularity in 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 50.0 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 of structures other than the expected 
mononuclear leucocytes, lymphocytes and haematopoietic precursor cells was observed. 
 
 Clinical Experience with MOR00208 
1.4.1.1 Protocol No. XmAb®5574-01 
A Phase 1 Study of mAb®5574 to Evaluate the Safety, Tolerability, and Pharmacokinetics 
in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia 
 
The first study in humans was a phase I study (now completed) exploring the use of MOR00208 
(also known as XmAb®5574) in adult patients diagnosed according to International Workshop 
on CLL guidelines (Hallek et al., 2008) with active, treatment-requiring, R-R CLL/SLL. The 
results of the study were reported by Woyach et al. (2014). 
 
A total of 27 patients were treated with MOR00208 IV in 6 dose cohorts: 0.3 mg/kg (n=1), 
1.0 mg/kg (n=1), 3.0 mg/kg (n=3), 6.0 mg/kg (n=3), 9.0 mg/kg (n=3) and 12.0 mg/kg (n=16) on 
a weekly schedule for 8 weeks (2 cycles), with an extra dose administered on Day 4 of Cycle 1. 
Patients received MOR00208 via IV infusion over a period of 2 hours on Days 1, 4, 8, 15 and 
22 of Cycle 1 and Days 1, 8, 15 and 22 of Cycle 2 for a total of 9 doses. Patients were evaluated 
at weeks 4, 8 and 12 following completion of Cycle 2 for safety and preliminary antitumour 
activity. Patients enrolled in the expansion phase of cohort 6 (12.0 mg/kg) received an additional 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 31 of 110 
four monthly doses of MOR00208 after completing the initial two 28-day cycles of therapy, if 
there was no evidence of disease progression or intolerable drug-related toxicity. 
 
All 27 enrolled patients received at least one dose of MOR00208, with 22 patients receiving all 
nine of the planned initial doses. Of the five patients who did not receive all nine doses, two 
experienced disease progression, one experienced a DLT (grade 4 neutropenia lasting at least 
7 days), one was omitted from the study by the treating physician, and one completed the study 
but missed a dose due to an AE (grade 3 thrombocytopenia). No patients had dose reductions 
during the study. Five patients had at least one dose delayed due to an AE. Eighteen patients had 
their infusion paused at least once due to an infusion-related reaction (IRR). Eight patients were 
included in a maintenance cohort. One patient received only three additional infusions and the 
other seven patients received all four planned additional infusions. 
 
All 27 patients treated with MOR00208 experienced treatment-emergent AEs (TEAEs) and 
24 patients experienced TEAEs that were assessed by the investigator to be possibly or probably 
related to MOR00208. No patient deaths were reported either on study or during the 12-week 
follow-up phase of the study. One DLT, grade 4 neutropenia lasting at least 7 days, was observed 
during the study in one of 16 patients treated at the maximum-administered 12.0 mg/kg dose 
level. Eight treatment-emergent serious AEs (SAEs) were reported in six patients; one at the 0.3 
mg/kg dose level and seven at the 12.0 mg/kg dose-level. Only two were considered to be related 
to the study drug: one of grade 3 febrile neutropenia in the same patient who experienced the 
DLT and one of grade 3 tumour lysis syndrome (TLS) in a patient receiving his first dose of 
study drug at 12.0 mg/kg. In the latter case, after resolution of the SAE, the patient continued to 
receive additional doses of MOR00208 without further complications. The six unrelated SAEs 
were two cases of pneumonia, sinusitis, acute otitis media and bacterial infection, all of them of 
grade 3 in severity and one grade 1 rash. With a data cut-off date of 28 March 2013, the most 
common TEAEs were IRRs in 66.7% of patients, diarrhoea, neutropenia, thrombocytopenia 
(29.6% of patients each), anaemia, increased alanine transaminase (ALT), hypoalbuminaemia, 
hypocalcaemia, insomnia and muscle spasms (22.2% of patients each) and increased aspartate 
aminotransferase (AST), headache, hyperglycaemia, pyrexia, rash and upper respiratory tract 
infection (18.5% of patients each). 
 
Twenty seven patients were evaluable for response. Blood disease cleared in the majority of 
patients, with a median reduction in absolute lymphocyte count (ALC) from baseline of 90.8% 
and a decrease in CLL cell count. Based upon physical examination and laboratory studies alone, 
18 patients (66.7%) achieved a PR, while the remaining nine (33.3%) achieved stable disease 
(SD). Using computed tomography (CT) criteria alongside examination and laboratory data, 
eight patients (29.6%) achieved a PR while an additional 16 patients (59.3%) achieved SD. Two 
patients had progressive disease according to CT criteria. 
 
Considering only those 16 patients who received the 12 mg/kg dose, 12 (75%) achieved a PR 
according to physical examination criteria while six (37.5%) achieved a PR according to CT 
criteria. Patients who responded according to physical examination criteria tended to do so 
quickly, with 14 of 18 patients achieving a PR by the first response evaluation (Cycle 2, Day 1). 
Patient responses according to CT criteria were slower, with three of eight patients achieving a 
PR by Cycle 2 (Day 28), three by the 4-week follow-up time point, and two patients in the 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 32 of 110 
expansion cohort by Cycle 5 and Cycle 7, respectively. Across all treatment groups eight (29.6%) 
and sixteen patients (59.3%) had a PR and SD, respectively. In the 12.0 mg/kg treatment group 
only, six (37.5%) and nine of 16 (56.3%) had best responses of PR and SD, respectively. The 
disease control rate was 88.9% (8 PR, 16 SD) across all cohorts, and 93.8% (6 PR, 9 SD) in the 
12 mg/kg cohort. 
 
At evaluation, 12 weeks post-Cycle 2 (Day 28), five patients (18.5%) had progressed according 
to CT criteria and eight (29.6%) according to physical examination criteria. No patient died 
during the observation period. PFS for all patients, including those in the extended treatment 
cohort, was 199 days (95% CI, 168–299) and for patients in the extended treatment cohort alone, 
PFS was 420 days (95% CI, 168–not reached). 
 
The results of the first clinical study showed MOR00208 to have an acceptable safety profile as 
well as providing preliminary evidence of antitumour activity in patients with high-risk, heavily 
pretreated CLL. Although IRRs were common, they were limited to grade 1/2. Since the MTD 
for MOR00208 was not established, due to the occurrence of only one DLT in the 12.0 mg/kg 
dose cohort, this dose of MOR00208 was selected for use in subsequent clinical studies. 
Promising antitumour activity of MOR00208, combined with the absence of safety signal, 
justified movement to phase II. 
 
Protocol MOR208C202 
A Phase IIa, Single-Arm, Open-Label Study of MOR00208, a Humanised Fc-Engineered Anti-
CD19 Antibody, in Patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia 
(B-ALL) 
This study is completed (study was terminated prematurely due to slow recruitment after 22 out 
of planned 30 patients were enrolled). For details, please refer to the MOR00208 IB. 
 
1.4.1.2 Ongoing Studies 
The following studies are ongoing and indicate a positive risk-benefit ratio for the patients so 
far. Details of safety and efficacy data will be reported on an ongoing basis in the IB. The studies 
are: 
 
Protocol MOR208C201 
A Phase IIa, Open-Label, Multicentre Study of Single-Agent MOR00208, an Fc-Optimised Anti-
CD19 Antibody, in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma. 
 
Protocol OSU-13031 
A Phase II Study of MOR00208 in combination with LEN for Patients with Relapsed or 
Refractory Chronic Lymphocytic Leukaemia (CLL)/Small Lymphocytic Lymphoma 
(SLL)/Prolymphocytic Leukaemia (PLL) or Patients with untreated CLL/SLL/PLL Investigator 
Initiated Trial (IIT). 
 
Protocol MOR208C204 
A Phase II/III, Randomised, Multicentre Study of MOR00208 with Bendamustine versus 
Rituximab with Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 33 of 110 
Lymphoma (R-R DLBCL) Who Are Not Eligible for High-Dose Chemotherapy (HDC) and 
Autologous Stem-Cell Transplantation (ASCT). 
 
Protocol MOR208C205 
A Phase II, Two-Cohort, Open-Label, Multicenter Study to Evaluate the Safety and Preliminary 
Efficacy of MOR00208 Combined with Idelalisib or Venetoclax in Patients with Relapsed or 
Refractory CLL/SLL Previously Treated with Bruton’s Tyrosine Kinase (BTK) Inhibitor. 
 
 Safety of MOR00208  
MOR00208 has a novel mechanism of action that may have the potential to add to the care of 
patients with NHL. Based on the available data from the completed clinical study of MOR00208 
(Protocol XmAb®5574-01), the preliminary data from the ongoing MOR208C201 clinical study, 
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 study (e.g., by the inclusion 
and exclusion criteria) and by frequent monitoring of potential adverse drug reactions throughout 
the entire study. Based on the results of the phase I clinical study of MOR00208 in patients with 
CLL/SLL (Woyach et al., 2014), and the preliminary results of the MOR208C201 and 
MOR208202 studies, the anticipated possible risks associated with administration of MOR00208 
to patients include the following AEs (incidence > 4%) with a suspected relationship to 
MOR00208 treatment: 
 IRRs (mostly Grade ½) 
 Febrile neutropenia 
 Neutropenia 
 Thrombocytopenia 
 Tumour lysis syndrome 
 Upper respiratory tract infections 
 Fatigue 
 Chills 
 Pyrexia 
 Nausea 
 Diarrhoea 
 Headache 
 Rash 
 Aspartate aminotransferase (AST) and alanine transaminase (ALT) increases. 
 
Since a major pharmacological effect of MOR00208 is B-cell depletion, the risks associated with 
the use of approved B-cell depleting therapeutics based on the labelling of other agents with 
similar effects should be considered. The anticipated possible risks include: B-cell depletion, 
ALC reduction, IRRs, TLS, neutropenia/thrombocytopenia, hepatitis B reactivation, progressive 
multifocal leukoencephalopathy, mucocutaneous reactions and infections. 
 
The possible risks associated with the administration of MOR00208 are described in detail in the 
MOR00208 IB. 
 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 34 of 110 
2 STUDY PURPOSE/RATIONALE 
Despite recent improvements in the management of DLBCL, approximately 30–40% of patients 
with DLBCL treated with R-CHOP relapse following initial immunochemotherapy (Coiffier et 
al., 2002; Feugier et al., 2005; Sehn et al., 2005; Habermann et al., 2006; Pfreundschuh et al., 
2006). Although a significant number of patients with R-R aggressive NHL can be salvaged with 
HDC and subsequent ASCT, the majority will succumb to the disease. Thus, the development of 
a more effective initial therapy in aggressive NHL is essential to improve long-term outcomes. 
 
LEN has been shown to have significant activity in relapsed aggressive B-cell NHL either alone 
or in combination with immunochemotherapeutic regimens. The mechanism of action of LEN is 
complex and involves 
immune modulation, 
antiangiogenesis, modulation of the 
microenvironment and direct antitumour activity (Hasslet et al., 2003; Zhang et al., 2005). 
 
As stated previously, the effects of MOR00208 appear to involve ADCC, ADCP, and direct 
cytotoxic activity (apoptosis). The B-lymphocyte lineage-specific surface antigen CD19 is the 
earliest and most broadly expressed of the selective B-cell markers, and is highly expressed on 
the malignant cells of most patients with B-cell NHL. As a consequence, it can be envisaged that 
a CD19 antibody may have clinical utility as a new therapeutic approach for the treatment of 
patients with B-cell malignancies. This hypothesis is supported by the preliminary results of 
ongoing clinical studies involving various CD19-targeting mAbs (Topp el al., 2012; Raufi et al., 
2013; Goswami et al., 2012) and the approval of blinatumomab for the treatment of patients with 
Philadelphia chromosome-negative, R-R B-cell ALL. 
 
As RTX-based regimens have become standard first-line treatment in DLBCL, the efficacy of 
RTX combined with chemotherapy in the second-line setting has decreased and there is a need 
for new therapies in patients progressing or relapsing after first- or second-line RTX-based 
treatment. It is anticipated that by using MOR00208 instead of RTX, it might be possible to 
partially overcome the RTX resistance in R-R NHL, improving ORRs and OS. Data from a phase 
I study in patients with R-R CLL/SLL (Woyach et al., 2014) and an ongoing phase IIa study in 
patients with R-R B-cell NHL previously treated with RTX demonstrate that MOR00208 is well-
tolerated, with a potential clinical benefit in patients with R-R DLBCL (Blum et al., 2014). 
 
MOR00208 and LEN, both as single agents and in combination show antileukaemic and 
antilymphoma activity in vivo and in vitro. The pattern of AEs is different. Recent data 
demonstrate that the modulation of immunoeffector cells by LEN enhances the NK-mediated 
ADCC exerted by MOR00208, increasing cancer cell killing compared with that seen with the 
single drugs (Awan et al., 2010). It seems justified to assume that this effect may be especially 
evident during chronic administration of LEN. 
 
Since the MTD for MOR00208 was not established during the course of the previous studies the 
12.0 mg/kg dose of MOR00208 was selected for use in subsequent clinical studies. 
 
 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Page 35 of 110 
The LEN starting dose is primarily based on a review of published data and the recommendations 
of expert clinicians. The published studies indicate a consistent, manageable and comparable 
(between studies) toxicity profile for patients with DLBCL beginning treatment with LEN, 25 
mg daily (Wiernik et al., 2008; Witzig et al., 2011), or a combination of 20–25 mg LEN with 
RTX (Zinzani et al., 2011; Wang et al., 2013; Ivanov et al., 2014) or R-CHOP (Nowakowski et 
al., 2011; Nowakowski et al., 2015; Vitolo et al., 2013). In the light of the available evidence, 
expert clinicians who were consulted thought an efficacious dose of LEN to be in the range of 
20–25 mg in patients with R-R DLBCL. 
 
As a result, MorphoSys designed MOR208C203 as an open-label, single-arm prospective phase 
II study investigating the safety, antitumour activity and preliminary efficacy of LEN in 
combination with MOR00208 in adult patients with R-R DLBCL who are not candidates for 
ASCT. The study will consist of two parts, which will be performed sequentially. The first part 
of the study (safety run-in) will conclude with an evaluation of safety data. The outcome of this 
evaluation will provide a recommendation for the LEN starting dose to be used in the following 
part of the study. The starting dose is 25 mg LEN daily on Days 1–21 of each 28-day cycle 
followed by a step-wise dose de-escalation if not tolerated. 
 
In this study, several correlative analyses may be conducted; for example, biomarkers that could 
be predictive of response to this therapeutic combination may be assessed. These markers may 
be genetic in nature, cellular, or protein-based and a range of laboratory methodologies may be 
used for their evaluation and possible quantitation. When relevant, the markers can be evaluated 
in the context of PK and clinical response analyses. 
 
 
3 STUDY OBJECTIVES 
 
3.1 Primary Objective 
To determine the activity of a combination of LEN with MOR00208 in terms of objective 
response rate (ORR = CR + PR) in adult patients with R-R DLBCL. 
 
3.2 Secondary Objectives 
1. To determine the disease control rate (DCR = CR + PR + SD) 
2. To determine the duration of response (DoR) 
3. To determine the activity of a combination of LEN with MOR00208 in terms of 
progression-free survival (PFS) 
4. To determine the overall survival (OS) 
5. To determine time to progression (TTP) 
6. To determine the time to next treatment (TTNT) 
7. To determine the safety of LEN combined with MOR00208 assessed according to 
the frequency and severity of adverse events (AEs) 
8. To assess the potential immunogenicity of MOR00208 
9. To assess the PK of MOR00208 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Page 36 of 110 
10. To make a preliminary evaluation of ORR, DCR, DoR, PFS, OS, TTP and TTNT in 
patients treated with a combination of LEN plus MOR00208 in cohorts with a “low 
risk”, “low-intermediate”, “high-intermediate” and “high” International Prognostic 
Index (IPI) (see Appendix B) 
11. To compare each patient’s TTP on LEN plus MOR00208 with the TTP of their most 
recent prior therapy 
12. To correlate efficacy parameters with certain biomarkers (e.g., baseline tumour CD19 
expression level, peripheral NK cell count, constitutional FcγRIIIa and FcγRIIa 
polymorphism status). 
 
 
4 STUDY ENDPOINTS 
 
4.1 Primary Endpoint: 
1. ORR, defined as the proportion of complete and partial responders (ORR = CR + 
PR). 
 
4.2 Secondary Endpoints: 
2. DCR, defined as the proportion of patients having CR or PR or stable disease (SD) 
(DCR = ORR + SD); DoR, defined as the time between the initial time point of 
tumour response and the first time point where a change in response is detailed 
(specifically, the duration of CRs or PRs until progression or relapse will be 
evaluated); PFS, defined as the time between first IMP dosing and tumour 
progression or death from any cause, whichever occurs first; TTP, defined as the time 
from first IMP dosing until time of progression (the only events of interest are limited 
to disease progression and death from lymphoma - death from other causes will not 
be considered in relation to the TTP evaluation); OS, defined as time from first IMP 
dosing to the date of death; time to next treatment (TTNT) 
3. Incidence and severity of AEs 
4. Determination and characterisation of a potential anti-MOR00208 antibody 
formation 
5. PK analysis of MOR00208 
6. Absolute and percentage change from baseline in measurements of B-, T- and NK 
cell populations  
7. Analysis of exploratory and diagnostic biomarkers from blood and tumour tissue 
(e.g., CD19, CD20, BCL-2, and BCL-6 expression, CD16 expression on NK cells, 
ADCC capacity), gene expression profiling for cell of origin subtyping and evaluation 
of AEs and ORR stratified by FcγRIIIa and FcγRIIa polymorphism, are planned to 
be investigated during the course of the study. 
 
 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 37 of 110 
5 INVESTIGATIONAL PLAN 
 
5.1 Study Design 
 Protocol-specific definitions 
For the purposes of this protocol, primary refractory disease is defined as a disease progressing 
in the course of the first line treatment as per International Working Group response criteria 
(Cheson et al., 2007), and / or, showing a response of less than a PR to first-line treatment or 
disease recurrence/progression within < 6 months from the completion of first-line therapy. 
 
Disease refractory to last treatment is defined as having had less than a partial response to the 
most recently administered systemic therapy. 
 
Relapsed/progressive/recurrent disease reflects the appearance of any new lesions or increase 
by ≥50% of previously involved sites from nadir according to the International Working Group 
response criteria (Cheson et al., 2007) after the most recent systemic therapy. 
 
 Description of study design 
This is a single-arm, multicentre, open-label phase II, study of LEN combined with MOR00208 
in adult patients with DLBCL who have relapsed after or are refractory to at least one, but no 
more than three previous systemic regimens administered for the treatment of their DLBCL and 
who are not candidates for HDC and subsequent ASCT and are thus considered to have 
exhausted their therapeutic options for demonstrable clinical benefit. One prior therapy line must 
include an anti-CD20 targeted therapy (e.g., RTX). 
 
