Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A First-in-Human, Open-label, Phase 1/2a Dose Escalation Trial With Dose Expansion Cohorts
Phase: PHASE1
Conditions: Diffuse Large B-cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia, High-grade B-cell Lymphoma, Primary Mediastinal Large B-cell Lymphoma
Sponsor: Genmab

Document Name: GCT3009-01 Protocol 
Genmab 
Document Number: TMF-29340 
 
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CLINICAL TRIAL PROTOCOL 
Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in 
Relapsed or Refractory B-cell Non-Hodgkin Lymphoma – A 
First-in-Human, Open-label, Phase I/IIa Dose Escalation 
Trial with Dose Expansion Cohorts 
 
 
Protocol no.: 
GCT3009-01  
Sponsor Name: 
Genmab* 
Clinical Research Organization: 
 
EudraCT No.: 
2019-002752-16 
IND No.: 
145264 
IMP Name: 
GEN3009 (DuoHexaBody®-CD37); 
GEN3013 (DuoBody®-CD3xCD20, Epcoritamab) 
Development Phase: 
1/2a 
Date of Protocol; version: 
09 Jul 2021 (Protocol Amendment 5 v 7.0) 
23 Jul 2020 (Protocol Amendment 4, v 6.0) 
30 Apr 2020 (Protocol Amendment 3, v 5.0) 
16 Dec 2019 (Protocol Amendment 2, v 4.0) 
09 Dec 2019 (Protocol Amendment 1, v 3.0) 
22 Oct 2019 (Original Protocol, v 2.0) 
15 Oct 2019 (not submitted, v 1.0) 
 
 
*Genmab is a global organization that operates through different legal entities in various 
countries. Therefore, the legal entity acting as the sponsor for Genmab trials may vary, such as, 
but not limited to Genmab Holding B.V.; or Genmab US, Inc. The term “sponsor” is used 
throughout the protocol to represent these various legal entities; the sponsor is identified on the 
following contact information page. 
The information in this document is confidential and is proprietary to Genmab. It is understood that information in 
this document shall not be disclosed to any third party, in any form, without prior written consent of an authorized 
officer of Genmab 
Sponsor information for all 
countries except the USA 
Genmab Holding B.V. 
Uppsalalaan 15 
PPD

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3584 CM Utrecht 
The Netherlands 
Sponsor information for the 
USA 
Genmab U.S., Inc. 
777 Scudders Mill Road 
Building 2 
Princeton, NJ 08536 
USA 
 

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TABLE OF CONTENTS 
STATEMENT OF COMPLIANCE .......................................................................................... 10 
ABBREVIATIONS AND DEFINITIONS OF TERMS .......................................................... 11 
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE .................................... 14 
TRIAL SYNOPSIS ...................................................................................................................... 17 
1 
VISIT ASSESSMENT SCHEDULES ...................................................................... 26 
2 
INTRODUCTION ...................................................................................................... 56 
2.1 
Background .................................................................................................................. 56 
2.1.1 
Overview of Disease .................................................................................................... 56 
2.1.1.1 
Therapy for DLBCL ..................................................................................................... 56 
2.1.1.2 
Therapy for FL ............................................................................................................. 56 
2.1.1.3 
Therapy for CLL ........................................................................................................... 57 
2.1.2 
Introduction to Investigational Medicinal Products ..................................................... 58 
2.1.2.1 
GEN3009 ...................................................................................................................... 58 
2.1.2.2 
GEN3013 ...................................................................................................................... 58 
2.1.3 
Summary of Nonclinical Studies.................................................................................. 59 
2.1.4 
Summary of Clinical Trials .......................................................................................... 59 
2.1.4.1 
Clinical Trials for GEN3009 ........................................................................................ 59 
2.1.4.2 
Clinical Trials for GEN3013 ........................................................................................ 60 
2.2 
Rationale ....................................................................................................................... 61 
2.2.1 
GEN3009 Monotherapy ............................................................................................... 61 
2.2.2 
GEN3009 + GEN3013 Combination ........................................................................... 61 
2.3 
Benefit-Risk Assessment .............................................................................................. 62 
2.3.1 
GEN3009 Monotherapy ............................................................................................... 62 
2.3.2 
GEN3009 + GEN3013 Combination ........................................................................... 63 
3 
OBJECTIVES AND ENDPOINTS........................................................................... 65 
4 
TRIAL DESIGN ......................................................................................................... 69 
4.1 
Description of Trial Design .......................................................................................... 69 
4.1.1 
Dose Escalation ............................................................................................................ 70 
4.1.1.1 
Dose Escalation and De-escalation rules .................................................................... 71 
4.1.2 
Expansion ..................................................................................................................... 72 
4.1.2.1 
Safety Run-in for the GEN3009 + GEN3013 Combination Cohort ............................. 73 
4.2 
Trial Design Rationale ................................................................................................. 73 
4.3 
Dose and Schedule Rationale ....................................................................................... 74 
4.3.1 
GEN3009 Monotherapy Cohorts ................................................................................. 74 
4.3.2 
GEN3009 + GEN3013 Combination Cohort ............................................................... 75 
4.4 
End of Trial and End of Treatment Definitions ........................................................... 76 
4.4.1 
End of Trial .................................................................................................................. 76 
4.4.2 
Treatment Discontinuation ........................................................................................... 76 
4.4.3 
Trial Stopping Rules ..................................................................................................... 76 
4.4.4 
Trial Termination ......................................................................................................... 77 
5 
TRIAL POPULATION(S) ......................................................................................... 78 

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5.1 
Inclusion Criteria .......................................................................................................... 78 
5.1.1 
Dose Escalation Inclusion Criteria ............................................................................... 78 
5.1.2 
Expansion (including Safety Run-in) Inclusion Criteria .............................................. 81 
5.2 
Exclusion Criteria ......................................................................................................... 83 
5.2.1 
Dose Escalation Exclusion Criteria .............................................................................. 83 
5.2.2 
Expansion (including Safety Run-in) Exclusion Criteria ............................................. 85 
5.3 
Screen Failures ............................................................................................................. 87 
6 
TREATMENT ............................................................................................................ 89 
6.1 
Treatment Assignment or Randomization .................................................................... 89 
6.1.1 
Subject Numbering ....................................................................................................... 89 
6.1.2 
Treatment Assignment ................................................................................................. 89 
6.2 
Premedication ............................................................................................................... 89 
6.2.1 
Premedication in GEN3009 Monotherapy Cohorts ..................................................... 89 
6.2.2 
Premedication and CRS Prophylaxis in GEN3009 + GEN3013 Combination Cohort 90 
6.3 
Management of Infusion-Related Reactions ................................................................ 91 
6.4 
Dosage(s) and Administration ...................................................................................... 92 
6.4.1 
GEN3009 Monotherapy Cohorts ................................................................................. 92 
6.4.2 
GEN3009 + GEN3013 Combination Cohort ............................................................... 93 
6.5 
Treatment Compliance ................................................................................................. 93 
6.6 
Concomitant Medications and Therapies ..................................................................... 93 
6.6.1 
Permitted Concomitant Medications and Therapies .................................................... 93 
6.6.1.1 
Antibiotic, Antiviral, and Antifungal Therapy .............................................................. 94 
6.6.1.2 
Immunizations .............................................................................................................. 94 
6.6.1.3 
Immunoglobulin Therapies .......................................................................................... 95 
6.6.2 
Prohibited Concomitant Therapy ................................................................................. 95 
6.7 
Investigational Medicinal Product Information ........................................................... 95 
6.7.1 
GEN3009 Information .................................................................................................. 95 
6.7.1.1 
Physical Description of GEN3009 ............................................................................... 95 
6.7.1.2 
Packaging and Labeling ............................................................................................... 95 
6.7.1.3 
Preparation, Handling, and Storage ............................................................................ 96 
6.7.2 
Epcoritamab (GEN3013) Information ......................................................................... 96 
6.7.2.1 
Physical Description of Epcoritamab (GEN3013) ....................................................... 96 
6.7.2.2 
Packaging and Labelling ............................................................................................. 96 
6.7.2.3 
Preparation, Handling, and Storage ............................................................................ 96 
6.7.3 
Drug Accountability ..................................................................................................... 96 
6.8 
Technical Complaint Handling .................................................................................... 96 
6.8.1 
Procedures .................................................................................................................... 97 
6.8.2 
Contacting Sponsor Regarding Product Quality .......................................................... 97 
7 
DOSE MODIFICATIONS AND SAFETY MANAGEMENT GUIDELINES ..... 98 
7.1 
Dose-limiting Toxicities ............................................................................................... 98 
7.2 
Dose Escalation: Dose-limiting Toxicity ..................................................................... 98 
7.3 
Safety Run-in for Expansion: Dose-limiting Toxicity ................................................. 99 
7.4 
Dose Modification Guidance and Safety Stopping Criteria ....................................... 100 
7.4.1 
Dose Escalation Part (GEN3009 Monotherapy) ........................................................ 100 
7.4.2 
Expansion Part (Including Safety Run-in) ................................................................. 101 
7.4.2.1 
GEN3009 Dose Modification Rules ........................................................................... 101 
7.4.2.2 
GEN3013 Dose Modification Rules ........................................................................... 101 

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7.4.3 
Dose Modification Guidelines for Toxicity Management ......................................... 102 
7.4.3.1 
Cytopenias (All Cohorts) ............................................................................................ 102 
7.4.3.2 
Cytokine Release Syndrome (the GEN3009 + GEN3013 Combination Cohort) ....... 102 
7.4.3.3 
Tumor Lysis Syndrome (All Cohorts) ......................................................................... 103 
7.4.3.4 
Immune Effector Cell-Associated Neurotoxicity Syndrome (GEN3009 + GEN3013 
Combination Cohort) ................................................................................................. 103 
7.4.3.5 
All Other AEs Related to GEN3009 and/or GEN3013 .............................................. 104 
7.5 
Management of Specific Adverse Events .................................................................. 104 
7.5.1 
Neutropenia and Other Cytopenias (All Cohorts) ...................................................... 104 
7.5.2 
Supportive Care for Cytokine Release Syndrome (Expansion GEN3009 + GEN3013 
Combination Cohort Only) ......................................................................................... 105 
7.5.3 
Supportive Care for Immune Effector Cell-Associated Neurotoxicity Syndrome 
(Expansion GEN3009 + GEN3013 Combination Cohort Only) ................................ 105 
7.5.4 
Tumor Lysis Syndrome Prevention and Management (All Cohorts) ........................ 105 
7.5.5 
Tumor Flare Reaction Management (All Cohorts) .................................................... 106 
8 
DISCONTINUATION, FOLLOW-UP AND COMPLETION ............................ 107 
8.1 
Discontinuation of Treatment ..................................................................................... 107 
8.2 
Withdrawal from the Trial .......................................................................................... 107 
8.3 
Safety Follow-up Visit ............................................................................................... 108 
8.4 
Lost to Follow-Up ...................................................................................................... 108 
9 
TRIAL ASSESSMENTS.......................................................................................... 109 
9.1 
Demography and Baseline Assessments .................................................................... 109 
9.1.1 
Demographics ............................................................................................................. 109 
9.1.2 
Disease Status ............................................................................................................. 109 
9.1.3 
Medical History .......................................................................................................... 109 
9.1.4 
Concomitant Medication and Procedures .................................................................. 109 
9.1.5 
Prior Cancer Therapy and Surgery ............................................................................. 109 
9.2 
Efficacy Assessment .................................................................................................. 110 
9.2.1 
Definition of Measurable and Assessable Disease ..................................................... 110 
9.2.2 
Evaluations ................................................................................................................. 110 
9.2.2.1 
Radiographic Assessment ........................................................................................... 110 
9.2.2.2 
Bone Marrow Assessment .......................................................................................... 112 
9.2.2.3 
Minimal Residual Disease Assessment (MRD) .......................................................... 113 
9.2.3 
Assessment of Disease Response and Progressive Disease ....................................... 114 
9.2.3.1 
Assessment of Response ............................................................................................. 114 
9.2.3.2 
Progressive Disease ................................................................................................... 115 
9.3 
Clinical Safety Assessments....................................................................................... 115 
9.3.1 
Physical Examination ................................................................................................. 115 
9.3.1.1 
Immune Effector Cell-Associated Neurotoxicity Syndrome Assessment (GEN3009 + 
GEN3013 Combination Cohort only) ........................................................................ 115 
9.3.2 
Vital Signs .................................................................................................................. 116 
9.3.3 
Electrocardiograms ..................................................................................................... 116 
9.3.4 
ECOG Performance Status ......................................................................................... 117 
9.3.5 
Constitutional Symptoms (B Symptoms) ................................................................... 117 
9.3.6 
Survival Status ............................................................................................................ 117 
9.4 
Clinical Laboratory Assessments ............................................................................... 117 
9.4.1 
Laboratory Parameters ............................................................................................... 117 

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9.5 
Pharmacokinetics ....................................................................................................... 120 
9.6 
Immunogenicity ......................................................................................................... 120 
9.7 
Tumor Biopsy ............................................................................................................. 121 
9.8 
Biomarkers ................................................................................................................. 121 
9.8.1 
Sample Collections ..................................................................................................... 122 
9.8.2 
Biomarker Assessments in Tumor Samples ............................................................... 122 
9.8.2.1 
Protein Expression Analyses ...................................................................................... 122 
9.8.2.2 
RNA Expression Analyses .......................................................................................... 123 
9.8.2.3 
DNA Analyses ............................................................................................................. 123 
9.8.3 
Biomarker Assessments in Blood Samples ................................................................ 123 
9.8.3.1 
Immunophenotyping Analyses .................................................................................... 123 
9.8.3.2 
Cytokine and Endothelial Activation Marker Analyses ............................................. 124 
9.8.3.3 
Complement Analyses ................................................................................................ 124 
9.8.3.4 
Cell-free DNA/RNA and Tumor-derived DNA (ctDNA) Analyses ............................. 124 
10 
SAFETY MONITORING AND ADVERSE EVENT REPORTING .................. 125 
10.1 
Adverse Event Definitions ......................................................................................... 125 
10.1.1 
Definition of Adverse Events ..................................................................................... 125 
10.1.2 
Definition of Serious Adverse Events ........................................................................ 125 
10.1.3 
Definition of Adverse Events of Special Interest ....................................................... 125 
10.1.4 
Definition of Infusion-Related Reactions .................................................................. 126 
10.2 
Adverse Event Reporting ........................................................................................... 126 
10.2.1 
Pre-existing Condition ................................................................................................ 127 
10.2.2 
Diagnosis .................................................................................................................... 127 
10.2.3 
Disease Progression or Death ..................................................................................... 127 
10.2.4 
Unrelated Procedures ................................................................................................. 127 
10.2.5 
Laboratory Test Abnormalities .................................................................................. 127 
10.3 
Adverse Events of Special Interest ............................................................................. 127 
10.4 
Events Requiring Immediate Reporting ..................................................................... 128 
10.4.1 
Serious Adverse Events .............................................................................................. 128 
10.4.2 
Serious Adverse Events With Onset After Ended Trial Participation ....................... 128 
10.4.3 
Overdose and Medication Errors ................................................................................ 128 
10.4.4 
Pregnancy ................................................................................................................... 129 
10.4.5 
Timelines for Immediate Reporting ........................................................................... 129 
10.5 
Suspected Unexpected Serious Adverse Reactions ................................................... 130 
10.6 
Follow Up on Adverse Events ................................................................................... 130 
10.7 
Warnings and Precautions .......................................................................................... 130 
10.8 
Data Monitoring Committee ...................................................................................... 130 
10.9 
Dose Escalation Committee and the Safety Committee ............................................. 131 
11 
STATISTICS ............................................................................................................ 132 
11.1 
Analysis Sets .............................................................................................................. 132 
11.1.1 
Full Analysis Set ........................................................................................................ 132 
11.1.2 
Dose-Determining Analysis Set ................................................................................. 132 
11.1.3 
Pharmacokinetic Analysis Set .................................................................................... 133 
11.1.4 
Immunogenicity Analysis Set .................................................................................... 133 
11.1.5 
Response Evaluable Set ............................................................................................. 133 
11.2 
Subject Demographics and Baseline Characteristics ................................................. 133 
11.3 
Treatments .................................................................................................................. 133 

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11.4 
Primary Objectives ..................................................................................................... 133 
11.4.1 
Primary Endpoints ...................................................................................................... 134 
11.4.1.1 Escalation and Safety Run-in in Expansion ............................................................... 134 
11.4.1.2 Expansion ................................................................................................................... 135 
11.4.2 
Statistical Hypothesis, Model, and Method of Analysis ............................................ 135 
11.5 
Secondary Safety Objectives ...................................................................................... 135 
11.5.1 
Other Safety Data ....................................................................................................... 135 
11.5.1.1 ECG ............................................................................................................................ 135 
11.5.1.2 Vital Signs .................................................................................................................. 135 
11.6 
Pharmacokinetics ....................................................................................................... 135 
11.6.1 
Pharmacodynamics ..................................................................................................... 136 
11.7 
Immunogenicity of GEN3009/GEN3013 ................................................................... 136 
11.8 
Secondary Efficacy Objectives .................................................................................. 136 
11.8.1 
Definition of Response ............................................................................................... 136 
11.8.1.1 Response in B-cell NHL Other Than CLL .................................................................. 136 
11.8.1.2 Response in CLL/SLL ................................................................................................. 137 
11.8.1.3 Definitions of Relapsed/Refractory ............................................................................ 137 
11.8.2 
Duration of Response ................................................................................................. 137 
11.8.3 
Time to Response ....................................................................................................... 137 
11.8.4 
Progression-free Survival ........................................................................................... 137 
11.8.5 
Overall Survival ......................................................................................................... 138 
11.8.6 
Minimal Residual Disease .......................................................................................... 138 
11.9 
Exploratory Endpoints ................................................................................................ 138 
11.10 
Interim Analyses ........................................................................................................ 138 
11.11 
Sample Size Calculation ............................................................................................. 138 
12 
DATA HANDLING AND RECORD KEEPING .................................................. 140 
12.1 
Source Documentation ............................................................................................... 140 
12.2 
Case Report Form Completion ................................................................................... 141 
12.3 
Data Quality Management ......................................................................................... 141 
12.4 
Record Retention ........................................................................................................ 141 
13 
ETHICS ..................................................................................................................... 143 
13.1 
Trial-Specific Design Considerations ........................................................................ 143 
13.2 
Regulatory Ethics Compliance ................................................................................... 143 
13.2.1 
Investigator Responsibilities ...................................................................................... 143 
13.2.2 
Independent Ethics Committee or Institutional Review Board .................................. 143 
13.2.3 
Informed Consent ....................................................................................................... 144 
13.2.4 
Privacy of Personal Data ............................................................................................ 144 
13.2.5 
Return of Exploratory Research Data to Subjects and Investigators ......................... 145 
14 
ADMINISTRATIVE PROCEDURES ................................................................... 146 
14.1 
Protocol Amendments ................................................................................................ 146 
14.2 
Regulatory Documentation ........................................................................................ 146 
14.2.1 
Regulatory Approval/Notification .............................................................................. 146 
14.3 
Subject Identification, Enrollment, and Screening Logs ............................................ 146 
14.4 
Monitoring .................................................................................................................. 146 
14.5 
On-Site Audits ............................................................................................................ 147 
14.6 
Publication .................................................................................................................. 147 
14.7 
Registration of Clinical Trials and Disclosure of Results .......................................... 148 

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15 
REFERENCES ......................................................................................................... 149 
16 
APPENDICES .......................................................................................................... 154 
 
TABLE OF TABLES 
Table 1 
Summary of Changes ................................................................................................ 14 
Table 2 
Visit Assessment Schedule for Screening and Cycle 1 - Dose Escalation ................ 27 
Table 3 
Visit Assessment Schedule from Cycle 2 and Beyond – Dose Escalation ............... 30 
Table 4 
Visit Assessment Schedule for PK, Immunogenicity, 
Biomarkers/Pharmacodynamics, and Tumor Lysis Syndrome Surveillance Sampling 
– Dose Escalation ...................................................................................................... 33 
Table 5 
Visit Assessment Schedule for Screening and Cycle 1 – Expansion GEN3009 
Monotherapy ............................................................................................................. 35 
Table 6 
Visit Assessment Schedule from Cycle 2 and Beyond – Expansion GEN3009 
Monotherapy ............................................................................................................. 37 
Table 7 
Visit Assessment Schedule for PK and ADA– Expansion GEN3009 Monotherapy 40 
Table 8 
Visit Assessment Schedule for Biomarkers – Expansion GEN3009 Monotherapy .. 41 
Table 9 
Visit Assessment Schedule for MRD – Dose Escalation and Expansion GEN3009 
Monotherapy ............................................................................................................. 43 
Table 10 Visit Assessment Schedule for Screening and Cycle 1 Expansion GEN3009 + 
GEN3013 (including Safety Run-in) ......................................................................... 44 
Table 11 Visit Assessment Schedule from Cycle 2 and Beyond – Expansion GEN3009 + 
GEN3013 (including Safety Run-in) ......................................................................... 47 
Table 12 Visit Assessment Schedule for PK and ADA – Expansion GEN3009 + GEN3013 
(including Safety Run-in) .......................................................................................... 50 
Table 13 Visit Assessment Schedule for Biomarkers – Expansion GEN3009 + GEN3013 
(including Safety Run-in) .......................................................................................... 52 
Table 14 Visit Assessment Schedule for MRD – Expansion GEN3009 + GEN3013 ............. 53 
Table 15 GEN3013 Repriming Cycle – Expansion GEN3009 + GEN3013 (including Safety 
Run-in) ...................................................................................................................... 54 
Table 16 Potential Risks from Combination Treatment ........................................................... 63 
Table 17 Objectives and Endpoints for Dose Escalation (GEN3009 for R/R B-cell NHL 
Including CLL/SLL) ................................................................................................. 65 
Table 18 Objectives and Endpoints for Expansion (GEN3009 for R/R, DLBCL, FL, and CLL 
Cohorts) ..................................................................................................................... 66 
Table 19 Objectives and Endpoints for Expansion (GEN3009 + GEN3013 Safety Run-in for 
R/R B-NHL) .............................................................................................................. 67 
Table 20 Objectives and Endpoints for Expansion (GEN3009 + GEN3013 for R/R DLBCL)
 ................................................................................................................................... 68 
Table 21 Dose and Schedule .................................................................................................... 69 
Table 22 Escalation Rules Based on Number of Subjects with DLTs ..................................... 72 
Table 23 Premedication and Post-infusion Medication for GEN3009 + GEN3013 
Combination .............................................................................................................. 90 
Table 24 GEN3009 Dose Modification Rules for IRRs ........................................................... 92 
Table 25 Dose Modification Rules for Cytopenias ................................................................ 102 
Table 26 GEN3013 Dose Modification for Cytokine Release Syndrome (GEN3009 + 
GEN3013 Combination Cohort) ............................................................................. 103 

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Table 27 GEN3013 Dose Modification for ICANS (GEN3009 + GEN3013 Combination 
Cohort) .................................................................................................................... 104 
Table 28 Dose Modification for All Other GEN3009 and/or GEN3013-Related AEs .......... 104 
Table 29 Imaging Assessments During Dose Escalation and Expansion .............................. 111 
Table 30 Bone Marrow Biopsy and Aspirate Collection During Dose Escalation and 
Expansion ................................................................................................................ 113 
Table 31 Protocol-Required Laboratory Assessments ........................................................... 119 
Table 32 Tumor Biopsy Collection During Dose Escalation and Expansion ........................ 121 
Table 33 Non-compartmental Pharmacokinetic Parameters .................................................. 136 
Table 34 Modified BOIN Design Characteristics .................................................................. 139 
 
TABLE OF FIGURES 
Figure 1 GCT3009-01 Trial Design .............................................................................................. 70 
Figure 2 MRD Assesment by Tracking Malignant Clonotype ................................................. 114 
 

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STATEMENT OF COMPLIANCE 
GCP Compliance 
This trial will be conducted in compliance with International Council for Harmonisation (ICH) 
GCP E6 (R2) and applicable regulatory requirements. 
 
Confidentiality Statement 
The information in this document contains trade secrets and commercial information that are 
privileged or confidential and may not be disclosed unless such disclosure is required by applicable 
law or regulations. In any event, persons to whom the information is disclosed must be informed 
that the information is privileged or confidential and may not be further disclosed by them. These 
restrictions on disclosure will apply equally to all future information supplied to you that is 
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ABBREVIATIONS AND DEFINITIONS OF TERMS  
5-PS 
5-point scale for evaluation of PET positivity 
ADA 
anti-drug antibody 
ADCC 
antibody-dependent cell-mediated cytotoxicity  
ADCP 
antibody-dependent cellular phagocytosis 
ADL 
activities of daily living 
AE 
adverse event 
AESI 
adverse event of special interest 
ALT 
alanine aminotransferase 
ANC 
absolute neutrophil count 
ASBMT 
American Society for Blood and Marrow Transplantation 
AST 
aspartate aminotransferase 
ASTCT 
American Society for Transplantation and Cellular Therapy 
AUC 
area under the curve 
B-cell NHL 
B-cell non-Hodgkin lymphoma 
BCR 
B-cell receptor 
BR 
bendamustine plus rituximab 
CAR 
chimeric antigen receptor 
CDC 
complement-dependent toxicity 
CL 
clearance 
CLL 
chronic lymphocytic leukemia 
Cmax 
maximum concentration 
CMV 
cytomegalovirus 
CNS 
central nervous system 
CR 
complete response 
CRF 
case report form 
CRO 
contract research organization 
CRS 
cytokine release syndrome 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
ctDNA 
circulating tumor DNA 
CTR 
clinical trial report 
Ctrough 
predose trough concentration 
DEC 
dose escalation committee 
DL 
dose level 
DLBCL 
diffuse large B-cell lymphoma 
DLT 
dose-limiting toxicity 
DMC 
data monitoring committee 
DoR 
duration of response 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EDC 
electronic data capture 
FAS 
full analysis set 
FCR 
fludarabine, cyclophosphamide, plus rituximab 
FcRn 
neonatal Fc receptor 
FDG-PET 
fluorodeoxyglucose (FDG)-positron emission tomography (PET) 
FIH 
first-in-human 

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FL 
follicular lymphoma 
FSH 
follicle-stimulating factor 
GCP 
Good Clinical Practice 
G-CSF 
granulocyte colony stimulating factor 
GDS&PV 
Global Drug Safety & Pharmacovigilance 
GFR 
glomerular filtration rate 
GLP 
Good Laboratory Practice 
HDT 
high-dose chemotherapy 
HGBCL 
high-grade B-cell lymphoma 
HIV 
human immunodeficiency virus 
HNSTD 
highest non-severely toxic dose 
HSCT 
hematopoietic stem cell transplantation 
IB 
Investigator’s Brochure 
ICANS 
immune effector cell-associated neurotoxicity syndrome 
ICE 
immune effector cell-associated encephalopathy 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 
IEC 
independent ethics committee 
IHC 
immunohistochemistry 
IMP 
investigational medicinal product 
IRB 
institutional review board 
IRR 
infusion-related reaction 
IV 
Intravenous(ly) 
iwCLL 
International Workshop on Chronic Lymphocytic Leukemia 
LDT 
lymphocyte doubling time 
MABEL 
minimum anticipated biological effect level 
mBOIN 
Modified Bayesian Optimal Interval 
MCL 
mantle cell lymphoma 
MDRD 
modification of diet in renal disease 
MoA 
mechanism of action 
MRD 
minimal residual disease 
MRD– 
minimal residual disease negative 
MRI 
magnetic resonance imaging 
MRSD 
maximum recommended starting dose 
MTD 
maximum tolerated dose 
MZL 
marginal zone lymphoma 
ND 
newly diagnosed 
NGS 
next generation sequencing 
NHL 
non-Hodgkin lymphoma 
NK 
natural killer 
ORR 
objective response rate 
OS 
overall survival 
OTC 
over-the-counter 
PD 
progressive disease 
PET 
positron emission tomography 
PFS 
progression-free survival 
PK 
pharmacokinetic(s) 
PMBCL 
primary mediastinal large B-cell lymphoma 

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PR 
partial response 
RP2D 
recommended phase 2 dose 
R/R 
relapsed or refractory 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SC  
safety committee 
s.c. 
subcutaneous(ly) 
SD 
stable disease 
SLL 
small lymphocytic lymphoma 
SOC 
standard of care 
SUSAR 
suspected unexpected serious adverse reaction 
T1/2 
half-life 
TEAEs 
treatment-emergent adverse events 
TFR 
tumor flare reaction 
TLS 
tumor lysis syndrome 
Tmax 
time to maximum concentration 
TTR 
time to response 
ULN 
upper limit of normal 
 

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PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE 
DOCUMENT HISTORY 
Document 
Date 
Amendment 5, v 7.0 (TMF 29340) 
09 Jul 2021 
Amendment 4/GB-1, v1.0 
22 Jan 2021 
Amendment 4, v 6.0 (TMF 29340) 
23 Jul 2020 
Amendment 3, v.5.0 (TMF 29340) 
30 Apr 2020 
Amendment 2, v 4.0 (TMF 29340) 
16 Dec 2019 
Amendment 1, v3.0 (TMF 29340) 
09 Dec 2019 
Original Protocol, v2.0 (TMF 29340) 
22 Oct 2019 
Protocol v1.0 (not submitted) (TMF 29340) 
15 Oct 2019 
 
Amendment 5 (09 Jul 2021) 
This amendment is considered substantial based on the criteria set forth in Article 10(a) of 
Directive 2001/20/EC of the European Parliament and the Council of the European Union.  
Table 1 Summary of Changes 
Section and Name 
Description of Change 
Brief Rationale 
Section 1 Visit Assessment Schedules - 
Tables 2-9 
Assessments, section references, and 
timepoints updated for Dose Escalation 
and Dose Expansion GEN3009 
monotherapy. 
To reflect current assessment practice 
and clarity 
Section 1 Visit Assessment Schedules - 
Tables 10-16 
Schedules of Assessments added for 
Dose Expansion GEN3009 + GEN3013 
combination therapy. 
To detail assessments planned for 
combination therapy. 
2.1.2.1 GEN3009 
Repetitive language removed. Language 
standardized. Reference to Investigator’s 
Brochure added 
For clarity. 
2.1.2.2 GEN3013 
Method of action described and 
DuoBody technology explained.  
To introduce product to be used in 
combination with GEN3009. 
2.1.3 Summary of Nonclinical Studies 
Language simplified. Information about 
combination added. Adverse reactions 
described. 
For clarity and to support changes in trial 
design. 
2.1.4. Summary of Clinical Trials 
Clinical trial information for 3009 added 
including dose, TEAEs, preliminary 
results, and progress on trial. Dose 
Escalation phase described. GCT3013-01 
Expansion described. Effect on 
circulating lymphocytes described. 
Preliminary anti-tumor therapy 
described.  
To provide up to date safety and efficacy 
information for GEN3009 and 
GEN3013. 
2.2 Rationale 
Language revised and supplemented.  
To explain and support changes in trial 
design. 
2.3 Benefit-Risk Assessment (including 
Table 17) 
Language updated for GEN3009. 
Benefit-risk assessment for GEN3009 + 
GEN3013 combination therapy added. 
To support changes in trial design.  
3 Objectives and Endpoints 
Updated to reflect the objectives and 
endpoints.  
To clarify the way results will be 
interpreted. 
4 Description of Trial Design 
Revised to include details of new trial 
design including the rationale behind the 
design, dose and schedule rationale for 
GEN3009 monotherapy and GEN3009 + 
GEN3013 combination, and end of trial 
and end of treatment definitions.  
To explain revised trial design and 
clarify key definitions for trial execution, 
discontinuation, and termination.  
 