Patients with primary refractory DLBCL or, patients with known "double/triple hit" DLBCL 
genetics or those who have undergone previous allogenic stem cell transplantation are not 
eligible for study participation. Additionally patients with a history of ASCT ≤3 months prior to 
the requirement to provide signed informed consent cannot be included in the study. 
 
This study will consist of two parts, which will be performed sequentially. During the course of 
the first part, six patients will be enrolled in the study and will complete the first cycle of study 
treatment. Once the sixth patient in the cohort has completed Cycle 1 Day 22 visit, a Safety 
Review Panel which consists of the sponsor, a representative of the participating investigators 
and two independent expert clinical haematologist will perform a clinical safety review based on 
the number and type of AEs occurring during the first cycle and on laboratory values 
(biochemistry and haematology). A LEN dose will be considered tolerated or in need of 
reduction after discussion of these data between the sponsor’s Clinical Program Leader (or 
designee), the sponsor’s Drug Safety Officer (or designee), a representative of the participating 
investigators and two expert clinical haematologists who are not participating in the study. The 
second part of the study will only be opened for enrolment by the sponsor following the outcome 
of this discussion. 
 
 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Treatment consisting of LEN and MOR00208 combination will be administered up to twelve 
28-day cycles (Figure 1) at specified dose levels. 
 
 
Figure 1 Study design 
 
Abbreviations: EOT=end of treatment; FU=follow-up; LEN=lenalidomide; R-R DLBCL=relapsed or refractory diffuse large B-
cell lymphoma; SD=stable disease. 
 
 
MOR00208 dose: 12 mg/kg 
For the first 3 cycles (Cycles 1-3) of the study each cycle will consist of a MOR00208 infusion 
on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally a loading dose will be 
administered on Day 4 of Cycle 1. Thereafter MOR00208 will be administered on a bi-weekly 
(every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. 
 
MOR00208 can be administered until disease progression, or unacceptable toxicity or 
discontinuation for any other reason, whichever comes first. It is up to the investigator to decide, 
according to the individual risk/benefit ratio, if the patient should continue on MOR00208 in 
spite of disease progression (refer to Section 7.2.3). 
 
LEN: 
Patients will self-administer a starting dose of 25 mg oral LEN daily on Days 1–21 of each cycle. 
Treatment with LEN may be modified in a de-escalating fashion or discontinued based upon 
clinical and laboratory findings. Detailed dose modification guidelines to manage haematologic 
and/or other toxicities are provided in the respective sections of the protocol. 
 
LEN can be given for up to 12 cycles in total. 
 
Treatment with LEN will have to be stopped in case of disease progression, or unacceptable 
toxicity, or discontinuation for any other reason, whichever comes first. 
 
Objective disease response assessments will be made according to the revised response criteria 
based on the guidelines of the International Working Group (IWG) reported by Cheson et al. 
(2007). The data used for the primary statistical analyses will be derived from a central 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 39 of 110 
independent review of the radiological + clinical disease assessments. A charter outlining the 
central imaging plus clinical assessment will be prepared. 
 
Approximately 80 patients with R-R DLBCL who meet the inclusion criteria and have none of 
the exclusion criteria will be enrolled in the study. This study will be conducted under a United 
States (US) Food and Drug Administration (FDA) Investigational New Drug (IND) application. 
 
5.2 Safety Run-in 
As the combination of MOR00208 with LEN has not previously been evaluated in a clinical 
study, an evaluation of safety data will occur after the first 6 patients have been accrued at the 
starting dose level of 25 mg LEN daily and 12 mg/kg MOR00208 Days 1, 8, 15 and 22 with an 
additional loading dose on Day 4 of Cycle 1. 
 
To enable the assessment of individual safety parameters by the investigators these patients will 
be enrolled sequentially with a 48 hours lag period between enrolment (same as start of treatment 
with study drugs, or Cycle 1 Day 1 Visit) of two consecutive patients. Accrual will be held until 
all patients have been followed for one treatment cycle. Once the sixth patient in the cohort has 
completed the Cycle 1 Day 22 visit, an evaluation based on the number and type of AEs occurring 
during the first cycle and laboratory values (biochemistry and haematology) will be performed 
by the sponsor’s Clinical Program Leader (or designee), the sponsor’s Drug Safety Officer (or 
designee), a representative of the participating investigators, and two expert clinical 
haematologists who are not participating in the study. The second part of the study will only be 
opened for enrolment by the sponsor following the outcome of this discussion. 
 
The outcome of this safety run-in evaluation will provide a recommendation on the starting dose 
of LEN to be used in the following part of the study. Patients involved in the safety run-in will 
continue the study as per protocol. 
 
5.3 Study Duration 
 Study Conduct 
The study duration per patient will be at least 5 years including periods of screening (up to 28 
days from signature of the Informed Consent Form (ICF), the treatment period (maximum 12 
cycles for LEN + MOR00208 followed by MOR00208 monotherapy thereafter) and the survival 
follow-up phase. MOR00208 can be administered until disease progression as described in 
Section 5.1.2.  
 
The survival follow-up phase begins with the End of Treatment (EOT) Visit (Section 7.2.2). 
Patients will have an on-site safety evaluation visit 30-days after last administration of study 
treatment (LEN + MOR208 combination or either LEN or MOR208 if one of these two drugs 
was discontinued earlier) (30-Day Follow-up Visit). All patients discontinued for any reason 
other than withdrawal of consent, or death, will be contacted every 90 days by phone from the 
date of the 30-Day (Safety) Follow-up Visit until end of study, or until withdrawal of consent, 
or death, whichever comes first. 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 40 of 110 
 End of Study 
The end of the study is defined as the date of the last visit of the last patient completing 5 years 
study duration.  If any patient is on treatment at the end of the study and MOR00208 is not yet 
commercially available, patients will be switched to alternative methods of supply with 
MOR00208, upon assessment of a clinical benefit of continued treatment by the investigator, 
and in accordance with the local regulatory guidance. Upon study closure, MorphoSys will notify 
the applicable regulatory agencies in accordance with local requirements. 
 
 
 
5.4 Patient Selection Criteria 
 Inclusion Criteria 
Patients must satisfy the following criteria to be enrolled in the study: 
 
Diagnosis/Study Population 
1. Age > 18 years 
2. Histologically confirmed diagnosis of DLBCL not otherwise specified (NOS); 
T cell/histiocyte rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus (EBV) 
positive DLBCL of the elderly (EBV-positive DLBCL), Grade 3b Follicular 
Lymphoma, Composite lymphoma with a DLBCL component with a subsequent 
DLBCL relapse, according to the Revised European American Lymphoma/World 
Health Organization (REAL/WHO) classification. Additionally, patients with the 
evidence of histological transformation to DLBCL from an earlier diagnosis of low 
grade lymphoma (i.e., an indolent pathology such as follicular lymphoma, marginal 
zone lymphoma, chronic lymphocytic leukaemia) into DLBCL with a subsequent 
DLBCL relapse are also eligible.  
3. Fresh tumour tissue for central pathology review and correlative studies must be 
provided as an adjunct to participation in this study. Should it not be possible to obtain 
a fresh tumour tissue sample from the patient, archival paraffin embedded tumour 
tissue acquired ≤3 years prior to screening for this protocol must be available for this 
purpose.  
4. Patients must have: 
a) relapsed and/or refractory disease as defined in the protocol (Section 5.1) 
b) at least one bidimensionally measurable disease site. The lesion must have a 
greatest transverse diameter of ≥1.5 cm and greatest perpendicular diameter of 
≥1.0 cm at baseline. The lesion must be positive on PET scan (for definition see 
Juweid et al., 2007) 
c) received at least one, but no more than three previous systemic regimens for the 
treatment of DLBCL and one therapy line must have included a CD20-targeted 
therapy (e.g., RTX) 
d) an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 
5. Patients not considered in the opinion of the investigator eligible or patients unwilling 
to undergo intensive salvage therapy including ASCT because of, but not limited to, 
advanced age, co-morbidities, impossibility or, refusal to perform ASCT. 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 41 of 110 
Documentation of the reason for a patient’s ineligibility must be provided in the 
patient’s source data. 
 
Laboratory Values 
6. Patients must meet the following laboratory criteria at screening: 
a) absolute neutrophil count (ANC) ≥1.5 × 109/L (unless secondary to bone marrow 
involvement by DLBCL as demonstrated by recent bone marrow aspiration and 
bone marrow biopsy) 
b) platelet count ≥90 × 109/L (unless secondary to bone marrow involvement by 
DLBCL as demonstrated by recent bone marrow aspiration and bone marrow 
biopsy) 
c) total serum bilirubin ≤2.5 × upper limit of normal (ULN) unless secondary to 
Gilbert’s syndrome or documented liver involvement by lymphoma. Patients 
with Gilbert’s syndrome or with documented liver involvement by lymphoma 
may be included if their total bilirubin is ≤5 × ULN (see exclusion criterion 5 g) 
d) ALT, AST and alkaline phosphatase (AP) ≤3 × ULN or <5 × ULN in cases of 
documented liver involvement 
e) serum creatinine clearance must be ≥60 mL/minute either measured or 
calculated using a standard Cockcroft and Gault formula (Cockroft and Gault, 
1976; see Appendix A) 
General Provisions 
7. Females of childbearing potential (FCBP) must:  
a) not be pregnant as confirmed by a negative serum pregnancy test at screening 
and a medically supervised urine pregnancy test prior to starting study therapy 
b) refrain from breastfeeding and donating blood or oocytes during the course of 
the study and for 3 months after the last dose of study medication. Restrictions 
concerning blood donation apply as well to females who are not of childbearing 
potential 
c) agree to ongoing pregnancy testing during the course of the study, and after end 
of study therapy. This applies even if the patients practice complete and 
continued sexual abstinence 
d) commit to continued abstinence from heterosexual intercourse if it is in 
accordance with her lifestyle (which must be reviewed on a monthly basis) or 
agree to use and be able to comply with the use of effective contraception 
without interruption during the study and for 3 months after the last dose of study 
medication 
8. Males must use an effective barrier method of contraception without interruption, 
refrain from donating blood or sperm during the study participation and for 3 months 
after the last dose of study medication if the patient is sexually active with a FCBP 
9. In the opinion of the investigator the patients must: 
a) be able and willing to receive adequate prophylaxis and/or therapy for 
thromboembolic events  
b) be able to understand, give written informed consent and comply with all study-
related procedures, medication use, and evaluations  

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 42 of 110 
c) not have a history of noncompliance in relation to medical regimens or be 
considered potentially unreliable and/or uncooperative 
d) be able to understand the reason for complying with the special conditions of the 
pregnancy prevention risk management plan and give written acknowledgement 
of this. 
 
 Exclusion Criteria 
Exclusionary Diagnosis 
1. Patients who have: 
a) any other histological type of lymphoma including primary mediastinal (thymic) 
large B-cell (PMBL) or Burkitt lymphoma 
b) primary refractory DLBCL (see Section 5.1.1 for definitions) 
c) a history of "double/triple hit" genetics DLBCL characterised by simultaneous 
detection of MYC with BCL-2 and/or BCL-6 translocation(s) defined by 
fluorescence in situ hybridisation. MYC, BCL-2, BCL-6 testing prior to study 
enrolment is not required 
 
Exclusionary Previous and Current Treatment 
2. Patients who have, within the 14 days prior to Day 1 dosing: 
a) not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, 
investigational anticancer therapy or other lymphomaspecific- therapy 
b) undergone major surgery or suffered from significant traumatic injury 
c) received live vaccines (see Section 6.7 for details)  
d) required parenteral antimicrobial therapy for active, intercurrent infections  
3. Patients who: 
a) have, in the opinion of the investigator, not recovered sufficiently from the 
adverse toxic effects of prior therapies  
b) were previously treated with CD19-targeted therapy or IMiDs® (e.g., 
thalidomide, LEN) 
c) have a history of hypersensitivity to compounds of similar biological or chemical 
composition to MOR00208, IMiDs® and/or the excipients contained in the study 
drug formulations 
d) have undergone ASCT within the period ≤3 months prior to the signing of the 
informed consent form. Patients who have a more distant history of ASCT must 
exhibit full haematological recovery before enrolment into the study 
e) have undergone previous allogenic stem cell transplantation 
f) have 
a 
history 
of 
deep 
venous 
thrombosis/embolism, 
threatening 
thromboembolism or known thrombophilia or are at a high risk for a 
thromboembolic event in the opinion of the investigator and who are not 
willing/able to take venous thromboembolic event prophylaxis during the entire 
treatment period  
g) concurrently use other anticancer or experimental treatments 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 43 of 110 
Exclusionary Patient’s Medical History 
4. Prior history of malignancies other than DLBCL, unless the patient has been free of 
the disease for ≥5 years prior to screening. Exceptions to the ≥5 year time limit 
include history of the following: 
a) basal cell carcinoma of the skin 
b) squamous cell carcinoma of the skin 
c) carcinoma in situ of the cervix 
d) carcinoma in situ of the breast 
e) carcinoma in situ of the bladder 
f) incidental histological finding of prostate cancer (Tumour/Node/Metastasis 
[TNM] stage of T1a or T1b) 
5. Patients with: 
a) positive hepatitis B and/or C serology (see Section 7.2.13.2 for details) 
b) known seropositivity for or history of active viral infection with human 
immunodeficiency virus (HIV) 
c) CNS lymphoma involvement – present or past medical history 
d) history or evidence of clinically significant cardiovascular, CNS and/or other 
systemic disease that would in the investigator’s opinion preclude participation 
in the study or compromise the patient’s ability to give informed consent 
e) history or evidence of rare hereditary problems of galactose intolerance, the 
Lapp lactase deficiency or glucose-galactose malabsorption 
f) gastrointestinal abnormalities including the inability to take oral medication, 
requiring intravenous alimentation, or prior surgical procedure affecting 
absorption 
g) history or evidence of severe hepatic impairment (total serum bilirubin 
> 3mg/dL), jaundice unless secondary to Gilbert’s syndrome or documented 
liver involvement by lymphoma (see inclusion criterion 6c) 
 
 
 Definition of Female of Childbearing Potential 
A sexually mature female patient or a sexually mature female partner of a male patient is 
considered to have childbearing potential unless she meets at least one of the following criteria: 
1. Age at least 50 years and naturally amenorrhoeic for at least 24 months (i.e. has not 
had menses at any time in the preceding 24 consecutive months). Amenorrhoea 
following cancer therapy or during lactation does not rule out childbearing potential 
2. Premature ovarian failure confirmed by a gynaecologist 
3. Previous bilateral salpingo-oophorectomy, or hysterectomy 
4. XY genotype, Turner syndrome, uterine agenesis. 
 
5.5 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 can only be performed if one of the 
following criteria is met: 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 44 of 110 
 the patient has already consented and met all of the inclusion and none of the exclusion 
criteria and his or her enrolment was delayed due to an unexpected change in the patient’s 
personal situation (e.g., family issues) 
 the patient previously failed to be eligible due to any event (e.g., planned surgery, 
laboratory test result) that has been resolved 
 the patient previously failed screening but has become eligible for the study based on a 
change in the inclusion and exclusion criteria as the result of a protocol amendment. 
 the patient failed screening due to non-progressed / non-relapsed disease at the time of 
screening and is later clinically diagnosed as having progressed / relapsed. 
 
A patient should only be rescreened if there is a clear indication that the patient may be eligible 
according to the currently valid study protocol. 
 
In cases where previous screening activities were discontinued and enrolment did not occur, the 
following procedures should be implemented: 
 the patient must sign and date a new informed consent form (ICF) as part of the 
re-screening procedure 
 the eligible patient will receive a new unique identification number via the interactive 
response technology 
 a new electronic case report form (eCRF) should be completed 
 the patient will be documented as rescreened in the source documents 
 all screening procedures must be completed again. 
 
A rescreened patient can be enrolled, if all of the current inclusion criteria are met and none of 
the exclusion criteria are met. 
 
6 STUDY TREATMENTS AND CONCOMITANT DRUGS 
Each investigator is responsible for ensuring that deliveries of study drugs and other study 
materials from the sponsor and other drugs from the appropriate suppliers 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 another person (according to the local laws and regulations). Drug accountability forms will 
be kept by each site participating in the study and will be checked during monitoring visits. 
 
Study drug must be handled and/or prepared as described in the Drug Preparation Manual, the 
IB for MOR00208, and other safety-relevant documents (e.g., Summary of Product 
Characteristics (SPC) for the European Medicines Agency [EMA] or the Prescribing Information 
[US FDA] for LEN) (see Appendix_C). 
 
6.1 MOR00208 
MOR00208 will be centrally supplied. MOR00208 drug product (DP) must be stored under 
refrigeration at 2° C to 8° C in its original package in an appropriate storage facility accessible 
only to the pharmacist(s), the investigator, or a duly designated person. 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 45 of 110 
MOR00208 DP is a yellowish 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 200 mg of 
MOR00208 in 5 ml of reconstituted solution. The solution after reconstitution is colourless to 
slightly yellow and essentially free of foreign particles; it may contain a few white to whitish 
product-related particles. 
 
For administration, MOR00208 will be diluted into a commercially available 250 mL infusion 
container with 0.9% (w/v) sodium chloride for injection. 
 
MOR00208 will be administered IV at a dose of 12.0 mg/kg.  
 
For the first 3 cycles (Cycles 1-3) of the study, each cycle will consist of a MOR00208 infusion 
on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally a loading dose will be 
administered on Day 4 of Cycle 1. Thereafter MOR00208 will be administered on a bi-weekly 
(every 14 days) basis with infusions on Days 1 and 15 of each 28-day cycle. 
 
 
The individual MOR00208 infusion will be prepared under aseptic conditions and administered 
at the study site, according to the 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. 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. 
 
The preferred procedure for destruction is for all IMPs (including used, partially used, not 
expired unused and expired unused vials, blisters, boxes or bottles) to be returned to the Drug 
Depot for destruction. 
 
In case the site is requesting formal approval for destruction of the IMP on site due to local 
requirements, the local destruction requirements for IMPs described in detail in the Drug 
Preparation Manual must be fulfilled. 
 
For the first infusion, the IV infusion rate should be 70 mL/h for the first 30 minutes and 
subsequently increased to a rate of 125 mL/h; the total infusion duration should ideally not 
exceed 2.5 hours. All subsequent MOR00208 infusions will be administered IV at a constant rate 
of 125 mL/h over a 2-hour period. MOR00208 should NOT be administered as an IV push or 
bolus. 
 
The infusion rate escalation schedules in this protocol and the Drug Preparation Manual are 
recommendations only. If required, the investigator should use clinical judgement to optimise 
patient safety by administering the infusion more slowly. 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 46 of 110 
6.2 Lenalidomide (LEN) 
Patients will self-administer a starting dose of 25 mg oral LEN daily on Days 1–21 of each cycle. 
Treatment with LEN may be modified in a de-escalating fashion or discontinued based upon 
clinical and laboratory findings. Detailed dose modification guidelines to manage 
haematological and/or other toxicities are provided in the respective sections of the protocol. 
 