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Section and Name 
Description of Change 
Brief Rationale 
5. Trial Population 
Inclusion and exclusion criteria 
delineated for Dose Esclation and Dose 
Expansion parts of trial.  
To ensure appropriate trial population is 
enrolled and to meet comitments to 
health authorities. 
6.1.2. Treatment Assignment or 
Randomization 
Added statements that subjects will be 
assigned based on slot availability.  
To describe method of assigning subjects 
to dose cohorts. 
6.2.1 Premedication in GEN3009 
Administration Monotherapy Cohorts 
Premedication 1-4 added and 
information regarding 
steroids/IRR/antipyretics and 
antihistamines are added. 
To provide clarity on premedications and 
procedures to be used in the GEN3009 
monotheraphy cohorts.  
6.2.2 Premedication and CRS 
Prophylaxis in GEN3009 + GEN3013 
Combination Cohort 
Premedications for combination therapy 
discussed.  
To provide information on 
premedications and procedures to be 
used in GEN3009 + GEN3013 
combination cohort. 
6.3 Management of Infusion-Related 
Reactions 
Section added. 
To provide information on how to handle 
IRRs (known to occur with GEN3009 
administration).  
6.4 Dosage(s) and Administration 
Section regarding GEN3009 + GEN3013 
combination cohort added. 
To provide details on the dose levels, 
routes, and schedules for GEN3009 and 
GEN3013 in the combination cohort. 
6.6 Concomitant Medications and 
Therapies 
Section revised.  
To indicate that medical monitor should 
be contacted for questions about 
concomitant medications and to describe 
in detail any medications or therapies 
that are/are not permitted for subjects 
receiving GEN3009 monotherapy or 
GEN3009 + GEN3013 combination 
therapy. 
6.7 Investigational Medicinal Product 
Information 
Section revised and expanded.  
To clarify information about GEN3009 
product and provide information about 
GEN3013. 
7.3 Safety Run-in for Expansion: Dose-
limiting Toxicity 
Section revised.  
To reflect Dose Expansion including 
combination therapy of GEN3009 + 
GEN3013. Grade 5 heme and non-heme 
toxicities are listed. Frequent lab blood 
monitoring discussed for tracking 
resolution of hematological AEs. 
7.4 Dose Modification Guidance and 
Safety Stopping Rules 
Section revised.  
To detail dose modification rules for 
safety run-in, GEN3013, and toxicity 
management.  
7.5 Management of Specific Adverse 
Events 
Section added. 
To describe what to do in the event that 
subjects experience neutropenia and 
other cytopenias, CRS, neurotoxicity 
syndrome, TLS, and tumor flare reaction. 
8 Discontinuation, Follow-up and 
Completion 
Section revised. 
To provide clarity for patient follow-up 
timeframes after discontinuation of 
treatment. 
9 Trial Assessments 
Section revised. 
To reflect updated descriptions of 
assessments and timepoints.  
10 Safety Monitory and Adverse Event 
Reporting 
Section revised. 
To reflect addition of combination 
therapy of GEN3009 + GEN3013 
combination therapy and template 
language, as appropriate.  
11 Statistics 
Section revised. 
To clarify analyses that will be 
performed based on new trial design, 
objectives, and endpoints. 
13 Ethics 
Section revised. 
To reflect new trial design as applicable. 
15. References 
Section revised. 
To reflect references currently cited in 
revised protocol. 

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Note: Commitments to health authorities have been met and incorporated into this global protocol amendment.  
Overall Rationale for the Amendment: Overall, the trial was amended to allow for higher doses 
(ie, ≥
 mg) of GEN3009 monotherapy in the Dose Escalation part and a combination of 
GEN3009 + GEN3013 in the Dose Expansion part. The bases for these changes are discussed in 
detail in Sections 4.3.1 and 4.3.2, respectively. 
Section and Name 
Description of Change 
Brief Rationale 
Appendix 4 Tumor Lysis Syndrome 
Section revised. 
To include updated cross references. 
Appendix 12 Definition of Reproductive 
Potential and Contraception 
Section replaced. 
To include information from latest 
version of CTFG recommendations. 
CCI

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TRIAL SYNOPSIS 
Title 
Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-cell Non-
Hodgkin Lymphoma – A First-in-Human, Open-label, Phase I/IIa Dose Escalation Trial with Dose 
Expansion Cohorts 
Brief Title 
First-in-Human (FIH) Trial of GEN3009 in Subjects with Relapsed or Refractory B-cell non-
Hodgkin Lymphoma  
Clinical 
Phase 
Phase 1/2a 
Purpose and 
Rationale 
Over the last 2 decades, the clinical course of B-cell non-Hodgkin lymphoma (B-cell NHL) has been 
changed dramatically by anti-CD20 antibody (eg, rituximab, ofatumumab, obinutuzumab)-
containing chemotherapies with substantially improved outcomes. However, for most relapsed or 
refractory (R/R) lymphomas and chronic lymphocytic leukemia (CLL), there is still no treatment 
that can lead to a cure. This unmet medical need warrants developing new efficacious therapies for 
patients with advanced B-cell NHL whose disease no longer responds to standard therapies. 
Identification of a target other than CD20, such as CD37, may represent an attractive alternative 
strategy. Furthermore, a chemo-free regimen by combining an anti-CD37 therapy with a T- cell- 
engaging therapy such as a CD3xCD20 bispecific antibody may present an efficacious treatment 
option for patients who have exhausted standard- of- care.  
GEN3009 (DuoHexaBody-CD37) is a bispecific antibody with a hexamerization-enhancing 
mutation that targets 2 different epitopes of the CD37 antigen. GEN3009 induced tumor cell killing 
via enhanced complement-dependent cytotoxicity (CDC) and by FcγR-mediated effector functions 
including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody antibody-dependent 
cell-mediated phagocytosis (ADCP). Nonclinically, CD37-targeting GEN3009 has demonstrated 
more potent tumor-cell killing than clinically validated CD20-targeting antibodies across a variety 
of B-cell NHL subtypes, regardless of the relapse status (ie, similar anti-tumor effect observed in 
newly diagnosed samples and R/R samples). GEN3009 also showed potent CDC activity in a limited 
set of primary samples from ibrutinib-treated NHL patients. In addition to these findings, therapeutic 
activity of GEN3009 was observed in tumor cell line-derived xenografts (ie., diffuse large B-cell 
lymphoma [DLBCL], Burkitt’s lymphoma, and CLL) and patient patient-derived xenografts (ie., 
DLBCL). 
GEN3013 (DuoBody-CD3xCD20, epcoritamab) is a fully human IgG1 bispecific antibody that 
induces potent T- cell-mediated cytotoxicity of CD20-expressing cells. Clinical data from an 
ongoing Phase 1/2 trial (GCT3013-01) demonstrated that GEN3013 as a single agent induced high 
objective response rate (ORR) with a manageable safety profile in heavily pre-treated B-cell NHL 
including DLBCL and follicular lymphoma (FL) (Hutchings, et al., 2020). As of 31 Jan 2021, a total 
of 178 subjects with aggressive and indolent NHL have been treated with GEN3013 across 5 ongoing 
trials. In the Dose Escalation (N=68) part of GCT3013-01 (NCT03625037), the most advanced 
study, GEN3013 was well tolerated at doses up to 60 mg. Recommended Phase 2 dose (RP2D) was 
declared as 48 mg for further development in the Expansion. Among 10 subjects treated at  48 mg, 
the ORR was 70.0% (3 complete response [CR], 4 partial response [PR]); among 9 DLBCL subjects, 
ORR was 77.8% (3 CR, 4 PR). The 4 most common treatment-emergent adverse events (TEAEs) 
were pyrexia (69.1%), cytokine release syndrome (CRS) (58.8%), injection site reaction (47.1%), 
and fatigue (44.1%). Adverse events of special interest (AESIs) occurred in approximately two-thirds 
of subjects; of these, 40 subjects (58.8%) experienced CRS, 4 subjects (5.9%) experienced 
neurological symptoms, and 1 subject (1.5%) experienced clinical tumor lysis syndrome. 
Due to the non-overlapping mechanisms of action (MoAs) for GEN3009 and GEN3013, it is 
hypothesized that the combination of GEN3009 with GEN3013 may induce deeper and durable 
remissions in R/R B-cell NHL.  
The aim of this first-in-human (FIH) trial is to characterize the safety and tolerability, 
pharmacokinetic (PK), and pharmacodynamic characteristics of GEN3009 as a single agent and in 
combination with GEN3013 in subjects with R/R B-cell NHL. In the Dose Escalation part, 
dose-limiting toxicity will be monitored to determine the maximum tolerated dose (MTD) and/or 
RP2D for GEN3009. In the Expansion part, clinical activity of GEN3009 monotherapy at the RP2D 

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in DLBCL, FL, and CLL will be assessed together with safety, tolerability, PK, pharmacodynamics, 
and biomarkers. In addition, the safety and preliminary efficacy of the combination regimen of 
GEN3009 and GEN3013 in R/R DLBCL will be evaluated. 
Objectives 
and 
Endpoints 
Dose Escalation: GEN3009 for R/R B-cell NHL Including CLL/Small Lymphocytic 
Lymphoma (SLL) 
OBJECTIVES 
ENDPOINTS 
Primary 
• Determine the MTD with and/or 
determine the RP2D of GEN3009 
• Rate of dose-limiting toxicities (DLTs)  
• Evaluate safety and tolerability of 
GEN3009 
• Frequency and severity of adverse events 
(AEs)/AESIs/SAEs 
• Changes in laboratory parameters 
• Changes in vital signs 
• Frequency of dose interruptions, dose delays, and 
dose intensity 
Secondary 
• Establish PK profile of GEN3009 
• PK parameters  
• Evaluate immunogenicity of 
GEN3009 
• Incidence of neutralizing anti-GEN3009 antibodies 
(ie, anti-drug antibodies [ADAs]) 
• Evaluate preliminary anti-tumor 
efficacy of GEN3009 
• ORR  
• CR rate 
• Duration of response (DoR) 
• Time to response (TTR) 
• Evaluate preliminary clinical 
efficacy of GEN3009 
• Progression-free survival (PFS) 
• Overall survival (OS) 
Exploratory 
• Assess potential biomarkers 
predictive of clinical response to 
GEN3009 and evaluate potential 
surrogacy with PFS and OS 
• CD37 expression  
• Minimal residual disease (MRD) status 
• Assess pharmacodynamic markers 
related to MoA of GEN3009 
• Pharmacodynamic markers in blood samples  
 
Expansion: GEN3009 for R/R DLBCL, FL, and CLL Cohorts 
OBJECTIVES 
ENDPOINTS 
Primary 
• Evaluate (preliminary) anti-tumor efficacy 
of GEN3009 
• ORR 
Secondary 
• Establish PK profile of GEN3009 
• PK parameters 
• Evaluate safety and tolerability of 
GEN3009 
• Frequency and severity of 
AEs/AESIs/SAEs 
• Changes in laboratory parameters 
• Changes in vital signs 
• Frequency of dose interruptions, dose 
delays, and dose intensity 
• Evaluate clinical efficacy of GEN3009 
• CR rate 
• DoR 
• TTR 
• PFS 
• OS 
• Evaluate immunogenicity of GEN3009 
• Incidence of neutralizing anti-GEN3009 
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Exploratory 
• Assess potential biomarkers predictive of 
clinical response to GEN3009 and evaluate 
potential surrogacy with PFS and OS 
• Expression of CD37 and CD59 in tumor 
biopsies before and during treatment  
• Abundance of immune effector cells in 
tumor microenvironment 
• Circulating tumor DNA (ctDNA) as 
response biomarker  
• MRD status as response biomarker in 
DLBCL, FL, and CLL and evaluate 
potential surrogacy with PFS/OS 
• DNA mutational status and gene 
expression profiling (RNA-seq) in blood 
and malignant cells 
• Assess pharmacodynamic markers related 
to MoA of GEN3009 
• Pharmacodynamic markers in blood 
samples and within tumor (on-treatment 
biopsy) (leukocyte subset frequencies and 
phenotype, target antigen expression, 
complement regulatory protein expression, 
plasma complement levels and activation 
[CH50], and cytokine levels) 
 
Expansion: GEN3009 + GEN3013 Safety Run-in for R/R B-cell NHL 
OBJECTIVES 
ENDPOINTS 
Primary 
• Identify the RP2D of GEN3009 + 
GEN3013 combination 
• Rate of DLTs 
• Evaluate safety and tolerability of 
GEN3009 + GEN3013 combination 
• Frequency and severity of AEs/AESIs/SAEs  
• Changes in laboratory parameters 
• Changes in vital signs  
• Frequency of dose interruptions, dose delays, and 
dose intensity 
 
Secondary 
• Establish the pharmacokinetic (PK) 
properties of GEN3009 and 
GEN3013 
• PK parameters 
• Evaluate immunogenicity 
• Incidence of neutralizing anti-drug antibodies 
(ADAs) to GEN3009 
• Incidence of neutralizing anti-drug antibodies 
(ADAs) to GEN3013 
• Assess the preliminary anti-tumor 
activity of GEN3009 + GEN3013 
combination 
• CR rate 
• ORR  
• DoR 
• TTR  
• PFS  
• OS 
Exploratory 
• Assess potential biomarkers 
predictive of clinical response to 
GEN3009 + GEN3013 combination 
• Expression of CD3, CD20, CD37, and molecular 
markers before and during treatment 
• MRD status 
• Assess pharmacodynamic markers 
related to MoA of GEN3009 and 
GEN3013 
• Pharmacodynamic markers in blood samples 
(leukocyte subset frequencies and phenotype, 
target antigen expression, complement regulatory 

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protein expression, plasma complement levels and 
activation [CH50], and cytokine levels) 
 
Expansion: GEN3009 + GEN3013 for R/R DLBCL 
OBJECTIVES 
ENDPOINTS 
Primary 
• Assess preliminary anti-
tumor activity of GEN3009 + 
GEN3013 combination 
• CR rate 
Secondary 
• Further assess the 
preliminary anti-tumor 
activity of GEN3009 + 
GEN3013 combination 
• ORR 
• DoR 
• TTR  
• PFS  
• OS 
• Rate and duration of MRD negativity 
• Evaluate the safety and 
tolerability of GEN3009 + 
GEN3013 
• Frequency and severity of AEs/AESIs/SAEs 
• Changes in laboratory parameters 
• Changes in vital signs 
• Frequency of dose interruptions, dose delays, and dose 
intensity 
• Establish the PK properties 
of GEN3009 and GEN3013 
• PK parameters 
• Evaluate immunogenicity 
• Incidence of neutralizing ADAs to GEN3009 
• Incidence of neutralizing ADAs to GEN3013 
Exploratory 
• Assess potential biomarkers 
predictive of clinical 
response to GEN3009 + 
GEN3013 combination 
• Expression of CD37, CD20, CD3 and other markers in 
tumor biopsies before and during treatment 
•  DNA mutation status and gene expression profiling (RNA-
seq) in blood and malignant cells  
• ctDNA as response biomarker 
• Evaluation of immune populations, phenotype and function 
in tumors and blood 
• To evaluate 
pharmacodynamic markers 
linked to efficacy and 
mechanism of action of 
GEN3009 and GEN3013 
• Pharmacodynamic markers in blood samples and within 
tumor (on-treatment biopsy) ((leukocyte subset frequencies 
and phenotype, target antigen expression, complement 
regulatory protein expression, plasma complement levels 
and activation [CH50], and cytokine levels) 
Trial Design 
This trial is a FIH, open-label, multicenter trial to evaluate the safety, tolerability, PK, 
pharmacodynamics, immunogenicity, and preliminary efficacy of GEN3009 as a single agent and in 
combination with GEN3013 in subjects with R/R B-cell NHL.  
The trial will be conducted in 2 parts, Dose Escalation and Expansion. In the Dose Escalation, 
GEN3009 will be administered by intravenous (IV) infusions at 10 dose levels (DLs) ranging from 
 mg to 
 mg in 28-day cycles. DLTs will be assessed during the first treatment cycle and the 
MTD may be identified. The totality of the data including safety, PK, pharmacodynamics, and 
preliminary efficacy will be evaluated to guide further development for Expansion, with additional 
subjects treated at the RP2D. 
In the Dose Expansion, there are 4 cohorts: 
• 
GEN3009 monotherapy cohorts: R/R DLBCL (N =20), R/R FL (N =20), and R/R CLL (N =20) 
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• 
GEN3009 + GEN3013: safety run-in phase in R/R DLBCL or FL (N=6-12) followed by R/R 
DLBCL (N =20) 
GEN3009 will be administered as IV infusions at 
 mg and RP2D and GEN3013 as subcutaneous 
injections with a step-up dosing method (ie, priming dose followed by intermediate dose and full 
dose) in 28-day treatment cycles.  
Dosing schedule for Cohort 4 GEN3009 + GEN3013 in R/R DLBCL 
(Each treatment cycle is 28 days) 
GEN3009 IV as assigned 
DL1: 
 mg 
DL2: RP2D 
GEN3013 s.c. 
DL1: 48 mg 
• 
Cycles 1-3: Days 1, 8, 15, 22 
• 
Cycles 4-12: Day 1 
• 
Cycle 1:  
o 
0.16 mg (priming dose) on Day 8  
o 
0.8 mg (intermediate dose) on Day 15  
o 
48 mg (full dose) on Day 22 
• 
Cycles 2 and 3: 48 mg on Days 1, 8, 15, and 22
• 
Cycles 4-12: 48 mg on Day 1 
After completion of Cycle 12:  
• 
Subjects who are in SD, PR or CR:  
o 
Every 4 weeks (Cycles 13, 14, 15+): 48 m
A safety run-in phase including 6-12 subjects with either R/R DLBCL or FL followed by 1 expansion 
cohort in R/R DLBCL. DLTs will be evaluated during the first treatment cycle (28 days). Subjects 
in the safety run-in will continue on treatment and subsequently in safety and survival follow-up.  
Subjects must be hospitalized for CRS monitoring for at least 24 hours after the third dose (first full 
dose) of GEN3013 (ie, 48 mg) at Cycle 1 Day 22. Additional or longer hospitalization is allowed at 
the investigator’s discretion. 
After completion of Cycle 12, subjects who have stable disease or better will have the option to 
continue receiving GEN3013 every 4 weeks until any discontinuation criterion is met. 
A data monitoring committee (DMC) will assess the totality of safety information of the safety run-in 
part and identify additional safety signal according to a DMC charter. 
Positron emission tomography computed tomography scan will be conducted at screening, at Cycle 
2 (Week 6), Cycle 3 (Week 12), Cycle 5 (Week 18), Cycle 6 (Week 24), Cycle 9 (Week 36), Cycle 
12 (Week 48), then every 24 weeks thereafter until confirmation of disease progression, start of new 
anti-cancer therapy, withdrawal of consent, or death, whichever comes first. 
Population 
For GEN3009 monotherapy, approximately 90 subjects with R/R B-cell NHL (including CLL/SLL, 
will be enrolled in the Dose Escalation). Approximately 92 subjects will be enrolled in the Dose 
Expansion.  
Key 
Inclusion 
Criteria 
Each potential subject must fulfill all of the following criteria to be enrolled in the trial (applicable 
to both Dose Escalation and Dose Expansion unless otherwise indicated). 
• 
Be at least 18 years of age. 
• 
Must sign an informed consent form (ICF) prior to any screening procedures. 
• 
Has histologically or cytologically confirmed relapsed or refractory B-cell NHL with no 
available standard therapy or is not a candidate for available standard therapy, and for whom, in 
the opinion of the investigator, experimental therapy with GEN3009 or GEN3009 + GEN3013 
may be beneficial. All subjects must have received at least 2 prior lines of systemic therapy, and,  
A. For all indolent NHL (FL, marginal zone lymphoma [MZL], and SLL) as well as aggressive 
NHL (DLBCL, high-grade B-cell lymphoma [HGBCL], and primary mediastinal large B-
CCI
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cell lymphoma [PMBCL]), at least 1 of the 2 prior lines of treatment must have been a 
CD20-containing systemic regimen; 
B. For mantle cell lymphoma (MCL), subjects must have had or are otherwise ineligible for 
treatment with a BTK inhibitor, and;  
C. For CLL, subjects must have received at least 1 prior line of BTK inhibitor or BCL-2 
inhibitor. 
Note: See Section 11.8.1.3 for definitions of “relapsed” disease. 
• 
Has 1 of the following B-cell NHL subtypes: 
• 
DLBCL, de novo or histologically transformed  
• 
HGBCL (Dose Escalation only) 
• 
PMBCL (Dose Escalation only) 
• 
FL, with advanced symptomatic disease and with a need for treatment (Dose Escalation 
only) 
Or 
FL Grade 1, 2 and 3a, with advanced symptomatic disease and with a need for treatment 
initiation (Expansion only) 
• 
MCL, without leukemic manifestation (Dose Escalation only) 
• 
MZL, either nodal, extranodal, or mucosa associated, with a need for treatment initiation 
based on symptoms and/or disease burden (Dose Escalation only) 
• 
SLL, with a need for treatment based on symptoms and/or disease burden (Dose Escalation 
only) 
• 
CLL, with B-cell count <100 × 109/L (100,000/µL) in the peripheral blood and presence of 
measurable lymphadenopathy and/or organomegaly (Dose Escalation only) 
Or  
CLL, must have active disease that needs treatment with at least 1 of the following criteria 
being met (Expansion only): 
• 
Evidence of progressive marrow failure as manifested by the development of, or 
worsening of, anemia and/or thrombocytopenia 
• 
Massive (ie, ≥6 cm below the left costal margin) or progressive or symptomatic 
splenomegaly 
• 
Massive nodes (ie, ≥10 cm in longest diameter) or progressive or symptomatic 
lymphadenopathy 
• 
Progressive lymphocytosis with an increase of ≥50% over a 2-month period, or 
lymphocyte doubling time <6 months 
• 
Autoimmune complications including anemia or thrombocytopenia poorly responsive 
to corticosteroids 
• 
Symptomatic or functional extra-nodal involvement (eg, skin, kidney, lung, spine) 
• 
Disease-related symptoms as defined by any of the following: 
• 
Unintentional weight loss ≥10% within the previous 6 months 
• 
Significant fatigue 
• 
Fevers ≥38.0°C (100.5°F) for 2 or more weeks without evidence of infection 
• 
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• 
Documented CD20+ DLBCL or FL based on representative pathology report (GEN3009 + 
GEN3013 combination Expansion cohort only) 
• 
Has measurable disease for B-cell NHL or active disease for CLL.  
• 
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 
• 
Has acceptable laboratory parameters.  
• 
Before the first dose of GEN3009, during the trial, and for 12 months after the last dose of 
GEN3009 and/or GEN3013, a woman must be either not of childbearing potential or of 
childbearing potential and practicing a highly effective method of birth control, and must have 
a negative serum beta-human chorionic gonadotropin (beta-hCG) at screening.  
• 
A man who is sexually active with a woman of childbearing potential and has not had a 
vasectomy must agree to use a barrier method of birth control.  
• 
Documented CD20+ DLBCL or FL based on representative pathology report (GEN3009 + 
GEN3013 combination Expansion cohort only). 
• 
Subjects must have a life expectancy of at least 3 months. 
Key 
Exclusion 
Criteria 
Any potential subject who meets any of the following criteria will be excluded from participating in 
the trial (applicable to both Dose Escalation and Expansion unless otherwise indicated).. 
• 
Prior treatment with a CD37-targeting agent. 
• 
Prior allogeneic hematopoietic stem cell transplantation (HSCT). 
• 
Prior treatment with a CD3xCD20 bispecific antibody (GEN3009 + GEN3013 combination 
Expansion cohort only). 
• 
Autologous HSCT within 3 months before the first dose of GEN3009. 
• 
Lymphomas leukemic phase: high absolute lymphocyte count or the presence of abnormal cells 
in the peripheral blood indicating circulating lymphoma cells. 
• 
Treatment with an anti-cancer biologic including anti-CD20 therapy, radio-conjugated or toxin-
conjugated antibody or chimeric antigen receptor T cell therapy within 4 weeks or 5 half-lives, 
whichever is shorter, before the first dose of GEN3009. Treatment with small molecules such as 
BTK inhibitors, BCL2 inhibitors, or PI3K inhibitors within 5 half-lives prior to the first dose of 
GEN3009. 
• 
Chemotherapy or radiation therapy within 2 weeks of the first dose of GEN3009. 
• 
Treatment with an investigational drug or an invasive investigational medical device within 4 
weeks or 5 half-lives, whichever is shorter, prior to the first dose of GEN3009, and at any time 
during the study treatment period. 
• 
Autoimmune disease or other diseases that require permanent or high-dose immunosuppressive 
therapy. 
• 
Received a cumulative dose of corticosteroids more than the equivalent of 250 mg of prednisone 
within the 2–week period before the first dose of GEN3009. 
• 
Has uncontrolled intercurrent illness, including but not limited to: 
a. 
Ongoing or active infection requiring intravenous antibiotics treatment at the time of 
enrollment or within the previous 2 weeks prior to the first dose of GEN3009 or 
GEN3013. 
b. Symptomatic congestive heart failure (grade III or IV as classified by the New York 
Heart Association ([NYHA]), unstable angina pectoris or cardiac arrhythmia (refer to 
Appendix 2) and/or known decrease ejection fraction of <45% 
c. 
Myocardial infarction, intracranial bleed, or stroke within the past 6 months.  