LEN will be obtained from a commercial source as capsules in various dose strengths for oral 
administration as will be outlined in the Drug Preparation Manual. If applicable, LEN will be 
labelled as per local regulations. Investigators must be registered through the Lenalidomide 
programme, as applicable in their countries (e.g., REVLIMID REMS™ programme in the US, 
T-register in Germany). Patients must be counselled on the reproductive risks associated with 
LEN, prior to enrolment and monthly, during therapy.  
 
6.3 Treatment with Study Drugs 
Treatment consisting of LEN and MOR00208 combination will be administered up to twelve 
28-day cycles at specified dose levels as scheduled until disease progression, unacceptable 
toxicity, or discontinuation for any other reason, whichever comes first. 
 
LEN can be given for up to 12 cycles in total. Treatment with LEN will have to be stopped after 
disease progression. On days when both study drugs are given together, LEN should be 
administered prior to MOR00208. 
 
MOR00208 can be administered at the dose and schedule described in Section 6.1 above, until 
disease progression, unacceptable toxicity, or discontinuation for any other reason, whichever 
comes first. 
 
It is up to the investigator to decide according to the individual risk/benefit ratio if the patient 
should further continue on MOR00208 in case of disease progression, after discussion with the 
Sponsor’s Medical Monitor or designee. For patients who will be administered MOR00208 
despite progression of disease / relapse, an Unscheduled Visit including all protocol prescribed 
procedures for the EOT Visit (except the PK sample and the anti-MOR00208 antibody sample) 
need to be performed in order to capture the event (i.e. disease progression/relapse) for the 
antibody treatment to continue further (Table 5). In such cases an EOT Visit will take place after 
these patients have finally stopped receiving the antibody. And lastly, a Safety Follow-Up will 
take place 30-Days after last administration of MOR00208.  
 
For patients receiving antibody treatment despite disease recurrence/progression, before the 
administration of MOR00208, blood parameters (haematology, serum chemistry) should be 
evaluated in the local lab according to local guidelines/standards of local medical practice for 
the administration of monoclonal antibodies. A urine pregnancy test should be performed for 
women of childbearing potential. Vital signs should be measured according to local practice for 
the administration of monoclonal antibodies. For this patient population only the antineoplastic 
therapy after the end of study drug combination treatment and AEs need to be captured in eCRF. 
Other procedures described in the column “MOR00208 Additional Treatment” in Table 5 will 
not apply for this patient population. 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 47 of 110 
 
6.4 Pre-Medication for MOR00208 Infusions 
IRRs have commonly been reported for patients with CLL or NHL treated with MOR00208. 
 
It is suggested that the pre-medication is administered between 30 minutes and 2 hours prior to 
the MOR00208 infusions. 
 
The pre-medication may include the following: 
 antipyretics (e.g., acetaminophen [paracetamol] 1000 mg per dose per mouth [p.o.] or IV 
or equivalent) 
 histamine H1 receptor blockers (e.g., diphenhydramine 25–50 mg per dose IV or 
equivalent) 
 histamine H2 receptor blockers (e.g., cimetidine 300 mg p.o., ranitidine 150 mg tablet 
p.o. or equivalent) 
 glucocorticosteroids (methylprednisolone 80–120 mg per dose IV or equivalent - please 
refer to Appendix_D) 
 meperidine (25 mg per dose p.o. or IV) may be added as required for rigors or chills. 
 
The investigator may repeat doses of individual agents as required and use other agents, doses 
and/or formulations in accordance with institutional guidelines. Equivalence for premedications 
includes variations to the stated dose due to the formulations available locally. Any 
premedication given should be reported in the eCRF. 
 
Premedication for patients who do not experience any IRRs to MOR00208 during the first 
3 infusions (doses) will be optional for subsequent infusions at the discretion of the investigator. 
Otherwise, the premedication should be continued for subsequent administrations. 
 
6.5 Patient Monitoring During MOR00208 Infusion 
Vital signs should be measured as outlined in Section 7.2.8. All supportive measures consistent 
with optimal patient care will be provided throughout the study according to institution 
standards. 
 
Precautions for anaphylaxis should be observed during MOR00208 administration. Emergency 
resuscitation equipment and medications should be readily available. Additional supportive 
measures should also be available and may include, but are not limited to, epinephrine, 
antihistamines, 
corticosteroids, 
IV 
fluids, 
vasopressors, 
oxygen, 
bronchodilators, 
diphenhydramine, and acetaminophen (paracetamol). 
 
6.6 Criteria for Dose Modifications and Drug Discontinuation 
 Management of MOR00208 Infusion-Related Reactions (IRRs) 
IRRs will be defined according to the National Cancer Institute Common Terminology Criteria 
for Adverse Events (NCI-CTCAE), Version 4.0 definition of IRR and cytokine release syndrome 
(Table 1). 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 48 of 110 
Table 1 
Definition of Infusion-Related Reaction 
NCI-CTCAE Version 4.0, Selection Criteria: Infusion-Related Reaction and Cytokine 
Release Syndrome 
 
Adverse 
Event 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
IRR 
Mild transient 
reaction; 
infusion 
interruption not 
indicated; 
intervention not 
indicated 
Therapy or infusion 
interruption indicated 
but responds 
promptly to 
symptomatic 
treatment (e.g., 
antihistamines, 
NSAIDS, narcotics, 
IV fluids); 
prophylactic 
medications indicated 
for ≤24 hours 
Prolonged (i.e. not rapidly 
responsive to symptomatic 
medication, brief 
interruption of infusion, or 
both); recurrence of 
symptoms following initial 
improvement; 
hospitalisation 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 (e.g., 
antihistamines, 
NSAIDS, narcotics, 
IV fluids); 
prophylactic 
medications indicated 
for ≤24 hours 
Prolonged (i.e. not rapidly 
responsive to symptomatic 
medication and/or brief 
interruption of infusion); 
recurrence of symptoms 
following initial 
improvement; 
hospitalisation indicated 
for other clinical sequelae 
(e.g., renal impairment, 
pulmonary infiltrates) 
Life-
threatening; 
consequences; 
pressor or 
ventilatory 
support 
indicated 
 
Abbreviations: IRR=infusion-related reaction; IV=intravenous; NSAIDs=non-steroidal anti-inflammatories. 
Please note: An acute infusion reaction may occur with an agent that causes cytokine release (e.g., 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; Dyspnoea (shortness of breath); Fatigue 
(asthenia, lethargy, malaise); Headache; Hypertension; Hypotension; Myalgia (muscle pain); Nausea; Pruritis/itching; 
Rash/desquamation; Rigors/chills; Sweating (diaphoresis); Tachycardia; Tumour pain (onset or exacerbation of tumour pain due 
to treatment); Urticaria (hives, welts, wheals); Vomiting 
 
 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 49 of 110 
6.6.1.1 Grade 2 IRRs 
If a patient presents with a grade 2 infusion reaction: 
 the infusion should be stopped immediately 
 the patient should receive appropriate further treatment with an antihistamine and/or 
acetaminophen (paracetamol) or methylprednisolone (or equivalent) if clinically 
indicated 
 once the symptoms have been resolved or reduced to “mild” according to 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 a grade 1 or 2 IRR receives further infusions, then premedication 
should be given before all subsequent infusions of MOR00208. 
 
6.6.1.2 Grade 3 IRRs 
If a patient presents with a grade 3 IRR: 
 the infusion should be stopped immediately 
 the patient must receive appropriate treatment with an antihistamine and/or 
acetaminophen (paracetamol) or methylprednisolone (or equivalent) and, if necessary, 
further medications (i.e. epinephrine, bronchodilator) 
 a blood sample for cytokine analysis should be obtained during the event and 
approximately 24 hours later 
 only after the complete resolution of all symptoms (to ≤grade 1), and after having 
received appropriate prophylactic medication(s) as described above, the infusion may be 
resumed at an infusion rate of 25%. If, after 1 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 the resumption of the infusion, symptoms return (irrespective of grade), the 
infusion must be stopped immediately and the infusion tubing should be disconnected 
from the patient. 
 
Based on the investigator’s decision the patient may receive further MOR00208 provided 
clinically appropriate precautions were undertaken. The patient may continue treatment with 
LEN. 
 
6.6.1.3 Grade 4 IRRs 
If a patient presents with a grade 4 IRR: 
 the infusion should be stopped immediately and the infusion tubing should be 
disconnected from the patient 
 the patient should receive appropriate treatment with an antihistamine and/or 
acetaminophen (paracetamol) or methylprednisolone (or equivalent) and, if necessary, 
further medications (i.e. epinephrine, bronchodilator) 
 a blood sample for cytokine analysis should be obtained during the event and 
approximately 24 hours later. 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Page 50 of 110 
 
The patient must not receive further MOR00208, but may continue treatment with LEN as per 
protocol. 
 
 Management of Toxicities 
The next cycle of treatment may begin on the scheduled Day 1 if: 
 ANC is ≥1.000/mm3 (unless neutropenia is due to infiltration of bone marrow) 
 Platelets ≥50000/mm3 (unless thrombocytopenia is due to infiltration of bone marrow, 
patient may have received transfusion) and absence of active bleeding 
 No serious organ or other toxicity present. 
 
If, based on medical judgment, the treating physician considers a change in laboratory parameter 
or AE not to be a study drug-related toxicity, but to represent a natural fluctuation in or 
progression of the underlying disease, then it is at the physician’s discretion and assessment of 
the individual risk/benefit ratio to determine whether the patient should be dosed. The decision 
and rationale behind the decision should be documented in the source data. 
 
If the above conditions are not met on Day 1 of a new cycle, the subject will be evaluated once 
every seven days and a new cycle will not initiated until the toxicity has resolved as described 
above. Specific course of action for a given toxicity occurring in the course of the treatment cycle 
is described below. 
 
If treatment needs to be interrupted for ≤28 days for the same study drugs-related toxicity, the 
patient’s treatment should continue, depending on the duration of treatment interruption, at the 
next protocol scheduled visit. No missed visits or doses of either drug should be made up. 
 
If treatment with one study drug needs to be interrupted for >28 days for the same, persistent, 
drug-related toxicity, the study drug judged by the investigator to have caused the toxicity should 
be discontinued and the patient should continue to be dosed with the other study drug, as per 
protocol. 
 
If treatment with both study drugs needs to be interrupted for >28 days for the same persistent 
study drug-related toxicity, judged by the investigator to be related to both study drugs (LEN 
and MOR00208), then the End of Treatment Visit will be performed and the patient will enter 
the follow-up phase (see Section 5.3.1). 
 
6.6.2.1 Haematological and Other Toxicities 
Subjects will be evaluated for AEs at each visit with the NCI CTCAE v4.0 used as a guide for 
grading severity. The dose of study drug(s) for each patient will be interrupted and/or modified 
following toxicity as described below. Refer to Table 2 and Table 3 for instructions on dosing 
interruptions/modifications and Table 4 for LEN dose reduction instructions. 
 
Guidance on managing specific toxicities is summarised in Table 2 and Table 3. 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Table 2 
Haematological and Other Toxicities 
Grade 3/4 thrombocytopenia 
judged to be related to study 
drugs 
PLTs fall to <50000/µl 
Interrupt MOR00208* and LEN 
dosing) 
Follow CBC every 7 days 
PLTs return to ≥50000/µl 
Provided all other criteria are 
fulfilled, resume dosing of 
MOR00208 and/or LEN. LEN 
should be administered at the 
next lower dose level (Table 4) 
Grade 3/4 neutropenia judged to 
be related to study drugs 
ANC falls to <1000/µl for at 
least 7 days  
or ANC falls to <1000/µl with 
an associated body temperature 
≥38.5°C 
or ANC falls to <500/µl 
Interrupt MOR00208* and LEN 
dosing 
Follow CBC every 7 days 
Growth factors (G-CSF) and 
antimicrobial prophylaxis is to 
be used, as per local guidelines 
ANC return to ≥1000/µl 
Provided all other criteria are 
fulfilled, resume dosing of 
MOR00208 and/or LEN. LEN 
should be administered at the 
next lower dose level (Table 4) 
Other clinically significant 
toxicities judged to be related to 
study drugs 
Grade 3/4 
Interrupt the administration of 
the study drug(s)* to which the 
toxicity is judged to be related 
to. 
Toxicities resolve to grade ≤2 
Provided all other criteria are 
fulfilled, resume dosing of study 
drug(s). LEN should be 
administered at the next lower 
dose level (Table 4) 
Abbreviations: ANC=absolute neutrophil count; CBC=complete blood count; G-CSF=granulocyte colony-stimulating factor; 
LEN=lenalidomide; PLT=platelets. 
*If, based on medical judgment, the treating physician considers a laboratory parameter change or AE not to be a study drug-
related toxicity, but to represent a natural fluctuation in or progression of the underlying disease, then it is at the physician’s 
discretion and assessment of the individual risk/benefit ratio to determine whether the patient should be dosed. The decision and 
rationale behind the decision should be documented in the source data.  
 
 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Table 3 
Other Toxicities Judged to be Related to LEN 
Thromboembolic events  
Grade 3/4 
Interrupt LEN dosing  
Start anticoagulation as per local 
guidelines 
Continue MOR00208 treatment 
as per protocol 
Toxicities resolve to grade ≤2 
Restart LEN at investigator’s 
discretion (maintain dose level) 
Continue MOR00208 treatment 
as per protocol 
Allergic reaction or 
hypersensitivity grade 3/4 
(including but not limited to 
Stevens-Johnson syndrome, 
toxic epidermal necrolysis, 
exfoliative or bullous rash, 
angioedema) 
Grade 3/4 
Discontinue LEN permanently  
Continue MOR00208 treatment 
as per protocol 
Allergic reaction or 
hypersensitivity 
Grade >2 
Interrupt LEN dosing 
Follow at least every 7 days 
Continue MOR00208 treatment 
as per protocol 
Resolved to ≤grade 2 severity or 
at least the baseline value (for 
pre-existing conditions; at 
screening) 
Restart LEN (next lower dose 
level) 
Desquamating (blistering) rash 
≥grade 3 or nondesquamating 
rash grade 4 considered to be 
related to LEN 
 
Discontinue LEN permanently  
Continue MOR00208 treatment 
as per protocol 
Nondesquamating rash  
Grade 3/4 
Interrupt LEN dosing 
Continue treatment with 
MOR00208 as per protocol 
Resolve to grade ≤1  
Restart LEN at next lower dose 
level 
 
Tumour flare reaction 
Grade 3/4 
Interrupt LEN dosing 
Provide symptomatic treatment 
as per local guidelines 
Continue treatment with 
MOR00208 as per protocol 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Page 53 of 110 
Resolve to grade ≤1 
Restart LEN (maintain same 
dose level) 
Tumour flare reaction 
Grade 1/2   
Provide symptomatic treatment 
as per local guidelines 
Continue LEN without dose 
modification or interrupt LEN 
dosing at investigator’s 
discretion 
Continue treatment with 
MOR00208 as per protocol 
Abbreviation: LEN=lenalidomide. 
 
 
6.6.2.2  LEN Dose Reduction Guidelines 
General rules 
If LEN dosing was halted during the previous cycle and was restarted with a one-level dose 
reduction without requiring an interruption for the remainder of the cycle, then that reduced dose 
level will be initiated on Day 1 of the new cycle. There will be no more than one dose reduction 
from one cycle to the next. Once a patient’s LEN dose has been reduced, no dose re-escalation 
is permitted. 
 
Specific LEN dose reduction guidelines 
The daily oral dose of LEN may be reduced successively by one level from the starting dose of 
25 mg daily on Days 1–21 every 28 days (Table 4). 
 
Table 4 
LEN Dose Reduction Guidelines 
Starting dose 
25 mg daily on Days 1–21, every 28 days 
Dose Level - 1 
20 mg daily on Days 1–21, every 28 days 
Dose Level - 2 
15 mg daily on Days 1–21, every 28 days 
Dose Level - 3 
10 mg daily on Days 1–21, every 28 days 
Dose Level - 4 
5 mg daily on Days 1–21, every 28 days  
 
Patients who cannot tolerate Dose Level - 4 are to be discontinued from LEN treatment in the 
study but should continue therapy with MOR00208 alone. 
 
Additional information 
The most up-to-date information regarding constitution, dosing and most frequent AEs related 
to the administration of LEN and MOR00208 are contained in the SmPC (EMA), Prescribing 
Information (US FDA) and the current MOR00208 IB, respectively (see Appendix_C). Dose 
reductions for MOR00208 are not allowed during the course of the study. 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Page 54 of 110 
6.6.2.3 Tumour Flare with LEN 
Patients in this study should be monitored for tumour flare (TFR). TFR is defined as a sudden 
and tender increase in the size of the disease bearing sites, including the lymph nodes, spleen 
and/or the liver, often accompanied by low-grade fever, non-pruritic diffuse rash and in some 
cases, an increase in the peripheral blood lymphocyte counts. TFR is an expected toxicity with 
LEN, especially in patients with a high tumour burden and may mimic disease progression. 
Therefore, careful monitoring and evaluation is important prior to discontinuing a study patient 
for progressive disease in the initial cycles of LEN therapy. There are currently no laboratory or 
radiological tests to help distinguish TFR from progressive disease. The distinction should be 
made on clinical grounds, incorporating observations such as associated physical findings, 
laboratory findings, and pace of disease before and after the initiation of treatment. TFR should 
be recorded as an AE of interest (graded using the NCI-CTCAE 4.0 criteria) and not as 
progressive disease. 
 
Treatment of TFR is at the discretion of the investigator and dependent on the severity, clinical 
situation and institutional standards. 
 
6.6.2.4 Tumour Lysis Syndrome 
TLS results from the rapid breakdown of tumour cells and the release of their intracellular 
content into the circulation resulting in metabolic derangements that can lead to acute renal 
failure and other life-threatening complications. The onset of TLS is rapid, usually within 24-48 
hours of receipt of the first dose of anticancer medication, but can also occur after the first week 
of treatment. Bulky disease, moderate renal insufficiency, a high number of circulating 
lymphoma cells and high uric acid levels (>8 mg/dL) prior to therapy, increase the likelihood of 
TLS. Early identification of patients at risk and the prevention of TLS development with the 
initiation of preventive measures as well as the careful monitoring for early signs of laboratory 
assessments consistent with TLS and the prompt initiation of supportive care are critical to the 
prevention of potentially life-threatening metabolic derangements. 
 
Medical prophylaxis and management should be initiated according to the institutional standard 
of care at the investigator’s discretion. 
 
6.6.2.5 Thromboembolism 
LEN increases the risk of thrombotic events in patients who are at high risk of thrombosis. High 
risk is defined, for example, as a history of a thromboembolic event and/or taking a concomitant 
medication associated with an increased risk of a thromboembolic event and/or a known 
hypercoagulable state, regardless of thromboembolic history. It is recommended that patients 
receive adequate anticoagulation therapy according to the institutional standards and 
investigator’s discretion. It should be tailored to the patient’s individual risk/benefit profile by 
taking into account the individual thrombotic and bleeding risk, and the quality of compliance 
with venous thromboembolic event (VTE) prophylaxis. Anticoagulants may include 
acetylsalicylic acid (e.g., aspirin) prophylaxis, low molecular weight heparin, warfarin or new 
oral anticoagulants (NOAKs, e.g., dabigatran, rivaroxaban). 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 55 of 110 
6.7 Prior and Concomitant Therapy 
 
Administration and Recording of Prior and Concomitant Therapy – General Instructions 
Any prior, concomitant, or procedural medications or therapy given to or taken by the patient 
within 1 month prior to commencement of the study (30 days prior to signing the ICF) and up to 
the End of Treatment Visit (EOT) must be recorded in the source documents and the eCRF along 
with the indication, route and dosage. Such medications (including over-the-counter 
medications) must be listed on the concomitant medications form in the eCRF. Starting from the 
EOT Visit, only anticancer treatments and, in case of an AE, other relevant concomitant 
medications (at the discretion of the investigator) should be entered. The investigator should 
instruct the patient not to take any additional medications (including over-thecounter--products) 
during the study without prior consultation. 
 
For patients who will be administered MOR208 despite progression of disease / relapse, an 
Unscheduled Visit including all procedures described for EOT Visit need to be performed in 
order to capture the event (i.e. disease progression/relapse) for the antibody treatment to continue 
further. 
 
At the EOT visit (or at the Unscheduled Visit after disease progression / relapse) as described in 
the above paragraph), any antineoplastic therapy after end of study drug treatment must be 
recorded as well. 
 
Patients may receive concomitant medications that are medically indicated as standard care for 
the treatment of symptoms, AEs, and intercurrent illnesses. Medications to treat concomitant 
diseases like diabetes, hypertension, bronchial asthma, chronic obstructive pulmonary disease 
(COPD) etc., are allowed. Patients will also receive therapy to mitigate side effects of the study 
medication as clinically indicated, as well as best supportive care (BSC) as per institutional 
guidelines. This may include, but is not limited to, antiemetics, antidiarrhoeals, anticholinergics, 
antispasmodics, antipyretics, antihistamines, analgesics, antibiotics, and other medications 
intended to treat symptoms. 
 
Recording of Prior Lines of Anti-lymphoma Therapy 
Information should be provided on any previous DLBCLspecific- therapies since the time point 
of the first diagnosis of DLBCL. The generic or the trade name may be recorded. 
To become eligible for the MOR208C203 study the patients must have received at least one, but 
no more than three previous systemic therapy lines for the treatment of DLBCL and at least one 
therapy line must have included a CD20-targeted therapy (e.g., RTX). 
 
Planned consolidation of responding patients, i.e. by radiotherapy or second line regimens with 
or without ASCT is regarded as one therapy line. Changing to a different chemotherapy regimen 
is regarded as a separate line of therapy, unless the change was caused by toxicity of the 
employed regimen. 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Page 56 of 110 
Radiotherapy of the involved site (limited field radiotherapy) or radiation pre-planned to occur 
at the conclusion of systemic cytotoxic therapy will not be considered a separate prior line of 
therapy. 
 
The administration of a mAb alone with a curative/therapeutic intent (e.g., RTX monotherapy) 
counts as a separate line of therapy. On the other hand the addition of a mAb to chemotherapy 
or mAb maintenance treatment subsequent to chemotherapy/chemoimmunotherapy regimen is 
considered one treatment therapy line, provided that the mAb was part of the initial treatment 
plan. 
 
As for the ASCT, the induction, consolidation, stem cell collection, preparative regimen 
including transplantation, and maintenance will be considered a single line of therapy. 
 
Growth Factors 
Growth factors may be prescribed during the treatment and follow-up periods at the 
investigator’s discretion, according to institutional standards. Growth factors or platelet 
transfusions should not be administered during the screening period solely for the purpose of 
improving a patient’s blood values in order to meet eligibility criteria. 
 
Infection Prophylaxis and Vaccines 
Live vaccines must not be administered to patients in this study. Killed, inactivated vaccines, 
such as an injectable annual influenza vaccine, are permitted. Investigators should follow 
institutional guidelines concerning infection chemoprophylaxis for patients regarded to be at 
high risk for infection. 
 
Anticancer Therapies 
Patients should not have received a CD20-targeted therapy, chemotherapy, radiotherapy, 
investigational anticancer therapy or other lymphomaspecific- therapy within 14 days prior to 
Cycle 1 day 1 of the study. In addition, no radiotherapy (including limited field radiotherapy) is 
permitted after the baseline PET/CT scan for initial disease assessment has been performed. 
Other than the study drugs, patients should not receive any other DLBCLspecific- therapy during 
the study treatment period. The patient should not receive any investigational agent other than 
MOR00208 and LEN during the treatment period of the study. 
 
The use of concurrent antineoplastic therapies other than study drugs, including, but not limited 
to, chemotherapies, hormonal therapy, immunotherapy, biological response modifiers, mAbs 
with or without conjugation, radioisotopic therapies, stem cell transplant and targeted small 
molecules are not permitted during the entire treatment period (i.e., prior to disease progression 
during this study) of this study. After disease progression has been recorded, additional 
antineoplastic therapies are permitted at the discretion of the investigator and in accordance with 
the local guidelines and should be recorded in the eCRF. 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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Systemic Glucocorticosteroids 
The use of systemic glucorticosteroids is generally discouraged because their potential 
antilymphoma activity in patients with DLBCL may confound interpretation of antitumor effects 
mediated by study drug treatment (MOR00208 and LEN). 
 
However systemic corticosteroids in doses up to 20 mg/day prednisone or equivalent (i.e. 
equipotent corticosteroid) are permitted, provided the dosing is stable (not increased within the 
last month), but only for the treatment of non-neoplastic comorbid indications (e.g, rheumatoid 
arthritis). 
 
- Screening: 
Patients may potentially receive systemic glucorticosteroids in doses above 20 mg/day 
(prednisone or equivalent) to manage severe DLBCL manifestations (e.g., compressive disease, 
rapidly progressing symptomatic adenopathy) during Screening as per institutional standards. 
For these patients the glucorticosteroids treatment needs to be tapered to a total daily dosage of 
20 mg or less of prednisone or its equivalent prior to study drug(s) administration on Cycle 1, 
Day 1. 
 
-Cycle 1 through EOT visit: 
Systemic glucocorticosteroids in doses above 20 mg/day (prednisone or equivalent) are not 
allowed during Cycle 1 through EOT visit, with the exceptions of premedication, cytokine 
release syndrome treatment at any time. Additionally, systemic doses above 20 mg/day 
(prednisone or equivalent; please refer to Appendix_D) will be allowed for antiemetic 
prophylaxis for up to 24 hours. 
 
In the event a patient experiences an exacerbation of a chronic non-neoplastic condition such as 
chronic obstructive pulmonary disease (COPD), bronchial asthma or rheumatoid arthritis, peak 
doses above 20 mg/day (prednisone or equivalent) may be allowed for a limited period of time; 
the glucocorticosteroid dosage and the allowable treatment period will be determined by the 
investigator on a case-by-case basis following agreement with the medical monitor of the study. 
The specified systemic glucocorticosteroid use at a daily dose above 20 mg, if short in duration, 
is not likely to confound the treatment effect and efficacy analysis. 
 
Similarly, patients who develop severe or life-threatening conditions that may be alleviated by 
systemic glucocorticosteroid (e.g., adrenal insufficiency) therapy are permitted to receive such 
drugs and are not required to discontinue study participation. 
 
The investigator should aim to discuss the systemic usage of glucocorticosteroids in doses above 
20 mg/day (prednisone or equivalent) with the medical monitor of the study prior to the 
implementation. 
 
Immunosuppressive therapies other than systemic glucocorticosteroids as described are not 
permitted. 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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-Other Provisions on Glucocorticosteroids: 
Single dose, topical, intranasal, inhaled eye drops or local injections (e.g., intra-articular) 
containing corticosteroids are permitted during study participation. 
 
Concomitant Therapies that May Increase the Risk of Thrombosis  
Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as oestrogen 
containing therapies, should be used with caution after making a careful benefit-risk assessment 
in patients receiving lenalidomide. 
 
6.8 Treatment Compliance 
Dosing modifications due to toxicity are described in Section 6.6.2. 
 
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. 
 
A patient will be considered compliant with the protocol if the MOR00208 dose administered is 
≥80% to ≤120% of the assigned dosage per single infusion. 
 
LEN is to be dispensed in 28-day cycles. Patients should return all unused or empty LEN 
bottles/blister packs to the site throughout the treatment period of the study, as instructed by the 
investigator. A patient will be considered compliant with the protocol if the LEN dose 
administered is ≥80% to ≤120% of the assigned dosage during a particular cycle.  
 
Drug accountability will be checked by the field monitor during site visits and at the completion 
of the study. 
 
6.9 Withdrawal from Study Treatment or Study/Site Termination 
  Withdrawal Criteria 
Patients may voluntarily withdraw from the study or be discontinued from it at the discretion of 
the investigator at any time. An excessive rate of withdrawals can render the study 
uninterpretable; therefore, unnecessary withdrawal of subjects should be avoided. 
 
The investigators are encouraged to keep a patient experiencing clinical benefit in the study 
unless significant toxicity puts the patient at risk or repeated cases of routine noncompliance puts 
the study outcomes at risk. 
 
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 at the 30-Day Follow-up Visit. 
 
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 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Page 59 of 110 
information on the eCRF. If the reason for withdrawal is an AE, monitoring should continue 
until the outcome is evident. The specific event or test result(s) must be recorded in the eCRF. 
 
Following events are reasons for discontinuing a patient from the use of investigational 
product(s) and/or from the study: 
 
 Withdrawal of informed consent (subject’s decision to withdraw for any reason) 
 Significant lack of co-operation or non-compliance on the side of the patient 
 Pregnancy or lack of adequate contraception in FCBPs  
 Any clinical adverse event (AE), laboratory abnormality or intercurrent illness which, 
in the opinion of the investigator, indicates that continued participation in the study is 
not in the best interest of the subject 
 Unacceptable and unmanageable, in the view of either patient or physician, toxicity 
judged to be related to study drugs 
 Occurrence of new diseases that could influence the treatment efficacy, for which the 
study medications are contraindicated or that are treated with a medication that is not 
permitted as a concomitant medication. 
 Loss of ability to freely provide consent through imprisonment or involuntarily 
incarceration for treatment of either a psychiatric or somatic disease (e.g., infectious 
disease) 
 Death 
 Lost to follow up 
 Major protocol violation (following discussion between the sponsor’s Clinical Program 
Leader, Drug Safety Physician and the Investigators) 
 Administrative reasons 
 Termination of the study by MorphoSys or Regulatory Authorities 
 Reconsideration of the risk/benefit ratio, in consensus with Ethical Committee 
 
Patients who are withdrawn for any reason may not re-enter this clinical study at any time. 
 
 

Product Name: MOR00208 
 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Page 60 of 110 
 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 centre. 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, 
for example, if during the ongoing evaluation of the risk/benefit ratio, the sponsor decides that 
the risks outweigh the benefits of MOR00208 and/or LEN. 
 
Should a termination of a given clinical study centre or the whole study become necessary, then 
the procedures will be arranged after review by, and consultation with, all involved parties. In 
terminating a study centre, or the entire study, the sponsor and the investigators will ensure that 
adequate consideration is given to the protection of the patients’ interests. Institutional Review 
Boards (IRBs)/Independent Ethics Committees (IECs) and competent authorities will be notified 
of premature termination in accordance with applicable regulatory requirements. 
 
 
 
7 VISIT ASSESSMENTS AND PROCEDURES 
 
7.1 Visit Schedule 
Table 5 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: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Table 5 
Schedule of Assessments 
Schedule: Screening and Cycles 1–3 
Evaluation or Procedure 
Screening 
Period 
Treatment Period 
Screening 
≤28 Days 
prior to 
D1 
Cycle 1 (28 days) 
Cycle 2 (28 days) 
Cycle 3 (28 days) 
Day 
Screen 
D1 
D4 
D8 
±1 day 
D15 
±1 day 
D22 
±1 day 
D1 
±1 day 
D8 
±1 day 
D15 
±1 day 
D22 
±1 day 
D1 
±1 day 
D8 
±1 day 
D15 
±1 day 
D22 
±1 day 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
X1 
 
 
 
 
 
 
 
 
 
 
 
 
Demography 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Disease staging/Ann Arbor 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Disease risk assessment (IPI) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Previous/concomitant 
medication 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Full physical examination 
(Limited physical examination - 
L) 
X 
L 
 
 
 
 
 
 
 
 
L 
 
 
 
ECOG performance status 
X 
X1 
 
 
 
 
X 
 
 
 
X 
 
 
 
Body weight/height2  
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
B-symptoms 
X 
X 
 
 
 
 
X 
 
 
 
X 
 
 
 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead resting ECG 
X 
X3 
 
 
X3 
 
X3 
 
 
 
X3 
 
 
 
Urinalysis 
X 
X 
 
 
 
 
X 
 
 
 
X 
 
 
 
Pregnancy test (FCBP)4 
X 
X1 
 
X1 
X1 
X1 
X1 
 
 
 
X1 
 
 
 
Pregnancy and risks counselling 
X 
X 
 
 
 
 
X 
 
 
 
X 
 
 
 
“Emergency laboratory”5 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Central laboratory blood 
sampling 1 
X 
X 
 
 
 
 
X 
 
 
 
X 
 
 
 
Serology Hepatitis B  
X16 
 
 
 
 
 
X16 
 
 
 
X16 
 
 
 
Serology Hepatitis C 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
B-, T- and NK cell flow 
cytometry (blood)1 
 
X 
 
X 
 
X 
X 
 
 
 
 
 
 
 
Anti-MOR00208 antibodies 
 
X1 
 
 
 
 
 
 
 
 
X1 
 
 
 
Optional FcγR polymorphism 
(mucosal cheek swab) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
ADCC and CD16 assessment 
(blood) 
 
X1 
 
 
 
 
 
 
 
 
 
 
 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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Evaluation or Procedure 
Screening 
Period 
Treatment Period 
Screening 
≤28 Days 
prior to 
D1 
Cycle 1 (28 days) 
Cycle 2 (28 days) 
Cycle 3 (28 days) 
Day 
Screen 
D1 
D4 
D8 
±1 day 
D15 
±1 day 
D22 
±1 day 
D1 
±1 day 
D8 
±1 day 
D15 
±1 day 
D22 
±1 day 
D1 
±1 day 
D8 
±1 day 
D15 
±1 day 
D22 
±1 day 
Disease and disease response 
assessment (CT/PET or 
PET/MRI) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
CT or MRI scan for tumour 
measurement and disease 
assessment (local) 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
Central pathology review and 
correlative studies involving 
tissue samples 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Bone marrow aspiration & 
biopsy 
X 
 
 
 
 
 
 
 
 
 
 
 
X7 
 
MOR00208 administration 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
LEN tablets allocation 
 
X 
 
 
 
 
X 
 
 
 
X 
 
 
 
(S)AE assessment 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
PK MOR00208 
 
X6 
X6 
 
X6 
 
X6 
 
X6 
 
X6 
 
X6 
 
Second primary malignancy 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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Schedule: Cycles 4–6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Evaluation or Procedure 
Treatment Period 
Cycle 4(28 days) 
Cycle 5 (28 days) 
Cycle 6 (28 days) 
Day 
D1  
±2 days 
D15  
±2 days 
D1  
±2 days 
D15  
±2 days 
D1  
±2 days 
D15  
±2 days 
Previous/concomitant medication 
X 
X 
X 
X 
X 
X 
Full physical examination 
(Limited physical examination - L) 
 
 
L 
 
 
 
ECOG performance status 
X 
 
X 
 
X 
 
Body weight/height2  
X 
X 
X 
X 
X 
X 
Vital signs 
X 
X 
X 
X 
X 
X 
B-symptoms 
X 
 
X 
 
X 
 
12-lead resting ECG 
 
 
 
 
X 
 
Urinalysis 
X 
 
X 
 
X 
 
Pregnancy test (FCBP)4 
X1 
 
X1 
 
X1 
 
Pregnancy and risks counselling 
X 
 
X 
 
X 
 
“Emergency laboratory”5 
X 
X 
X 
X 
X 
X 
Central laboratory blood sampling 1 
X 
 
X 
 
X 
 
Serology (Hepatitis B) 
X16 
 
X16 
 
X16 
 
B-, T- and NK cell flow cytometry 
(blood)1 
 
 
X 
 
 
 
Anti-MOR00208 antibodies 
 
 
X1 
 
 
 
Disease and disease response 
assessment (CT/PET) 
 
 
 
 
 
 
CT or MRI scan for tumour 
measurement and disease 
assessment (local) 
 
 
X 
 
 
 
Bone marrow aspiration & biopsy 
 
 
 
X7 
 
 
MOR00208 administration 
X 
X 
X 
X 
X 
X 
LEN tablets allocation 
X 
 
X 
 
X 
 
(S)AE assessment 
X 
X 
X 
X 
X 
X 
PK MOR00208 
X1 
 
X1 
 
X1 
 
Second primary malignancy 
X 
X 
X 
X 
X 
X 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 64 of 110 
Schedule: Cycles 7–12 
Evaluation or Procedure 
Treatment Period 
Cycle 7 (28 days) 
Cycle 8 (28 days) 
Cycle 9 (28 days) Cycle 10 (28 days) Cycle 11 (28 days) 
Cycle 12 (28 days) 
Day 
D1 
±2 days 
D15 
±2 days 
D1 
±2 days 
D15 
±2 days 
D1 
±2 days 
D15 
±2 days 
D1 
±2 days 
D15 
±2 days 
D1 
±2 days 
D15 
±2 days 
 
D1 
±2 days 
D15 
±2 days 
D28 
±4 days 
Previous/concomitant 
medication 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Full physical examination 
(Limited physical examination 
 - L) 
L 
 
 
 
 
 
L 
 
 
 
L 
 
 
ECOG performance status 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
Body weight/height2  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
B-symptoms 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
12-lead resting ECG 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
Urinalysis 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
Pregnancy test (FCBP)4 
X1 
 
X1 
 
X1 
 
X1 
 
X1 
 
X1 
 
 
Pregnancy and risks 
counselling 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
“Emergency laboratory”5 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Central laboratory blood 
sampling  1 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
Serology (Hepatitis B) 
X16 
 
X16 
 
X16 
 
X16 
 
X16 
 
X16 
 
 
B-, T- and NK cell flow 
cytometry (blood)1 
 
 
 
X 
 
 
 
 
 
 
 
 
 
Anti-MOR00208 antibodies 
X1 
 
 
 
X1 
 
 
 
X1 
 
 
 
 
Disease and disease response 
assessment (CT/PET) 
 
 
 
 
 
 
 
 
 
 
 
 
X 
CT or MRI scan for tumour 
measurement and disease 
assessment (local) 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
Bone marrow aspiration & 
biopsy 
 
X7 
 
 
 
 
 