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d. Screening 12-lead electrocardiogram showing a baseline QT interval as corrected by 
Fridericia’s formula (QTcF) >480 msec. 
• 
Seizure disorder requiring therapy (such as steroids or anti-epileptics) (GEN3009 + GEN3013 
combination Expansion cohort only). 
• 
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy 
• 
Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade 
1 or less except for alopecia and peripheral neuropathy. 
• 
Primary central nervous system (CNS) lymphoma or known CNS involvement at screening. 
• 
Has known past or current malignancy other than inclusion diagnosis, except for: 
• 
Cervical carcinoma of Stage 1B or less 
• 
Non-invasive basal cell or squamous cell skin carcinoma 
• 
Non-invasive, superficial bladder cancer 
• 
Prostate cancer with a current PSA level <0.1 ng/mL 
• 
Any curable cancer with a CR of >2 years duration 
• 
Had allergic reactions to anti-CD20 or anti-CD37 monoclonal antibody treatment or intolerant 
to GEN3009 excipients (refer to the GEN3009 Investigator’s Brochure (IB) for more 
information) 
• 
Intolerant to GEN3013 excipients (refer to the GEN3013 IB for more information) (GEN3009 
+ GEN3013 combination Expansion cohort only). 
• 
Has had major surgery within 4 weeks before screening or will not have fully recovered from 
surgery, or has major surgery planned during the time the subject is expected to participate in 
the trial (or within 4 weeks after the last dose of GEN3009 and/or GEN3013). 
• 
Has known history/positive serology for hepatitis B.  
• 
Known medical history or ongoing hepatitis C infection that has not been cured. 
• 
Known history of seropositivity for HIV infection. Note: HIV testing is required at screening 
only if required per local health authorities or institutional standards. 
• 
Is a woman who is pregnant or breast-feeding, or who is planning to become pregnant while 
enrolled in this trial or within 12 months after the last dose of GEN3009 and/or GEN3013. 
• 
Is a man who plans to father a child while enrolled in this trial or within 12 months after the last 
dose of GEN3009 and/or GEN3013. 
• 
Has any condition for which, in the opinion of the investigator, participation would not be in the 
best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or 
confound the protocol-specified assessments. Additionally, vulnerable subjects or subjects under 
guardianship, curatorship, judicial protection or deprived of liberty), are excluded from 
participation in this trial. 
• 
Exposed to live/live attenuated vaccine within 4 weeks prior to initiation of GEN3009 treatment.  
IMP 
GEN3009 will be administered intravenously in 4-week cycles (ie., 28 days). 
In the Dose Escalation, the starting dose is  mg. Ten DLs may be tested. Additional/intermediate 
DLs may also be explored based upon emerging data. 
In the Expansion, 
 mg and the RP2D of GEN3009 will be investigated together with GEN3013 
at 48 mg. 
GEN3013 will be administered s.c. in 4-week cycles (ie., 28 days). 
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In the Expansion, 48 mg of GEN3013 will be investigated together with GEN3009 at 
 mg and 
the RP2D. 
Statistics 
In the Dose Escalation, MTD and/or RP2D will be determined using a modified Bayesian Optimal 
Interval (mBOIN) design. Expansion of GEN3009 monotherapy will be conducted in 3 indications 
with a maximum sample size of 20 per indication. Expansion of GEN3009 in combination with 
GEN3013 will be conducted in 1 indication following a safety run-in phase with a maximum sample 
size of 32 for the cohort. No formal statistical hypothesis testing will be performed. AEs will be 
described using summary statistics. Individual curves of plasma concentration for GEN3009 or 
GEN3013 will be presented for all subjects. PK parameters will be calculated based on non-
compartmental methods and calculated separately. The revised response criteria (Cheson et al., 2014) 
will be used to assess the response for B-cell NHL and the International Workshop on Chronic 
Lymphocytic Leukemia (Hallek et al., 2018) for CLL.  
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1 
VISIT ASSESSMENT SCHEDULES 
The following visit assessments are provided in this section: 
• Table 2 
Visit Assessment Schedule for Screening and Cycle 1 - Dose Escalation 
• Table 3 
Visit Assessment Schedule from Cycle 2 and Beyond – Dose Escalation 
• Table 4 
Visit Assessment Schedule for PK, Immunogenicity, 
Biomarkers/Pharmacodynamics, and Tumor Lysis Syndrome Surveillance Sampling – 
Dose Escalation 
• Table 5 
Visit Assessment Schedule for Screening and Cycle 1 – Expansion GEN3009 
Monotherapy 
• Table 6 
Visit Assessment Schedule from Cycle 2 and Beyond – Expansion GEN3009 
Monotherapy 
• Table 7 
Visit Assessment Schedule for PK and ADA– Expansion GEN3009  
• Table 8 
Visit Assessment Schedule for Biomarkers – Expansion GEN3009 
Monotherapy  
• Table 9 
Visit Assessment Schedule for MRD – Dose Escalation and Expansion 
GEN3009  
• Table 10 Visit Assessment Schedule for Screening and Cycle 1 Expansion GEN3009 + 
GEN3013 (including Safety Run-in) 
• Table 11 Visit Assessment Schedule from Cycle 2 and Beyond – Expansion GEN3009 + 
GEN3013 
• Table 12 Visit Assessment Schedule for PK and ADA – Expansion GEN3009 + 
GEN3013 (including Safety Run-in)   
• Table 13 Visit Assessment Schedule for Biomarkers – Expansion GEN3009 + GEN3013 
(including Safety Run-in) 
• Table 14 Visit Assessment Schedule for MRD – Expansion GEN3009 + GEN3013 
• Table 15 GEN3013 Repriming Cycle – Expansion GEN3009 + GEN3013 (including 
Safety Run-in) 
The assessment schedules list all the assessments and indicates with an “X” the visits when they 
are performed. In addition to the fixed visits, it may be necessary to perform some of the 
assessments at unscheduled time points if deemed clinically necessary by the investigator. All data 
obtained from these assessments must be supported in the subject’s source documentation.  
 

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Table 2 Visit Assessment Schedule for Screening and Cycle 1 - Dose Escalation 
Treatment Cycle: 
28-day cycle 
Section 
Screening 
Cycle 1 
 
Day 
≤ 21 days prior 
to C1D1 
1da 
2d 
4d 
8da 
9d 
11d 
15da 
16d 
18d 
22da 
23d 
25d 
Visit Window 
 
 
 
±1d 
±1d 
 
±1d 
±1d 
 
 
±1d 
 
 
Informed Consent 
13.2.3 
X (before any 
trial-specific 
procedures) 
 
Eligibility Criteria 
5.1, 5.2 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
9.1.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Disease Status: Includes diagnosis 
and staging criteria 
9.1.2 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Medical Historyb 
9.1.3 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Prior Anti-neoplastic Therapy 
9.1.5 
X 
 
 
 
 
 
 
 
 
 
 
 
 
DLBCL or CLL Cytogenetics and 
Molecular Status 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
FDG-PET CT/CT/MRIc 
9.2.2.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Lymphoma with Bone Marrow 
Involvement and CLL: Unilateral 
bone marrow biopsy and aspirated 
9.2.2.2 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Height 
9.3.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Body Weight 
9.3.1 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Physical Examination (including 
lymph node assessment)e 
9.3.1 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Vital Signs 
9.3.2 
X 
Xf 
Xf 
X 
Xf 
X 
X 
Xf 
X 
 
Xf 
X 
 
ECG (in triplicate) 
9.3.3 
X 
Xg 
Xg 
X 
Xg 
X 
X 
Xg 
 
 
Xg 
 
 
ECOG Performance Status 
9.3.4 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Constitutional Symptoms 
9.3.5 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Adverse Eventsh 
10 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medication and 
Procedures 
9.1.4 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Premedication prior to GEN3009 
Administration 
6.2 
 
X 
Xj 
 
X 
 
 
X 
 
 
X 
 
 
GEN3009 Administration 
6.4.1 
 
X 
Xj 
 
X 
 
 
X 
 
 
X 
 
 

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Treatment Cycle: 
28-day cycle 
Section 
Screening 
Cycle 1 
 
Day 
≤ 21 days prior 
to C1D1 
1da 
2d 
4d 
8da 
9d 
11d 
15da 
16d 
18d 
22da 
23d 
25d 
Visit Window 
 
 
 
±1d 
±1d 
 
±1d 
±1d 
 
 
±1d 
 
 
LABORATORY ASSESSMENTS 
Hematology: Complete blood count 
and differential counte 
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Quantitative Lymphocyte Subsets 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Biochemistrye 
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Coagulatione 
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Immunoglobulins (IgA, IgE, IgG, 
IgM) 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Urinalysise 
9.4.1 
X 
X 
 
 
X 
 
 
 
 
 
 
 
 
Serum β2-microglobulin 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy Test (serum) 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy Test (either urine or 
serum)e 
9.4.1 
 
X 
 
 
 
 
 
 
 
 
 
 
 
HIV Serologyi 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Hepatitis B and C Serology 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Cytomegalovirus (CMV) Serology 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
a. 
Subjects must remain at the clinic for at least 4 hours for observation following GEN3009 administration. Subjects must be instructed to contact the investigator should signs or 
symptoms of infusion-related reactions occur following discharge from the 4-hour observation period. Observation of up to 24 hours postdose during Cycle 1 is permissible at the 
discretion of the investigator. 
b. Any medical condition (ie, signs, symptoms and diagnosis) occurring prior to the first GEN3009 dose should be recorded as medical history.  
c. 
Refer to Section 9.2.2.1 for imaging requirements. Imaging assessments performed as SOC prior to the subject signing of informed consent may be submitted as screening assessment, 
if imaging is performed within 21 days of the first dose of GEN3009, and all other requirements for imaging are met. 
d. CLL/SLL subjects and lymphoma subjects with bone marrow involvement: fresh bone marrow biopsy and aspirate are required. Prior bone marrow biopsy samples done within 4 
weeks before Cycle 1 Day 1 are acceptable. Fresh bone marrow aspirate is mandatory at screening. 
e. 
Physical examination or clinical laboratory tests may be performed within 1 day prior to GEN3009 dosing  
f. 
On GEN3009 administration days in Cycle 1, vital signs are to be obtained: 1) Before administration, 2) 15 minutes (± 5 minutes) after administration and 3) every 30 minutes (± 5 
minutes) during the 4-hour postdose observation period.  
g. In triplicate, 5 minutes apart (± 5 minutes), before GEN3009 administration and 1-2 hours (± 15 minutes) after administration. 
h. All AEs must be reported from the first GEN3009 dose until 30 days after the last dose (refer to Table 3 for details on the safety follow-up visit). Medical conditions that occur after 
the ICF is signed and prior to first GEN3009 dose should only be reported as AEs if they were assessed by the investigator to be caused by a protocol-mandated procedure (ie, tumor 
biopsy and/or CT scan), including washout or discontinuation of prior medications. 
i. 
HIV testing is required at screening only if required per local health authorities or institutional standards. 

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j. 
At dose levels ≥
 mg, the first dose of GEN3009 can be split into 2 consecutive days (ie, 
 mg at C1D1 and remaining amount at C1D2) after approval of the sponsor’s medical 
monitor.  
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Table 3 Visit Assessment Schedule from Cycle 2 and Beyond – Dose Escalation 
Treatment Cycle:  
28-day cycle  
Section 
Cycle 2-3 
Cycle 
4-9 
Cycle 
10 and 
Beyond 
Unscheduled 
Treatment 
Discontinuati
on Visita 
Safety Follow-
up Visita 
Survival 
Follow-
upb 
Day 
1d 
4d 
8d 
11d 
15d 
22d 
1d 
15d 
1d 
-- 
As soon as 
possible after 
withdrawn 
from 
treatment 
30 days after 
last dose 
Every 12 
weeks 
after last 
dose 
Visit Window 
±2d 
 
±2d 
 
±2d 
±2d 
±2d 
±2d 
±2d 
 
+7d 
+14d 
±14d 
Body Weight 
9.3.1 
X 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Physical 
Examination 
(including lymph 
node assessment)c 
9.3.1 
X 
 
 
 
 
 
X 
 
X 
X 
X 
 
 
Vital Signs  
9.3.2 
Xd 
 
Xd 
 
Xd 
Xd 
Xd 
Xd 
Xd 
X 
X 
 
 
ECG (in triplicate) 
9.3.3 
Xe 
 
Xe 
 
Xe 
Xe 
Xe 
Xe 
Xe 
X 
X 
 
 
ECOG Performance 
Status  
9.3.4 
X 
 
 
 
 
 
X 
 
X 
X 
X 
 
 
Constitutional 
Symptoms  
9.3.5 
X 
 
 
 
 
 
X 
 
X 
X 
X 
 
 
Adverse Eventsf 
10 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Concomitant 
Medication and 
Procedures  
9.1.4 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Premedication prior 
to GEN3009 
Administration 
6.2 
X 
 
X 
 
X 
X 
X 
X 
X 
 
 
 
 
GEN3009 
Administration 
6.4.1 
X 
 
X 
 
X 
X 
X 
X 
X 
 
 
 
 
New Anti-cancer 
Treatment  
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
Survival Status 
9.3.6 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
EFFICACY ASSESSMENTS 
FDG-PET 
CT/CT/MRI 
9.2.2.1 
Xg 
 
 

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Treatment Cycle:  
28-day cycle  
Section 
Cycle 2-3 
Cycle 
4-9 
Cycle 
10 and 
Beyond 
Unscheduled 
Treatment 
Discontinuati
on Visita 
Safety Follow-
up Visita 
Survival 
Follow-
upb 
Day 
1d 
4d 
8d 
11d 
15d 
22d 
1d 
15d 
1d 
-- 
As soon as 
possible after 
withdrawn 
from 
treatment 
30 days after 
last dose 
Every 12 
weeks 
after last 
dose 
Visit Window 
±2d 
 
±2d 
 
±2d 
±2d 
±2d 
±2d 
±2d 
 
+7d 
+14d 
±14d 
Lymphoma with 
Bone Marrow 
Involvement and 
CLL: Unilateral 
bone marrow 
biopsy and aspirate  
9.2.2.2 
X  
(at time of CR and clinically indicated) 
 
 
LABORATORY ASSESSMENTS 
Hematology: 
Complete blood 
count and 
differential countc 
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Biochemistryc  
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Coagulationc 
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Immunoglobulins 
(IgA, IgE, IgG, 
IgM)  
9.4.1 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
 
Urinalysisc  
9.4.1 
X 
 
 
 
 
 
X 
 
X 
X 
X 
 
 
Pregnancy Test 
(either urine or 
serum)  
9.4.1 
X 
 
 
 
 
 
X 
 
X 
X 
X 
X 
 
Hepatitis B and C 
Serology 
9.4.1 
 
 
 
 
 
 
 
 
 
 
Xh 
 
 
a. 
Subjects discontinuing from treatment for any reason will have a safety follow-up visit 30 days after the last dose of GEN3009. If the subject initiates new anti-lymphoma therapy 
within 4 weeks of the last dose of GEN3009, the safety follow-up visit should be performed prior to starting new anti-cancer therapy. 
b. Subjects will enter the survival follow-up after completion of the safety follow-up or if new anti-cancer treatment has been started. Survival follow-up contact may be performed as a 
telephone call, email, or on-site visit. 
c. 
Physical examination and clinical laboratory tests may be performed within 1 day prior to GEN3009 dosing.  
d. On dosing days, vital signs are performed predose and postdose, and more frequently at the discretion of the investigator. If the subject has stable vital signs and no other issues, the 
subject may be discharged from the clinic after all assessments are completed as required by protocol. Subjects must be instructed to contact the investigator should signs or symptoms 
of infusion-related reactions occur following discharge from the clinic. 
e. 
In triplicate, 5 minutes apart (± 5 minutes), before GEN3009 administration and 1-2 hours (± 15 minutes) after administration.  

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f. 
All AEs must be reported from the first GEN3009 dose until 30 days after the last dose. If the subject initiates new anti-lymphoma therapy within 30 days of the last dose of GEN3009, 
the safety follow-up visit should be performed prior to starting new anti-cancer therapy. 
g. Refer to Section 9.2.2.1 for imaging requirements. 
h. Only for subjects with positive serology. 

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Table 4 Visit Assessment Schedule for PK, Immunogenicity, Biomarkers/Pharmacodynamics, and Tumor Lysis Syndrome 
Surveillance Sampling – Dose Escalation 
Treatment Cycle: 
28-day cycle  
Screening 
Cycle 1 and 2 
Day 
≤ D21 prior to C1D1 
1d 
2d 
4d 
8d 
9d 
15d 
16d 
22d 
23d 
Visit window 
 
 
 
 
 
 
 
 
 
 
Predose (-30 minutes) 
Fresh tumor biopsy or 
archival samples for IHC 
PK/ADAa/Cy/Co/I/TLS 
PKg 
 
PK/I/TLS 
 
PK/ADAb/Cy/Co/I 
 
PK/ADAb/I 
 
End of infusionc (+5 
minutes)  
 
PK/Cyf/TLS 
PKg/Cyg 
 
PK/TLS 
 
PK/Cyb 
 
PK  
 
End of infusion +2 hours 
(±15 minutes) 
 
PKf/Cyf/TLS 
PKg/Cyg 
 
TLS 
 
Cyb 
 
 
 
End of infusion +4 hours 
(±30 minutes)  
 
PKf/Cyf/Cof/If/TLS 
PKg/Cyg/Cog/Ig 
 
 Ib/TLS 
 
Cyb/Cob/Ib 
 
Ib 
 
End of infusion +24 
hours 
(±2 hours) 
 
 
PKf/Cyf/If/TLS 
 
 
Ib/TLS 
 
Ib 
 
Ib 
End of infusion +72 
hours (±24 hours)h 
 
 
 
PK/I/TLS 
 
 
 
 
 
 
 
Treatment Cycle: 
28-day cycle  
Cycle 3 
Cycle 4-9 
Cycle 10 
And Beyond 
Unscheduled 
Treatment 
Discontinuation 
Visit 
Day 
1d 
8d 
15d 
22d 
1d 
15d 
1d 
 
 
Visit window 
 
+2d 
+2d 
+2d 
+3d 
±3d 
±4d 
 
 
Predose (-30 minutes) 
PK/I/Co 
PK/I/Co 
PK/I/Co 
PK/I/Co 
PK/ADAd/Id/Cod 
PK/Id/Cod 
PK/ADAd/Id/Cod 
 
 
End of infusionc (+5 
minutes) 
PK 
PK 
PK 
PK 
PK 
PK 
PK 
 
 
Unscheduled Visit 
 
 
 
 
 
 
 
PK/ADA/I/Co/Cy/
TBe 
PK/ADA 
Note: Sample collection timing may be modified during the trial based on emerging data. 
PK=Pharmacokinetics (Section 9.5); ADA=anti-drug antibody (Section 9.6); Cy=cytokine (Section 9.8.3.2); Co=complement (Section 9.8.3.3); 
I=immunophenotyping on peripheral blood (Section 9.8.3.1); TLS=tumor lysis syndrome (Table 31); TB=tumor biopsy (Section 9.7/9.8.2) 
a. 
Day 1 ADA in Cycle 2 only. 
b. Cycle 1 only. 
c. 
After flush. 
d. ADA and biomarker samples in even cycles only. 
e. 
Refer to Section 9.7. 

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f. 
Only in case of full dose on Day 1 
g. Only in case of split dose between Day 1 and Day 2. 
h. In case of split dose between Day 1 and Day 2, the Day 4 sample will be 48 hours after the complete infusion. 
 

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Table 5 Visit Assessment Schedule for Screening and Cycle 1 – Expansion GEN3009 Monotherapy 
Treatment Cycle: 
28-day cycle 
Section 
Screening 
Cycle 1 
 
Day 
≤21 days prior to 
C1D1 
1da 
2d 
4d 
8da 
9d 
11d 
15da 
16d 
18d 
22da 
23d 
25d 
Visit Window 
 
 
 
±1d 
±1d 
 
±1d 
±1d 
 
 
±1d 
 
 
Informed Consent 
13.2.3 
X (before any 
trial-specific 
procedures) 
 
Eligibility Criteria 
5.1, 5.2 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
9.1.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Disease Status: Includes diagnosis and 
staging criteria 
9.1.2 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Medical Historyb 
9.1.3 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Prior Anti-neoplastic Therapy 
9.1.5 
X 
 
 
 
 
 
 
 
 
 
 
 
 
DLBCL or CLL Molecular Status 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
FDG-PET CT/CT/MRIc 
9.2.2.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Lymphoma with Bone Marrow 
Involvement and CLL: Unilateral bone 
marrow biopsy and aspirated 
9.2.2.2 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Height 
9.3.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Body Weight 
9.3.1 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Physical Examination (including 
lymph node assessment)e 
9.3.1 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Vital Signs 
9.3.2 
X 
Xf 
Xf 
X 
Xf 
X 
X 
Xf 
X 
 
Xf 
X 
 
ECG (in triplicate) 
9.3.3 
X 
Xg 
Xg 
X 
Xg 
X 
X 
Xg 
 
 
Xg 
 
 
ECOG Performance Status 
9.3.4 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Constitutional Symptoms 
9.3.5 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Adverse Eventsh 
10 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medication and 
Procedures 
9.1.4 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Premedication prior to GEN3009 
Administration 
6.2 
 
X 
X 
 
X 
 
 
X 
 
 
X 
 
 
GEN3009 Administration 
6.4.1 
 
X 
X 
 
X 
 
 
X 
 
 
X 
 
 
LABORATORY ASSESSMENTS 

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Treatment Cycle: 
28-day cycle 
Section 
Screening 
Cycle 1 
 
Day 
≤21 days prior to 
C1D1 
1da 
2d 
4d 
8da 
9d 
11d 
15da 
16d 
18d 
22da 
23d 
25d 
Visit Window 
 
 
 
±1d 
±1d 
 
±1d 
±1d 
 
 
±1d 
 
 
Hematology: Complete blood count 
and differential counte 
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Quantitative Lymphocyte Subsets 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Biochemistrye 
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Coagulatione 
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Tumor Lysis Syndrome Panel  
9.4.1 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Immunoglobulins (IgA, IgE, IgG, IgM) 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Urinalysise 
9.4.1 
X 
X 
 
 
X 
 
 
 
 
 
 
 
 
Serum β2-microglobulin 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy Test (serum) 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy Test (either urine or serum)e 
9.4.1 
 
X 
 
 
 
 
 
 
 
 
 
 
 
HIV Serologyi 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Hepatitis B and C Serology 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Cytomegalovirus (CMV) Serology 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
a. 
Subjects must remain at the clinic for at least 2 hours for observation following GEN3009 administration. Subjects must be instructed to contact the investigator should signs or 
symptoms of infusion-related reactions occur following discharge from the 2-hour observation period.  
b. Any medical condition (ie, signs, symptoms and diagnosis) occurring prior to the first GEN3009 dose should be recorded as medical history.  
c. 
Refer to Section 9.2.2.1 for imaging requirements. Imaging assessments performed as SOC prior to the subject signing of informed consent may be submitted as screening assessment, 
if imaging is performed within 21 days of the first dose of GEN3009, and all other requirements for imaging are met.  
d. CLL/SLL subjects and lymphoma subjects with bone marrow involvement: fresh bone marrow biopsy and aspirate are required. Prior bone marrow biopsy samples done within 
4 weeks) before Cycle 1 Day 1 are acceptable. Fresh bone marrow aspirate is mandatory at screening. 
e. 
Physical examination and clinical laboratory tests may be performed within 1 day prior to GEN3009 dosing.  
f. 
On GEN3009 administration days in Cycle 1, vital signs are to be obtained: 1) Before administration, 2) 15 minutes (± 5 minutes) after administration and 3) every 30 minutes 
(±5 minutes) during the 2-hour postdose observation period.  
g. In triplicate, 5 minutes (± 5 minutes) apart, before GEN3009 administration and 1-2 hours (± 15 minutes) after administration.  
h. All AEs must be reported from the first GEN3009 dose until 30 days after the last dose. Medical conditions that occur after the ICF is signed and prior to first GEN3009 dose should 
only be reported as AEs if they were assessed by the investigator to be caused by a protocol-mandated procedure (ie, tumor biopsy and/or CT scan), including washout or discontinuation 
of prior medications. 
i. 
HIV testing is required at screening only if required per local health authotites or institutional standards. 
j. 
At dose levels ≥
 mg, the first dose of GEN3009 can be split into 2 consecutive days (ie, 
 mg at C1D1 and remaining amount at C1D2) after approval of the sponsor’s medical 
monitor.   
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Table 6 Visit Assessment Schedule from Cycle 2 and Beyond – Expansion GEN3009 Monotherapy 
Treatment Cycle:  
28-day cycle  
Section 
Cycle 2-3 
Cycle 
4-9 
Cycle 
10 And 
Beyond 
Unscheduled 
Treatment 
Discontinuation 
Visita 
Safety 
Follow-up 
Visita 
Survival 
Follow-up 
Visitb 
Day 
1d 
4d 
8d 
11d 
15d 
22d 
1d 
15d 
1d 
-- 
As soon as 
possible after 
withdrawn 
from treatment 
30 days after 
last dose 
Every 12 
weeks 
after last 
dose 
Visit window 
±2d 
 
±2d 
 
±2d 
±2d 
±2d 
±2d 
±2d 
 
+7d 
+14d 
±14d 
Body Weight 
9.3.1 
X 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Physical 
Examination 
(including lymph 
node assessment)c 
9.3.1 
X 
 
 
 
 
 
X 
 
X 
X 
X 
 
 
Vital Signs  
9.3.2 
Xd 
 
Xd 
 
Xd 
Xd 
Xd 
Xd 
Xd 
X 
X 
 
 
ECG (in triplicate) 
9.3.3 
Xe 
 
Xe 
 
Xe 
Xe 
Xe 
Xe 
Xe 
Xe 
X 
 
 
ECOG Performance 
Status  
9.3.4 
X 
 
 
 
 
 
X 
 
X 
X 
X 
 
 
Constitutional 
Symptoms  
9.3.5 
X 
 
 
 
 
 
X 
 
X 
X 
X 
 
 
Adverse Eventsf 
10 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Concomitant 
Medication and 
Procedures  
9.1.4 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Premedication prior 
to GEN3009 
administration 
6.2 
X 
 
X 
 
X 
X 
X 
X 
X 
 
 
 
 
GEN3009 
Administration 
6.4.1 
X 
 
X 
 
X 
X 
X 
X 
X 
 
 
 
 
New Anti-Cancer 
Treatment  
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Survival Status 
9.3.6 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
EFFICACY ASSESSMENTS 
FDG-PET/CT/MRI 
9.2.2.1 
Xg 
 
 

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Treatment Cycle:  
28-day cycle  
Section 
Cycle 2-3 
Cycle 
4-9 
Cycle 
10 And 
Beyond 
Unscheduled 
Treatment 
Discontinuation 
Visita 
Safety 
Follow-up 
Visita 
Survival 
Follow-up 
Visitb 
Day 
1d 
4d 
8d 
11d 
15d 
22d 
1d 
15d 
1d 
-- 
As soon as 
possible after 
withdrawn 
from treatment 
30 days after 
last dose 
Every 12 
weeks 
after last 
dose 
Visit window 
±2d 
 
±2d 
 
±2d 
±2d 
±2d 
±2d 
±2d 
 
+7d 
+14d 
±14d 
Lymphoma with 
bone marrow 
involvement and 
CLL: Unilateral 
bone marrow biopsy 
and aspirate 
9.2.2.2 
X 
(at time of CR and clinically indicated) 
 
 
LABORATORY ASSESSMENTS 
Hematology: 
complete blood 
count with 
differentialc  
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Biochemistryc  
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Coagulationc 
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Immunoglobulins 
(IgA, IgG, IgM)  
9.4.1 
X 
 
 
 
 
 
X 
 
X 
 
X 
 
 
Urinalysisc  
9.4.1 
X 
 
 
 
 
 
X 
 
X 
X 
X 
 
 
Pregnancy Test 
(either urine or 
serum)  
9.4.1 
X 
 
 
 
 
 
X 
 
X 
X 
X 
X 
 
Hepatitis B and C 
Serology 
9.4.1 
 
 
 
 
 
 
 
 
 
 
Xh 
 
 
a. 
Subjects discontinuing from treatment for any reason will have a safety follow-up visit 30 days after the last dose of GEN3009. If the subject initiates new anti-lymphoma therapy 
within 4 weeks of the last dose of GEN3009, the safety follow-up visit should be performed prior to starting new anti-cancer therapy. 
b. 
Subjects will enter the survival follow-up after completion of the safety follow-up or if new anti-cancer treatment has been started. Survival follow-up contact may be performed as a 
telephone call, email, or on-site visit. 
c. 
Physical examination and clinical laboratory tests may be performed within 1 day prior to GEN3009 dosing.  
d. 
On dosing days, vital signs are performed predose and postdose, and more frequently at the discretion of the investigator. If the subject has stable vital signs and no other issues, the 
subject may be discharged from the clinic after all assessments are completed as required by protocol. Subjects must be instructed to contact the investigator should signs or symptoms 
of infusion-related reactions occur following discharge from the clinic. 
e. 
In triplicate, 5 minutes apart (± 5 minutes), before GEN3009 administration and 1-2 hours (± 15 minutes) after administration. During Cycle 4 and for all subsequent cycles, ECGs are 
required at predose only. During an unscheduled visit, ECG is performed only if clinically indicated.  
f. 
All AEs must be reported from the first GEN3009 dose until 30 days after the last dose. If the subject initiates new anti-lymphoma therapy within 30 days of the last dose of GEN3009, 
the safety follow-up visit should be performed prior to starting new anti-cancer therapy. 

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g. 
Refer to Section 9.2.2.1 for imaging requirements.  
h. 
Only for subjects with positive serology. 

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Table 7 Visit Assessment Schedule for PK and ADA– Expansion GEN3009 Monotherapy 
Treatment Cycle: 
28-day cycle  
Section  
Cycle 1 
Day 
1d 
2d 
4d 
8d 
9d 
15d 
16d 
22d 
23d 
Visit window 
 
 
 
 
 
 
 
 
 
Predose (-30 minutes) 
9.5, 9.6 
ADA/PK 
PKc 
 
PK 
 
PK 
 
PK 
 
End of infusiona (+5 minutes)  
PK 
PKc 
 
PK 
 
PK 
 
PK 
 
End of infusion +2 hours 
(+1 hour) 
PKb 
PKc 
 
 
 
 
 
 
 
End of infusion +24 hours 
(±2 hours) 
 
PKb 
 
 
 
 
 
 
 
End of infusion +72 hours (±24 
hours)d 
 
 
PK 
 
 
 
 
 
 
 
Treatment Cycle:  
28-day cycle  
Section 
Cycles 2 and 3 
Cycles 4-9 
Cycle 10 and 
Beyond 
Unscheduled 
Treatment 
Discontinuation Visit 
Day 
1d 
8d 
15d 
22d 
1d 
15d 
1d 
 
 
Visit Window 
 
+2d 
+2d 
+2d 
+3d 
±3d 
±4d 
 
 
Predose (-30 min) 
9.5, 9.6 
ADAe/ 
PK 
PK 
PK 
PK 
ADAe/ 
PK 
PK 
ADAe/ 
PK 
 
 
End of infusiona (+5 min) 
PK 
 
 
 
 
 
 
 
 
Unscheduled Visit 
 
 
 
 
 
 
 
ADA/ 
PK 
ADA/ 
PK 
Note: Sample collection timing may be modified during the trial based on emerging data. 
a. 
After flush. 
b. 
Only in case of full infusion on Day 1. 
c. 
Only in case of split dose between Day 1 and Day 2. 
d. 
In case of split dose between Day 1 and Day 2, the Day 4 sample will be 48 hours after the complete infusion. 
e. 
Even cycles only. 
 
 

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Table 8 
Visit Assessment Schedule for Biomarkers – Expansion GEN3009 Monotherapy 
Treatment Cycle:  
28-day cycle  
Section 
 
 
Cycles 1 and 2 
Day 
Screening 
1d 
2d 
2d+2h 
4d 
8d 
15d 
16d 
22d 
Visit window 
 
 
 
 
 
 
 
 
 
Tumor biopsy 
9.7/9.8.2 
Xa 
 
 
 
 
 
Xb,f 
 
 
Cytokines 
9.8.3.2 
 
Xc 
 
 
 
 
Xc 
 
 
Complement 
9.8.3.3 
 
Xc 
Xd,h 
Xd,i 
 
 
Xc 
Xd 
 
Immunophenotyping 
9.8.3.1 
 
Xc 
Xd,h 
 
Xd,i 
 
Xc 
Xd 
 
PBMC 
9.8.3.1 
 
Xc 
 
 
 
Xc,d 
Xc,d 
 
Xc,d 
Saliva DNA 
9.8.3.4 
X 
 
 
 
 
 
 
 
 
ctDNA/MRD plasma 
9.8.3.4/9.2.2.3 
 
Xc 
 
 
 
 
Xc,f 
 
 
 
Treatment Cycle:  
28-day cycle  
Section 
Cycle 3 
Cycle 4-9 
Cycle 10 and Beyond 
Unscheduled 
Treatment Discontinuation Visit 
Day 
1d 
15d 
1d 
15d 
1d 
Visit window 
+2d 
+3d 
±3d 
±4d 
Tumor biopsy 
9.7/9.8.2 
 
 
 
 
 
 
Xb 
Cytokine 
9.8.3.2 
 
 
 
 
 
X 
 
Complement 
9.8.3.3 
Xe 
Xe 
Xe 
X 
X 
Immunophenotyping 
9.8.3.1 
Xc 
Xc 
Xc,e 
Xc,e 
Xc,e 
X 
 
PBMC 
9.8.3.1 
Xc,e 
X 
X 
Saliva DNA 
9.8.3.4 
 
 
 
 
 
 
 
ctDNA/MRD plasma 
9.8.3.4/9.2.2.3 
Xc 
Xc,g 
Xc,g 
X 
a. 
Fresh lymph node biopsy (to be taken from patients with easily accessible lesions) or an archival lymph node biopsy (formalin-fixed paraffin-embedded [FFPE], which is taken after 
most recent therapy prior to enrollment and taken within 6 months of Cycle 1 Day 1) is mandatory for lymphoma, SLL and CLL. Baseline biopsy samples are requested to be submitted 
by C1D1.  

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b. 
Unless otherwise agreed with sponsor’s medical monitor or delegate, a fresh core biopsy is to be taken from patients with easily accessible lesions in Cycle 2 (Week 6) and at the End 
of Treatment visit. 
c. 
If the visit occurs on an infusion day, the sample must be taken before IMP treatment (-30 minutes). 
d. 
Cycle 1 only. 
e. 
Samples in even cycles only, starting Cycle 4. 
f. 
Cycle 2 only. 
g. 
Samples to be taken C5, C7, C10 and C13 only. After C13 a sample will be obtained every 6 months (±1 month) for up to 3 years. 
h. 
Only in case of full infusion on Day 1 
i. 
Only in case of split dose between Day 1 and Day 2 

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Table 9 
Visit Assessment Schedule for MRD – Dose Escalation and Expansion GEN3009 Monotherapy 
 
Cycles 1, 2, 3, 5, 7, and 10 
Cycle 13 and onward 
Day or Time post 
dose (window) 
Day 1 (+2 days) 
Day 1 (+2 days) 
Whole blood MRDa 
X 
A whole blood sample will 
be obtained every 6 months (±1 month) for up to 3 years 
Bone marrow aspirate 
MRD 
• For CLL, SLL and B-cell NHL subjects with bone marrow involvement at baseline: If a subject is in CR by imaging, a portion of the aspirate collected 
to confirm CR will be used to assess MRD.  
• For B-cell NHL subjects with no bone marrow involvement at baseline, no bone marrow examination for MRD is required.  
• If a subject is MRD-positive in the bone marrow but maintains CR, an additional bone marrow aspirate will be collected after 3 months, if clinically 
feasible. 
a. 
Upon reaching CR on PET-CT scan, an additional blood sample will be collected if not within 2 weeks of another collection to evaluate MRD. 

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Table 10 Visit Assessment Schedule for Screening and Cycle 1 Expansion GEN3009 + GEN3013 (including Safety Run-in) 
Treatment Cycle: 
28-day cycle 
Section 
Screening 
Cycle 1 
Day 
≤ 21 days 
prior to 
C1D1 
1da 
2d 
4d 
8da 
9d 
11d 
15da 
16d 
18d 
22da 
23d 
25d 
Visit Window 
 
 
 
±1d 
±1d 
 
±1d 
±1d 
 
 
±1d 
 
 
Informed Consent 
13.2.3 
X (before 
any trial-
specific 
procedures) 
 
Eligibility Criteria 
5.1, 5.2 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
9.1.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Disease Status: Includes 
diagnosis and staging criteria 
9.1.2 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Medical Historyb 
9.1.3 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Prior Anti-neoplastic Therapy 
9.1.5 
X 
 
 
 
 
 
 
 
 
 
 
 
 
DLBCL Molecular Status 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
FDG-PET CT/CT/MRIc 
9.2.2.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Lymphoma with Bone Marrow 
Involvement: Unilateral bone 
marrow biopsy and aspirated 
9.2.2.2 
X 
 
 
 
 
 
 
 
 
 
 
 
 
MRI/CT Scan and Lumbar 
Puncture (brain)i 
9.2.2.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Height 
9.3.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Body Weight 
9.3.1 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Physical Examination 
(including lymph node 
assessment)e 
9.3.1 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
Neurotoxicity Syndrome 
Assessment  
9.3.1.1 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Vital Signs 
9.3.2 
X 
Xf 
Xf 
X 
Xf 
X 
X 
Xf 
X 
 
Xf 
X 
 
ECG (in triplicate) 
9.3.3 
X 
Xg 
Xg 
 
Xg 
 
 
Xg 
 
 
Xg 
 
 
ECOG Performance Status 
9.3.4 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Constitutional Symptoms 
9.3.5 
X 
X 
 
 
X 
 
 
X 
 
 
X 
 
 

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Treatment Cycle: 
28-day cycle 
Section 
Screening 
Cycle 1 
Day 
≤ 21 days 
prior to 
C1D1 
1da 
2d 
4d 
8da 
9d 
11d 
15da 
16d 
18d 
22da 
23d 
25d 
Visit Window 
 
 
 
±1d 
±1d 
 
±1d 
±1d 
 
 
±1d 
 
 
Adverse Eventsh 
10 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medication and 
Procedures 
9.1.4 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Premedication & CRS 
Prophylaxis  
6.2 
 
X 
Xk 
 
X 
 
 
X 
 
 
X 
 
 
GEN3009 Administration 
6.4.2 
 
X 
Xk 
 
X 
 
 
X 
 
 
X 
 
 
GEN3013 Administration  
6.4.2 
 
 
 
 
X 
 
 
X 
 
 
X 
 
 
Hospitalization  
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
LABORATORY ASSESSMENTS 
Hematology: Complete blood 
count and differential counte 
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Quantitative Lymphocyte 
Subsets 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Biochemistry 
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Tumor Lysis Syndrome Panel 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
Coagulation 
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Immunoglobulins (IgA, IgE, 
IgG, IgM) 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Urinalysis 
9.4.1 
X 
X 
 
 
X 
 
 
 
 
 
 
 
 
Serum β2-microglobulin 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy Test (serum) 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy Test (either urine 
or serum) 
9.4.1 
 
X 
 
 
 
 
 
 
 
 
 
 
 
HIV Serologyj 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Hepatitis B and C Serology 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Cytomegalovirus (CMV) 
Serology 
9.4.1 
X 
 
 
 
 
 
 
 
 
 
 
 
 

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a. 
Subjects must remain at the clinic for at least 2 hours for observation following GEN3009 administration. Subjects must be instructed to contact the investigator should signs or 
symptoms of infusion-related reactions and/or CRS (eg, fever, lightheadedness, shortness of breath, etc) occur following discharge from the 2-hour observation period. Observation 
of up to 24 hours postdose during Cycle 1 is permissible at the discretion of the investigator. All subjects must be hospitalized for CRS monitoring for at least 24 hours after the third 
dose (first full dose) of GEN3013 (ie, 48 mg) at C1D22. 
b. 
Any medical condition (ie, signs, symptoms and diagnosis) occurring prior to the first GEN3009 dose should be recorded as medical history.  
c. 
Refer to Section 9.2.2.1 for imaging requirements. Imaging assessments performed as SOC prior to the subject signing of informed consent may be submitted as screening assessment, 
if imaging is performed within 21 days of the first dose of GEN3009, and all other requirements for imaging are met.  
d. 
Lymphoma subjects with bone marrow involvement: fresh bone marrow biopsy and aspirate are required. Prior bone marrow biopsy samples done within 4 weeks before Cycle 1 Day 
1 are acceptable. Fresh bone marrow aspirate is mandatory at screening. 
e. 
Physical examination may be performed within 1 day prior to GEN3009 dosing. Refer to Section 9.4.1 for timing of laboratory assessments. 
f. 
On GEN3009 administration days in Cycle 1, vital signs are to be obtained: 1) Before administration, 2) 15 minutes (± 5 minutes) after administration and 3) every 30 minutes (± 5 
minutes) during the 2-hour postdose observation period.  
g. 
In triplicate, 5 minutes (± 5 minutes) apart, before GEN3009 administration and 1-2 hours (± 15 minutes) after administration.  
h. 
All AEs must be reported from the first GEN3009 dose until 30 days after the last dose (refer to Table 6 for details on the safety follow-up visit). Medical conditions that occur after 
the ICF is signed and prior to first GEN3009 dose should only be reported as AEs if they were assessed by the investigator to be caused by a protocol-mandated procedure (ie, tumor 
biopsy and/or CT scan), including washout or discontinuation of prior medications. 
i. 
MRI/CT scan of the brain is mandatory during screening within 21 days of C1D1. Lumbar puncture is required only if clinically indicated and required within 21 days of C1D1. 
j. 
HIV testing is required at screening only if required per local health authorities or institutional standards 
k. 
At dose levels >=
 mg, the first dose of GEN3009 can be split into 2 consecutive days (ie, 
 mg at C1D1 and remaining amount at C1D2) after approval of the sponsor’s medical 
monitor.    
 
  
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Table 11 Visit Assessment Schedule from Cycle 2 and Beyond – Expansion GEN3009 + GEN3013 (including Safety Run-in) 
Treatment Cycle  
28-day cycle  
Section 
Cycle 2-3 
Cycle 
4 -12 
Cycle 13 
and 
Beyond 
Unscheduled 
Treatment 
Discontinuation 
Visita 
Safety 
Follow-
up Visita 
Survival 
Follow-
up Visitb 
Day 
 
1d 
4d 
8d 
11d 
15d 
22d 
1d 
1d 
-- 
As soon as 
possible after 
withdrawn from 
treatment 
60 days 
after last 
dose 
Every 12 
weeks 
after last 
dose 
Visit Window 
 
±2d 
 
±2d 
 
±2d 
±2d 
±2d 
+7d 
 
+7d 
+14d 
±14d 
Body Weight 
9.3.1 
X 
 
X 
 
X 
X 
X 
X 
X 
X 
 
 
Physical 
Examination 
(including lymph 
node assessment)c 
9.3.1 
X 
 
 
 
 
 
X 
X 
X 
X 
 
 
Neurotoxicity 
Syndrome 
Assessment 
9.3.1.1 
X 
 
X 
 
X 
X 
X 
X 
X 
X 
 
 
Vital Signs  
9.3.2 
Xd 
 
Xd 
 
Xd 
Xd 
Xd 
X 
X 
X 
 
 
ECG (in triplicate) 
9.3.3 
Xe 
 
Xe 
 
Xe 
Xe 
Xe 
 
Xe 
X 
 
 
ECOG 
Performance 
Status  
9.3.4 
X 
 
 
 
 
 
X 
X 
X 
X 
 
 
Constitutional 
Symptoms  
9.3.5 
X 
 
 
 
 
 
X 
X 
X 
X 
 
 
Adverse Eventsf 
10 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Concomitant 
Medication and 
Procedures  
9.1.4 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Premedication & 
CRS Prophylaxis 
6.2 
X 
 
X 
 
X 
X 
X 
X 
 
 
 
 
GEN3009 
Administration  
6.4.2 
X 
 
X 
 
X 
X 
X 
 
 
 
 
 
GEN3013 
Administration  
6.4.2 
X 
 
X 
 
X 
X 
X 
Xg 
 
 
 
 
New Anti-cancer 
Treatment  
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Survival Status 
9.3.6 
 
 
 
 
 
 
 
 
 
 
X 
X 
EFFICACY ASSESSMENTS 

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Treatment Cycle  
28-day cycle  
Section 
Cycle 2-3 
Cycle 
4 -12 
Cycle 13 
and 
Beyond 
Unscheduled 
Treatment 
Discontinuation 
Visita 
Safety 
Follow-
up Visita 
Survival 
Follow-
up Visitb 
Day 
 
1d 
4d 
8d 
11d 
15d 
22d 
1d 
1d 
-- 
As soon as 
possible after 
withdrawn from 
treatment 
60 days 
after last 
dose 
Every 12 
weeks 
after last 
dose 
Visit Window 
 
±2d 
 
±2d 
 
±2d 
±2d 
±2d 
+7d 
 
+7d 
+14d 
±14d 
FDG-
PET/CT/MRI 
9.2.2.1 
Xh 
 
 
Lymphoma with 
Bone Marrow 
Involvement: 
Unilateral bone 
marrow biopsy 
and aspirate 
9.2.2.2 
X 
(at time of CR and clinically indicated) 
 
 
LABORATORY ASSESSMENTS 
Hematology: 
Complete blood 
count with 
differentialc  
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
biochemistry  
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Coagulation 
9.4.1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Immunoglobulins 
(IgA, IgE, IgG, 
IgM)  
9.4.1 
X 
 
 
 
 
 
X 
X 
 
X 
 
 
Urinalysis  
9.4.1 
X 
 
 
 
 
 
X 
X 
X 
X 
 
 
Pregnancy Test 
(either urine or 
serum)  
9.4.1 
X 
 
 
 
 
 
X 
X 
X 
X 
X 
 
Hepatitis B and C 
Serology 
9.4.1 
 
 
 
 
 
 
 
 
 
Xi 
 
 
a. 
Subjects discontinuing from treatment for any reason will have a safety follow-up visit 60 days after the last dose of GEN3009 and/or GEN3013. If the subject initiates new anti-
lymphoma therapy within 60 days of the last dose of GEN3009 and/or GEN3013, the safety follow-up visit should be performed prior to starting new anti-cancer therapy. 
b. 
Subjects will enter the survival follow-up after completion of the safety follow-up or if new anti-cancer treatment has been started. Survival follow-up contact may be performed as a 
telephone call, email, or on-site visit. 
c. 
Physical examination may be performed within 1 day prior to GEN3009 dosing. Refer to Section 9.4.1 for timing of laboratory assessments. 
d. 
On dosing days, vital signs are performed predose and postdose, and more frequently at the discretion of the investigator. If the subject has stable vital signs and no other issues, the 
subject may be discharged from the clinic after all assessments are completed as required by protocol. Subjects must be instructed to contact the investigator should signs or symptoms 
of infusion-related reactions and/or CRS (eg, fever, lightheadedness, shortness of breath, etc.) occur following discharge from the clinic. 

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e. 
In triplicate, 5 minutes apart (± 5 minutes), before GEN3009 administration and 1-2 hours (± 15 minutes) after administration. During Cycle 4 and for all subsequent cycles, ECGs are 
required at predose only. During an unscheduled visit, ECG is performed only if clinically indicated.  
f. 
All AEs must be reported from the first GEN3009 dose until 60 days after the last dose. If the subject initiates new anti-lymphoma therapy within 60 days of the last dose of GEN3009 
and/or GEN3013, the safety follow-up visit should be performed prior to starting new anti-cancer therapy. 
g. 
After completion of Cycle 12, subjects who are in SD or better will have the option to continue receiving GEN3013 every 4 weeks until any discontinuation criteria is met. 
h. 
Refer to Section 9.2.2.1 for imaging requirements.  
i. 
Only for subjects with positive serology. 
j. 
Even cycles only. 

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Table 12 Visit Assessment Schedule for PK and ADA – Expansion GEN3009 + GEN3013 (including Safety Run-in)  
Treatment Cycle: 
28-day cycle  
Section 
Cycle 1  
Day 
1d 
2d 
4d 
8d 
9d 
15d 
16d 
18d 
22d 
23d 
Visit Window 
 
 
 
 
 
 
 
 
 
 
Predose (-30 min) 
9.5, 9.6 
ADA: 09 
and 013 / 
PK: 09 only 
PK: 09 onlyc 
 
PK: 09 and 
13 
 
PK: 09 and 
13 
 
 
PK: 09 and 13 
 
Start of GEN3013 Injection +1 
hour (+15 min) 
 
 
 
 
 
PK: 13 only 
 
 
PK: 13 only 
 
End of GEN3009 infusiona (+5 
min)  
PK: 09 only PK: 09 onlyc 
 
PK: 09 only 
 
PK: 09 and 
13 
 
 
PK: 09 and 13 
 
End of GEN3009 infusion +2 
hours (+1 hour) 
PK: 09 onlyb PK: 09 onlyc 
 
 
 
 
 
 
 
 
End of GEN3009 Infusion +24 
hours (±2 hours) 
 
PK: 09 onlyb 
 
 
 
 
PK: 13 only 
 
 
PK: 13 only 
End of GEN3009 Infusion +72 
hours (±24 hours)d 
 
 
PK: 09 
only 
 
 
 
 
PK: 13 only 
 
 
 
Treatment Cycle: 
28-day cycle  
Section 
Cycle 2 
Day 
1d 
2d 
4d 
8d 
9d 
15d 
16d 
22d 
23d 
Visit Window 
  
  
  
  
  
  
  
  
  
Predose (-30 min) 
9.5, 9.6 
ADA/PK: 09 and 13 
  
  
PK: 09 
and 13 
  
PK: 09 and 
13 
  
PK: 09 
and 13 
  
Start of GEN3013 injection +1 hour (+15 min) 
PK: 13 only 
  
  
  
  
  
  
  
  
End of GEN3009 infusion +5 mina (+5 min) 
PK: 09 and 13 
  
  
  
  
  
  
  
  
End of GEN3009 infusion +2 hours (+1 hour) 
PK: 09 only 
  
  
  
  
  
  
  
  
End of GEN3009 Infusion +24 hours (±6 hours) 
  
PK: 09 
and 13 
  
  
  
  
  
  
  
End of GEN3009 Infusion +72 hours (±24 hours) 
  
  
PK: 09 
and 13 
  
  
  
  
  
  
 
Treatment Cycle: 
28-day cycle  
Section 
Cycle 3 
Cycle 4-
12 
Cycle 13 
and 
Beyond 
Unscheduled 
Treatment 
Discontinuation 
Visit 

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Day 
1d 
8d 
15d 
22d 
1d 
1d 
  
  
Visit Window 
  
+2d 
+2d 
+2d 
±4d 
+7d 
  
  
Predose (-30 min) 
9.5, 9.6 
ADA/PK: 
09 and 13 
PK: 09 
and 13 
PK: 09 
and 13 
PK: 09 
and 13 
ADAe/PK: 
09 and 13 
ADAe 
  
  
Start of GEN3013 injection +1 hour (+15 min) 
  
  
  
  
  
 
  
  
End of GEN3009 Infusion +5 mina (+5 min) 
PK: 09 
only 
  
  
  
 
 
  
  
Unscheduled Visit 
  
  
  
  
  
 
PK: 09 and 13 
PK: 09 and 13 
Note: Sample collection timing may be modified during the trial based on emerging data. 
09=GEN3009; 13=GEN3013. 
a. 
After flush. 
b. 
Only in case of full infusion on Day 1. 
c. 
Only in case of split dose between Day 1 and Day 2. 
d. 
In case of split dose between Day 1 and Day 2, the Day 4 sample will be 48 hours after the complete infusion. 
e. 
Even cycles only. 

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Table 13 
Visit Assessment Schedule for Biomarkers – Expansion GEN3009 + GEN3013 (including Safety Run-in)  
Treatment Cycle: 
28-day cycle  
Section 
 
 
Cycles 1 and 2 
Day 
Screenin
g 
1d 
2d 
2d+2h 
4d 
8d 
15d 
16d 
22d 
22d+6h 
23d 
Visit Window 
 
 
 
 
 
+2d 
+2d 
 
+2d 
+8h 
 
Tumor Biopsy 
9.7/ 
9.8.2 
Xa 
Xb,f 
 
 
 
 
 
 
 
 
 
Cytokines 
9.8.3.2 
 
Xc 
 
 
 
Xc,d 
Xd,h 
 
Xc,d 
Xd 
Xd 
Complement 
9.8.3.3 
 
Xc 
Xd,i 
Xd,j 
 
 
Xc, d 
Xd 
 
 
 
Immunophenotypi
ng 
9.8.3.1 
 
Xc 
Xd,i 
 
Xd,j 
Xc,d 
Xc 
 
Xc,d 
  
Xd 
PBMC 
9.8.3.1 
 
Xc 
 
 
 
Xc,d 
Xc,d 
 
Xc 
 
 
Saliva DNA 
9.8.3.4 
X 
 
 
 
 
 
 
 
 
 
 
ctDNA/MRD 
Plasma 
9.8.3.4/ 
9.2.2.3 
 
Xc 
 
 
 
 
 
 
 
 
 
 
Treatment Cycle 
Section  
Cycle 3 
Cycles 4-12 
Unscheduled 
Treatment 
DiscontinuationVisit 
Day 
1d 
15d 
1d 
  
  
Visit Window 
+2d 
±4d 
  
  
Tumor Biopsy  
9.7 
/9.8.2 
Xb 
Cytokine 
9.8.3.2 
Xc 
X 
Complement 
9.8.3.3 
 
 
Xc,e  
X 
X 
Immunophenotyping 
9.8.3.1 
Xc 
Xc 
Xc,e  
X 
PBMC 
9.8.3.1 
 
 
Xc,e 
X 
X 
Saliva DNA 
9.8.3.4 
 
 
 
 
 

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ctDNA/MRD 
Plasma 
9.8.3.4/ 
9.2.2.3 
Xc 
 
Xc,g 
X 
 
a. Fresh lymph node biopsy (to be taken from patients with easily accessible lesions) or an archival lymph node biopsy (formalin-fixed paraffin-embedded, which is taken after most 
recent therapy prior to enrollment and taken within 6 months of Cycle 1 Day 1) is mandatory for lymphoma.  
b. Unless otherwise agreed with sponsor’s medical monitor or delegate, a fresh core biopsy is to be taken from patients with easily accessible lesions in Cycle 2 and at the End of 
Treatment visit. 
c. If the visit occurs on an infusion day, the sample must be taken before IMP treatment(s) (-30 minutes).  
d. Cycle 1 only. 
e. Samples in even cycles only, starting Cycle 4. 
f. Cycle 2 only. 
g. Samples to be taken C5, C7, C10 and C13 only. After C13 a sample will be obtained every 6 months (±1 month) for up to 3 years. 
h. Sample to be taken during Safety Run-in only. 
i. Only in case of full infusion of GEN3009 on Day 1 
j. Only in case of GEN3009 split dose between Day 1 and Day 2  
 
Table 14 Visit Assessment Schedule for MRD – Expansion GEN3009 + GEN3013  
Cycle 
Cycles 1, 2, 3, 5, 7, and 10 
Cycle 13 and onward 
Day or Time post dose 
(window) 
Day 1 (+2 days) 
Day 1 (+2 days) 
Whole blood MRDa  
X 
A whole blood sample will 
be obtained every 6 months (±1 month) for up to 3 years 
Bone marrow aspirate MRD 
• 
For B-cell NHL subjects with bone marrow involvement at baseline: If a subject is in CR by FDG-PET, a portion of the aspirate collected to 
confirm CR will be used to assess MRD.  
• 
For B-cell NHL subjects with no bone marrow involvement at baseline, no bone marrow examination for MRD is required.  
• 
If a subject is MRD-positive in the bone marrow but maintains CR, an additional bone marrow aspirate will be collected after 3 months, if 
clinically feasible. 
a. 
Upon reaching CR on PET-CT scan, an additional blood sample will be collected if not within 2 weeks of another collection to evaluate MRD. 
 

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Table 15 GEN3013 Repriming Cycle – Expansion GEN3009 + GEN3013 (including Safety Run-in) 
 
Day 1  
Day 8 
Day 15 
Day 22 
Body Weight 
X 
 
X 
 
Complete physical examination 
X 
 
 
 
Lymph node examination 
X 
 
 
 
Neurological Evaluation (ICANS)b 
X 
X 
X 
X 
Vital signsc 
X 
X 
X 
X 
12-Lead ECG (triplicate) 
X 
 
 
 
ECOG Performance Status 
X 
 
 
 
Constitutional Symptoms (ie, B Symptoms) 
X 
 
X 
 
Adverse Events  
X 
X 
X 
X 
Previous and concomitant medications 
X 
X 
X 
X 
Concomitant procedures 
X 
X 
X 
X 
STUDY TREATMENT ADMINISTRATION 
Hospitalizationd 
 
 
X 
 
Premedicationse  
X 
X 
X 
X 
CRS prophylaxisf 
X 
X 
X 
X 
GEN3013 administration 
X 
X 
X 
X 
LOCAL LABORATORY ASSESSMENTS  
Hematology 
X 
 
X 
 
Biochemistry 
X 
 
X 
 
Coagulation 
X 
 
X 
 
Immunoglobulins (IgA, IgE, IgG, gM) 
X 
 
 
 
Urinalysis 
X 
 
 
 
Pregnancy Test (urine or serum)g 
X 
 
 
 
TLS Monitoring 
X 
CENTRAL LABORATORY ASSESSMENTS 
Immunophenotyping (by flow cytometry) 
Xh 
Xh 
Xh 
X 
Pharmacokinetics (GEN3009 and GEN3013) 
Xh 
Xh,i 
Xh,i 
Xh,i 
Anti-drug antibodies 
Xh 
 
 
 
a. 
Once the full repriming cycle is completed, the subject should resume treatment with Day 1 of the next planned cycle (subsequent to the cycle during which the dosing was 
delayed); see Section 7.4.2.2. 
b. 
ICANS evaluation, based on (Lee et al., 2019), must also be performed in the presence of CRS-type symptoms or any neurological signs/symptoms. 
c. 
Vital sign assessment must be conducted before dosing and 1 hr (±30 min) following each dose 

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d. 
Subjects are to be hospitalized for at least 24 hours after the third (full dose) administration of GEN3013 in a repriming cycle. Additional or longer hospitalization should be 
per the investigator’s discretion. 
e. 
Premedication should be administered 30 min to 2 hours before administration of GEN3013. 
f. 
CRS prophylaxis consists of prednisolone 100 mg (or alternative steroid equivalent) daily for Days 1-4, 8-11, 15-18, and 22-25 of a repriming cycle. On GEN3013 dosing 
days, corticosteroid should be given 30 min to 2 hrs prior to GEN3013 injection. See also Section 6.2.2. 
g. 
Results must be available before dosing. 
h. 
Predose only. 
i. 
PK sample for GEN3009 only if dosed weekly. 
 