X7 
 
 
 
 
X7 
MOR00208 administration 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
LEN tablets allocation 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
(S)AE assessment 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
PK MOR00208 
X1 
 
 
 
X1 
 
 
 
X1 
 
 
 
 
Second primary malignancy 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 65 of 110 
Schedule: Additional Treatment Period and Follow-Up Period 
Evaluation or 
Procedure 
MOR00208 Additional 
Treatment Phase 
(28 Days Cycles #13–24) 
(First cycle of additional 
treatment possible up to 
2 weeks ±2 days after 
Cycle 12 Day 28) 
MOR00208 Additional Treatment Phase19, 20 
(28 Days Cycles #25 onwards) 
 
Unscheduled Visit  (in case 
MOR00208 is to be 
administered despite disease 
progression)8 
End of Treatment Visit 
(EOT) 
30 Day  
Follow-up 
Visit 
Survival 
Follow-up9 
(every 3 
months ±2 
weeks from 
last visit by 
phone) 
Day 
D1 
±2 days 
D15 
±2 days 
D1 ±2 days 
D15 ±2 days 
 
(assessments can take place 
within 7 days period of the 
actual visit) 
±2 days 
 
Previous/concom
itant 
medication10 
X17 
X17 
X17 
X17 
X 
X 
 
 
Full physical 
examination 
(Limited 
physical 
examination - L) 
L11, 17 
 
L11, 17 
 
X 
X 
L 
 
ECOG 
performance 
status 
 
 
 
 
X 
X 
 
 
Body 
weight/height2 
X 
X 
X 
X 
X 
X 
 
 
Vital signs 
X 
X 
X 
X 
X 
X 
 
 
B-symptoms 
X17 
 
 
 
X 
X 
X 
 
12-lead resting 
ECG 
 
 
 
 
X 
X 
 
 
Urinalysis18 
X17 
 
 
 
X18 
X18 
 
 
Pregnancy test 
(FCBP)4 
X1 
 
X1 
 
X18 
X18 
 
 
“Emergency 
laboratory”5 
X 
X 
X 
X 
 
 
 
 
Central 
laboratory blood 
sampling  1, 18 
X17 
 
 
 
X18 
X18 
 
 
Serology 
(Hepatitis B)18 
X16, 17 
 
 
 
X16, 18 
X16, 18 
 
 
Anti-MOR00208 
antibodies 
X1,12, 17 
 
 
 
 
X18 
 
 
CT or MRI scan 
for tumour 
measurement 
and disease 
X13, 17 
 
X13, 17 
 
 
 
 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Evaluation or 
Procedure 
MOR00208 Additional 
Treatment Phase 
(28 Days Cycles #13–24) 
(First cycle of additional 
treatment possible up to 
2 weeks ±2 days after 
Cycle 12 Day 28) 
MOR00208 Additional Treatment Phase19, 20 
(28 Days Cycles #25 onwards) 
 
Unscheduled Visit  (in case 
MOR00208 is to be 
administered despite disease 
progression)8 
End of Treatment Visit 
(EOT) 
30 Day  
Follow-up 
Visit 
Survival 
Follow-up9 
(every 3 
months ±2 
weeks from 
last visit by 
phone) 
Day 
D1 
±2 days 
D15 
±2 days 
D1 ±2 days 
D15 ±2 days 
 
(assessments can take place 
within 7 days period of the 
actual visit) 
±2 days 
 
assessment 
(local) 
Disease and 
disease response 
assessment 
(CT/PET) 
 
 
X17, 19 
 
X13, 14 
X13, 14, 17 
 
 
Bone marrow 
aspiration & 
biopsy 
 
X7, 15, 17 
 
 
 
 
 
 
MOR00208 
administration 
X 
X 
X 
X 
 
 
 
 
(S)AE 
assessment 
X 
X 
X 
X 
X 
X 
X 
 
PK MOR00208 
X1, 12, 17 
 
 
 
 
X18 
 
 
Second primary 
malignancy 
X 
X 
X 
X 
X 
X 
X 
X 
Antineoplastic 
therapy other 
than the study 
drug treatment21 
X21 
X21 
X21 
X21 
X21 
X21 
X21 
X 
 
Abbreviations: ADCC=antibody-dependent cell-mediated cytotoxicity; AE=adverse event; β-HCG=beta-human chorionic gonadotropin; CT=computed tomography; 
ECG=electrocardiogram; ECOG=Eastern Cooperative Oncology Group; FCBP=female of childbearing potential; IPI= International Prognostic Index; IV = intravenous; 
L= Limited physical examination; LEN=lenalidomide; MRI=magnetic resonance imaging; NK=natural killer; PET=positron emission tomography; PK=pharmacokinetics; 
SAE=serious adverse event. 
1Before study drug administration. 
2Body height will be measured at Cycle 1 Day 1 only. Body weight can be measured up to 24 hours prior to the study drug administration. 
312-lead resting ECG performed no later than 3 hours post-MOR00208 dose (see Section 7.2.10). 
4Pregnancy tests: for FCBP, two pregnancy tests must be performed before enrolment; the first, a serum pregnancy test at screening within 10 to 14 days prior to the start of study 
drug and the second, a medically supervised urine pregnancy test within 24 hours prior to the start of study drug. The results of both tests must be negative in order to receive Cycle 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 67 of 110 
1 Day 1 dosing. At all other indicated time points, a urine pregnancy test for FCBP will be performed locally and the result must be negative for dosing. A β-HCG pregnancy test 
should also be performed at the End of Study Visit. 
5Sample to be collected and evaluated in the local laboratory (up to 24 hours prior to study drug administration) and reviewed by study treating physician before study drug 
administration. 
6MOR00208 PK sample will be taken pre-dose and 1 hour ± 10 min after the end of MOR00208 infusion. 
7Repeat bone marrow biopsy to confirm a CR only in those patients who had known bone marrow involvement prior to dosing (see Section 7.2.14.2 for details). 
8For patients receiving antibody treatment despite disease progression / relapse, an Unscheduled Visit covering all assessments described under EOT visit should be completed 
(except PK sample) before the continuation of antibody therapy. These procedures, if performed within less than two weeks preceding this visit, need not be repeated. PET/CT 
need not be repeated if it was performed during previous treatment cycle.  
9After 30-Day Follow-up Visit, a call will be made to the patient (or the patient’s family) every 90 days for at least 5 years from Cycle 1 Day 1 to inquire about the patient’s status, 
second primary malignancy (SPM) and information on any antineoplastic therapies utilised since discontinuation of study treatment. 
10After disease progression has been recorded, only anticancer treatments and, in case of an AE, other relevant concomitant medications (at the discretion of the investigator) 
should be entered. Before and up to the End of Treatment Visit, the complete concomitant medication needs to be recorded. 
11A limited PE (L) will be performed on Day 1 of each Cycle, every 12 weeks +2 days from the previous PE. 
12Anti-MOR00208 antibody sample and MOR00208 PK sample (pre-dose only) will be taken in odd numbered additional treatment cycles only (i.e. treatment Cycles 13, 15, 17, 
19, 21, 23). No samples to be collected after Cycle 23. 
13Disease assessment by CT/MRI of neck, chest, abdomen & pelvis with iv contrast during additional treatment phase; Cycles 13-24: approximately every 3 months ± 2 days from 
the previous scan. First assessment during this phase can be done directly 3 months after Cycle 12 D28 PET/CT assessment. Thus, this assessment is not needed at Cycle 13 Day 1, 
and an interval longer than ~3 months is acceptable for Cycle 16 Day 1 assessment; Cycle 25 onwards: approximately once every year ± 2 weeks from the previous scan. Images 
will have to be transferred to the central imaging laboratory. 
14In case the patient is withdrawn from treatment before the end of Cycle 12 for reasons other than progression of disease. PET/CT is only required at the EOT visit if it was not 
performed in the cycle before the end of treatment visit. 
15Bone marrow assessment during additional treatment phase (Cycles 13 to 24) approximately every 3 months ± 2 weeks from the previous assessment; to be performed to confirm 
a CR only in those patients who had known bone marrow involvement prior to dosing. Refer to Section 7.2.14.2 for further details. 
16HBV-DNA to be measured and re-measured only if anti-HBc was positive at screening. If HBV-DNA is positive at screening, or during treatment, please see Section 7.2.13.2. 
17Not applicable for patients who continue receiving MOR208 despite disease progression. 
18Central laboratory tests will be performed only until Cycle 24 for each patient, as applicable. Not to be performed from Cycle 25 onwards. 
19PET/CT Cycle 25 onwards should be performed only if deemed necessary, and not more than once per year. 
20This treatment is planned for a total treatment duration (from Cycle 1 Day 1 onwards) of at least 5 years, including the safety follow-up visit and survival follow-up duration, as 
applicable. 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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21Antineoplastic therapy other than study treatment can be administered, and will be recorded in eCRF only for those patients who continue to receive MOR208 despite disease 
progression / relapse, and have completed an Unscheduled Visit covering all assessments described for the EOT visit. For further clarification please refer to Section 7.2.3. 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 69 of 110 
7.2 Procedures 
All study-required procedures should occur as outlined in Table 5. Excursions from the timing 
of assessments will be considered protocol deviations and should be recorded in the source 
documents along with the reason for the excursion. 
 
For patients receiving antibody treatment despite disease progression / relapse, an 
Unscheduled Visit covering all assessments described under EOT visit should be completed 
before the continuation of antibody therapy. Blood parameters (haematology, serum 
chemistry) should be evaluated in the local lab according to local guidelines/standards of local 
medical practice for the administration of monoclonal antibodies. A urine pregnancy test should 
be performed for women of childbearing potential, prior to each infusion. Vital signs should be 
measured according to local practice for the administration of monoclonal antibodies. For this 
patient population only the antineoplastic therapy and AEs need to be captured in eCRF. Other 
procedures described in the column MOR00208 Additional Treatment will not apply for this 
patient population. 
 
 
 Screening followed by Enrolment (Start of IMP) 
The Screening Period begins on the date the Informed Consent Form (ICF) is signed and will 
last for up to 28 days. The ICF must be signed prior to beginning any assessments solely for the 
purpose of this study. Standard of care assessments done on the day of consent (but prior to 
signing the ICF) do not need to be repeated solely for the purpose of screening and may be used 
as study data, if they meet the protocol requirements. 
 
During screening, it is permitted to repeat on a single occasion the central laboratory 
assessment of serum chemistry and haematology parameters due to the variability of the 
parameters and their dependence on multitude of factors (e.g., hydration, muscle mass). This is, 
provided no safety concerns arise and that such laboratory results might have been caused by a 
transient, medically plausible event, which resolved spontaneously or as result of a medical 
intervention in the meantime (e.g., dehydration, vomiting, imaging procedure with a contrast). 
This procedure and the rationale behind it must be explicitly documented in source data. Such 
repeated assessment (once only) of the concerned parameters will not be counted as “re-
screening” for that patient. 
 
On Cycle 1 Day 1, patient eligibility must be confirmed before drug administration. Local 
laboratory parameters should be used for this purpose, as specified in Section 7.2.13 Laboratory 
Assessments. 
 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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 End of Treatment (EOT) Visit 
An end of treatment visit will have to be completed for all patients, including, but not limited to 
the following circumstances: 
a. After disease progression / relapse, any time after start of the study treatment, provided 
MOR00208 will not be administered despite progression 
b. After last administration of study drugs. 
c. Withdrawal from study treatment as specified in Section 6.9. 
If the EOT visit is after 24 cycles (i.e., Cycle 25 onwards), only the applicable laboratory tests 
in the local laboratory will need to be performed. 
 
 MOR00208 Administration Despite Disease Progression 
It is up to the investigator to decide according to the individual risk/benefit ratio if the patient 
should continue on MOR00208 in case of disease progression, after discussion with the 
Sponsor’s Medical Monitor. For patients who will be administered MOR00208 despite 
progression of disease / relapse, an Unscheduled Visit including all protocol prescribed 
procedures for the EOT Visit need to be performed in order to capture the event (i.e. disease 
progression/relapse) for the antibody treatment to continue further. These procedures, if 
performed within less than two weeks preceding this visit, need not be repeated. PET/CT need 
not be repeated if it was performed during previous treatment cycle. Note: Central laboratory 
tests will need to be performed only until Cycle 24 for each patient, as applicable. 
 
Following procedures will be performed (and documented in source) for these patients during 
the period of MOR00208 administration despite disease progression (prior to each infusion): 
a. Emergency Laboratory (Local Lab) evaluations consisting of haematology, serum 
chemistry according to local guidelines/standards of local medical practice for the 
administration of monoclonal antibodies. 
b. A urine pregnancy test for women of childbearing potential 
c. Vital signs 
 
These patients will follow a visit schedule as mentioned under “MOR00208 Additional 
Treatment Phase”, whereas their treatment cycle and visit numbers will be captured in a 
continuum with their previous applicable treatment visit, prior to disease progression. For this 
patient population only the antineoplastic therapy and AEs are going to be captured in eCRF. 
Other procedures described in the column MOR00208 Additional Treatment will not apply for 
this patient population. 
 
In such cases an EOT Visit will take place after these patients have finally stopped receiving the 
antibody. At this EOT visit only anticancer therapy and AEs will be recorded. And lastly, a 
Safety Follow-Up will take place 30-Days after last administration of MOR00208. 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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 Safety Follow-up Visit 
A Safety Follow-Up will take place 30-Days after last administration of IMP. Following 
assessments will be performed and recorded in eCRF: 
a. Limited physical examination 
b. Adverse events including second primary malignancies 
c. Antineoplastic therapy 
 
 Survival Follow-up 
After Safety Follow-up Visit, a phone call will be made to the patient (or the patient’s family) 
every 90 days (+ 2 weeks) for to cover a duration of up to 5 years from Cycle 1 Day 1 to inquire 
about the patient’s status, second primary malignancy (SPM) and information on any 
antineoplastic therapies utilised since discontinuation of study treatment. For patients who are lost 
to follow-up, at least three attempts of contact by the site should be made and documented in the 
source data. 
 
 Diagnostic Biopsy 
Patients must be eligible and willing to undergo a biopsy of a lymph node or other pathological 
tissue, providing enough tumour tissue for correlative studies, as a part of participation in this 
study. Histological confirmation of the diagnosis of DLBCL will be performed by a central 
pathologist, retrospectively after enrolment. Surgically acquired tissue samples are preferred, but 
core biopsies are permitted. Bone marrow biopsies are not adequate for this purpose and should 
be performed only for disease staging. 
 
Should it not be possible to obtain a fresh tumour tissue sample from the patient, archival paraffin 
embedded tumour tissue acquired < 3 years prior to screening for this protocol must be available 
for this purpose. 
 
The local pathology report indicating DLBCL diagnosis is acceptable for determining a patient’s 
eligibility. Central pathology review is mandatory, but retrospective in nature. Tissue samples 
(or archival paraffin blocks, as stated above) should be submitted within 30 days of patient 
enrolment in the study. Patients can be enrolled prior to submission of tissue sample(s). 
 
In case of discrepancies between the assessments of the local and the central pathologists, the 
one of the central pathologist prevails. If the DLBCL diagnosis of the local pathologist cannot 
be confirmed by the central pathologist, and a patient’s treatment has already commenced, they 
may remain in the study. 
 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
Confidential 
Page 72 of 110 
 Demographic Data/Relevant Medical History and Current Medical 
Conditions/Baseline Stage and Prognostic Classification 
Demographic variables to be recorded will include age, gender, race, body height, and body 
weight. Weight and height should be measured while the patient is without shoes, but dressed. 
 
At the time of signing of the ICF, relevant medical history and current medical conditions should 
be recorded. The medical history of DLBCL should be documented in detail, including baseline 
symptoms as well as a detailed history of prior cancer therapies for DLBCL, with start and stop 
dates, number of therapy line(s), disease progression during or after therapy, as well as 
discontinuations due to intolerability or any other clinically significant illness. Any previous 
therapy (e.g., chemotherapy, immunotherapy, or radiation therapy) for DLBCL should be 
recorded in the eCRF. Also, examinations leading to the diagnosis of the latest progression of 
DLBCL 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 
DLBCL. The assessment of the lymphoma should include staging. In order to reflect the patient’s 
status at the time of enrolment, the standard staging system used for DLBCL reflecting the 
number of sites of involvement and their relation to the diaphragm, the existence of B-symptoms, 
and the presence of extranodal disease, will be documented (see Appendix_E for Ann Arbor 
Staging). 
 
Additionally the disease risk assessment as per IPI (see Appendix_B) and patient status as per 
Eastern Cooperative Oncology Group (ECOG) performance status criteria (see Appendix_F), 
will be recorded. 
 
Examples of clinical significant systemic diseases, which may exclude patient participation 
include, but are not limited to: 
a) A diagnosis of a myocardial infarction within the 6 months prior to enrolment, 
New York Heart Association (NYHA) class II or higher congestive heart failure, 
uncontrolled angina pectoris, severe uncontrolled ventricular arrhythmias, 
clinically significant pericardial disease, or electrocardiographic evidence of 
acute ischaemia or significant conduction system abnormalities, in the opinion of 
the investigator. Patients with stable, asymptomatic atrial fibrillation are allowed 
in the study provided they do not meet the other cardiac exclusion criteria 
b) Systemic diseases (e.g., cardiovascular, renal, hepatic) that would in the 
investigator’s opinion preclude participation in the study or compromise the 
patient’s ability to give informed consent 
c) History or evidence of clinically significant peripheral nervous system, 
cerebrovascular, or CNS diseases, meningeal (e.g., meningeosis leukaemica), or 
epidural malignancy including brain metastasis or cerebrovascular event(s) with 
clinically significant sequelae. Screening for cerebrospinal fluid (CSF)/CNS 
involvement is not required but may be performed at the discretion of the 
investigator. 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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 Vital Signs 
Vital signs will be measured at the time points described in the Schedule of Assessments  
(Table 5). 
 
These assessments include body temperature, systolic and diastolic blood pressure readings 
(mmHg), heart rate (beats per minute [bpm]), and respiratory rate (respirations per minute 
[rpm]). Vital signs will be measured immediately prior to infusion, 15 ± 5, 30 ± 10, and then 
every 60 ±15 minutes during infusion and at end of infusion (± 20 min). The actual time of vital 
sign measurements should be accurately documented. If the infusion is interrupted and/or 
subsequently restarted, vital signs should be assessed every 60 ± 15 minutes after the first hour. 
 
The frequency or the length of the monitoring period may be adapted if clinically indicated, for 
example if in the opinion of the investigator the vital sign results, at the time of event onset, are 
clinically significant. In such a case the patient’s vital sign measurements should continue to be 
recorded until they have returned to normal or pre-infusion levels and an AE recorded. If 
possible, before vital signs are measured, the patient should be resting for at least 5 minutes. The 
same position should be used each time vital signs are measured for a given patient, and blood 
pressure should be measured from the arm contralateral to the site of study drug administration. 
Body temperature should be measured according to normal hospital practice. 
 
  Physical Examination (PE) 
7.2.9.1 Full PE 
A full PE will be performed by the Investigator or a qualified designee during the screening and 
at the EOT Visit. 
 
Full PE must be performed according to the best standards of local medical practice but should 
include at least vital signs and palpable tumour assessments, general appearance, skin, head, 
eyes, ears, nose, throat including Waldeyer lymphatic structures, 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. 
 
7.2.9.2 Limited PE 
Limited PEs may be focused on tumour response assessment (e.g., lymph nodes, liver, spleen) 
and AEs per investigator discretion will be performed on Day 1 of Cycles 1, 3, 5, 7, 10 and 12. 
Additionally, a limited PE will be performed on the 30-Day Follow-up Visit. 
 
During the course of the Additional Treatment Phase of the study a limited PE will be performed 
on Day 1 every 12 weeks ± 2 weeks. 
 
Symptom-driven full PEs may be performed as clinically indicated at any study visit. 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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7.2.9.3 Body Weight and Height Measurements 
Body height will be measured at Cycle 1 Day 1 only. 
 
Body weight can be measured up to 24 hours prior to MOR00208 administration on Day 1 of 
each cycle. This baseline weight will be used to calculate the MOR00208 dose during the given 
cycle provided the weight does not deviate >±10% from baseline during the course of this cycle. 
In cases where the patient’s body weight changes more than ± 10% from baseline, the current 
weight will be used to calculate the next and subsequent doses of MOR00208. Using actual body 
weight prior to each MOR00208 infusion is also allowed, if this is preferred by investigators. 
 
Weight measurements should be performed at each visit and the values will need to be entered 
into the eCRF on the actual day of measurement. 
 
7.2.9.4 B-Symptoms 
B-symptoms are defined as any one or more of the disease-related symptoms or signs mentioned 
in Appendix_E. 
 
Assessment of the presence or absence of B-symptoms will be performed at screening and on 
Day 1 for all cycles, as well as the End of Treatment Visit and at the 30-Day Follow-up Visit. 
 
 Electrocardiogram 
Standard 12-lead resting ECGs will be obtained at the various time points described in the 
Schedule of Assessments (Table 5). ECGs will be recorded after the patient has rested in a supine 
position for at least 5 minutes. Heart rate, PR, QRS, RR and QT intervals will be determined. 
All ECGs will be performed and interpreted locally. 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. 
 
If clinically significant abnormalities are observed or artefacts are present that result in an 
inability to adequately interpret the results, the ECG will be repeated. An average of all intervals 
measured in all ECG tracings recorded at a given time point may be taken if necessary. 
 
 Adverse Event Monitoring 
AEs will be assessed at each visit and reported as specified in Section 8.2 of the protocol. 
 
For screening failure patients only SAEs will be recorded in the eCRF. 
 
 Monitoring of Second Primary Malignancies 
SPMs will be monitored as events of interest and should be included as part of the assessment of 
AEs throughout the course of the study. Investigators are to report any SPMs as serious AEs, 
regardless of causal relationship to the study drugs, occurring at any time, for the duration of the 
study, from Cycle 1, Day 1 up to and including the follow-up period of up to 3 years. Events of 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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SPM are to be reported using the SAE report form and must be considered an important medical 
event even if no other serious criteria apply; these events must also be documented in the 
appropriate page(s) of the eCRF and the patient’s source documents. 
 
Documentation on the diagnosis of the SPMs must be provided at the time of reporting as an 
SAE (e.g., any confirmatory histology or cytology results, X-rays, computed tomography [CT] 
scans). 
 
 Laboratory Assessments 
Detailed instructions and amounts of biological samples needed for the respective laboratory 
measurements will be summarised in the laboratory manual. All samples will be collected as 
non-fasting samples. 
 
7.2.13.1 Safety and Haematology Laboratory Testing 
Clinical laboratory tests will be performed according to Table 6. During the course of the study, 
local (“emergency”) and central laboratories will be used. 
 
Central laboratory results are required for determining patient eligibility for study enrolment and 
will be used in the primary statistical analysis of the study results. Note: for eligibility 
confirmation prior to study drug administration at Cycle 1 Day 1, local laboratory results should 
be used. During the course of the study, all scheduled central laboratory results should be 
reviewed as soon as possible after Day 1 of each cycle. 
 
During screening, it is permitted to repeat on a single occasion the central laboratory assessment 
of serum chemistry and haematology parameters due to the variability of the parameters and their 
dependence on multitude of factors (e.g., hydration, muscle mass). This is, provided no safety 
concerns arise and that such laboratory results might have been caused by a transient, medically 
plausible event, which resolved spontaneously or as result of a medical intervention in the 
meantime (e.g., dehydration, vomiting, imaging procedure with a contrast). This procedure and 
the rationale behind it must be explicitly documented in source data. Such repeated assessment 
(once only) of the concerned parameters will not be counted as “re-screening” for that patient. 
 
Local (“emergency”) laboratory results will be used for treatment or clinically related decisions, 
or for the immediate safety needs of a study patient. “Emergency laboratory” (local) results 
should be reviewed as soon as possible after their receipt and before dosing so that the 
administration of the investigational medicinal product (IMP) may be adjusted or interrupted if 
necessary. 
 
The signed and interpreted laboratory results (both local and central) will be kept in the patient’s 
source documentation. The laboratory results should be reviewed, dated and signed in a timely 
manner by the investigator. Any clinically significant discrepancies will be evaluated on a case-
by-case basis. All blood samples will be processed and handled according to standard laboratory 
procedures. The time of blood collection should be documented in the source data. 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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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 (identified either through local or central laboratory analysis) 
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 (e.g., ordering a white blood cell (WBC) differential count to help 
characterise a high or low WBC count, or ordering a determination of red blood cell (RBC) 
indices to help characterise a low haematocrit). 
 
Central laboratory tests will be performed only until Cycle 24 for each patient, as applicable. 
 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Page 77 of 110 
Table 6 
Laboratory Evaluations 
Evaluation 
Analysis 
“Emergency laboratory”1 
(EDTA blood and serum 
sample) 
Serum creatinine, haemoglobin, WBCs, WBC differential, 
platelets, sodium, potassium, AST, ALT, total bilirubin 
Haematology 
(EDTA blood) 
WBC with differential count, haematocrit, haemoglobin, mean 
corpuscular volume, mean corpuscular haemoglobin 
concentration, platelet count, RBC count, lymphocytes, 
monocytes, neutrophils, band neutrophils, eosinophils, basophils 
At screening: will include a peripheral blood smear 
Erythrocyte sedimentation rate kit from central lab will be used, 
however, the test as such has to be performed locally at the site.  
Serum chemistry 
(serum sample) 
ALT, total albumin, alkaline phosphatase, amylase, AST, 
bicarbonate, bilirubin (total), urea, total calcium, chloride, 
creatinine, creatinine kinase, GGT, glucose, LDH, lipase, 
phosphate, potassium, protein (total), sodium, uric acid, 
magnesium, β2-microglobulin, C-reactive protein 
Coagulation parameters 
(sodium citrate blood) 
Activated partial thromboplastin time, prothrombin time, 
international normalisation ratio, immunoglobulin concentrations 
(IgG, IgM, IgA) 
Serology parameters 
(serum sample) 
Hepatitis B: HbsAg, anti-Hbc and anti-HBs. HBV-DNA if 
anti-Hbc positive (until Cycle 24),   
Hepatitis C: HCV antibody (HCV RNA quantification if 
anti-HCV-positive) 
Pregnancy test  
(serum sample) 
β-HCG serum, females of childbearing potential only 
Pregnancy test  
(urine) 
β-HCG urine, females of childbearing potential only. The 
pregnancy test assay should have a minimum sensitivity of 
25 IU/mL (urine sticks will be provided centrally, until Cycle 24).  
Urinalysis 
Appearance, colour, urine bilirubin, glucose, haemoglobin, 
ketones, pH, protein, specific gravity, urobilinogen.  
Microscopy will only be performed if clinically indicated 
Genotyping 
FcγRIIa and FcγRIIIa polymorphism 
CD16 expression on 
peripheral NK cells 
(heparinised blood) 
(exploratory assay) 
CD16 expression on NK cells (Flow cytometry) 
Immunogenicity 
(serum sample) 
Anti-MOR00208 antibodies 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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Page 78 of 110 
Abbreviations: 
ADCC=antibody-dependent 
cell-mediated 
cytotoxicity; 
ALT=alanine 
transaminase; 
AST=aspartate 
aminotransferase; β-HCG=beta-human chorionic gonadotropin; EDTA=thylenediaminetetraacetic acid; GGT=gamma-
glutamyltransferase; anti-HBc=hepatitis B core antibody; anti-HBs=hepatitis B surface antibody; HbsAg=hepatitis B surface 
antigen; LDH=lactate dehydrogenase; NK=natural killer; RBC=red blood cell; WBC=white blood cells. 
1WBC differential can be automated or manual as per institutional standards. Reticulocytes may be determined only when 
clinically indicated. 
 
7.2.13.2 Hepatitis Virus Serology 
Patients will be examined according to the schedule in Table 5 for viral hepatitis B and C 
serology. Hepatitis B biomarkers include hepatitis B surface antigen (HbsAg), total anti-hepatitis 
B core antibody (anti-Hbc) and hepatitis B surface antibody (anti-HBs). Patients with a positive 
test for anti-Hbc can only be included if hepatitis B viral DNA (HBV DNA) is not detected. In 
these patients only, HBV DNA should be assessed at various subsequent visits as outlined in 
Table 5. Note: Central laboratory tests will need to be performed only until Cycle 24 for each 
patient, as applicable. 
 
In the context of exclusion criteria, seropositive for or active viral infection with hepatitis B virus 
(HBV) means: 
a) HBV surface antigen positive 
b) HBV surface antigen negative, HBV surface antibody positive and/or HBV core antibody 
positive and detectable viral DNA. Note: Subjects who are HBV surface antigen negative 
and viral DNA negative are eligible. 
c) Patients who exhibit the classical vaccination profile of HBV surface antibody positive, 
HBV core antibody negative, and HBV surface antigen negative are eligible. 
 
If HBV-DNA becomes detectable during treatment, patients should be prophylactically treated 
and followed-up for potential hepatitis B reactivation as per local medical practice or institutional 
guidelines for CD20 antibodies such as RTX. If the HBV-DNA assay is positive, then patients 
can only stay in the study if they are assessed by a physician experienced in the treatment of 
 
continued 
 
Evaluation 
Analysis 
Pharmacokinetics 
(serum sample) 
MOR00208 
 
ADCC assessment 
(heparinised blood) 
(exploratory assay) 
ADCC with peripheral blood mononuclear cells (Flow cytometry) 
B-/T-/NK cell counting 
(heparinised blood) 
(exploratory assay) 
Cell counts (Flow Cytometry) 
Analysis of exploratory 
biomarkers 
(pathology samples) 
For example: CD19, CD20, BCL-2, BCL-6  

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Page 79 of 110 
hepatitis B and pre-emptive treatment is initiated, if deemed appropriate, and/or according to 
local practice/guidelines. 
 
Hepatitis C serology is to be done at screening only. Hepatitis C biomarkers include 
anti-hepatitis C virus antibody (anti-HCV). For patients who are positive for anti-HCV antibody, 
HCV-RNA should be measured 
 
A positive Hepatitis C test is defined as a positive test for Hepatitis C Virus (HCV) antibodies 
and a positive test for HCV RNA. 
 
7.2.13.3 Pregnancy Testing 
A pregnancy test will be performed for females of childbearing potential (FCBP) at various pre- 
and post-treatment time points either by urine pregnancy test or beta-human chorionic 
gonadotropin (β-HCG) test of a serum sample (see Table 5). The pregnancy test assay should 
have a minimum sensitivity of 25 IU/mL. At screening and the End of Treatment Visit, a serum 
β-HCG pregnancy test should be performed for FCBP.  
 
FCBP must have two negative pregnancy tests prior to starting the study drug. The first 
pregnancy test must be performed within the 10–14 days prior to the start of study drug and the 
second pregnancy test must be performed within the 24 hours prior to the start of study drug. 
The patient must not receive study drug until the study doctor has verified that the results of 
these pregnancy tests are negative. 
 
Subsequent pregnancy tests will be conducted: 
 every week for the first 28 days of the study 
 every 28 days thereafter (or every 14 days if the patient has irregular periods) 
 if the FCBP patient misses a period 
 if the FCBP patient has unusual menstrual bleeding 
 at the EOT Visit 
 fourteen (14) days and 28 days (if irregular periods) and 28 days only (with regular 
periods) after stopping LEN. 
 
Note: Central laboratory tests will need to be performed only until Cycle 24 for each patient, as 
applicable. 
 
In addition, pregnancy and risk counselling will be conducted at the time points specified in the 
LEN Pregnancy Risk Minimisation Plan for Clinical Trials. 
 
7.2.13.4 PK Assessments 
Concentration-time profiles and PK parameters will be assessed for MOR00208 according to the 
Schedule of Assessments (Table 5). Neither samples nor concentration-time profiles or PK 
parameters will be assessed for LEN. 
 
Serum samples for PK analysis of MOR00208 will be handled and stored as specified in the 
laboratory manual at the study site until shipment on dry ice to an external analytical laboratory. 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
MorphoSys AG 
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Page 80 of 110 
At each sampling time point, the obtained serum sample should be split into 2 aliquots (a primary 
and a back-up sample). 
 
7.2.13.5 Immunogenicity 
Serum samples for anti-MOR00208 antibody analysis will be collected according to the 
Schedule of Assessments (Table 5). 
Serum samples for anti-MOR00208 antibody analysis will be handled and stored as specified in 
the laboratory manual at the study site until shipment on dry ice to an external analytical 
laboratory. At each sampling time point, the obtained serum sample should be split into 
2 aliquots (a primary and a back-up sample). 
 
7.2.13.6 Other Laboratory Evaluations 
A mucosal cheek swab will be used for DNA analysis of FcγRIIa and FcγRIIIa polymorphisms. 
The evaluation will be performed at a specified laboratory. 
 
Genotyping is optional; it will only be performed if the patient specifically consents to this 
analysis. A patient can participate in the study regardless of whether they consent to undergo 
genotyping. 
 
Biomarker analysis on collected tissue samples, for example CD19 and CD 20 expression 
assessments will be performed at a central specified laboratory. 
 
For evaluation of the status of the patient’s immune system, B-, T- and NK cells in peripheral 
blood will be measured frequently throughout the study (exploratory assay). The absolute and 
percentage changes from baseline will be evaluated. 
 
Baseline CD16 expression on NK cells in peripheral blood will be evaluated at baseline 
(exploratory assay). In addition, the ADCC capacity of the patient will be assessed. 
 
 Efficacy Assessments 
Efficacy will be evaluated in terms of ORR, DCR, DoR, PFS, OS, TTP and TTNT: For 
definitions see Section 10.6. 
 
Disease response assessments will be made according to the revised response criteria based on 
the guidelines of the IWG reported by Cheson et al. (2007) (see Appendix_G). Response 
assessment made by the central radiology + clinical review at Cycle 12 Day 28 (+4 days) (and / 
or at the EOT visit, as applicable) will be considered for the main efficacy analysis (primary 
endpoint).  
 
Local assessment of efficacy / disease response will be recorded in addition to central review at 
the end of Cycle 12 (for decisions concerning the additional Cycle 13 through Cycle 24 
MOR00208 treatment) and at the EOT Visit (to determine whether the disease has progressed), 
and at additional time points specified in Table 5. Disease assessment by CT/MRI during 
additional treatment phase will be done as follows: 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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 
Cycle 13 until Cycle 24: First assessment during this phase can be done after 
approximately 3 months + 2 days after Cycle 12 D28 PET/CT assessment. Thus, this 
assessment is not needed at Cycle 13 Day 1, and an interval longer than 3 months is 
acceptable for Cycle 16 Day 1 assessment. Thereafter, it will be repeated approximately 
every 3 months ± 2 days from the previous scan. 
 
Cycle 25 onwards: approximately once every year from the previous scan. 
 
7.2.14.1 Tumour Imaging Assessment 
In the course of the study, disease and response assessments as well as tumour measurements 
will be performed. 
 
Initial disease and disease response assessments for the primary endpoint will be made by 
positron emission tomography (PET)/ CT (CT should be done with IV contrast) at screening and 
Day 28 (±4 days) of Cycle 12 and at the EOT Visit, in the cases where a patient is withdrawn 
from treatment before the end of Cycle 12 for reasons other than progressive disease. PET/CT 
scanning during additional treatment phase (Cycle 13 onwards) with MOR00208 will be 
performed at the decision of the investigator, and should not be performed more than 
approximately once per year. 
 
Tumour measurements and disease assessment (local) will be performed as indicated in Table 5 
by CT. The CT portion of PET/CT will be acceptable in place of CT for tumour measurement 
and disease assessment, only when the CT portion is of adequate diagnostic-quality, and using 
adequate intravenous contrast. 
 
Magnetic resonance imaging (MRI) may be used in lieu of CT, and PET/MRI in lieu of PET/CT 
for patients with contraindications to the administration of contrast agents, or due to other 
medical reasons, at the same time points 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. 
 
If available and of acceptable quality, previously performed PET/CT examinations, in 
accordance with the standard of care, that were done up to four weeks prior to the date of 
informed consent may be used for a patient’s baseline central radiology assessment. Additional 
PET/CT or CT or MRI examinations may be performed by the investigator in the course of the 
study, if deemed necessary (e.g., to confirm the occurrence of a CR or to make important 
treatmentrelated- decisions). Whenever feasible, in such cases the investigator should seek prior 
approval of the sponsor for the additional imaging. 
 
If the patient discontinues from treatment, a PET/CT scan is only required at the EOT Visit if it 
was not performed in the cycle prior to the end of treatment. CT may be performed in lieu of 
PET/CT if the patient discontinues from treatment within Cycle 1. 
 
The same scan modality should be used for all assessments, and all patients are required to have 
scans of the neck/chest/abdomen/pelvis. All scans conducted during the study will be provided 
to a central imaging laboratory for independent radiological and clinical evaluation. 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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If it is impossible for the patient to have their PET examination in fasted state, adequate 
procedures should be in place to measure and control blood glucose level. 
 
7.2.14.2 Bone Marrow 
At the screening visit, a uni- or bilateral bone marrow aspirate and a biopsy should be obtained 
to assess bone marrow involvement. Results from a bone marrow examination done within the 
4 weeks prior to the date of informed consent will be acceptable if the patient’s disease has been 
stable since then. 
 
The achievement of CR in the course of MOR208C203 study must be confirmed locally, by 
clinical and radiologic evaluation along with bone marrow confirmation. The latter applies only 
in case the bone marrow was involved by lymphoma before study entry. If bone marrow was not 
involved by lymphoma before commencing the study treatment, then bone marrow confirmation 
biopsy is not required. The repeated bone marrow examination is also not required for patients 
in whom bone marrow has already been cleared of the infiltrate at previous evaluation, i.e. their 
previous response was CR. 
 