 

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2 
INTRODUCTION 
2.1 
Background 
2.1.1 
Overview of Disease 
Non-Hodgkin lymphomas (NHLs) comprise a heterogeneous group of lymphoid malignancies that 
originate from B-cell lymphocytes, T-cell lymphocytes, and natural killer (NK) cells. In the US, 
an estimated 74,200 new cases of NHL will be diagnosed in 2019 with 19,970 deaths expected 
(SEER, 2019). Approximately 85-90% of NHLs are derived from B cells (B-cell NHL). According 
to the World Health Organization 2016 classification of lymphoid neoplasm (Swerdlow et al., 
2016), B-cell NHL subtypes including diffuse large B cell lymphoma (DLBCL), high-grade B-cell 
lymphoma (HGBCL), mantle cell lymphoma (MCL), primary mediastinal large B-cell lymphoma 
(PMBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), chronic lymphocytic 
leukemia/small lymphocytic lymphoma (CLL/SLL), etc, are categorized as mature B-cell 
neoplasms.  
2.1.1.1 
Therapy for DLBCL 
DLBCL is the most common aggressive lymphoma representing 30-35% of all NHL cases 
(Ghielmini et al., 2013). Although the majority of DLBCL patients can be cured with 
combinational immuno-chemotherapy (ie, rituximab plus doxorubicin-based combination 
chemotherapy, R-CHOP), approximately one-third of patients will develop relapsed or refractory 
(R/R) disease. It is known DLBCL patients with high-risk features (eg, double-hit lymphoma, 
transformed lymphomas, or early relapse) will become refractory to standard therapies and will 
have limited alternatives for cure. 
For patients with R/R DLBCL, approximately 60% remain sensitive to conventional second-line 
immunochemotherapy; and these patients can undergo subsequent high-dose chemotherapy 
(HDT) followed by autologous hematopoietic stem cell transplantation (HSCT) and achieve long-
term survival (Gisselbrecht et al., 2010; Sehn et al., 2012). On the contrary, R/R DLBCL patients 
who do not respond to second-line immunochemotherapy only have a life expectancy of 3 to 4 
months (Elstrom et al., 2010; Friedberg, 2011). Due to advanced age and/or comorbidities only 
half of R/R DLBCL patients are eligible for HDT-HSCT. For transplant-eligible candidates who 
have failed second-line therapy or whose disease has relapsed post-transplantation, the prognosis 
is dismal. Recently, CD19-directed chimeric antigen receptor (CAR) T cell therapies (ie, 
KYMRIAH®, YESCARTA®) have revolutionized the treatment of refractory B-cell lymphoid 
malignancies and demonstrated durable remissions in R/R large B-cell lymphomas including 
DLBCL, HGBCL, and PMBCL (Locke et al., 2019; Schuster et al., 2019). However, potentially 
life-threatening toxicities including cytokine release syndrome (CRS) and neurotoxicity, extended 
production time precluding patients with rapidly progressing disease, and high-treatment expense 
have limited the access. Taken together, most patients with R/R DLBCL cannot expect to be cured 
with secondary therapies and a new investigational therapy with manageable toxicities is needed. 
2.1.1.2 
Therapy for FL 
FL is the most common subtype of indolent NHL and accounts for 22-25% of all new diagnoses. 
Although indolent in nature and often responding to the initial treatment, FL of advanced stage is 

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incurable with frequent relapses. In advanced, symptomatic FL, first-line treatment is anti-CD20 
monoclonal antibodies (ie, rituximab or obinutuzumab) in combination with multi-agent 
chemotherapy. HSCT is typically reserved for patients with relapsed disease (Cheson et al., 2014; 
NCCN, 2019). Although the current treatments are initially effective in inducing responses in most 
patients, they are not curative and show decreasing efficacy with increasing lines of therapy. 
In relapsed FL, treatment in patients with late relapse (>2 years; 80%) is reinduction by salvage 
treatment with rituximab-containing chemotherapy followed by rituximab maintenance therapy 
for 2 years. Irrespective of first-line treatment choice, early relapse occurs in 20% within 
24 months and is a robust predictor of poorer overall survival (OS), with only 34-50% of patients 
being alive at 5 years. Second-line treatments include lenalidomide with rituximab (Andorsky et 
al., 2016; Leonard et al., 2019), polatuzumab vedotin with rituximab (Morschhauser et al., 2019), 
idelalisib for double-refractory cases (Gopal et al., 2014a; Gopal et al., 2017), and allogeneic 
HSCT in selected fit patients. Finally, bispecific antibodies targeting CD3 and CD20 may 
represent an attractive treatment as preliminary data have shown high response rates in R/R FL 
with acceptable toxicity profiles (Dickinson et al., 2019; Topp et al., 2019). In summary, early 
relapsed FL represents a particular unmet medical need; treatment options are limited for patients 
who have failed several lines of therapy. 
2.1.1.3 
Therapy for CLL 
CLL is the most common leukemia in adults in Western countries, accounting for approximately 
25% to 30% of all leukemias in the US with estimated 20,720 new cases and 3,930 deaths (Siegel 
et al., 2019). Worldwide, there are approximately 105,000 cases per year, of which 35,000 are 
deaths (Global Burden of Disease Cancer et al., 2018). 
Most patients with newly diagnosed CLL present with asymptomatic disease and can be monitored 
without therapy until disease progression. For symptomatic or high-risk disease, standard of care 
includes cytotoxic chemotherapy (fludarabine, cyclophosphamide, bendamustine, and 
chlorambucil) in combination with anti-CD20 monoclonal antibodies (ie, rituximab or 
obinutuzumab) (Hallek et al., 2010); (Goede et al., 2014). Although bendamustine plus rituximab 
(BR) had shorter median progression-free survival (PFS) as compared to fludarabine, 
cyclophosphamide, plus rituximab (FCR) (Eichhorst et al., 2016), BR regimen can be an 
alternative first-line treatment for physically fit older patients (>65 years) due to decreased 
toxicity. Recently, kinase inhibitors ibrutinib and idelalisib have gained considerable momentum 
as first-line treatment for high-risk CLL with TP53 aberrations (O'Brien et al., 2016; Sharman et 
al., 2014). Ibrutinib demonstrated improved objective response rate (ORR) (86% vs 35%), 2-year 
PFS (89% vs. 34%) and 2-year OS (98% vs. 85%) as compared to chlorambucil (Burger et al., 
2015). Subsequently, 2 large Phase 3 studies comparing ibrutinib alone or with rituximab to BR 
(older patients ≥65 years) or FCR (younger patients <65 years) in the front-line setting were 
conducted. Although both studies showed the ibrutinib rituximab combination was superior to BR 
and FCR with longer PFS, a notable lack in the ability of ibrutinib to induce complete response 
(CR) and minimal residual disease (MRD)-negative remissions were observed: 30% CR, with 
MRD-negative in 59% on FCR and 8% on BR; whereas ibrutinib-containing regimens on these 
trials, the CR rates were <20% with <10% of patients achieved MRD negativity in the peripheral 
blood (Woyach et al., 2018). Most recently, in an international Phase 3 CLL14 study, the 
combination of venetoclax and obinutuzumab was compared to chlorambucil and obinutuzumab 
in patients with untreated CLL with medical comorbidities; a superior 2-year PFS rate of 88% over 
64% was observed (Fischer et al., 2019). 

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In R/R CLL, a Phase 3 study comparing the combination of venetoclax and rituximab to BR has 
shown very encouraging activity: 2-year PFS 85% vs. 36% with BR. This PFS improvement was 
observed across all high-risk groups including patients with del(17p) karyotype. There was also 
an impressive ORR of 92% with 84% achieving MRD-negative status in the peripheral blood 
(Seymour et al., 2018). Preliminary data from a Phase 1 study showed the doublet of venetoclax 
and obinutuzumab appeared to be highly effective in R/R CLL irrespective of cytogenetic risk 
factors with an overall best response rate of 95% (CR/CRi, 37%) (Flinn et al., 2019). Overall, in 
CLL, a new agent that can potentially induce deeper remission with higher percentage of MRD 
negativity is warranted for further investigations.  
2.1.2 
Introduction to Investigational Medicinal Products 
2.1.2.1 
GEN3009 
GEN3009 (DuoHexaBody®-CD37) is a bispecific antibody with a hexamerization-enhancing 
mutation that targets 2 different epitopes of the CD37 antigen (biparatopic binding). GEN3009 
was designed to induce highly potent cytotoxicity towards B cells in a variety of B-cell 
malignancies 
through 
enhanced 
complement-dependent 
cytotoxicity 
(CDC) 
and 
by 
FcγR-mediated effector functions including antibody-dependent cell-mediated cytotoxicity 
(ADCC) and antibody-dependent cell-mediated phagocytosis (ADCP). 
The bispecific antibody is generated by controlled Fab arm exchange (DuoBody® technology (de 
Jong et al., 2016; Labrijn et al., 2014) of 2 humanized CD37-specific immunoglobulin G (IgG) 
molecules that were originally obtained by immunization of rabbits with human and cynomolgus 
monkey CD37. Introduction of an E430G mutation results in enhanced Fc-Fc–mediated antibody 
hexamerization on the cell surface (HexaBody® technology) upon CD37 binding, while retaining 
monomeric properties in solution (de Jong et al., 2016). Moreover, GEN3009 has CMC properties 
comparable to regular human IgG1 and the HexaBody mutation was shown to have no meaningful 
impact on nonclinical pharmacokinetic (PK) behavior in absence of target.  
Please refer to the GEN3009 Investigator’s Brochure (IB) for more detailed information.  
2.1.2.2 
GEN3013 
GEN3013 is a bispecific antibody recognizing the T-cell antigen CD3 and the B-cell antigen 
CD20. GEN3013 triggers potent T-cell-mediated killing of CD20-expressing cells. 
The mechanism of action (MoA) of GEN3013 is engagement of T-cells as effector cells to induce 
killing of CD20-expressing B-cells and tumor cells. This is a different MoA compared to that of 
chemotherapy or conventional CD20-targeting monoclonal antibodies that can induce cytotoxicity 
through Fc-mediated effector functions such as ADCC, ADCP and CDC and in some cases 
programmed cell death.  
GEN3013 is generated using Genmab’s DuoBody technology (Labrijn et al., 2013; Labrijn et al., 
2014). DuoBody molecules are bispecific antibodies with a regular IgG1 structure and biochemical 
characteristics typical of human IgG1. Accordingly, DuoBody molecules show normal binding to 
the neonatal Fc receptor (FcRn), resulting in the relatively long plasma half-life that is typical for 
IgG1 molecules. The Fc domain of GEN3013 has been modified to silence Fc-mediated effector 
functions, ensuring that GEN3013 does not activate T cells through Fcγ-mediated CD3 
crosslinking. FcRn binding was preserved.  

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Please refer to the epcoritamab (GEN3013) IB for more detailed information.  
2.1.3 
Summary of Nonclinical Studies 
GEN3009 showed dose-dependent binding to both malignant B cells and normal B cells from 
healthy donors with minimal binding to other leukocyte populations. 
GEN3009 induced potent CDC of malignant B cells in primary samples obtained from patients 
with DLBCL, FL, and CLL, including patients who had been previously treated with anti-CD20 
monoclonal antibodies. GEN3009 CDC activity was superior to that of rituximab, ofatumumab 
and obinituzumab. The nonclinical anti-tumor activity of GEN3009 was confirmed in vivo in 
multiple mouse xenograft lymphoma models. 
GEN3009 combined with GEN3013 showed increased cytotoxicity in DLBCL derived cell lines 
in the presence of T cells and normal human serum (
). GEN3009 did not affect 
GEN3013-mediated T-cell activation.  
Nonclinical safety assessment of GEN3009 included in vitro studies using human cells and tissues 
(cytokine release assay, tissue cross-reactivity, hemolytic potential and plasma compatibility 
assays), which identified no significant safety concerns.  
A Good Laboratory Practice (GLP) toxicity study was conducted in cynomolgus monkeys, with 
5 weekly intravenous (IV) doses of 3, 10, or 30 mg/kg. Pharmacology was observed at all doses 
including complement activation/consumption and decreases in CD20+ total B-cells. Adverse 
observations at ≥10 mg/kg included petechial bleeding after the third dose, and microscopic 
adrenal findings of cortical hemorrhage, vacuolation and/or degeneration and medullary 
congestion, which were reversible during a 4-week postdose recovery period. At 30 mg/kg, severe 
but transient decreases in systolic, diastolic, and mean arterial blood pressure were observed after 
the fourth dose. Consequently, the highest non-severely toxic dose (HNSTD) following 5 weekly 
IV administrations was 10 mg/kg.  
An integrated evaluation of the data from nonclinical pharmacology, PK, and toxicology studies 
led to the first-in-human (FIH) starting dose of  mg (refer to Section 4.3).  
Refer to the IB for more detailed information on GEN3009 nonclinical studies. 
2.1.4 
Summary of Clinical Trials 
2.1.4.1 
Clinical Trials for GEN3009 
This is the first time GEN3009 is being tested in humans; no prior clinical experience of GEN3009 
is available. In this FIH trial of GEN3009 in R/R B-cell NHL, as of the data cut: 11 Jun 11 2021, 
there were 18 subjects evaluated for dose-limiting toxicities for GEN3009 at doses ranging from 
 mg to 
 mg:  mg (N=1), 
 mg (N=1), 
 mg (N=1), 
 mg (N=4), 
 mg (N=4), 
 mg 
(N=4), and 
 mg (N=3). No dose-limiting toxicity (DLT) was observed. Based on the 
preliminary safety, PK, biomarker, and efficacy data accumulated, the dose escalation committee 
(DEC) and safety committee (SC) approved to add additional dose levels (ie, 
 mg and 
 
mg) to further assess the safety, tolerability, PK, and biomar of GEN3009 in R/R B-cell NHL.  
Among the 18 subjects treated with GEN3009, the most common treatment-emergent adverse 
events (TEAEs) in ≥ 20% of subjects treated across all dose levels include infusion-related 
reactions (IRRs) (61.1%); heamatlogical adverse events such as neutropenia (94.4%), leukopenia 
CCI
CCI
CCI
CCI
CCI
CCI
CCI
CCI
CCI
CCI

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(50.0%), lymphopenia (38.9%), thrombocytopenia (38.9%), and anemia (27.8%); and fatigue and 
fatigue (22.2%) and headache (22.2%). IRR is an adverse event of special interest (AESI) for 
GEN3009 and mostly occurred during the first infusion and was of Grade 1 or 2 in severity. IRRs 
are manageable with interruption of the infusion, treatment, and lowering the infusion rate upon 
resuming the infusion. Neutropenia events were observed in majority of subjects post-GEN3009 
infusions; neutrophil counts typically recovered by the next dose of GEN3009 without any clinical 
consequences.  
Preliminary anti-tumor activity has been observed in R/R B-cell NHL subjects with GEN3009 
monotherapy including 1 CR in DLBCL at 
 mg; 1 CR in SLL, 1 CR in MZL, and 1 PR in FL 
at 
 mg.  
2.1.4.2 
Clinical Trials for GEN3013 
There are 5 ongoing trials investigating GEN3013 either as monotherapy or in combination with 
standard of care. As of 31-Jan-2021, GEN3013 has been tested in a total of 178 subjects with 
various subtypes of B-cell NHL. In the FIH Phase 1/2 trial (GCT3013-01; NCT03625037), among 
the 68 subjects with R/R B-cell NHL, no DLT was reported at doses up to 60 mg; the maximum 
tolerated dose (MTD) was not reached; and the recommended Phase 2 dose (RP2D) was declared 
to be a full dose of 48 mg. Major safety findings from the Dose Escalation and Expansion parts 
are summarized as below: 
• All 68 subjects in the GCT3013-01 Dose Escalation part experienced at least 1 TEAE; 80.9% 
of subjects had at least one Grade 3 or higher TEAE. The 4 most common TEAEs were pyrexia 
(69.1%), CRS (58.8%), injection site reaction (47.1%), and fatigue (44.1%). AESIs occurred 
in approximately two-thirds of subjects; of these, 40 subjects (58.8%) experienced CRS, 4 
subjects (5.9%) experienced neurological symptoms, and 1 subject (1.5%) experienced clinical 
tumor lysis syndrome (TLS). 
There were 13 subjects with TEAEs leading to death (11 subjects with malignant neoplasm 
progression, 1 with euthanasia [also in the context of progressive disease], and 1 with 
COVID-19 pneumonia). Serious adverse events (SAEs) were reported for 67.6% of subjects. 
The most common SAE considered related to trial drug was pyrexia, which was reported as a 
symptom of CRS. TEAEs leading to permanent treatment discontinuation were reported in 
13.2% of subjects. 
• A total of 76 subjects (89.4%) in the GCT3013-01 Dose Expansion part experienced at least 
1 TEAE; 40.0% of subjects had at least one Grade 3 or higher TEAE. The most common 
TEAEs were CRS, fatigue, and pyrexia. There were 7 subjects with TEAEs leading to death 
(disease progression [1], general physical health deterioration [1], COVID-19 [2], 
hepatotoxicity [1], malignant neoplasm progression [1], and immune effector cell-associated 
neurotoxicity syndrome [1]). SAEs were reported for 55.3% of subjects. The most common 
SAE considered related to trial drug was CRS. TEAEs leading to permanent treatment 
discontinuation were reported in 5.9% of subjects. AESIs included the following: 40 subjects 
experienced CRS, 3 subjects experienced ICANS, and 1 subject experienced clinical TLS. 
GEN3013 administration induced rapid and sustained depletion of circulating B cells (in the subset 
of subjects with detectable B cells, which are absent in most patients due to prior anti-CD20 
therapy) and increases in peripheral T cells and circulating IFNγ.  
No significant anti-drug antibody (ADA, titers >1) against GEN3013 has been observed. 
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Preliminary anti-tumor activity has been observed in R/R B-cell NHL subjects treated with 
GEN3013 monotherapy. In the GCT3013-01 Dose Escalation part, the ORR was 44.1% for all 
dose levels (DLs) combined and 66.7% for the RP2D level (48 mg). GEN3013 is currently being 
evaluated in multiple expansion cohorts in GCT3013-01 as well as in 4 other global studies. 
2.2 
Rationale 
Over the last 2 decades, the clinical course of B-cell NHL has been changed dramatically by anti-
CD20 antibody (eg, rituximab, ofatumumab, obinutuzumab)-containing immunochemotherapies 
with substantially improved outcome. However, for most R/R lymphomas and CLL, there is still 
no treatment that can lead to cure. This unmet medical need warrants developing new efficacious 
therapies for patients with advanced B-cell NHL whose disease no longer responds to standard 
therapies. Identification of a target other than CD20 such as CD37 may represent an attractive 
alternative strategy. Furthermore, a chemo-free regimen by combining an anti-CD37 therapy with 
a T cell- engaging therapy such as a CD3xCD20 bispecific antibody may present an efficacious 
treatment option for patients who have exhausted SOC.  
2.2.1 
GEN3009 Monotherapy 
Nonclinically, CD37-targeting GEN3009 has demonstrated more potent tumor-cell killing than 
clinically validated CD20-targeting antibodies across a variety of B-cell NHL subtypes regardless 
of the relapse status (ie., similar anti-tumor effect observed in ND samples and R/R samples). 
GEN3009 also showed potent CDC activity in a limited set of primary samples from ibrutinib-
treated NHL patients. In addition to these findings, therapeutic activity of GEN3009 was observed 
in tumor cell line-derived xenografts (ie, DLBCL, Burkitt’s lymphoma, and CLL) and 
patient-derived xenografts (ie., DLBCL). 
The aim of this FIH trial is to characterize the safety and tolerability, PK, and pharmacodynamic 
characteristics of GEN3009 in subjects with R/R B-cell NHL (eg, DLBCL, HGBCL, PMBCL, FL, 
MCL, MZL, CLL/SLL). In the Dose Escalation, DLTs will be monitored to determine the MTD 
and/or RP2D for GEN3009. The totality of the data including safety, PK, pharmacodynamics, and 
preliminary efficacy will be evaluated to guide further development for Expansion. In the 
Expansion, clinical activity of GEN3009 at the RP2D in R/R DLBCL, R/R FL, and R/R CLL will 
be assessed together with safety, tolerability, PK, pharmacodynamic, and biomarkers.  
2.2.2 
GEN3009 + GEN3013 Combination 
GEN3013 (DuoBody®-CD3xCD20, epcoritamab) is a fully human IgG1 bispecific antibody that 
induces potent T cell-mediated cytotoxicity of CD20-expressing cells. Clinical data from an 
ongoing Phase 1/2 trial (GCT3013-01; NCT03625037) demonstrated that GEN3013 as a single 
agent induced high ORR with manageable safety profile in heavily pre-treated B-cell NHL 
including DLBCL and FL (ASH 2020). In the Dose Escalation (N=68), GEN3013 was well 
tolerated at doses up to 60 mg. RP2D was declared as 48 mg for further development in the 
Expansion. At 48 mg, the ORR was 70.0% (N=10; 1 FL and 9 DLBCL); among 9 DLBCL 
subjects, the ORR was 77.8% (3 CR, 4 PR).  
Due to the non-overlapping MoAs for GEN3009 and GEN3013, it is hypothesized that the 
combination of GEN3009 with GEN3013 may induce deeper and durable remissions in R/R B-cell 
NHL. Nonclinically, GEN3009 combined with GEN3013 showed increased cytotoxicity in 
DLBCL-derived cell lines in the presence of T-cells and normal human serum. 

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In the Expansion, the safety and preliminary efficacy of the combination regimen of GEN3009 
and GEN3013 in R/R DLBCL will be evaluated. 
2.3 
Benefit-Risk Assessment 
2.3.1 
GEN3009 Monotherapy 
GCT3009-01 is a FIH trial of GEN3009 in R/R B-cell NHL, and the safety profile for GEN3009 
is still being established with limited data collected. However, the benefit-risk profile of GEN3009 
appears to be favorable. The trial population is limited to subjects with R/R B-cell NHL who have 
exhausted standard therapies or are ineligible for standard therapies. The risks to subjects in this 
trial are being minimized by compliance with the eligibility criteria, trial procedures, with close 
monitoring, and proper/prompt management of TEAEs. 
CD37 is exclusively expressed in hematopoietic lineage cells with a high expression in B cells and 
a much lower expression on T cells, monocytes, NK cells, and neutrophils. In recent years, several 
CD37-targeting biologics including otlertuzumab, BI836826, IMGN529, betalutin (177Lu-
conjugated lilotumab), and AGS-67E have been developed and evaluated in Phase 1/2a clinical 
trials in various B-cell NHL (Stathis et al., 2018); (Stilgenbauer et al., 2019); (Witkowska et al., 
2018); (Blakkisrud et al., 2017); (Payandeh et al., 2018; Salles, 2019). Findings from these early 
phase studies indicate manageable safety profiles with majority of adverse reactions being 
hematological (eg, neutropenia, thrombocytopenia, anemia). IRRs and infections were common 
TEAEs. Of note, no CRS was reported. Preliminary data showed single-agent activity: betalutin 
in relapsed indolent B-cell NHL including FL, MCL, and MZL: ORR 69% with 28% being CR 
(Kolstad et al., 2017); IMGN529 in R/R B-cell NHL: ORR 13% with 4 responders in DLBCL 
(Stathis et al., 2018); BI836826 in R/R CLL: ORR 35% all being PR (Stilgenbauer et al., 2019). 
Promising clinical efficacy of otlertuzumab was observed in indolent B-cell NHL when combined 
with BR (Gopal et al., 2014b) and in relapsed CLL when combined with bendamustine (Robak et 
al., 2017). Collectively, these data warrant clinical development of CD37-targeting compounds for 
B-cell NHL. 
The expected MoA for GEN3009 include: 1) enhanced CDC activity through Fc-Fc–mediated 
hexamerization upon binding to CD37 on the target cell surface, and 2) FcγR-mediated effector 
functions including ADCC activity and ADCP activity. 
Toxicology studies in cynomolgus monkeys have shown that GEN3009 was tolerated when 
administered intravenously at doses 0.1, 1, 3, and 10 mg/kg. MTD was deemed as 3 mg/kg in a 
GLP study where monkeys received 5 weekly doses and the HNSTD was considered as 10 mg/kg. 
Major findings from this pivotal GLP repeated-dose toxicity study include: 
• B-cell depletions in peripheral blood and lymph nodes at doses ranging from 3 to 30 mg/kg;  
• Transient and reversible decrease in lymphocyte, T cell, NK cell and platelet counts at 3, 10, 
and 30 mg/kg; 
• Minimal elevations in cytokines (eg, IL-6, IL-10, and/or MCP-1) occurring shortly after dosing 
and returning to baseline within 12 to 24 hours which is not indicative of a CRS; 
• IRRs were observed after GEN3009 administrations; 
• Clinically significant and reversible hypotension observed immediately after infusion at 
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• Adverse microscopic findings in the adrenal gland at 10 or 30 mg/kg; 
• All GEN3009-treated animals tested positive for ADA from Day 15.  
TLS is a known risk in the treatment of hematological malignancies and prophylaxis guidelines 
are provided in Section 6.6.1. Premedication and management for IRRs are provided in Section 
6.2. Scheduled blood collections for immunogenicity are provided in Section 9.6.  
2.3.2 
GEN3009 + GEN3013 Combination 
The expected MoA of GEN3013 is activation of the T cells upon binding to CD3, simultaneously 
with CD20 binding, with release of perforin/granzymes and Fas ligand and lysis of the CD20-
expressing target cell. CD20 is exclusively expressed on B-cells, so eradication of cells other than 
B cells is not expected.  
The main risks identified for GEN3013 are CRS and ICANS. ICANS was not a frequent event 
with GEN3013 (see epcoritamab IB). It was reported that obinutuzumab (anti-CD20 mAb) 
pretreatment was effective in mitigating the risk of CRS of glofitamab (CD3 × CD20 bispecific 
antibody in R/R B-cell NHL (Dickinson  et al., 2019; Hutchings, 2021). The incidence and severity 
of CRS caused by GEN3013 are expected to be decreased or downgraded as a result of 
pretreatment with GEN3009 1 week prior to the combination; 2 additional doses of GEN3009 in 
concomitant with step-up doses of GEN3013 (ie, priming dose, intermediate dose) followed by 
clinical active full doses of GEN3013 will further reduce the risk of CRS. Investigators and site 
staff will be trained for early detection, prophylaxis and management of CRS and ICANS to reduce 
the frequency or severity of these events. Immediate access to tocilizumab is mandated on site.  
Identification of potential risks and the risk mitigation strategies are detailed for epcoritamab (with 
which GEN3009 will be combined) in Table 16. 
Table 16 Potential Risks from Combination Treatment 
Potential Risk 
Risk Mitigation 
IRR (including 
injection site 
reactions) 
• Premedication prior to GEN3009 and/or GEN3013 is mandated in 
all cycles as described in Section 6.2.2.  
• Instructions are provided for appropriate management of IRRs in 
Section 6.3. 
• Subjects will be asked to stay in the clinic for at least 2 hours after 
completion of GEN3009 infusion for monitoring of signs and 
symptoms of IRRs until administration of GEN3009 in combination 
with the second full dose of GEN3013 (ie, C2D1), and instructed to 
contact the investigator should any reactions occur following 
discharge at any cycle.  
CRS symptoms 
(not limited to chills, 
fever, hypotension, 
and hypoxia) 
• The first dose of GEN3013 is a priming dose (ie, a lower dose than 
subsequent doses); the second dose is an intermediate dose (ie, higher 
than the priming dose but lower than the subsequent full-dose levels) 
(Section 6.4.2).  
• Premedication is mandatory prior to the first 4 administrations of 
GEN3013 and optional for later administrations (Section 6.2.2).  

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• Prophylactic corticosteroids are mandatory for 2 days following each 
of the first 4 weekly administrations of GEN3013; for subsequent 
administrations, prophylactic steroids are only necessary if CRS 
≥Grade 2 occurs following the fourth GEN3013 administration 
(Section 6.2.2).  
• Hospitalization for CRS monitoring is mandatory for at least 24 hours 
following the third dose (first full dose) of GEN3013 administration 
only. A lead-in dose of GEN3009 will be given a week before 
GEN3009 + GEN3013 combination to reduce the potential risk of 
CRS with GEN3013. 
See Section 7.5.2 and Appendix 13 for supportive care and management 
of CRS. 
ICANS 
Monitoring of the neurologic and cognitive status (including, but not 
limited to, confusion, expressive aphasia, headache, seizures and altered 
level of consciousness) of subjects to secure timely introduction of 
supportive care (Sections 7.5.3 and 9.3.1.1 and Appendix 14) 
Clinical TLS 
Laboratory monitoring; prophylaxis and management guidelines 
(Appendix 4). 
 