Histological examination of the bone marrow should be performed locally at the protocol 
specified time-points (see Table 5). 
 
 
8 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 non-leading 
questioning (e.g., “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 
lifethreatening-. Personnel who are trained in the acute management of IRRs, cytokine release 
syndrome, anaphylaxis, and other emergencies, and who have access to appropriate clinical 
supplies, should be readily available. 
 
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, hospitalisation, 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. 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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8.1 Definition of Adverse Events, Serious Adverse Events, 
Adverse Events of Special Interest 
An AE is defined as any untoward medical occurrence in a patient or clinical patient 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. 
 
AEs include any clinically significant deterioration of a patient’s medical status after the signing 
of the ICF. Also, an increase in the frequency or intensity of a pre-existing episodic event or 
conditions and events resulting from protocol mandated procedures (e.g., invasive procedures) 
fall under the definition of AEs. In addition, overdoses (defined as exceeding the planned dose 
by more than 20%) should be recorded as AEs. 
 
 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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Page 84 of 110 
As far as possible, each AE should be evaluated to determine the following: 
 relationship to the 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 activities or 
     work) 
 toxicity grade: determined according to the NCI-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.) 
grade 3: 
severe 
or 
medically 
significant 
but 
not 
immediately 
life-threatening; hospitalisation or prolongation of hospitalisation 
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; 
hospitalisation/prolonged hospitalisation) 
 seriousness: whether it is serious, where a SAE is defined as one that: 
o results in death 
o is life-threatening 
o requires inpatient hospitalisation or prolongation of existing hospitalisation 
(hospitalisation signifies that the patient was an inpatient for at least one overnight 
stay) unless hospitalisation 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 pre-existing 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 
 hospitalisation signifies that the patient was an inpatient 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, i.e. defined as an event that jeopardises the patient or 
may require medical intervention to prevent one of the outcomes listed 
previously. 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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Page 85 of 110 
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 lifethreatening- or do not result in death or hospitalisation but may 
jeopardise the patient or may require intervention to prevent one of the other outcomes listed in 
the previous definitions should also be considered as serious. 
 
AEs of special interest are TFR, TLS, SPM, IRRs and allergic reactions to study drug ≥grade 3, 
cytokine release syndrome and overdoses. 
 
Unlike routine safety assessments, SAEs and AEs of special interest are monitored continuously 
and have special reporting requirements (see Section 8.2). 
 
The investigator should determine the causality (relationship to the study drugs) based on his/her 
clinical experience and on the information given in the IB for MOR00208 and the SmPC / 
Prescribing Information for lenalidomide. 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 the study drug. 
 
Information about adverse drug reactions already known about the investigational study drugs 
can be found in the IB for MOR00208 and the SmPC from lenalidomide, or will be 
communicated in the form of Investigator Notifications. This information will be included in the 
patient ICF and should be discussed with the patient during the study, as needed. 
 
8.2 Adverse Event and Serious Adverse Event Recording and 
Reporting 
All AEs (except non-serious AEs for screening failures) that occur after the provision of 
informed consent and up to 30 days after last study drug administration will be recorded in the 
eCRF and in the patient’s medical records, whether or not they are 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, 
non-serious AEs will not be recorded in the eCRF but only in the patient’s medical records. 
 
In addition, all SAEs and AEs of special interest will be recorded on the SAE report form. Study 
centres and investigators are instructed to report all SAEs and AEs of special interest to the 
contract research organisation (CRO) mentioned below within 24 hours using the 
studyspecific- SAE report form. Preferably, the diagnosis instead of the individual symptoms 
should be reported. For overdoses, the diagnosis and if applicable the accompanying 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 a myocardial infarction is reported as an AE, there 
is no need to report elevated creatine phosphokinase and abnormal ECG, or other related signs, 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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symptoms, or laboratory values as separate AEs. However, if such events occur in isolation, and 
myocardial infarction is not diagnosed, then each event should be reported as an AE. 
 
All non-serious 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 non-serious 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 
stabilisation or death. The follow-up for SAEs that are a progression of DLBCL 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 the case of a fatal outcome, the cause of death. 
 
Events that are clearly caused by progression of the underlying disease (for example 
transformation to more aggressive histology) should not be recorded as AEs or SAEs. These data 
will be captured as efficacy assessment data only. If there is any uncertainty as to whether an 
event is due to disease progression, it should be recorded as an adverse event. 
 
Deaths that occur during the protocol-specified adverse event reporting period that are being 
attributed to progression of the underlying disease should not be recorded as AEs or SAEs. All 
other on-study deaths, regardless of relationship to study drug, must be recorded on the Adverse 
Event eCRF and immediately reported to the Sponsor. Death should be considered an outcome 
and not a distinct event. The event or condition that caused the fatal outcome should be recorded 
as the single medical concept on the Adverse Event eCRF. Generally, only one such event should 
be reported. 
 
During survival follow-up, deaths attributed to progression of the underlying disease should be 
recorded in the eCRF. 
 
Notification of initial or followup- SAE information (by using the standard SAE form provided 
by the sponsor) must be sent by fax to the CRO at the following numbers as appropriate: 
 
 
 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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For any safetyrelated- or protocol related questions, please use the contact numbers below (24/7 
coverage): 
 
24/7 Medical Emergency 
Coverage (out of office 
hours) 
Medical Emergency 
Coverage (during Medical 
Monitor office hours) 
 
 
8.3 Pregnancies 
As detailed in the Schedule of Assessments (Table 5) and Section 7.1, serum pregnancy testing 
will be carried out at the Screening, and End of Treatment Visits (performed centrally). During 
the treatment period of the study, urine pregnancy testing will be performed locally and can be 
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 
by fax at the following number: 
 
Female study patients who become pregnant must be withdrawn from the study treatment period 
(IMP is to be discontinued immediately). 
 
A newly diagnosed pregnancy in a patient or female partner of a study patient who has received 
study medication is not considered an SAE unless it meets any criteria of seriousness or it is 
suspected that the study medication interacted with a contraceptive method and led to pregnancy. 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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If the pregnancy results in clinical consequences/complications in mother or child, e.g., 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. 
 
 
9 DATA HANDLING AND ARCHIVING 
 
9.1 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. 
 
9.2 Clinical Data Management 
The CRO will be responsible for the processing and quality control of the data according to the 
CRO’s standard operating procedures (SOPs). Data management will be carried out by the 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 Medical Dictionary for Regulatory Activities (MedDRA, Version 18.0 
or higher) for AEs and medical history and the WHO-drug dictionary enhanced for medication. 
 
9.3 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 Good Clinical Practice (GCP) 
guidance and the clinical trial agreement. 
 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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10 STATISTICAL METHODS AND PLANNED ANALYSIS 
 
10.1  Populations for Analysis 
The following analysis populations will be used: 
 
Full analysis set (FAS): 
The FAS includes all patients who received at least one dose of MOR00208 and one 
dose of LEN. This means that both study drugs must have been applied at least once. 
 Per protocol set (PPS): 
The PPS is the subset of all subjects in the FAS without any major protocol 
non-compliances. All patients in the FAS, had at least one dose of MOR00208 and one 
dose of LEN drug. Patients without any post-baseline assessment of DLBCL response 
or having major protocol deviations will be excluded from the PPS. 
 Safety analysis set (SAF): 
All patients who received at least one dose of MOR00208 or LEN study drug. 
 
Primary, secondary and supportive efficacy parameters will be evaluated using the FAS and PPS, 
while safety parameter evaluations will use the safety set (SAF), as well as for evaluations on 
immunogenicity and biomarkers. 
 
The primary analysis of the primary efficacy endpoint will be based on the FAS, whereas the 
analysis using the PPS has a supportive function. Decisions about whether a protocol deviation 
is relevant for the exclusion of a patient from the PPS will be made before database closure. 
 
10.2 Primary Endpoint 
1. The primary efficacy endpoint will be ORR (ORR = CR + PR) 
 
10.3 Secondary Endpoints 
2. DCR, DoR, PFS, OS, TTP and TTNT 
3. Incidence and severity of AEs 
4. Determination and characterisation of a potential anti-MOR00208 antibody formation 
5. PK analysis of MOR00208 
6. Absolute and percentage change from baseline in measurements of B-, T- and NK cell 
populations 
7. Analysis of exploratory and diagnostic biomarkers (e.g., CD19, CD20, BCL2, and BCL6 
expression, CD16 expression on NK cells, ADCC capacity, and gene expression profiling 
for cell of origin subtyping and evaluation of AEs and ORR stratified by FcγRIIIa and 
FcγRIIa polymorphism) are planned to be investigated during the course of the study. 
 
10.4 General Statistical Methods 
Tabulation of summary statistics, graphical presentations, and statistical analyses will be 
performed using appropriate statistical software. Continuous, quantitative variable summaries 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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will include the number of patients (N) (with non-missing values/valid cases), mean, standard 
deviation, minimum, 25th quartile, median, 75th quartile and maximum, except for 
pharmacokinetic metrics, where additional statistics may be used. 
 
Categorical, qualitative variable summaries will include the frequency and percentage of 
patients/entries, who/which are in the particular category. 
 
The assumed overall type I error rate/significance level for the primary and secondary efficacy 
parameters is 5%, two-sided. Two-sided confidence limits will be evaluated at 95%, p-values 
from inferential tests comparing specific patient cohorts/patient subgroups will be compared 
to 5%. 
 
Missing values will not be substituted by estimated values. All statistical evaluations will be 
based on valid cases except for procedures described for calculating response rates or in case of 
censoring within the Kaplan-Meier methodology. In the case of incomplete start or stop dates of 
AEs or concomitant medication appropriate conservative imputation methods will be specified 
in the Statistical Analysis Plan (SAP). 
 
Baseline values will be defined as the last pre-administration observation used for calculating 
post-administration changes from baseline. 
 
All data obtained and entered into the database will be provided in separate data listings showing 
individual patient values. A SAP detailing the statistical analyses and possible deviations from 
the protocol will be prepared before hard lock of database. 
 
10.5 Patient Disposition 
An overview table will be provided for all patients and will include the number of patients 
enrolled, the number of patients in each analysis population set, the number of completers and 
the number of withdrawals and the reasons for withdrawal. Compliance parameters for drug 
administration will be tabulated. 
 
Demographic information will be summarised using descriptive statistics or counts and 
percentages. 
 
General medical histories and DLBCLspecific- medical histories will be summarised by counts 
and percentages using appropriate classification codes. Concomitant medications will be 
recorded and tabulated with counts/percentages showing the number of medications/percentage 
used in each medication class. 
 
10.6 Analysis of Efficacy Data 
 Primary Efficacy Endpoint ORR 
Local and independent response evaluations (progressive disease, SD, PR and CR) will be 
tabulated with counts/percentages for each visit available. Missing response evaluations will be 
taken into account, with patients with missing responses included in the denominator for 
calculating the rates). 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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Objective response is defined as being when a patient is classified as having a CR or PR after 
DLBCL evaluation using the IWG treatment response criteria for malignant lymphoma (Cheson 
et al., 2007; see Appendix_G). 
 
The ORR, for the primary efficacy endpoint, is defined as the proportion of patients with a CR 
or PR (ORR = CR + PR) up until disease progression, based on central radiological + clinical 
evaluations. 
 
The denominator for calculating the rate will be based upon the total number of patients in the 
FAS population. As a sensitivity analysis, patients without any post-baseline assessment of 
response will be included in the denominator for ORR calculation. The number of responding 
patients and respective rates as well as the 95% confidence limits will be presented. 
 
The SAP will specify further sensitivity and supportive analyses, as well as possible evaluation 
of further response parameters (e.g., best response). 
 
 Secondary Endpoints 
10.6.2.1 Disease Control Rate (DCR) 
The DCR is defined as CR + PR + SD (i.e. ORR + SD) and will be evaluated as for ORR. 
 
10.6.2.2 Duration of Response (DoR) and Time to Next Treatment (TTNT) 
DoR is defined as the time interval between the initial time point of tumour response (CR or PR 
whichever status is recorded first) and the first date that recurrence of progressive disease is 
documented. Response duration by the local and central assessment will be tabulated with 
descriptive statistics. 
 
Disease progression is defined as the first occurrence of progressive disease according to the 
revised response criteria (Cheson et al., 2007) as assessed by central radiology / clinical readers. 
 
TTNT is defined as the time from study entry (= first dosing) to the institution of next therapy 
for any reason including disease progression, treatment toxicity and patient preference. TTNT 
will be descriptively analysed. 
 
10.6.2.3 Time to Event Variables: Progression-Free Survival (PFS), Overall Survival 
(OS), and Time to Progression (TTP) 
PFS is defined as the time elapsed between study entry (= first dosing) and lymphoma 
progression or death from any cause, whichever occurs first. Patients not experiencing a 
lymphoma progression or death from any cause will be censored at the last available tumour 
assessment. The same holds true for patients who are lost-to-follow-up. 
 
OS is defined as time from study entry (= first dosing) until the date of death from any cause. 
Patients who are alive but have dropped out early will be censored at the time of the last available 
study visit assessment. 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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TTP is defined as the time from study entry (= first dosing) until documented lymphoma 
progression or death as a result of lymphoma. The events of interest are only disease progression 
and death from lymphoma. Death from other causes will not be taken into account (will be 
censored) in the TTP evaluation. Patients not experiencing progressive disease will be censored 
at the last NHL assessment. Deaths from other causes will be censored at the time of death. Early 
drop-outs without any documented date of progression will be censored at the time of the last 
NHL assessment. 
 
Kaplan-Meier methodology will be used to evaluate median survival, presenting corresponding 
statistical parameters and Kaplan-Meier survival curves. Further analyses concerning influence 
of IPI and GC/non-GC B-cells will be specified in the SAP. 
 
TTP will be compared to the TTP of the patients’ most recent therapy by tabulating descriptive 
statistics (including 95% confidence limits). 
 
For the purposes of the protocol the day of enrolment is defined as the date of the first treatment 
(study entry). 
 
The SAP will provide further details on how to evaluate the influence of IPI and GC/non-GC B-
cells on ORR, DCR, PFS, OS, DoR, TTP and TTNT. Analyses will apply Kaplan-Meier methods 
using these parameters as factors, as well as stratifying analyses results by these factors or 
including these factors in appropriate multivariate models (e.g., analysis of variance [ANOVA]). 
 
The analysis of incidence and severity of AEs has been described below. 
 
10.6.2.4 Immunogenicity Analysis 
The absolute number and percentage of patients, who develop anti-MOR00208 antibodies, and 
the results of semi-quantitative anti-MOR00208 antibody titre determinations of confirmed 
positive sample assessments will be tabulated. Further details will be specified in the SAP. 
 
10.6.2.5 Pharmacokinetic Analysis 
Appropriate PK parameters for MOR00208, with a focus on, but not limited to, accumulation 
ratios, will be computed based on non-compartmental data analysis and summarised using 
descriptive statistics. Mean concentrations (on original and on log-linear scale) will be visualised 
in figures. Further details of the PK analysis will be specified in the SAP. 
 
10.6.2.6 Biomarkers 
Blood and protein biomarkers which are important in the mechanism of action of, or could 
predict response to, the study drugs will be descriptively tabulated, presenting absolute and 
change to baseline values, if applicable. 
 
For example: 
a. FcγRIIa and FcγRIIIa genotyping results will be descriptively tabulated, whereas ORR 
and selective AEs tabulations will be split by these factors  

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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b. Flow cytometry results of CD16 expression on NK cells will be descriptively tabulated, 
as well as ADCC results. 
 
10.7 Analysis of Safety Data 
 Adverse Events 
MedDRA (version 18.0 or higher) coded AEs will be used to show the incidence of all AEs by 
SOC, PT, relationship to treatment, severity and seriousness. 
An AE summary table will present the number of events, number of patients and the percentage 
of patients having TEAEs, SAEs, and TEAEs that led to study discontinuation. 
 
AE frequency tables will display event and patient counts by MedDRA, SOC and PT for each 
treatment arm. Such summaries will be displayed for all TEAEs, TEAEs by maximum 
severity/toxicity, TEAEs by relationship to study drug, SAEs, drug-related TEAEs and TEAEs 
that led to study discontinuation. 
 
 Clinical Laboratory Evaluations 
The analysis of laboratory parameters for each treatment arm will be presented separated into 
blood parameters (e.g., haematology, serum chemistry, coagulation, serology for hepatitis B and 
C) urine parameters (e.g., urinalysis) and serum pregnancy test. 
 
Descriptive summaries of actual (absolute) values and selected change-from-baseline values for 
continuous laboratory parameters of interest will be presented. Investigator assessments of the 
clinical relevance of each laboratory parameter will be analysed by frequency tabulations. 
 
The assessment of categorical urinalysis variables will be tabulated by time point, results for 
example of hepatitis B and C serology and pregnancy test results will be summarised using 
counts/percentages. Further details (e.g., tabulation of shifts, special analyses with respect to NCI 
CTC grading) will be detailed in the SAP. 
 
 Physical Examination, Vital Signs and Electrocardiogram (12-lead 
ECG) 
Complete and limited PE results will be summarised by body system and tabulated as 
counts/percentages. New and worsening abnormal physical examination findings during the 
study will be entered as AEs and analysed within the AE tables in detail. Descriptive summaries 
of vital sign parameters will be calculated. Summary ECG assessments will be tabulated by time 
point using frequency tabulations. Results of the 12-lead ECG (PR, QRS, QT, RR interval 
values) will be flagged to show whether a value is below or above the normal limit and summary 
statistics will be provided for ECG parameters. 
 
10.8 Sample Size Determination 
Approximately 80 patients with R-R DLBCL who meet the inclusion criteria and have none of 
the exclusion criteria will be randomly enrolled into the study. The study will be performed with 
an interim stop for the evaluation of the safety of the LEN dosage. No adjustment of sample size 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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or adaptation of efficacy evaluations will be made at this point. As the primary purpose of this 
study is to evaluate the clinical efficacy of 25 mg daily oral LEN combined with 12 mg/kg 
MOR00208 administered by IV infusion in patients with R-R DLBCL, no formal statistical 
hypothesis testing will be performed. 
 
For the determination of a suitable sample size, it is assumed that the combination treatment 
could improve the ORR from a value of 20% (under monotherapy) to 35% (under combination 
therapy). Applying an exact binomial test with a two-sided significance level of 5% and a power 
of 85% the estimated sample size is 73 patients (calculation performed by nQuery Advisor® 
7.0). According to this scenario an observed ORR of 32% would lead to a statistically significant 
study outcome. Assuming a drop-out rate of 10%, a total sample size of about 80 patients is 
estimated. 
 
The sample size determination has been conducted using various possible monotherapy and 
combination effect ORR rates and various power assumptions. Literature evaluation of study 
results concerning the ORR rates of LEN or comparable products (as mono- or 
combination-therapy) as well as former study results for MOR00208 were used to justify 
assumptions on response rates (Witzig et al., 2011; Wang et al., 2013). 
 