The risks to subjects treated with the GEN3009 and GEN3013 combination will be minimized by 
a preceding safety run-in phase to inform the tolerability of the combination treatment before 
opening the Expansion phase, staggered dosing among subjects within a DL, requirement for 
hospitalization following the third dose (first full dose) of GEN3013 treatment, and established 
guidelines for the recognition and management of CRS and ICANS in addition to the compliance 
with the eligibility criteria, trial procedures, and close monitoring and management of TEAEs.  
Furthermore, aggregate safety data will be reviewed by an independent data monitoring committee 
(DMC) on a regular basis to ensure the benefit to risk ratio remain acceptable for trial subjects.  
In summary, this trial explores GEN3009 as a single agent and in combination with GEN3013 in 
subjects with R/R B-cell NHL who have limited treatment options. Based on nonclinical data and 
preliminary clinical data from GEN3009 and GEN3013 and clinical data from other 
CD37-targeting compounds, GEN3009 monotherapy and in combination with GEN3013 have the 
potential to address the highly unmet medical need in this patient population. With safety 
precautions and close monitoring plan in place, the described risks are outweighed by the potential 
benefit subjects might receive from GEN3009 alone or in combination with GEN3013. 

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3 
OBJECTIVES AND ENDPOINTS 
Objectives and related endpoints are described for the Dose Escalation in Table 17 and for the 
Expansion in Table 18, Table 19, and Table 20. 
Table 17 Objectives and Endpoints for Dose Escalation (GEN3009 for R/R B-cell NHL 
Including CLL/SLL) 
OBJECTIVES 
ENDPOINTS 
Primary 
• Determine the MTD with and/or determine the 
RP2D of GEN3009 
• Rate of DLTs  
• Evaluate safety and tolerability of GEN3009 
• Frequency and severity of adverse events 
(AEs)/AESIs/SAEs 
• Changes in laboratory parameters 
• Changes in vital signs 
• Frequency of dose interruptions, dose delays, and 
dose intensity 
Secondary 
• Establish PK profile of GEN3009 
• PK parameters: clearance, volume of distribution 
and area under the curve (AUC) at different time 
points (AUC7days, AUClast and AUCinf), maximum 
concentration (Cmax), time to Cmax (Tmax), predose 
trough concentrations (Ctrough), and half-life (T1/2) 
• Evaluate immunogenicity of GEN3009 
• Incidence of neutralizing anti-GEN3009 antibodies 
(ie, ADAs) 
• Evaluate preliminary anti-tumor efficacy of 
GEN3009 
• ORR  
• CR rate  
• DoR 
• TTR 
• Evaluate preliminary clinical efficacy of GEN3009 
• PFS 
• OS 
Exploratory 
• Assess potential biomarkers predictive of clinical 
response to GEN3009 and evaluate potential 
surrogacy with PFS and OS 
• CD37 expression  
• Minimal residual disease (MRD) status 
• Assess pharmacodynamic markers related to MoA 
of GEN3009 
• Pharmacodynamic markers in blood samples 
(leukocyte subset frequencies and phenotype, target 
antigen expression, complement regulatory protein 
expression, plasma complement levels and 
activation [CH50], and cytokine levels) 
 

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Table 18 Objectives and Endpoints for Expansion (GEN3009 for R/R, DLBCL, FL, and 
CLL Cohorts) 
OBJECTIVES 
ENDPOINTS 
Primary 
• Evaluate (preliminary) anti-tumor efficacy of 
GEN3009 
• ORR 
Secondary 
• Establish PK profile of GEN3009 
• PK parameters: CL, AUC7days, AUClast, Cmax, Tmax, 
Ctrough and T1/2 
• Evaluate safety and tolerability of GEN3009 
• Frequency and severity of AEs/AESIs/SAEs 
• Changes in laboratory parameters 
• Changes in vital signs 
• Frequency of dose interruptions, dose delays, and 
dose intensity 
• Evaluate clinical efficacy of GEN3009 
• CR rate 
• DoR 
• TTR 
• PFS 
• OS 
• Evaluate immunogenicity of GEN3009 
• Incidence of neutralizing anti-GEN3009 antibodies 
(ie, ADAs) 
Exploratory 
• Assess potential biomarkers predictive of clinical 
response to GEN3009 and evaluate potential 
surrogacy with PFS and OS 
• Expression of CD37 and CD59 in tumor biopsies 
before and during treatment  
• Abundance of immune effector cells in tumor 
microenvironment 
• Circulating tumor DNA (ctDNA) as response 
biomarker  
• MRD status as response biomarker in DLBCL, FL, 
and CLL and evaluate potential surrogacy with 
PFS/OS 
• DNA mutational status and gene expression 
profiling (RNA-seq) in blood and malignant cells 
• Assess pharmacodynamic markers related to MoA 
of GEN3009 
• Pharmacodynamic markers in blood samples and 
within tumor (on-treatment biopsy) (leukocyte 
subset frequencies and phenotype, target antigen 
expression, complement regulatory protein 
expression, plasma complement levels and 
activation [CH50], and cytokine levels) 
 

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Table 19 Objectives and Endpoints for Expansion (GEN3009 + GEN3013 Safety Run-in 
for R/R B-NHL) 
OBJECTIVES 
ENDPOINTS 
Primary 
• Identify the RP2D of GEN3009 + 
GEN3013 combination 
• Rate of DLTs 
• Evaluate safety and tolerability of 
GEN3009 + GEN3013 combination 
• Frequency and severity of AEs/AESIs/SAEs  
• Changes in laboratory parameters 
• Changes in vital signs  
• Frequency of dose interruptions, dose delays, and dose 
intensity 
 
Secondary 
• Establish the PK properties of GEN3009 
and GEN3013 
• PK parameters: CL, AUC7days, AUClast, Cmax, Tmax, Ctrough, 
and T1/2 
• Evaluate immunogenicity 
• Incidence of neutralizing ADAs to GEN3009 
• Incidence of neutralizing ADAs to GEN3013 
• Assess the preliminary anti-tumor activity 
of GEN3009 + GEN3013 combination 
• CR rate 
• ORR  
• DoR 
• TTR  
• PFS  
• OS 
Exploratory 
• Assess potential biomarkers predictive of 
clinical response to GEN3009 + GEN3013 
combination 
• Expression of CD3, CD20, CD37, and molecular markers 
before and during treatment 
• MRD status 
• Assess pharmacodynamic markers related 
to MoA of GEN3009 and GEN3013 
• Pharmacodynamic markers in blood samples (leukocyte 
subset frequencies and phenotype, target antigen expression, 
complement regulatory protein expression, plasma 
complement levels and activation [CH50], and cytokine 
levels) 
 

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Table 20 Objectives and Endpoints for Expansion (GEN3009 + GEN3013 for R/R 
DLBCL) 
OBJECTIVES 
ENDPOINTS 
Primary 
• Assess preliminary anti-tumor activity of 
GEN3009 + GEN3013 combination 
• CR rate 
Secondary 
• Further assess the preliminary anti-tumor 
activity of GEN3009 + GEN3013 
combination 
• ORR 
• DOR  
• TTR  
• PFS  
• OS 
• Rate and duration of MRD negativity 
• Evaluate the safety and tolerability of 
GEN3009 + GEN3013 
• Frequency and severity of AEs/AESIs/SAEs 
• Changes in laboratory parameters 
• Changes in vital signs 
• Frequency of dose interruptions, dose delays, and dose 
intensity 
• Establish the PK properties of GEN3009 and 
GEN3013 
• PK parameters: CL, AUC7days, AUClast, Cmax, Tmax, Ctrough, 
and T1/2 
• Evaluate immunogenicity 
• Incidence of neutralizing ADAs to GEN3009 
• Incidence of neutralizing ADAs to GEN3013 
Exploratory 
• Assess potential biomarkers predictive of 
clinical response to GEN3009 + GEN3013 
combination 
• Expression of CD3, CD20, CD37, and other markers in 
tumor biopsies before and during treatment 
• DNA mutation status and gene 
expression profiling (RNA-seq) in 
blood and malignant cells  
• ctDNA as response biomarker 
• Evaluation of immune populations, phenotype and 
function in tumors and blood 
• Assess pharmacodynamic markers linked to 
efficacy and MoA of GEN3009 and GEN3013 
• Pharmacodynamic markers in blood samples and 
within tumor (on-treatment biopsy) ((leukocyte subset 
frequencies and phenotype, target antigen expression, 
complement regulatory protein expression, plasma 
complement levels and activation (CH50), cytokine 
levels) 
 

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4 
TRIAL DESIGN 
4.1 
Description of Trial Design 
This trial is a FIH, open-label, multicenter trial to evaluate the safety, tolerability, PK, 
pharmacodynamics, immunogenicity, and preliminary efficacy of GEN3009 (DuoHexaBody®-
CD37) as a single agent and in combination with GEN3013 (DuoBody®-CD3xCD20, 
epcoritamab) in subjects with R/R B-cell NHL.  
The trial will be conducted in 2 parts, Dose Escalation and Expansion. Up to 90 subjects with R/R 
B-cell NHL will be enrolled in the Dose Escalation, and approximately 92 subjects will be enrolled 
in the Expansion as follows: 
• GEN3009 monotherapy cohorts: R/R DLBCL (N=20), R/R FL (N=20), and R/R CLL 
(N=20)  
• GEN3009 + GEN3013 combination cohorts: safety run-in phase in R/R DLBCL or R/R 
FL (N=6-12) followed by Expansion phase in R/R DLBCL(N = 20).  
For GEN3009 monotherapy cohorts , GEN3009 will be administered IV in 4-week cycles (ie, 
28 days), with a schedule of weekly dosing in Cycles 1 through 3, every second week in Cycles 4 
through 9, and every 4 weeks in Cycle 10 until disease progression, unacceptable toxicity, death 
or end of trial.  
For GEN3009 + GEN3013 combination cohorts, GEN3009 will be administered IV in 4-week 
cycles (ie, 28 days), with a schedule of weekly dosing in Cycles 1 through 3, and every 4 weeks 
in Cycles 4 through 12 until up to a maximum of 12 cycles or any discontinuation criteria met (see 
Section 8), whichever occurs earlier. GEN3013 will be administered subcutaneously (s.c.) in 
Cycles 1 (starting from C1D8) through 3 , and then every 4 weeks in Cycles 4 through 12 until up 
to a maximum of 12 cycles or any discontinuation criteria met, whichever occurs earlier (see Table 
21). After completion of Cycle 12, subjects who are in SD or better will have the option to continue 
receiving GEN3013 every 4 weeks until any discontinuation criterion is met. 
Table 21 Dose and Schedule 
GEN3009 IV as assigned 
DL1: 
 mg 
DL2: RP2D 
GEN3013 s.c. 
DL1: 48 mg 
• 
Cycles 1-3: Days 1, 8, 15, 22 
• 
Cycles 4-12: Day 1 
• 
Cycle 1:  
o 
0.16 mg (priming dose) on Day 8  
o 
0.8 mg (intermediate dose) on Day 15  
o 
48 mg (full dose) on Day 22 
• 
Cycles 2 and 3: 48 mg on Days 1, 8, 15, and 22 
• 
Cycles 4-12: 48 mg on Day 1 
After completion of Cycle 12:  
• 
Subjects who are in SD, PR or CR:  
o 
Every 4 weeks (Cycles 13, 14, 15+): 48 mg on Day 1 
 
In treatment Cycle 1 during the Dose Escalation, all subjects are required to remain at the clinic 
after the GEN3009 administration for at least 4 hours where they will be observed for AEs, have 
vital signs measured, and have blood samples taken for laboratory parameters such as cytokines, 
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PK, and pharmacodynamic measurements. Observation of up to 24 hours postdose during Cycle 1 
is permissible at the discretion of the investigator.  
In treatment Cycle 1 during the Expansion, all subjects (including those in the combination cohort) 
are required to remain at the clinic after the GEN3009 administration for at least 2 hours where 
they will be observed for AEs and other assessments.  
In the GEN3009 + GEN3013 combination cohort, all subjects must be hospitalized for CRS 
monitoring for at least 24 hours after the third dose (first full dose) of GEN3013 (ie, 48 mg) at 
Cycle 1 Day 22. Additional or longer hospitalization is based per the investigator’s discretion. 
The design of the GCT3009-01 trial is shown in Figure 1. 
Figure 1 GCT3009-01 Trial Design  
 
 
4.1.1 
Dose Escalation 
The Dose Escalation will consist of 10 DLs (including one optional intermediate dose level) as 
shown in Figure 1.  
The initial 3 DLs will be single-subject cohorts, which is the accelerated titration part of the Dose 
Escalation. The start of standard titration begins with the enrollment of the 3-subject cohorts at the 
fourth DL. Additional intermediate dose levels (eg, 
 mg) may also be explored based upon 
emerging data.  
In the accelerated titration part of Dose Escalation, single-subject cohorts will be expanded to a 
3-subject cohort if the subject experiences a grade ≥2 toxicity (ie, related AE), during the DLT 
evaluation period (ie, 28 days), or based on the decision of the sponsor’s SC. When those subjects 
have completed their DLT evaluation period, the escalation model in Section 4.1.1.1 will be 
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initiated. If any single-subject cohort is expanded to a total of 3 subjects, all subsequent cohorts 
will initially have 3 subjects per cohort.  
After all subjects within a DL cohort have completed the DLT evaluation period, the DEC will 
review the data and propose for initiation of the next DL cohort. The sponsor’s SC will have to 
endorse the proposal before the next DL cohort can start dosing subjects. To supplement routine 
safety monitoring by the SC, as outlined in this protocol, a DMC will monitor safety data for the 
trial on a quarterly basis or more frequently as determined by the sponsor. Recommendations from 
the DEC, SC, and DMC will be based on evaluation of all available data including but not limited 
to clinical, safety, PK and pharmacodynamic data. Additional details regarding DEC, SC, and the 
DMC can be found in Sections 10.8 and 10.9. 
The timeframe for dosing subjects in a DL cohort should proceed as follows: 
• For an investigated, non-cleared DL, there should be at least 3 days between administration of 
the first dose to the first subject and the second subject within the same DL. 
• Any additional subjects dosed in the investigated, non-cleared DL should receive their first 
dose at least 1 day apart. 
• For a DL cleared for safety as recommended by the DEC/SC, there is no specific timeframe 
for subjects to receive their first dose (ie, additional subjects may be treated in parallel at the 
respective DLs that are considered safe). 
4.1.1.1 
Dose Escalation and De-escalation rules 
A modified Bayesian Optimal Interval (mBOIN) design will be utilized to make optimal 
recommendations at the end of each observed cohort (Yuan et al., 2016). A property of the mBOIN 
design is that re-escalation is allowed when the previous DL is considered safe (based on data from 
additional subjects). However, re-escalation is not allowed to DLs that have been terminated. For 
this trial, a target toxicity level of φ=25% has been chosen.  
For DLs with 3 DLT-evaluable subjects the decision regarding dose escalation and de-escalation 
will be consistent with the “3+3” design, ie, escalate if no DLT is observed, enroll 3 additional 
subjects if 1 DLT is observed and de-escalate if 2 DLTs are observed. If 3 DLTs are observed, the 
DL will be terminated. 
For DLs with 4 or more DLT-evaluable subjects the decision regarding dose escalation and de-
escalation will be based on the rules of the BOIN design. With the assumptions that φ1=0.6φ is the 
highest sub-therapeutic DLT rate and φ2=1.4φ is the lowest DLT rate that has excessive toxicity, 
the thresholds that minimizes the decision error at end of each cohort are λ1=0.197 and λ2=0.298 
(Yuan et al., 2016). If an additional DLT-free cohort on the same DL would lead to de-escalation, 
the DL will be terminated. 
After completion of the DLT period, based on cumulative safety data and the recommendation 
from the design rules presented in Table 22, the DEC will recommend the DL for the next cohort 
of subjects to the SC. The SC must endorse using the recommended or higher dose in the next 
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Table 22 Escalation Rules Based on Number of Subjects with DLTs 
Decision, Based on the Number of Subjects 
with DLTs (NDLT) 
Number of Subjects Evaluable for DLT 
at the Current DL 
 
3 
4 
5 
6 
7 
8 
9 
Escalate 
0 
0 
0 
≤1 
≤1 
≤1 
≤1 
Remain on the same dose level 
1 
1 
1 
NA 
2 
2 
2 
De-escalate 
2 
2 
2 
2 
3 
3 
3 
Terminate a dose level 
≥3 
≥3 
≥3 
≥3 
≥4 
≥4 
≥4 
 
Parallel Cohort Enrollment 
To better understand the safety, tolerability, PK, pharmacodynamic, or anti-tumor activity, 
approximately 7 additional subjects in total may be allocated in parallel to DLs (in the 3-subject 
cohorts only) that are considered safe for such allocation (DLs at or below the currently 
investigated one). In total, up to 49 additional subjects may be recruited in this manner. Any DLTs 
observed in such subjects will not directly contribute to the mBOIN design evaluation of the higher 
DL being investigated but will be reported to the DMC who will review the data in totality.  
Cohort Size 
During the standard titration part, it is allowed to execute the BOIN if 1 subject is 
non-DLT-evaluable and the remaining 2 subjects are deemed DLT-evaluable, provided neither of 
these 2 subjects experienced any grade ≥2 toxicity (ie, related AE) during the DLT evaluation 
period. If a DL has, in total, 2 subjects being DLT-evaluable and no DLTs are observed, the BOIN 
rule is to escalate. Also, over-recruitment by 1 subject is allowed in each cohort so that each cohort 
may consist of 2 to 4 subjects who are evaluable for DLT. 
In case a DL is being revisited (eg, due to de-escalation) and less than 3 subjects have previously 
been evaluated on this DL, the next cohort on this DL may be enlarged to bring the number of 
DLT-evaluable subjects up to a multiple of 3. 
Stopping Rules 
The Dose Escalation stops, when either: 
• there are 9 DLT-evaluable subjects on the current DL and according to the escalation rules the 
decision will be to remain on the same DL, or 
• the lowest dose is disallowed 
Recommended Phase 2 Dose 
The MTD is defined as the highest dose with DLT rate closest to 25%. By the end of the Dose 
Escalation, all available data, including but not limited to safety, PK, pharmacodynamics, and 
preliminary efficacy will be evaluated and incorporated in a PK/pharmacodynamic modeling to 
guide RP2D selection and the RP2D would not exceed the MTD. A RP2D can be declared without 
exploring the highest dose level planned based on the totality of emerging clinical and PK/PD data.  
4.1.2 
Expansion  
Following the determination of the MTD/RP2D, the Expansion will recruit approximately 
92 subjects in 4 parallel expansion cohorts (GEN3009 in R/R DLBCL [n=20], GEN3009 in R/R 
FL [n=20], GEN3009 in R/R CLL [n=20], and GEN3009 + GEN3013 in R/R DLBCL [n=20] with 

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a preceding safety run-in [n = ~6-12; R/R DLBCL or FL]) to provide additional safety and initial 
efficacy information, as well as more detailed data related to the MoA. Expansion cohorts will 
start and enroll in parallel and independently unless otherwise decided by the sponsor.  
4.1.2.1 
Safety Run-in for the GEN3009 + GEN3013 Combination Cohort 
The safety run-in will be conducted to assess the initial safety and tolerability of escalating 
GEN3009 DLs in combination with GEN3013 RP2D prior to the initiation of the GEN3009 + 
GEN3013 DLBCL expansion cohort. 
GEN3013 will be administered as s.c. injections at RP2D with a step-up dosing method (ie, 
priming dose followed by intermediate and full dose while GEN3009 monotherapy will be 
administered as IV infusions at assigned DL (ie, 
 mg [DL1] and RP2D from Dose Escalation 
part [DL2]). Only cleared DLs of GEN3009 monotherapy at Dose Escalation can be studied in 
combination with GEN3013. 
Decision regarding dose escalation and de-escalation will follow the dose escalation/de-escalation 
rules specified in Section 4.1.1.1. For DLs with 3 DLT-evaluable subjects, the decision will be 
consistent with the “3+3” design, ie, escalate if no DLT is observed, enroll 3 additional subjects if 
1 DLT is observed and de-escalate if 2 DLTs are observed. If 3 DLTs are observed, the DL will 
be terminated. For DLs with 4 or more DLT-evaluable subjects the decision will be based on the 
rules of mBOIN design.  
Dosing of subjects will be staggered following the same rules described in Section 4.1.1. 
One combination treatment cycle will be 28 days. DLTs (see Section 7.3) will be evaluated during 
the first 28 days. After completion of the DLT period, based on cumulative safety data and the 
recommendation from the dose decision criteria described above, the DEC will provide a 
recommendation on the respective DL to the SC. The SC must endorse using the recommended or 
higher dose prior to implementation. Refer to Section 4.1.1.1 for further information including, 
but not limited to, mBOIN design and MTD/RP2D definitions.  
4.2 
Trial Design Rationale 
This trial is being conducted to identify the MTD and/or RP2D of GEN3009, evaluate safety, and 
obtain preliminary efficacy of GEN3009 as a single agent and in combination with GEN3013 in 
subjects with R/R B-cell NHL, including CLL. 
Escalation and de-escalation in the Dose Escalation and combination safety run-in cohorts will be 
guided by the mBOIN approach. To collect further data on the safety, tolerability, PK and anti-
lymphoma activity, the selected RP2D of GEN3009 from the Dose Escalation will be studied in 
the Expansion. The Expansion will include 4 cohorts (ie, R/R DLBCL, R/R FL and R/R CLL in 
monotherapy cohorts, and R/R DLBCL in the GEN3009 + GEN3013 cohort with a preceding 
safety run-in) for further investigation. A safety run-in for the combination cohort, evaluating 
escalating DLs of GEN3009 with GEN3013 for DLTs, will ensure the safety and tolerability of 
the GEN3009 + GEN3013 combination prior to the initiation of the combination expansion. 
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4.3 
Dose and Schedule Rationale 
4.3.1 
GEN3009 Monotherapy Cohorts 
A starting dose of  mg of GEN3009 is proposed for this FIH clinical trial. This dose was derived 
by an integrated evaluation of preclinical pharmacology, PK, and toxicology studies. 
A maximum recommended starting dose (MRSD) was defined using the HNSTD of 10 mg/kg in 
the pivotal GLP toxicity study as a starting point. A translational PK model based on cynomolgus 
monkey PK data was used to derive the human dose expected to give rise to 1-week average plasma 
exposure equivalent to one-sixth that in cynomolgus monkey at the HNSTD. The resulting dose 
of 2.34 mg/kg can be considered the MRSD.  
GEN3009 was shown to have pharmacological activity at lower DLs. It showed significant effects 
on tumor size and inhibition of tumor outgrowth in various mouse xenograft models at 0.1 mg/kg. 
Furthermore, transient but substantial B-cell depletion was observed in cynomolgus monkey at 
0.1 mg/kg. This pharmacological activity in vivo was compared to a minimum anticipated 
biological effect level (MABEL) approach based on CDC in vitro as an endpoint. CDC is expected 
to be the driving effector mechanism given that the DuoHexaBody format strongly enhances 
hexamer formation and C1q binding. The EC50 for CDC was established in a clinically relevant 
setting using ex vivo primary subject samples. The translational PK model was used to derive the 
dose expected to give rise to a 1-week average concentration equal to the CDC EC50 of 
0.145 µg/mL, resulting in a dose of 0.25 mg/kg.  
As a conservative approach, a FIH starting dose of 
 mg/kg was selected, which is expected to 
be at the lower end of the pharmacologically active range. The dose was converted to a flat dose 
equivalent of  mg.  
A high degree of receptor occupancy (ie, target saturation) throughout the dosing interval is often 
correlated with optimal anti-tumor activity of therapeutic antibodies with similar MoAs (CDC, 
ADCC, ADCP [eg, daratumumab and ofatumumab], etc). Therefore, maintaining a high % of 
CD37 saturation would be critical for efficacy. IgG1 Fc-domain associated effector functions 
including CDC, ADCC, and ADCP are known to require a high degree of receptor occupancy 
throughout the dosing interval for optimal effect. In cynomolgus monkey, approximately linear 
PK was observed at 3 mg/kg and above, suggesting sustained saturation of target mediated 
clearance. A near complete depletion of B cells in circulation was observed at these dose levels. 
In patients, the additional CD37 on malignant cells is expected to increase the dose required for 
sustained target saturation compared to healthy cynomolgus monkeys. Target mediated clearance 
is expected to be reduced over the course of treatment at efficacious dose levels due to the depletion 
of malignant cells, so that target saturation can be maintained with less frequent dosing. The 
schedule therefore starts with weekly dosing for the first 3 cycles of 28 days before the dosing 
frequency is reduced to once every 2 weeks (six 28-day cycles; Cycle 4 through 9) and once every 
4 weeks (Cycle 10 and onwards).  
Preliminary results from the Dose Escalation part of GCT3009-01 among patients treated with 
GEN3009 at doses ranging from  mg to 
 mg at dose intervals of weekly in cycles 1-3, 
biweekly in cycles 4-9, and monthly from cycle 10 and beyond have shown the following: 
• 
GEN3009 was well-tolerated with clinically manageable side effects at doses up to 
 mg. The most common TEAEs were IRRs and the most frequent laboratory 
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abnormalities were neutropenia. Both IRR and neutropenia are not dose-dependent; No 
dose-dependent toxicity has been observed so far.  
• 
From the PK perspective, GEN3009 exhibited target-mediated drug disposition as 
expected, particularly at lower dose/concentration levels and resulting in rapid clearance 
of the drug-CD37 complex. High interindividual variability in target-mediated clearance 
was observed. For the majority of subjects doses up to 
 mg and for one out of three 
subjects at 
 mg were not sufficient to maintain saturating exposure throughout the 
dosing interval.  
It is at present apparent that the highest dose initially planned of 
 mg is not sufficient to 
overcome target-mediated drug disposition in all subjects, and higher doses (eg, ≥
 mg) are 
required to improve target saturation and minimize the impact of target-mediated clearance. 
Higher dose levels of GEN3009 (ie, 
 mg, 
 mg [optional intermediate dose], and 
 mg) 
are therefore added to the Dose Escalation to achieve target saturating exposure.  
4.3.2 
GEN3009 + GEN3013 Combination Cohort 
The dosage of GEN3013 that will be tested in the combination regimens is the RP2D (ie, full dose 
of 48 mg) declared for R/R DLBCL and FL from the GCT3013-01 trial (NCT03625037). A step-
up dosing schedule (ie, 0.16 mg on C1D8 [priming dose]; 0.80 mg on C1D15 [intermediate dose]; 
48 mg on C1D22 [full dose]; and onward) for GEN3013 is selected to reduce the risk of CRS. 
There will be 2 parts to test the GEN3009 + GEN3013 combination regimen:  
• A safety run-in phase in R/R DLBCL and FL: to assess the safety, tolerability, PK, and 
immunogenicity of the GEN3009 + GEN3013 combination regimen. GEN3009 will be 
tested at 2 DLs: DL1 at 
 mg and DL2 at RP2D. GEN3013 will only be tested at a fixed 
DL at 48 mg. 
• Expansion phase in R/R DLBCL: to assess the preliminary efficacy of the GEN3009 + 
GEN3013 combination regimen at the selected DL of GEN3009 from the safety run-in 
phase combined with GEN3013 at 48 mg. Safety, PK, and MRD will also be studied for 
the combination.  
Starting with GEN3009 at 
 mg is considered to be appropriate based on the safety findings 
from subjects (N=18) treated with GEN3009 at up doses up to 
 mg. Specifically, IRRs 
observed with GEN3009 treatment were not dose-dependent and IRRs could be well managed. 
Laboratory abnormalities such as neutropenia were transient and neutrophil counts recovered 
within a few days. Granulocyte colony stimulating factor (G-CSF) administration at the onset of 
Grade 3 or Grade 4 neutropenia was sufficient for count recovery by the next dose.  
Due to the non-overlapping MoAs for the individual study drugs (ie, GEN3009, GEN3013), it is 
deemed safe to start GEN3009 at 
 mg on C1D1 followed by the combination regimen from 
C1D8 and onward. The lead-in dose of GEN3009 can potentially reduce the risk of CRS with 
GEN3013. 
It is hypothesized that a more robust (ie, deeper, earlier, and more durable) overall clinical benefit 
can be achieved with the GEN3009 + GEN3013 regimen. Target-mediated clearance of GEN3009 
is expected to be reduced over the course of treatment given to the depletion of malignant cells as 
a result of a potentially deeper and earlier tumor response with the combination treatment, so that 
target saturation can be maintained with less frequent dosing. Thus, this trial will test a less 
frequent schedule of GEN3009 in the combination cohort as compared to the GEN3009 
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monotherapy cohorts (ie, every 4 weeks instead of q2w in Cycle 4 and onward, and a fixed duration 
of 12 months instead of continuous treatment until disease progression). Subjects who achieve SD 
or better at the completion of 12 months will have the option to receive GEN3013 until disease 
progression to maintain the clinical benefit based on the investigator’s discretion.  
4.4 
End of Trial and End of Treatment Definitions 
4.4.1 
End of Trial 
The trial is considered completed when the last subject dies or withdraws from the trial. However, 
the maximum trial duration is 5 years after the last subject’s first treatment in the trial. Following 
trial termination, the sponsor will make their best effort to ensure provision of post-trial access to 
GEN3009 and/or GEN3013 for those ongoing trial subjects with a potential treatment benefit, in 
accordance with local laws and requirements.  
4.4.2 
Treatment Discontinuation 
Treatment should continue until the subject fulfills 1 of the treatment discontinuation criteria (refer 
to Section 8.1). 
4.4.3 
Trial Stopping Rules 
If any of the events listed below occur, a prompt cumulative review of safety data will be 
conducted by the DMC to determine whether the trial should be discontinued permanently. 
• Events outside of the DLT window, in the Dose Escalation part and in the expansion part of 
the trial, that in the judgment of the sponsor are deemed serious enough to warrant an 
immediate comprehensive evaluation by the SC; 
• If at any time, all DLs are considered unsafe as defined by the mBOIN; 
• Any safety finding assessed as related to GEN3009 and/or GEN3009 + GEN3013 combination 
treatment that, in the opinion of the DMC, contraindicates further dosing of trial subjects. 
Any recommendation of the DMC must be approved by the sponsor SC. 
In addition, to ensure subject safety, the following stopping criteria are applicable to subjects who 
have completed the DLT period during the Dose Escalation, as well as subjects enrolled in 
Expansion: 
• ≥33% of subjects experiencing Grade 3 or greater treatment-emergent IRRs, or 
• ≥33% of subjects experiencing Grade 4 neutropenia lasting >7 days not attributable to 
underlying disease, or  
• ≥33% of subjects experiencing Grade 3 or greater CRS or ICANS. 
As noted in Section 10.8, the DMC will review the totality of the data and monitor safety for the 
trial on a quarterly basis or more frequently during the Dose Escalation and at pre-specified 
intervals during the Expansion (including safety run-in) as defined in the DMC charter. 
For each individual subject who has already received GEN3009 or GEN3009 + GEN3013 
combination and is currently in the trial at the time the trial stopping criteria are met, the benefit-
risk whether to stop or continue treatment will be assessed. To allow continuation of treatment, 
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combination after trial termination should continue to have investigator follow-up for safety until 
the subject’s condition returns to baseline or until the start of a new anti-cancer therapy, whichever 
comes first. 
Where applicable, regulatory authorities and independent ethics committees (IECs)/institutional 
review board (IRBs) will be notified of any significant actions taken with the trial. 
4.4.4 
Trial Termination 
The sponsor reserves the right to close the trial site or terminate the trial at any time for any reason 
at the sole discretion of the sponsor.  
In addition, the investigator may initiate trial-site closure at any time, provided there is reasonable 
cause and sufficient notice given in advance of the intended termination. Reasons for the early 
closure of a trial site by the sponsor or investigator may include, but are not limited to: 
• Failure of the investigator to comply with the protocol, the requirements of the IEC/IRB or 
local health authorities, the sponsor's procedures, or ICH Good Clinical Practice (GCP) 
guidelines 
• Inadequate recruitment of subjects by the investigator 
• Discontinuation of further trial drug development 
The sponsor may, based on available data, need to discontinue further development of GEN3009 
and/or the combination of GEN3009 + GEN3013. Following trial termination, the sponsor will 
make their best effort to provision post-trial access to GEN3009 and/or GEN3013 for those 
ongoing trial subjects with a potential treatment benefit, in accordance with local laws and 
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5 
TRIAL POPULATION(S) 
5.1 
Inclusion Criteria 
5.1.1 
Dose Escalation Inclusion Criteria 
Each potential subject must fulfill all of the following criteria to be enrolled in the trial. 
1. Be at least 18 years of age. 
2. Must sign an informed consent form (ICF) prior to any screening procedures indicating that 
they understand the purpose of the trial, the procedures required for the trial, and are willing 
to participate in the trial prior to any other trial-related assessments or procedures. 
3. Criterion updated as per Amendment 1 
3.1 Criterion updated as per Amendment 3 
3.2 Criterion updated as per Amendment 5 
3.3 Has histologically or cytologically confirmed relapsed or refractory B-cell NHL with no 
available standard therapy or is not a candidate for available standard therapy, and for whom, 
in the opinion of the investigator, experimental therapy with GEN3009 may be beneficial. All 
subjects must have received at least 2 prior lines of systemic therapy, and,  
a. For all indolent NHL (FL, MZL, and SLL) as well as aggressive NHL (DLBCL, 
HGBCL, and PMBCL), at least 1 of the 2 prior lines of treatment must have been a 
CD20-containing systemic regimen; 
b. For MCL, subjects must have had or are otherwise ineligible for treatment with a BTK 
inhibitor, and;  
c. For CLL, subjects must have received at least 1 prior line of BTK inhibitor or BCL-2 
inhibitor. 
4. Criterion updated as per Amendment 5 
4.1 Has 1 of the following B-cell NHL subtypes for the Dose Escalation: 
a. DLBCL, de novo or histologically transformed 
b. HGBCL (Swerdlow et al., 2016) 
c. PMBCL 
d. FL, with advanced symptomatic disease and with a need for treatment 
e. MCL, without leukemic manifestation 
f. MZL, either nodal, extranodal, or mucosa associated, with a need for treatment 
initiation based on symptoms and/or disease burden 
g. SLL, with a need for treatment based on symptoms and/or disease burden 
h. CLL with active disease that needs treatment based on the International Workshop on 
Chronic Lymphocytic Leukemia [iwCLL] criteria) (Hallek et al., 2018)  
i. Criterion updated as per Amendment 3 

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5. Criterion removed as per Amendment 5  
6. Criterion updated as per Amendment 5 
6.1 Has measurable disease:  
i. B-cell NHL: 
a. A fluorodeoxyglucose (FDG)-positron emission tomography (PET) computed 
tomography (CT) scan demonstrating positive lesion compatible with CT (or magnetic 
resonance imaging [MRI])-defined anatomical tumor sites 
and 
b. A CT scan (or magnetic resonance imaging [MRI]) with involvement of ≥2 clearly 
demarcated lesions/nodes with long axis >1.5 cm and short axis >1.0 cm or 1 clearly 
demarcated lesion/node with a long axis >2.0 cm and a short axis ≥1.0 cm. 
Note: Subjects who do not have FDG-avid lymphoma at screening will be eligible if they meet 
“criterion 5b”.  
ii. CLL:  
c. ≥5 × 109/L (5,000/μL) B lymphocytes in peripheral blood, or 
d. Presence of measurable lymphadenopathy and/or organomegaly 
7. Has active disease for CLL: Progressive or symptomatic disease with at least 1 of the following 
criteria being met (Hallek et al., 2018): 
a. Evidence of progressive marrow failure as manifested by the development of, or 
worsening of, anemia and/or thrombocytopenia 
b. Massive (ie, ≥6 cm below the left costal margin) or progressive or symptomatic 
splenomegaly 
c. Massive nodes (ie, ≥10 cm in longest diameter) or progressive or symptomatic 
lymphadenopathy 
d. Progressive lymphocytosis with an increase of ≥50% over a 2-month period, or 
lymphocyte doubling time (LDT) <6 months. 
e. Autoimmune complications including anemia or thrombocytopenia poorly responsive 
to corticosteroids 
f. Symptomatic or functional extranodal involvement (eg, skin, kidney, lung, spine) 
g. Disease-related symptoms as defined by any of the following: 
i. Unintentional weight loss ≥10% within the previous 6 months 
ii. Significant fatigue 
iii. Fevers ≥100.5°F or 38.0°C for 2 or more weeks without evidence of infection. 
iv. Night sweats for ≥1 month without evidence of infection. 
8. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 
9. Criterion updated as per Amendment 5. 
9.1 Has acceptable laboratory parameters as follows: 

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Parameter 
Result 
a. 
Creatinine clearance 
>50 mL/min (Cockcroft-Gault) or serum creatinine ≤1.5 × upper 
limit of normal (ULN) (refer to Appendix 1) 
b. 
Serum alanine transaminase (ALT)  
≤2.5 × upper limit of normal (ULN) 
c. 
Serum aspartate transaminase (AST) 
≤2.5 × ULN 
d. 
Total bilirubin 
≤1.5 × ULN  
 
Note: Subjects with Gilbert’s syndrome may be included if total 
bilirubin is ≤3 × ULN and direct bilirubin is ≤1.5 × ULN  
e. 
Hemoglobin  
≥5.6 mmol/L (9.0 g/dL) 
 
Note: Without transfusion within 7 days of determination of 
eligibility. 
f. 
Absolute neutrophil count 
B-cell NHL: ≥1.0×109/L (1,000/µL) 
CLL: ≥1.0×109/L (1,000/µL) unless due to bone marrow 
involvement 
 
Note: Without growth factor support within 7 days of 
determination of eligibility (14 days if pegylated growth factor 
such as pegfilgrastim). 
g. 
Platelet count  
B-cell NHL: ≥ 75×10
9
/L (75,000/µL) 
 
Note: In presence of bone marrow involvement, platelets 
≥50×109/L. 
 
CLL: ≥30×109/L (30,000/µL) 
 
Note: Without transfusion within 7 days of determination of 
eligibility. 
h. 
Coagulation Status: PT/INR/aPTT 
Prothrombin time (PT)/International normalized ratio 
(INR)/Activated partial thromboplastin time (aPTT) ≤1.5×ULN 
 
10. Criterion updated as per Amendment 3 
10.1 A woman of reproductive potential must agree to use adequate contraception during the 
trial and for 12 months after the last GEN3009 administration. Adequate contraception is 
defined as highly effective methods of contraception (refer to Appendix 12 for more 
information). In countries where 2 highly effective methods of contraception are required, both 
methods will be required for inclusion.  
11. Criterion updated as per Amendment 3 
11.1 A woman of childbearing potential must have a negative serum beta-human chorionic 
gonadotropin (beta-hCG) at screening. 
12. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted 
reproduction during the trial and for 12 months after receiving the last dose of GEN3009. 
13. A man who is sexually active with a woman of childbearing potential and has not had a 
vasectomy must agree to use a barrier method of birth control, eg, condom only and 
spermicidal foam/gel/film/cream/suppository, and partner with occlusive cap (diaphragm or 
cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also 
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14. Must be willing and able to adhere to the requirements and restrictions specified in the ICF 
and this protocol. 
15. Subjects must have a life expectancy of at least 3 months. 
16. Sites in France only: Must have a social security number or equivalent per local requirements. 
5.1.2 
Expansion (including Safety Run-in) Inclusion Criteria 
Each potential subject must fulfill all of the following criteria to be enrolled in the trial. 
1. Be at least 18 years of age. 
2. Must sign an ICF prior to any screening procedures indicating that they understand the purpose 
of the trial, the procedures required for the trial, and are willing to participate in the trial prior 
to any other trial-related assessments or procedures. 
3. Has histologically or cytologically confirmed relapsed or refractory B-cell NHL. All subjects 
must have received at least 2 prior lines of systemic therapy, and, 
a. For FL and DLBCL, at least 1 of the 2 prior lines of treatment must have been a 
CD20-containing systemic regimen; 
b. For CLL, subjects must have received at least one prior line of BTK inhibitor or BCL-2 
inhibitor. 
Note: See Section 11.8.1.3 for definitions of “relapsed” disease. 
4. Has 1 of the following B-cell NHL subtypes for the Expansion (including safety run-in): 
a. DLBCL, de novo or histologically transformed 
b. FL Grade 1, 2 and 3a, with advanced symptomatic disease and with a need for treatment 
initiation 
c. CLL, must have active disease that needs treatment with at least 1 of the following 
criteria being met (Hallek et al., 2018): 
i. Evidence of progressive marrow failure as manifested by the development of, 
or worsening of, anemia and/or thrombocytopenia 
ii. Massive (ie, ≥6 cm below the left costal margin) or progressive or symptomatic 
splenomegaly 
iii. Massive nodes (ie, ≥10 cm in longest diameter) or progressive or symptomatic 
lymphadenopathy 
• Progressive lymphocytosis with an increase of ≥50% over a 2-month period, or 
LDT <6 months 
• Autoimmune complications including anemia or thrombocytopenia poorly 
responsive to corticosteroids 
• Symptomatic or functional extranodal involvement (eg, skin, kidney, lung, spine) 
• Disease-related symptoms as defined by any of the following: 
o Unintentional weight loss ≥10% within the previous 6 months 

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o Significant fatigue 
o Fevers ≥38.0°C (100.5°F) for 2 or more weeks without evidence of infection 
o Night sweats for ≥1 month without evidence of infection 
 
d. GEN3009 + GEN3013 combination cohort only: Documented CD20+ DLBCL or FL 
based on representative pathology report  
5. Has measurable disease for B-cell NHL: 
a. A FDG-PET CT scan demonstrating positive lesion compatible with CT (or MRI)-
defined anatomical tumor sites, and  
b. A CT scan (MRI) with involvement of ≥ 2 clearly demarcated lesions/nodes with long 
axis >1.5 cm and short axis >1.0 cm or 1 clearly demarcated lesion/node with a long 
axis >2.0 cm and a short axis ≥1.0 cm. 
Note: Subjects who do not have FDG-avid lymphoma at screening will be eligible if they meet 
criterion “5b”.  
6. Has measurable disease for CLL with at least one of the following criteria: 
a. ≥5 × 109/L (5,000/μL) B lymphocytes in peripheral blood 
b. Presence of measurable lymphadenopathy and/or organomegaly 
7. Has ECOG performance status of 0 or 1. 
8. Has acceptable laboratory parameters as follows: 
 
Parameter 
Result 
a. 
Creatinine clearance 
>50 mL/min (Cockcroft-Gault) or serum creatinine ≤1.5 × ULN 
(refer to Appendix 1) 
b. 
Serum alanine transaminase (ALT)  
≤2.5 × ULN 
c. 
Serum aspartate transaminase (AST) 
≤2.5 × ULN 
d. 
Total bilirubin 
≤1.5 × ULN  
 
Note: Subjects with Gilbert’s syndrome may be included if total 
bilirubin is ≤ 3 × ULN and direct bilirubin is ≤1.5 × ULN  
e. 
Hemoglobin  
≥5.6 mmol/L (9.0 g/dL) 
 
Note: Without transfusion within 7 days of determination of 
eligibility. 
f. 
Absolute neutrophil count 
B-cell NHL: ≥1.0×109/L (1,000/µL) 
CLL: ≥1.0×109/L (1,000/µL) unless due to bone marrow 
involvement 
 
Note: Without growth factor support within 7 days of 
determination of eligibility (14 days if pegylated growth factor 
such as pegfilgrastim). 
g. 
Platelet count  
B-cell NHL: ≥75×109/L (75,000/µL) 
 
Note: In presence of bone marrow involvement, platelets 
≥50×109/L. 
 
CLL: ≥30×109/L (30,000/µL)  

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Note: Without transfusion within 7 days of determination of 
eligibility. 
h. 
Coagulation status: PT/INR/aPTT 
Prothrombin time (PT)/International normalized ratio 
(INR)/Activated partial thromboplastin time (aPTT) ≤1.5 × ULN 
9. Subjects must have a life expectancy of at least 3 months. 
10. A woman of reproductive potential must agree to use adequate contraception during the trial 
and for 12 months after the last GEN3009 and/or GEN3013 administration. Adequate 
contraception is defined as highly effective methods of contraception (refer to Appendix 12 
for more information). In countries where 2 highly effective methods of contraception are 
required, both methods will be required for inclusion.  
11. A woman of childbearing potential must have a negative serum beta-hCG at screening.  
12. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted 
reproduction during the trial and for 12 months after receiving the last dose of GEN3009 and/or 
GEN3013. 
13. A man who is sexually active with a woman of childbearing potential and has not had a 
vasectomy must agree to use a barrier method of birth control, eg, condom only and with 
spermicidal foam/gel/film/cream/suppository and partner with occlusive cap (diaphragm or 
cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also 
not donate sperm during the trial and for 12 months after receiving the last dose of GEN3009 
and/or GEN3013. 
14. Must be willing and able to adhere to the requirements and restrictions specified in the ICF 
and this protocol. 
15. Sites in France only: Must have a social security number or equivalent per local requirements. 
5.2 
Exclusion Criteria 
5.2.1 
Dose Escalation Exclusion Criteria 
Any potential subject who meets any of the following criteria will be excluded from participating 
in the trial. 
1. Prior treatment with a CD37-targeting agent. 
2. Prior allogeneic HSCT. 
3. Autologous HSCT within 3 months before the first dose of GEN3009.  
4. Criterion updated as per Amendment 5 
4.1 Treatment with an anti-cancer biologic including anti-CD20 therapy, radio-conjugated or 
toxin-conjugated antibody or chimeric antigen receptor (CAR) T cell therapy within 4 weeks 
or 5 half-lives, whichever is shorter, before the first dose of GEN3009. Treatment with small 
molecules such as BTK inhibitors, BCL2 inhibitors, or PI3K inhibitors within 5 half-lives prior 
to the first dose of GEN3009. 
5. Chemotherapy or radiation therapy within 2 weeks of the first dose of GEN3009. 
6. Criterion updated as per Amendment 5. 

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6.1 Treatment with an investigational drug or an invasive investigational medical device within 
4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of GEN3009, and at any 
time during the study treatment period. 
7. Autoimmune 
disease 
or 
other 
diseases 
that 
require 
permanent 
or 
high-dose 
immunosuppressive therapy. 
8. Received a cumulative dose of corticosteroids more than the equivalent of 250 mg of 
prednisone within the 2–week period before the first dose of GEN3009.  
Note: Refer to Section 6.6.2 for steroid dosing limitations during study treatment period.  
9. Has uncontrolled intercurrent illness, including but not limited to: 
a. Ongoing or active infection requiring intravenous antibiotics treatment at the time of 
enrollment or within the previous 2 weeks prior to the first dose of GEN3009 
b. Symptomatic congestive heart failure (grade III or IV as classified by the New York 
Heart Association ([NYHA]), unstable angina pectoris or cardiac arrhythmia (refer to 
Appendix 2) 
c. Myocardial infarction, intracranial bleed, or stroke within the past 6 months  
d. Screening 12-lead electrocardiogram (ECG) showing a baseline QT interval as corrected 
by Fridericia’s formula (QTcF) >480 msec 
10. Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade 
1 or less except for alopecia and peripheral neuropathy. 
11. Primary central nervous system (CNS) lymphoma or known CNS involvement at screening. 
12. Has known past or current malignancy other than inclusion diagnosis, except for:  
a. Cervical carcinoma of Stage 1B or less 
b. Non-invasive basal cell or squamous cell skin carcinoma 
c. Non-invasive, superficial bladder cancer 
d. Prostate cancer with a current PSA level <0.1 ng/mL 
e. Criterion deleted as per Amendment 3  
f. Any curable cancer with a CR of >2 years duration 
13. Criterion updated per Amendment 5 
14.1 Had allergic reactions to anti-CD20 or anti-CD37 monoclonal antibody treatment or 
intolerant to GEN3009 excipients (refer to the GEN3009 IB for more information). 
14. Criterion updated per Amendment 5 
14.1 Has had major surgery, (eg, requiring general anesthesia) within 4 weeks before screening 
or will not have fully recovered from surgery, or has major surgery planned during the time 
the subject is expected to participate in the trial (or within 4 weeks after the last dose of 
GEN3009 and/or GEN3013). 
Note: Subjects with planned minor surgical procedures to be conducted under local anesthesia 
may participate. 

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15. Has known history/positive serology for hepatitis B (unless immune due to vaccination or 
resolved natural infection or unless passive immunization due to immunoglobulin therapy): 
• Positive test for antibodies to the hepatitis B core antigen (anti-HBc) 
and 
• Negative test for antibodies to the hepatitis B surface antigen (anti-HBs).  
16. Known medical history or ongoing hepatitis C infection that has not been cured.  
17. Criterion updated per Amendment 5 
17.1 Known history of seropositivity for HIV infection. Note: HIV testing is required at 
screening only if required per local health authorities or institutional standards. 
18. Is a woman who is pregnant or breast-feeding, or who is planning to become pregnant while 
enrolled in this trial or within 12 months after the last dose of GEN3009. 
19. Is a man who plans to father a child while enrolled in this trial or within 12 months after the 
last dose of GEN3009. 
20. Criterion updated as per Amendment 5 
20.1 Has any condition for which, in the opinion of the investigator, participation would not 
be in the best interest of the subject (eg, compromise the well-being) or that could prevent, 
limit, or confound the protocol-specified assessments. Additionally, vulnerable subjects 
or subjects under guardianship, curatorship, judicial protection or deprived of liberty), are 
excluded from participation in this trial. 
21. Prior treatment with live, attenuated vaccines within 4 weeks prior to initiation of GEN3009. 
Examples of live vaccines include, but are not limited to, the following: measles, mumps, 
rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin, and 
typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines 
and are allowed; however, intranasal influenza vaccines (eg, FluMist) are live attenuated 
vaccines and are not allowed. Experimental and/or non authorized SARS-CoV-2 vaccinations 
are not allowed. 
22. Lymphomas leukemia phase: high absolute lymphocyte count or the presence of abnormal 
cells in the peripheral blood indicating circulating lymphoma cells. 
5.2.2 
Expansion (including Safety Run-in) Exclusion Criteria 
Any potential subject who meets any of the following criteria will be excluded from participating 
in the trial. 
1. Prior treatment with a CD37-targeting agent. 
2. GEN3009 + GEN3013 combination cohort only: Prior treatment with a CD3 × CD20 
bispecific antibody.  
3. Prior allogeneic HSCT. 
4. Autologous HSCT within 3 months before the first dose of GEN3009.  
5. Lymphomas leukemia phase: high absolute lymphocyte count or the presence of abnormal 
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6. Treatment with an anti-cancer biologic including anti-CD20 therapy, radio-conjugated or 
toxin-conjugated antibody or CAR T cell therapy within 4 weeks or 5 half-lives, whichever is 
shorter, before the first dose of GEN3009. Treatment with small molecules such as BTK 
inhibitors, BCL2 inhibitors, or PI3K inhibitors within 5 half-lives prior to the first dose of 
GEN3009. 
7. Chemotherapy or radiation therapy within 2 weeks of the first dose of GEN3009. 
8. Treatment with an investigational drug or an invasive investigational medical device within 
4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of GEN3009, and at any 
time during the study treatment period 
9. Autoimmune 
disease 
or 
other 
diseases 
that 
require 
permanent 
or 
high-dose 
immunosuppressive therapy. 
10. Received a cumulative dose of corticosteroids more than the equivalent of 250 mg of 
prednisone within the 2–week period before the first dose of GEN3009.  
Note: Refer to Section 6.6.1 for steroid dosing limitations during the study treatment period.  
11. Has uncontrolled intercurrent illness, including but not limited to: 
a. Ongoing or active infection requiring intravenous antibiotics treatment at the time 
of enrollment or within the previous 2 weeks prior to the first dose of GEN3009 
or GEN3013 
b. Symptomatic congestive heart failure (grade III or IV as classified by the NYHA), 
unstable angina pectoris or cardiac arrhythmia (refer to Appendix 2) and/or known 
decrease ejection fraction of <45% 
c. Myocardial infarction, intracranial bleed, or stroke within the past 6 months  
d. Screening 12-lead ECG showing a baseline QTcF >480 msec 
12. GEN3009 + GEN3013 combination cohort only: Seizure disorder requiring therapy (such 
as steroids or anti-epileptics) 
13. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy. 
14. Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to 
Grade 1 or less except for alopecia and peripheral neuropathy. 
15. Primary CNS lymphoma or known CNS involvement at screening. 
16. Has known past or current malignancy other than inclusion diagnosis, except for:  
a. Cervical carcinoma of Stage 1B or less 
b. Non-invasive basal cell or squamous cell skin carcinoma 
c. Non-invasive, superficial bladder cancer 
d. Prostate cancer with a current PSA level < 0.1 ng/mL 
e. Any curable cancer with a CR of >2 years duration 
17. Had allergic reactions to anti-CD20 or anti-CD37 monoclonal antibody treatment or intolerant 
to GEN3009 excipients (refer to the GEN3009 IB for more information) 
18. GEN3009 + GEN3013 combination cohort only: Intolerant to GEN3013 excipients (refer to 
the GEN3013 IB for more information)  

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19. Has had major surgery, (eg, requiring general anesthesia) within 3 weeks before screening or 
will not have fully recovered from surgery, or has major surgery planned during the time the 
subject is expected to participate in the trial (or within 4 weeks after the last dose of GEN3009). 
Note: Subjects with planned minor surgical procedures to be conducted under local anesthesia 
may participate. 
20. Has known history/positive serology for hepatitis B (unless immune due to vaccination or 
resolved natural infection or unless passive immunization due to immunoglobulin therapy): 
• Positive test for anti-HBc 
and 
• Negative test for anti-HBs.  
21. Known medical history or ongoing hepatitis C infection that has not been cured.  
22. Known history of seropositivity for HIV infection. Note: HIV testing is required at screening 
only if required per local health authorities or institutional standards.  
23. Is a woman who is pregnant or breast-feeding, or who is planning to become pregnant while 
enrolled in this trial or within 12 months after the last dose of GEN3009 and/or GEN3013. 
24. Is a man who plans to father a child while enrolled in this trial or within 12 months after the 
last dose of GEN3009 and/or GEN3013. 
25. Has any condition for which, in the opinion of the investigator, participation would not be in 
the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or 
confound the protocol-specified assessments. Additionally, vulnerable subjects or subjects 
under guardianship, curatorship, judicial protection or deprived of liberty), are excluded from 
participation in this trial. 
26. Prior treatment with live, attenuated vaccines within 4 weeks prior to initiation of GEN3009. 
Examples of live vaccines include, but are not limited to, the following: measles, mumps, 
rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin, and 
typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines 
and are allowed; however, intranasal influenza vaccines (eg, FluMist) are live attenuated 
vaccines and are not allowed. Experimental and/or non-authorized SARS-CoV-2 vaccinations 
are not allowed.  
5.3 
Screen Failures 
Screen failures are defined as subjects who consent to participate in the clinical trial but do not 
meet the protocol-defined eligibility criteria (refer to Section 5.1 and 5.2). Minimal information to 
be documented includes demography, reason for screening failure (eg, eligibility criteria not met, 
subject withdrew consent, other reasons) and any SAEs or AEs related to a trial assessment. 
Individuals who do not meet the criteria for participation in this trial (screen failures) may be 
rescreened. The rescreening must be approved by the sponsor to ensure that the safety of the 
subject is not compromised. Screen failures may be rescreened only once. Subjects are required to 
sign a new ICF if updates have been made since signing the most recent ICF. All eligibility criteria 
must be re-assessed at the rescreening visit.  

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Previously submitted tumor biopsy samples are acceptable if obtained within 6 months prior to 
Cycle 1 Day 1. The following screening assessments may be used for rescreening if performed 
≤3 weeks prior to Cycle 1 Day 1 or if approved by sponsor: 
• Previously submitted FDG-PET CT, CT, or MRI scans with acquisition date ≤3 weeks prior to 
Cycle 1 Day 1. Scans that exceed the 3-week window may be used for trial enrollment with 
sponsor’s approval.  
• Screening laboratory assessments with the protocol-defined timelines as indicated in the visit 
assessment schedules (refer to Table 2 and Table 5). 
 

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6 
TREATMENT 
6.1 
Treatment Assignment or Randomization 
6.1.1 
Subject Numbering 
After signing the ICF, subjects will be assigned a unique subject identification number before 
undergoing any screening procedure(s).  
6.1.2 
Treatment Assignment 
This is an open-label trial; therefore, blinding of treatment will not be performed. Subjects will be 
assigned to a dose cohort based on slot availability.  
During Dose Escalation, site personnel must contact the contract research organization (CRO) 
when a potential subject has been identified. If there is an available enrollment slot in any currently 
enrolling cohort, the site will be given approval to start the screening process. If there is no 
opening, the subject will be placed on a waiting list, and the site will be alerted of the next available 
opening either in the currently enrolling DL or at the next opened DL. 
During the Expansion, subjects that meet the eligibility criteria will be assigned a subject number. 
6.2 
Premedication 
6.2.1 
Premedication in GEN3009 Monotherapy Cohorts  
The purpose of premedication is to reduce the risk of IRRs. It is mandatory to premedicate subjects 
in the first treatment cycle with corticosteroids, antihistamines, antipyretics, and a leukotriene 
receptor antagonist before each infusion of GEN3009 (ie, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 
Day 15, and Cycle 1 Day 22). Premedication should be administered 30 minutes to 2 hours prior 
to the GEN3009 infusion: 
1. Prednisolone 100 mg, or equivalent, administered IV. Only intermediate-acting and long-
acting steroids are allowed (refer to Appendix 3 for the equivalent). 
2. Antipyretics: Acetaminophen 650 to 1000 mg PO, or equivalent. 
3. Antihistamine: Diphenhydramine 25 to 50 mg IV or PO, or equivalent.  
4. A leukotriene receptor antagonist: Montelukast 10 mg PO. 
In addition to the corticosteroid administered on the day of the GEN3009 infusion, dexamethasone 
5 mg PO is allowed at the investigator’s discretion for up to 3 days prior to the day of GEN3009 
infusion. 
If there is no IRR or there is only Grade 1 or 2 IRR during Cycle 1, the use of corticosteroid is 
optional for subsequent cycles.  
If there is a Grade 3 IRR during the Cycle 1, corticosteroid is required for Cycle 2 but may be at a 
reduced dose, ie, prednisolone at 80 mg IV. The use of corticosteroid is optional for subsequent 
cycles. 
Premedication with antipyretics and antihistamines should be administered at all cycles. The 
leukotriene receptor antagonist only needs to be given in Cycle 1. 