10.9 Safety Run-In 
The study will consist of two parts, which will be performed sequentially. The first part of the 
study (safety run-in) will conclude with an interim safety review after the first 6 patients have 
been accrued (see Section 5.1). This interim safety assessment will evaluate the number and type 
of AEs occurring during the first cycle, as well as the laboratory values (e.g., biochemistry and 
haematology) and other relevant safety data as necessary, with a view to providing a 
recommendation on the LEN dose to be used in the study, going forward. 
 
The second part of the study will only be authorised to open for enrolment following the outcome 
of this evaluation. If, during the second part of the study, the safety profile of the combination is 
satisfactory, study patient accrual will continue until the full goal of approximately 80 patients 
is achieved. 
11 SPECIAL REQUIREMENTS AND PROCEDURES 
 
11.1 Charters 
A charter outlining the central independent assessment (radiological and clinical) and review 
processes will be made available. 
 
11.2 Protocol Amendments and Other Changes in Study Conduct  
Any changes to the protocol will be made in the form of an amendment. 
 
Changes to the conduct of the study are not permitted. Any unforeseen changes in the study 
conduct will be recorded in the clinical study report. 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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11.3 Regulatory and Ethical Considerations, Including the 
Informed Consent Process 
Prior to initiation of a study site, MorphoSys will obtain favourable opinion/approval from the 
appropriate regulatory bodies/local health authorities (in accordance with local regulations) and 
the IRB/IEC to conduct the study in accordance with ICH GCP and applicable country-specific 
regulatory requirements. 
 
No substantial changes to the final approved protocol will be initiated without the IRB’s/IEC’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. 
 
This clinical study was designed and shall be conducted and reported in accordance with the 
protocol, with ICH E6 GCP guidelines, with applicable local regulations, and with the ethical 
principles laid down in the Declaration of Helsinki, including, but not limited to: 
 IRB/IEC review and favourable opinion/approval of the study protocol and any 
subsequent amendments 
 patient informed consent 
 investigator reporting requirements 
 MorphoSys will provide full details of the above procedures, either verbally, in writing, 
or both. 
 
The investigator will obtain 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 ICF must be signed, with name and date noted by the patient, before the patient is exposed 
to any study-related procedure, including screening tests for eligibility. 
 
11.4 Quality Control (Study Monitoring) 
Study monitoring will be performed in accordance with ICH E6 GCP guidelines, the sponsor’s 
and CRO’s SOPs, the sponsor’s and CRO’s written instructions, the protocol, and all applicable 
laws and regulations. 
 
The sponsor’s monitors will contact the site prior to the start of the study to review with the site 
staff the protocol, study requirements, and their responsibilities to satisfy regulatory, ethical, and 
the sponsor’s requirements. 
 
MorphoSys will monitor the study to ensure that the: 
 data are authentic, accurate, and complete 
 safety and rights of patients are being protected 
 study is conducted in accordance with the currently approved protocol and any other 
study agreements, GCP, and all applicable regulatory requirements. 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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The investigator and the head of the medical institution (where applicable) agree to allow the 
monitor direct access to all source data documents. 
 
11.5 Quality Assurance 
According to ICH E6 GCP guidelines, the sponsor or regulatory authorities may audit the 
investigational sites. The sponsor’s Quality Assurance Unit and/or their authorised 
representative(s), independent of the Clinical Operations and Clinical Development Department, 
are responsible for auditing the study. The investigator must accept such audits by the sponsor’s 
Quality Assurance Unit and/or their authorised representative(s) and ensure access to all source 
data/documents. 
 
The investigator must accept that regulatory authorities may conduct an inspection to verify 
compliance of the study with GCP guidelines. If informed that a regulatory inspection will take 
place, the investigator must inform the sponsor without delay. 
 
11.6 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. 
 
11.7 Publication Policy 
Any presentation or publication of data from this study will be intended as a joint publication by 
the investigator(s)/appropriate study site personnel and appropriate sponsor personnel. 
Authorship will follow the International Committee of Medical Journal Editors (ICMJE) 
Uniform Requirements for Manuscripts Submitted to Biomedical Journals and will be defined 
prior to the first publication. 
 
For multicentre studies, it is mandatory that the first publication be based on data from all centres, 
and that the data are analysed and submitted as stipulated in the protocol by a statistician assigned 
by the sponsor. 
 
Thus, no investigator or institution may publish any results of the study conducted at their site, 
before such a first multicentre publication is made which covers the data from all sites. 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. 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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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 at least 60 days 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 be available to the investigator. 
 
At the sponsor’s request, any confidential information (other than study results) will be deleted 
and all reasonable comments made by the sponsor will be incorporated prior to the submission 
for publication or presentation. 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: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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12 REFERENCES 
 
Armitage JO, Weisenburger DD. New approach to classifying non-Hodgkin's lymphomas: 
clinical features of the major histologic subtypes. Non-Hodgkin's Lymphoma Classification 
Project. J Clin Oncol. 1998;16:2780-95. 
 
Awan FT, Lapalombella R, Trotta R, et al. CD19 targeting of chronic lymphocytic leukemia 
with a novel Fc-domain-engineered monoclonal antibody. Blood. 2010;115(6):1204-13. 
 
Bargou R, Leo E, Zugmaier G, et al. Tumor regression in cancer patients by very low doses of a 
T cell-engaging antibody. Science. 2008;321:974–7. 
 
Blum KA, Maddocks K, Nagy Z, et al. 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. Abstract 3089 56th ASH Annual Meeting & 
Exposition December 6-9, 2014; San Francisco, CA, USA. 
 
Chanan-Khan A, Miller KC, Musial L, et al. Clinical efficacy of lenalidomide in patients with 
relapsed or refractory chronic lymphocytic leukemia: results of a phase II study. J Clin Oncol. 
2006;24:5343-9. 
 
Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J 
Clin Oncol. 2007;25(5):579-86. 
 
Chiappella A, Tucci A, Castellino A, et al. Lenalidomide plus cyclophosphamide, doxorubicin, 
vincristine, prednisone and rituximab is safe and effective in untreated, elderly patients with 
diffuse large B-cell lymphoma: a phase I study by the Fondazione Italiana Linfomi. 
Haematologica. 2013;98(11):1732-8. 
 
Cockcroft DW, Gault MH. Prediction of creatine clearance from serum creatine. Nephron. 
1976;16(1):31-41. 
 
Coiffier B, Lepage E, Briere J, et al. CHOP chemotherapy plus rituximab compared with CHOP 
alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002;346:235-42. 
 
Feldman T, Mato AR, Chow KF, et al. Addition of lenalidomide to rituximab, ifosfamide, 
carboplatin, etoposide (RICER) in first-relapse/primary refractory diffuse large B-cell 
lymphoma. Br J Haematol. 2014;166:77-83. 
 
Ferlay J, Soerjomataram I, Dikshit R, et al. Cancer incidence and mortality worldwide: Sources, 
methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2014;123:1917-23. 
 
Feugier P, Van Hoof A, Sebban C, et al. Long-term results of the R-CHOP study in the treatment 
of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d'Etude des 
Lymphomes de l'Adulte. J Clin Oncol. 2005;23:4117-26. 
 

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Galustian C, Dalgleish A. Lenalidomide: a novel anticancer drug with multiple modalities. 
Expert Opin Pharmacother. 2009;10:125-33. 
 
Ginaldi L, De Martinis M, Matutes E, et al. Levels of expression of CD19 and CD20 in chronic 
B cell leukaemias. J Clin Pathol. 1998;51(5):364-9. 
 
Goswami T, Forero A, Hamadani M, et al. Phase I/II study of MEDI-551, a humanized 
monoclonal antibody targeting CD19, in subjects with relapsed or refractory advanced B-cell 
malignancies. J Clin Oncol. 2012;30(suppl):8065. 
 
Habermann TM, Weller EA, Morrison VA, et al. Rituximab-CHOP versus CHOP alone or with 
maintenance rituximab in older patients with diffuse large B-cell lymphoma. J Clin Oncol. 
2006;24:3121-7. 
 
Hallek M, Cheson BD, Catovsky D, et al. International Workshop on Chronic Lymphocytic 
Leukemia. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report 
from the International Workshop on Chronic Lymphocytic Leukemia updating the National 
Cancer Institute-Working Group 1996 guidelines. Blood. 2008;111:5446-56. 
 
Haslett PA, Hanekom WA, Muller G, Kaplan G. Thalidomide and a thalidomide analogue drug 
costimulate virus-specific CD8+ T cells in vitro. J Infect Dis. 2003;187:946-55. 
 
Hernandez-Ilizaliturri FJ, Deeb G, Zinzani PL, et al. Higher response to lenalidomide in 
relapsed/refractory diffuse large B-cell lymphoma in nongerminal center B-cell-like than in 
germinal center B-cell-like phenotype. Cancer. 2011;117:5058-66. 
 
Ivanov V, Coso D, Chetaille B, et al. Efficacy and safety of lenalinomide combined with 
rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 
2014;55:2508-13. 
 
Juweid ME, Stroobants S, Hoekstra OS, et al. Imaging Subcommittee of International 
Harmonization Project in Lymphoma. Use of positron emission tomography for response 
assessment of lymphoma: consensus of the Imaging Subcommittee of International 
Harmonization Project in Lymphoma. J Clin Oncol. 2007; 25:571-78. 
 
Matlawska-Wasowska K, Ward E, Stevens S, et al. Macrophage and NK-mediated killing of 
precursor-B acute lymphoblastic leukemia cells targeted with a-fucosylated anti-CD19 
humanized antibodies. Leukemia. 2013;27:1263-74. 
 
Nowakowski GS, LaPlant B, Habermann TM, et al. Lenalidomide can be safely combined with 
R-CHOP (R2CHOP) in the initial chemotherapy for aggressive B-cell lymphomas: phase I study. 
Leukemia. 2011;25:1877-81. 
Nowakowski GS, LaPlant B, Macon WR, et al. Lenalidomide Combined With R-CHOP 
Overcomes Negative Prognostic Impact of Non-Germinal Center B-Cell Phenotype in Newly 
Diagnosed Diffuse Large B-Cell Lymphoma: A Phase II Study. J Clin Oncol. 2015;33(3):251-
7. 

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Olejniczak SH, Stewart CC, Donohue K, Czuczman MS. A quantitative exploration of surface 
antigen expression in common B-cell malignancies using flow cytometry: Immunol Invest. 
2006;35(1):93-114. 
 
Pan B, Lentzsch S. The application and biology of immunomodulatory drugs (IMiDs) in cancer. 
Pharmacol Ther. 2012;136:56-68. 
 
Pfreundschuh M, Trümper L, Osterborg A, et al. CHOP-like chemotherapy plus rituximab versus 
CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell 
lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. 
Lancet Oncol. 2006;7:379-91. 
 
Philip T, Guglielmi C, Hagenbeek A, et al. Autologous bone marrow transplantation as compared 
with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma. N 
Engl J Med. 1995;333:1540-5. 
 
Raufi A, Ebrahim AS, Al-Katib A. Targeting CD19 in B-cell lymphoma: emerging role of 
SAR3419. Cancer Manag Res. 2013;5:225-33. 
 
Ribrag V, Dupuis J, Tilly H, et al. A dose-escalation study of SAR3419, an anti-CD19 antibody 
maytansinoid conjugate, administered by intravenous infusion once weekly in patients with 
relapsed/refractory B-cell non-Hodgkin lymphoma. Clin Cancer Res. 2014;20:213-20. 
 
Saloura V, Grivas PD. Lenalidomide: a synthetic compound with an evolving role in cancer 
management. Hematology. 2010;15:318-31. 
 
Sehn LH, Donaldson J, Chhanabhai M, et al. Introduction of combined CHOP plus rituximab 
therapy dramatically improved outcome of diffuse large B-cell lymphoma in British Columbia. 
J Clin Oncol. 2005;23:5027-33. 
 
Swerdlow SH, Campo E, Harris NL, et al. WHO Classification of Tumours of Haematopoietic 
and Lymphoid Tissues. Lyon, France: IARC Press; 2008. 
 
Thieblemont C, Coiffier B. Lymphoma in older patients. J Clin Oncol. 2007;25:1916-23.  
 
Topp MS, Gökbuget N, Zugmaier G, et al. Long-term follow-up of hematologic relapse-free 
survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL. Blood. 
2012;120:5185-7. 
 
Viardot A, Goebeler M, Noppeney R et al. Blinatumomab Monotherapy Shows Efficacy in 
Patients with Relapsed Diffuse Large B Cell Lymphoma. ASH Annu Meet Abstr. 
2011;118:1637. 
 

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Vitolo U, Chiappella A, Franceschetti S, et al. Lenalidomide plus R-CHOP21 in elderly patients 
with untreated diffuse large B-cell lymphoma: results of the REAL07 open-label, multicentre, 
phase 2 trial. Lancet Oncol. 2014;15:730-7. 
 
Vose JM, Habermann TM, Czuczman MS, et al. Single-agent lenalidomide is active in patients 
with relapsed or refractory aggressive non-Hodgkin lymphoma who received prior stem cell 
transplantation. Br J Haematol. 2013;162:639-47. 
 
Wang M, Fowler N, Wagner-Bartak N, et al. Oral lenalidomide with rituximab in relapsed or 
refractory diffuse large cell, follicular and transformed lymphoma: a phase II clinical trial. 
Leukemia. 2013;27:1902-9. 
 
Wiernik PH. Lenalidomide in lymphomas and chronic lymphocytic leukemia. Expert Opin 
Pharmacother. 2013;14:475-88. 
 
Wiernik PH, Lossos IS, Tuscano JM, et al. Lenalidomide monotherapy in relapsed or refractory 
aggressive non-Hodgkin's lymphoma. J Clin Oncol. 2008;26:4952-7. 
 
Witzig TE, Vose JM, Zinzani PL, et al. An international phase II trial of single-agent 
lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. Ann Oncol. 
2011;22:1622-7. 
 
Woyach JA, Awan F, Flinn IW, et al. A Phase I Trial of the Fc Engineered CD19 Antibody 
XmAb®5574 (MOR00208) Demonstrates Safety and Preliminary Efficacy in Relapsed Chronic 
Lymphocytic Leukemia. Blood. 2014;124(24):3553-60. 
 
Younes A, Kim S, Romaguera J, et al. Phase I multidose-escalation study of the anti-CD19 
maytansinoid immunoconjugate SAR3419 administered by intravenous infusion every 3 weeks 
to patients with relapsed/refractory B-cell lymphoma. J Clin Oncol. 2012; 30: 2776-82. 
 
Zhang H, Vakil V, Braunstein M, et al. Circulating endothelial progenitor cells in multiple 
myeloma: implications and significance. Blood. 2005;105:3286-9. 
 
Zinzani PL, Pellegrini C, Gandolfi L, et al. Combination of lenalidomide and rituximab in elderly 
patients with relapsed or refractory diffuse large B-cell lymphoma: a phase 2 trial. Clin 
Lymphoma Myeloma Leuk. 2011;11:462-6. 
 
Zinzani PL, Rigacci L, Cox MC, et al. Lenalidomide monotherapy in heavily pretreated patients 
with non-Hodgkin lymphoma: an Italian observational multicenter retrospective study in daily 
clinical practice. Leuk Lymphoma. 2014 (doi: 10.3109/10428194.2014.964702).  
 
 

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13 APPENDICES 
 
 
 
 

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Appendix A: 
Cockcroft-Gault Formula: 
 
 
 
This formula presumes weight to be measured in kilograms and creatinine to be measured in 
mg/dL. 
 
When serum creatinine is measured in µmol/L: 
 
Where Constant is 1.23 for men and 1.04 for women. 
 
 
 
 

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IND Number: 114,856 
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Appendix B: 
International Prognostic Index (IPI): 
 age older than 60 
 lactate dehydrogenase level higher than normal 
 ECOG performance status score of 2 or greater (see Appendix_F) 
 stage III or IV disease 
 more than one involved extranodal disease site 
 
The International Prognostic Index (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 
 
 
 
 
 
 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
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IND Number: 114,856 
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Appendix C: 
Information on Investigational and Registered Products 
The Investigator’s Brochure for MOR00208, Summary of Product Characteristics (EMA) or 
Prescribing Information (US FDA) for LEN will be supplied to the study sites. 
 
 
 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
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IND Number: 114,856 
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Appendix D: 
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: MOR208C203 
Date: 24 February 2021 
IND Number: 114,856 
Protocol Amendment 5, Final Version 8.0 
EudraCT Number: 2014-004688-19 
 
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Appendix E: 
Ann Arbor Staging* - Cotswolds Recommendations** 
(Sources: *Carbone PP, Kaplan HS, Musshoff K, et al. Report of the committee on Hodgkin's 
disease staging classification. Cancer Res. 1971; 31:1860-61. **Lister TA, Crowther D, Sutcliffe 
SB, et al. Staging for Hodgkin's disease. Report of a committee convened to discuss the 
evaluation and staging of patients with Hodgkin's disease: Cotswolds meeting. J Clin Oncol. 
1989; 7:1630-36, [Erratum; J Clin Oncol. 1990; 8:1602]) 
 
Stage I: involvement of a single lymphatic region (I), or localised involvement of a single 
extralymphatic organ or site (IE). 
 
Stage II: involvement of two or more lymphatic regions on the same side of diaphragm (II) or 
localised involvement of an extralymphatic organ or site and one or more lymph node regions 
the same side of diaphragm (IIE). 
 
Stage III: involvement of two or more lymphatic regions on both sides of diaphragm (III) which 
may also be accompanied either by localised involvement of an extralymphatic organ or site 
(IIIE), or by involvement of the spleen (IIIS). 
 
Stage IV: Diffuse or disseminated involvement of one or more extralymphatic organs or tissue, 
with or without associated lymph node involvement.  
Bone marrow or liver involvement will always be considered as stage IV. 
 
Criteria for B-symptoms 
The presence of: (a) unintentional weight loss of more than 10% within the previous 6 months 
and/or  (b) fevers of greater than 100.5° F or 38.0° C for at least 3 consecutive days without 
other evidence of infection and/or (c) drenching night sweats without evidence of infection, is 
denoted by the suffix letter ‘B’. ‘A’ indicates the absence of these symptoms. 
 
 
 
 

Product Name: MOR00208 
Protocol Number: MOR208C203 
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IND Number: 114,856 
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Appendix F: 
ECOG Performance Status 
 
Grade Performance status 
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, e.g., 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 
Publication: 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. 1982;5:649-55. 
  
Credit: the Eastern Cooperative Oncology Group, Robert Comis M.D., Group Chair. 
 
 
 
 

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Appendix G: 
Response Criteria 
The response criteria in this study are those defined in the table below. All are based on the 
International Working Group Response Criteria (Cheson et al., 2007). 
 
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 but criteria 
for  progressive 
disease not met 
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 
 
 

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Relapsed 
disease or 
progressive 
disease 
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 >1 cm 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 response; CT=computed tomography; FDG=[18F]fluorodeoxyglucose; PET=positron emission 
tomography; PR=partial response; SD=stable disease; SPD=sum of the product of the diameters.