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6.2.2 
Premedication and CRS Prophylaxis in GEN3009 + GEN3013 Combination 
Cohort 
Premedication (ie, corticosteroids, antihistamines, antipyretics and a leukotriene receptor 
antagonist) 
and 
post-infusion 
corticosteroids 
are 
mandatory 
for 
GEN3009 
and 
GEN3009 + GEN3013 doses in Cycle 1 and Cycle 2 Day 1 as described in Table 23. In subsequent 
treatment (ie., Cycle 2 Day 8 and beyond), steroid may be optional. Refer to Appendix 3 for 
corticosteroid equivalent. The leukotriene receptor antagonist only needs to be given in Cycle 1. 
Premedication with antipyretics and antihistamines should be administered at all cycles. 
If there is a Grade 3 IRR during Cycle 1, corticosteroid is required for Cycle 2 but may be at a 
reduced dose ie, prednisolone at 80 mg IV. The use of corticosteroid is optional for subsequent 
cycles. 
If CRS ≥ Grade 2 occurs following the fourth dose of epcoritamab administration (Cycle 2 Day 1 
dose), premedication with corticosteroid and 3-day consecutive corticosteroid administration is 
recommended to continue for the rest of GEN3013 doses in Cycle 2. From Cycle 3 and onward, 
corticosteroid may be optional for premedication with antipyretics and antihistamines should be 
administered at all cycles. 
Table 23 Premedication and Post-infusion Medication for GEN3009 + GEN3013 
Combination  
 
Corticosteroids 
Antihistamines 
Antipyretics 
Leukotriene 
receptor 
antagonist 
Cycle 1 
Premedication 
for GEN3009  
Day 1 
(Predose)* 
Prednisolone 100 mg 
IV (or equivalent)  
Diphenhydramine 50 
mg IV or oral (PO) or 
equivalent) 
Acetaminophen 
650 to 1000 mg 
PO (or equivalent) 
Montelukast, 10 
mg PO 
Premedication 
for GEN3009 + 
GEN3013 
(priming dose 
at 0.16 mg)  
Day 08 
(Predose)* 
Prednisolone 100 mg 
IV (or equivalent) 
Diphenhydramine 50 
mg IV or PO (or 
equivalent) 
Acetaminophen 
650 to 1000 mg 
PO (or equivalent) 
Montelukast, 10 
mg PO 
 
Day 09 
Prednisolone 100 mg 
IV or PO (or 
equivalent) 
 
 
 
Day 10 
Prednisolone 100 mg 
IV or PO (or 
equivalent) 
 
 
 
Premedication 
for GEN3009 + 
GEN3013 
(intermediate 
dose at 0.8 mg) 
Day 15 
(Predose)* 
Prednisolone 100 mg 
IV (or equivalent) 
Diphenhydramine 50 
mg IV or PO (or 
equivalent) 
Acetaminophen 
650 to 1000 mg 
PO (or equivalent) 
Montelukast, 10 
mg PO 
 
Day 16 
Prednisolone 100 mg 
IV or PO (or 
equivalent) 
 
 
 
Day 17 
Prednisolone 100 mg 
IV or PO (or 
equivalent) 
 
 
 
Premedication 
for GEN3009 + 
GEN3013 
administration 
48 mg) 
Day 22 
(Predose)* 
Prednisolone 100 mg 
IV (or equivalent 
including oral dose) 
Diphenhydramine 
50 mg IV or PO (or 
equivalent) 
Acetaminophen 
650 to 1000 mg 
PO (or equivalent) 
Montelukast, 10 
mg PO 

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Corticosteroids 
Antihistamines 
Antipyretics 
Leukotriene 
receptor 
antagonist 
 
Day 23 
Prednisolone 100 mg 
IV or PO (or 
equivalent) 
 
 
 
Day 24 
Prednisolone 100 mg 
IV (or equivalent 
including oral dose) 
 
 
 
Cycle 2 
Premedication 
for GEN3009 + 
4th GEN3013 
administration 
(48 mg) 
Day 1 
(Predose)* 
Prednisolone 100 mg 
IV (or equivalent) 
Diphenhydramine 
50 mg IV or PO (or 
equivalent) 
Acetaminophen 
650 to 1000 mg 
PO (or equivalent) 
 
 
Day 2 
Prednisolone 100 mg 
IV or PO (or 
equivalent) 
 
 
 
Day 3 
Prednisolone 100 mg 
IV or PO (or 
equivalent) 
 
 
 
 
Day 8 and 
beyond 
If CRS ≥Grade 2 
occurs following the 
4th dose of 
epcoritamab 
administration 
(Cycle 2 Day 1 
dose), premedication 
with corticosteroid 
and 3-day 
consecutive 
corticosteroid 
administration is 
recommended to 
continue for the rest 
of GEN3013 doses 
in Cycle 2. From 
Cycle 3 and onward, 
corticosteroid may 
be optional. 
 
 
 
* Premedication should be given 30 minutes - 1 hour prior to the trial treatment. On the days when both trial drugs are 
given, administer GEN3013 s.c. first, monitor the subject for 30 minutes to 1 hour, then start the GEN3009 infusion. 
GEN3013 will be administered prior to GEN3009.  
6.3 
Management of Infusion-Related Reactions 
IRRs can occur with GEN3009 administration. All patients must receive premedication for IRRs 
as described in Section 6.2.1. 

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Table 24 GEN3009 Dose Modification Rules for IRRs 
IRR Grade 
Dose Modification 
Grade 1 or 2 
• 
Stop GEN3009 infusion immediately and treat the subject based on local 
institutional guidelines. 
• 
Once reaction symptoms resolve, resume the infusion at no more than half 
the rate at which the IRR occurred.  
• 
If the subject does not experience any further IRR symptoms, infusion rate 
escalation may resume at increments and intervals as clinically appropriate. 
Please refer to Section 6.2.1 for premedication instructions. 
Grade 3 
• 
Stop GEN3009 infusion immediately and treat the subject based on local 
institutional guidelines 
• 
Once reaction symptoms resolve, resume the infusion at no more than half 
the rate at which the IRR occurred.  
• 
If the subject does not experience any further IRR symptoms, infusion rate 
escalation may resume at increments and intervals as clinically appropriate.  
• 
If, after resumption of the infusion, symptoms return (irrespective of 
grade), permanently discontinue administration of GEN3009 and manage 
the IRR symptoms accordingly. 
Please refer to Section 6.2.1  for premedication instructions. 
Grade 4 (life-threatening) 
• 
Permanently discontinue administration of GEN3009 and institute 
appropriate emergency care. 
 
Trained trial staff should be prepared to intervene in case of any IRRs occurring, with resources 
necessary for resuscitation (eg, agents such as epinephrine and aerosolized bronchodilator, also 
medical equipment such as oxygen tanks, tracheostomy equipment, and a defibrillator) available. 
6.4 
Dosage(s) and Administration 
6.4.1 
GEN3009 Monotherapy Cohorts 
GEN3009 will be administered as an IV infusion according to the following schedule until 1 or 
more of the discontinuation criteria in Section 8.1 are met: 
• Cycles 1 through 3: Days 1*, 8, 15, and 22 (once weekly for a 28-day cycle) 
• Cycles 4 through 9: Days 1 and 15 (every 2 weeks for a 28-day cycle) 
• Cycle 10 and beyond: Day 1 (every 4 weeks for a 28-day cycle) 
*At dose levels≥
 mg, the first dose of GEN3009 can be split into 2 consecutive days (eg, 
 mg at C1D1 and remaining amount at C1D2) after approval of the sponsor’s medical monitor.  
Refer to the GEN3009 investigational medicinal product (IMP) manual for additional information 
and guidance on dosage and administration. 
Refer to Section 6.6 for information regarding concomitant therapy. Detailed dose modification 
guidance is provided in Section 7.  
In the Dose Escalation, the DLs will be determined by the starting dose and the escalation steps 
taken in the trial (refer to Section 4.1.1). 
During the Dose Escalation, all subjects must remain at the clinic for at least 4 hours after each 
GEN3009 administration in Cycle 1. Subjects must be instructed to contact the investigator should 
signs or symptoms of IRRs occur following discharge from the 4-hour observation period. An 
CCI
CCI

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observation of up to 24 hours postdose during Cycle 1 is permissible at the discretion of the 
investigator. 
During the Expansion (including safety run-in), all subjects are required to remain at the clinic for 
at least 2 hours after the GEN3009 administration in Cycle 1. Subjects must be instructed to contact 
the investigator should signs or symptoms of IRRs and/or CRS (eg, fever, lightheadedness, 
shortness of breath, etc) occur following discharge. 
6.4.2 
GEN3009 + GEN3013 Combination Cohort 
GEN3009 will be administered as an IV infusion and GEN3013 will be given as an s.c. injection.  
A lead-in dose of GEN3009 will be given 7 days prior to the GEN3009 + GEN3013 combination. 
A step-up dosing of GEN3013 will be used to further reduce the risk of CRS: 0.16 mg on Day 8 
of Cycle 1, 0.8 mg on Day 15 of Cycle 1, then 48 mg on Day 22 of Cycle 1 followed by 48 mg for 
the rest of the cycles.  
On the days when both treatments were given, GEN3013 will be administered at least 1 hour prior 
to the GEN3009 infusion.  
In the safety run-in, 2 DLs of GEN3009 (ie, 
 mg and RP2D) and 1 DL of GEN3013 (ie, 48 mg) 
will be tested. Detailed dosing and schedule are shown in Table 21. 
After safety and tolerability of GEN3009 + GEN3013 in combination have been evaluated in the 
safety run-in, the Expansion of the combination will be opened to further evaluate the preliminary 
anti-tumor activity of GEN3009 at the recommended dose with GEN3013 at 48 mg in R/R 
DLBCL.  
Refer to the IMP manual for additional information and stepwise guidance on dosage and 
administration. 
Refer to Section 6.6 for information regarding concomitant therapy. Detailed dose modification 
guidance is provided in Section 7.  
In the GEN3009 + GEN3013 combination cohort, all subjects are required to remain at the clinic 
for at least 2 hours after the GEN3009 infusion in Cycle 1. Subjects must be instructed to contact 
the investigator should signs or symptoms of IRRs and/or CRS (eg, fever, lightheadedness, 
shortness of breath, etc) occur following discharge. In addition, all subjects must be hospitalized 
for mandatory CRS monitoring for at least 24 hours after the third dose (first full dose) at Cycle 1 
Day 22 of GEN3013 (ie, 48 mg). Additional or longer hospitalization are based on the 
investigator’s discretion. 
6.5 
Treatment Compliance 
All trial medications will be administered by site personnel to assure compliance with trial 
requirements. 
6.6 
Concomitant Medications and Therapies 
6.6.1 
Permitted Concomitant Medications and Therapies 
Investigators may prescribe concomitant medications or treatments deemed necessary to provide 
adequate supportive care except for those medications identified as “prohibited” (Section 6.6.2). 
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The following concomitant medication and therapies are permitted during the trial: 
• Local palliative radiotherapy on non-target lesions is allowed. 
• G-CSF and other hematopoietic growth factors may be used in the management of acute 
toxicity, such as febrile neutropenia and neutropenia, when clinically indicated or at the 
investigator’s discretion. In case of ≥ Grade 3 neutropenia, use of growth factors is mandated 
in the Dose Escalation and Safety Run-in parts of the study. 
• Blood cell transfusion is allowed if clinically indicated. 
• Intravenous immunoglobulin (IVIg) is permitted, if clinically indicated. 
• Multivitamins, vitamin D, calcium, and supplements in prevention of weight loss. Prescribed 
medicinal cannabinoids as palliative therapy are allowed. 
• Anti-hypertensives are allowed as concomitant medications. However, due to the transient 
hypotension observed in the monkey toxicology study, consider withholding anti-hypertensive 
medication for 12 hours prior to infusions. 
The sponsor’s medical monitor/designee should be contacted if there are any questions regarding 
concomitant medication or prior therapy. Refer to Section 7.4.3 for additional guidance on 
permitted/required treatments for toxicity management.  
The trial site will supply supportive medications, eg, premedication, anti-viral medication, anti 
IL-6R. Immediate access to tocilizumab is mandated on site.  
6.6.1.1 
Antibiotic, Antiviral, and Antifungal Therapy  
Prophylactic antibiotic, antiviral and antifungal therapies are allowed. For subjects who are 
considered to have an increased risk for herpes and/or Pneumocystis jiroveci infections, 
prophylaxis is recommended, unless medically contraindicated. For subjects who are considered 
to have an increased risk for other infections, prophylactic therapy is recommended, unless 
medically contraindicated.  
For subjects with a history of recurrent herpes virus infections, herpes infection during previous 
anti-lymphoma therapy, neutropenia and/or low CD4+ cell counts (<200 cells/μL) prophylactic 
antiviral therapy is mandatory, eg, acyclovir 400 mg 3 times a day PO. Prophylaxis against 
P jiroveci, eg, oral trimethoprim/sulfamethoxazole 160 mg/800 mg every other day is mandatory 
to subjects who are considered at increased risk, eg, subjects with low CD4+ cell counts 
(<350 cells/μL). 
Cytomegalovirus reactivation during treatment should be treated according to local standards or 
available guidelines (O'Brien et al., 2006). 
6.6.1.2 
Immunizations 
For subjects treated with GEN3009 and/or GEN3013, physicians should review the subject’s 
vaccination status and subjects should, if possible, be brought up to date with all immunizations 
in agreement with current immunization guidelines prior to initiating treatment. Administer 
vaccines at least 4 weeks prior to start of treatment. 

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6.6.1.3 
Immunoglobulin Therapies  
Immunoglobulins administered at doses on the order of 1 g/kg body weight have the potential to 
alter the clearance of other antibodies. Investigators should therefore be aware that the efficacy of 
GEN3009 and/or GEN3013 may be decreased when administering immunoglobulins at these 
doses, for example for the treatment of immune thrombocytopenia, or other immune, 
inflammatory, or paraneoplastic conditions.  
6.6.2 
Prohibited Concomitant Therapy 
The following medications are prohibited during the trial: 
• Any anti-lymphoma therapy, eg, chemotherapy, radiotherapy or experimental therapy or other 
investigational drugs 
Note: Local palliative radiotherapy for pain relief may be allowed after discussion with the 
sponsor’s medical monitor. Irradiated site cannot be used as measurable, target lesions when 
assessing response to treatment. 
• Corticosteroid that exceed a total daily dose of 10 mg of prednisone or equivalent administered 
for more than 10 days unless for the management of AEs (eg, excluding corticosteroids given 
as premedication or CRS management) 
• Herbal preparations or related OTC preparations containing herbal ingredients are not 
permitted during participation in the trial  
• The use of live, attenuated vaccines is not allowed through the entire duration of trial. Killed 
virus vaccines are allowed. Note: SARS-CoV-2 vaccine is generally permitted, including 
mRNA-based, protein-based, or non-replicating viral vector-based vaccines. Consider 
choosing an appropriate type of SARS-CoV-2 vaccine and consult with an infectious disease 
expert if desired. SARS-CoV-2 vaccine should not be administered during the DLT 
observation period.  
• Investigational agents 
If a subject receives any of these during the trial, the sponsor must be notified for evaluation of 
whether the subject can continue treatment in the trial. 
6.7 
Investigational Medicinal Product Information 
6.7.1 
GEN3009 Information 
GEN3009 is intended for administration by the IV route after dilution. 
6.7.1.1 
Physical Description of GEN3009 
GEN3009 is supplied at 
 mg/mL by the sponsor.  
6.7.1.2 
Packaging and Labeling 
GEN3009 labels will contain information to meet the applicable regulatory requirements. For 
further details see the trial-specific IMP manual. 
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6.7.1.3 
Preparation, Handling, and Storage 
GEN3009 must be stored at controlled temperatures ranging from 2°C to 8°C (35.6°F to 46.4°F). 
GEN3009 must be prepared aseptically at the site pharmacy. Refer to the IMP manual for 
additional guidance on trial drug preparation, handling, and storage. 
6.7.2 
Epcoritamab (GEN3013) Information 
Epcoritamab (GEN3013) is to be administered as an s.c. injection by qualified site personnel. 
Injection site is preferably in the lower part of the abdomen or the thigh. Change of injection site 
from left or right side or vice versa is recommended especially during weekly administration. 
6.7.2.1 
Physical Description of Epcoritamab (GEN3013) 
Epcoritamab (GEN3013) is supplied at 5 mg/mL or 60 mg/mL by the sponsor. 
6.7.2.2 
Packaging and Labelling 
Epcoritamab (GEN3013) labels will contain information to meet the applicable regulatory 
requirements. For further details see the trial-specific IMP manual. 
6.7.2.3 
Preparation, Handling, and Storage 
Epcoritamab (GEN3013) must be stored in a refrigerator at 2°C to 8°C (35.6°F to 46.4°F)  until 
use.  
Epcoritamab (GEN3013) is supplied as a concentrate for solution for s.c. injection. Priming and 
intermediate doses of epcoritamab must be diluted at the site/pharmacy using aseptic techniques. 
Detailed dose preparation instructions including the important dilution steps will be provided in 
the IMP manual. 
6.7.3 
Drug Accountability 
The investigator or designee must maintain an accurate record of the shipment and dispensing of 
trial drug in a drug accountability log. Drug accountability will be verified by the field monitor 
during site visits and at the completion of the trial. At trial close-out, and as appropriate during the 
trial, the investigator is to destroy all used and unused GEN3009 and/or epcoritamab (GEN3013), 
packaging, and drug labels, as per local regulations. A copy of the completed drug accountability 
log and documentation of drug destruction must be provided to the monitor or to the address 
provided in the investigator folder (unless otherwise agreed with sponsor).  
6.8 
Technical Complaint Handling 
A technical complaint is defined as any suspicion of a product defect related to manufacturing, 
labeling, or packaging, ie, any dissatisfaction relative to the identity, quality, durability, or 
reliability of a product, including its labeling or package integrity. A technical complaint may have 
an impact on the safety and efficacy of the product. Timely, accurate, and complete reporting and 
analysis of technical complaint information from trials are crucial for the protection of subjects, 
investigators, and the sponsor, and are mandated by regulatory agencies worldwide. The sponsor 
has established procedures in conformity with regulatory requirements worldwide to ensure 

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appropriate reporting of technical complaint information; all trials conducted by the sponsor or its 
affiliates will be conducted in accordance with those procedures. 
6.8.1 
Procedures 
All initial technical complaints must be reported to the sponsor by the trial-site personnel within 
24 hours after being made aware of the event. 
If the defect is combined with an AE, the trial-site personnel must report the AE to the sponsor 
according to the AE and SAE reporting process and timelines (Section 10.4) in addition to 
reporting the technical complaint. A sample of the suspected product should be maintained for 
further investigation if requested by the sponsor. 
6.8.2 
Contacting Sponsor Regarding Product Quality 
The names (and corresponding telephone numbers) of the individuals who should be contacted 
regarding technical complaint issues are listed on the contact information page(s), which will be 
provided as a separate document. 

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7 
DOSE MODIFICATIONS AND SAFETY MANAGEMENT GUIDELINES 
7.1 
Dose-limiting Toxicities 
7.2 
Dose Escalation: Dose-limiting Toxicity  
For the Dose Escalation, the DLT assessment period is defined as 28 days from the start of the 
first GEN3009 administration on C1D1. 
The occurrence of any of the toxicities outlined in this section will be considered a DLT.  
All Grade 5 toxicities 
Hematologic: 
• Thrombocytopenia Grade 4 (<25.0 × 109/L [<25,000/µL]) that is not due to underlying 
malignancy or extraneous cause 
• Neutropenia Grade 4 (<0.5 × 109/L [<500/µL]) lasting >7 days not attributable to underlying 
disease 
• Febrile neutropenia Grade 3 or 4 lasting >2 days (ie, absolute neutrophil count [ANC] <1.0 × 
109 cells/L with a single temperature of >38.3°C [100.9°F] or a sustained temperature of ≥38°C 
[100.4°F] for more than 1 hour) 
• Grade 3 or 4 hemorrhage associated with thrombocytopenia of ≥Grade 3 requiring platelet 
transfusion 
• Anemia Grade 4. 
• TLS Grade 4 (see Appendix 4 for additional information) 
Non-hematologic: 
• All non-hematological AEs of grade ≥ 3 (severe or life-threatening), excluding the following: 
a. Fever Grade 3 (>40.0°C [>104.0°F]) for ≤24 hours  
b. Hypotension Grade 3 (medical intervention indicated; hospitalization indicated) 
resolving in ≤24 hours  
c. Laboratory values out of normal range that do not have any clinical consequence, are 
clinically transient in nature and that resolve in ≤3 days (including electrolyte 
abnormalities that respond to medical intervention) 
d. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) Grade 3 
returning to Grade 1 or baseline in ≤7 days 
e. Nausea Grade 3 that responds to adequate antiemetic treatment in ≤3 days 
f. Vomiting Grade 3 that responds to adequate antiemetic treatment in ≤3 days 
g. Diarrhea Grade 3 that responds to adequate antidiarrheal treatment in ≤3 days 
h. Fatigue/asthenia Grade 3 when fatigue/asthenia was present at baseline or that lasts for 
<14 days 
i. Alopecia (no grading) 

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Frequent laboratory monitoring of complete blood count including differential should be initiated 
to document start and resolution of hematological AEs. All AEs occurring during the defined DLT 
evaluation period will be assessed according to the criteria above. All AEs, including those not 
qualifying for a DLT, will be monitored and included in the evaluation of the toxicity profile of 
GEN3009 unless the event is clearly determined to be unrelated to GEN3009. 
7.3 
Safety Run-in for Expansion: Dose-limiting Toxicity  
For the Expansion GEN3009 + GEN3013 combination cohort safety run-in, the DLT assessment 
period is defined as 28 days from the start of the first GEN3009 administration on C1D1. 
The occurrence of any of the toxicities outlined in this section will be considered a DLT.  
All Grade 5 toxicities 
Hematologic: 
• Thrombocytopenia Grade 4 (<25.0 × 109/L [<25,000/µL]) lasting >7 days not attributable 
to underlying disease 
• Neutropenia Grade 4 (<0.5 × 109/L [<500/µL]) lasting >7 days not attributable to 
underlying disease 
• Febrile neutropenia Grade 3 or 4 lasting >2 days (ie, ANC <1.0 × 109 cells/L with a single 
temperature of >38.3°C [100.9°F] or a sustained temperature of ≥38°C [100.4°F] for more 
than 1 hour) 
• Grade 3 or 4 hemorrhage associated with thrombocytopenia of ≥Grade 3 requiring platelet 
transfusion 
• Anemia Grade 4 
• TLS Grade 4 (see Appendix 4 for additional information) 
Non-hematologic: 
• All non-hematological AEs of Grade ≥3 (severe or life-threatening), excluding the 
following: 
a. CRS Grade 3 according to American Society for Transplantation and Cellular Therapy 
(ASTCT) criteria (Lee et al., 2019), which has improved to Grade ≤2 or resolved 
(Grade 0) within 48 hours 
b. ICANs Grade 3 according to ASTCT criteria (Lee et al., 2019), which has improved to 
Grade ≤2 or resolved (Grade 0) within 48 hours 
c. Fever Grade 3 (>40.0°C [>104.0°F]) for ≤24 hours (this applies to fever not considered 
a symptom of other toxicities such as CRS) 
d. Hypotension Grade 3 (medical intervention indicated; hospitalization indicated) 
resolving in ≤24 hours (this applies to hypotension not considered a symptom of other 
toxicities such as CRS) 
e. Laboratory values out of normal range that do not have any clinical consequence, are 
clinically transient in nature and that resolve in ≤ 7 days (including electrolyte 
abnormalities that respond to medical intervention) 
f. AST and/or ALT Grade 3 returning to Grade 1 or baseline in ≤7 days 

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g. Nausea Grade 3 that responds to adequate antiemetic treatment in ≤3 days 
h. Vomiting Grade 3 that responds to adequate antiemetic treatment in ≤3 days 
i. 
Diarrhea Grade 3 that responds to adequate antidiarrheal treatment in ≤3 days 
j. 
Fatigue/asthenia Grade 3 when fatigue/asthenia was present at baseline or that lasts for 
<14 days 
k. Alopecia (no grading) 
Frequent laboratory monitoring of complete blood count including differential should be initiated 
to document start and resolution of hematological AEs. All AEs occurring during the defined DLT 
evaluation period will be assessed according to the criteria above. All AEs, including those not 
qualifying for a DLT, will be monitored and included in the evaluation of the toxicity profile of 
GEN3009 in combination with GEN3013 unless the event is clearly determined to be unrelated to 
GEN3009 and/or GEN3013. 
7.4 
Dose Modification Guidance and Safety Stopping Criteria 
7.4.1 
Dose Escalation Part (GEN3009 Monotherapy) 
If a subject experiences a DLT, the subject may continue treatment with GEN3009, if the toxicity 
recovers to ≤ Grade 2 or baseline within 4 weeks from occurrence of the DLT. Continued 
administration of GEN3009 must be agreed to between the sponsor and the investigator based on 
a thorough assessment of the event, the duration of the event, and benefit-risk for the subject. In 
the event a subject experiences a second episode of a DLT with GEN3009, the treatment will be 
permanently discontinued. Treatment with GEN3009 will be discontinued in the event the DLT is 
not resolved within 4 weeks. 
• If a subject experiences toxicity that qualifies as a DLT but occurs after the 4-week DLT 
evaluation period, the subject’s benefit-risk must be thoroughly assessed. Continued treatment 
with GEN3009 must be agreed between the sponsor and the investigator. 
• For the subject who receives more than 4 doses of GEN3009, ie, treatment beyond the DLT 
evaluation period, all corresponding AEs that meet the DLT criteria will be considered for the 
purpose of determining the MTD and/or the RP2D. For the declaration of the RP2D of 
GEN3009 in the Expansion and for further development, the totality of the data from Dose 
Escalation (including safety, PK, pharmacodynamics, and preliminary efficacy will be 
evaluated). 
• During the trial, a planned dose of GEN3009 can be postponed for up to 4 weeks from the last 
dose of trial drug for an AE whether it is considered drug-related or not. 
• In case of dose delay of more than 4 weeks from the last trial drug administration due to 
toxicity, GEN3009 should be discontinued, unless approved by the sponsor’s medical monitor. 
• During the trial, the GEN3009 dose can be held for the following laboratory results: 
a. If platelet count <50×109/L, hold dose until platelet count is ≥ 50×109/L. 
b. If febrile neutropenia <0.5×109/L, hold dose until neutrophil count is ≥0.5×109/L. 
c. If hemoglobin is <8 g/dL (<5 mmol/L), hold dose until hemoglobin ≥8 g/mL 
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Note: If the investigator deems any of the above cytopenia as bone marrow involvement due to 
the disease, continuation of GEN3009 treatment can be discussed with the sponsor’s medical 
monitor. Transfusion with blood products and/or administration with G-CSF is permitted if needed 
(refer to Section 6.6.1). 
7.4.2 
Expansion Part (Including Safety Run-in) 
7.4.2.1 
GEN3009 Dose Modification Rules 
Dose reduction is not allowed for GEN3009.  
Dose delay is allowed for GEN3009 for the management of toxicities. GEN3009 administration 
can be postponed up to 4 weeks from the next scheduled date.  
• If a dose is delayed more than 4 weeks from the next scheduled dosing date due to toxicity, 
GEN3009 should be discontinued, unless approved by the sponsor’s medical monitor. 
• If a GEN3009 dose is delayed or withheld for any reason, GEN3013 may be continued, if 
clinically indicated, after consultation with the sponsor’s medical monitor. 
• If GEN3009 is discontinued, GEN3013 can be continued if approved by the sponsor’s 
medical monitor. 
7.4.2.2 
GEN3013 Dose Modification Rules 
Dose reduction is not allowed for GEN3013 on an individual subject level in this trial. Refer to 
Section 4.3 for dosing rationale. 
If a dose is delayed more than 6 weeks, the subject should be asked to perform an unscheduled 
visit for collection of AEs, concomitant medications, laboratory values (including hematology, 
biochemistry, and coagulation values), and a limited physical examination (as clinically indicated) 
after consultation with the sponsor’s medical monitor. 
A repriming cycle is necessary if dose is delayed at certain time points, as described below. A 
repriming cycle consists of a weekly schedule of a priming dose, intermediate dose, and 2 full 
doses. Refer to Table 15 for the repriming cycle Visit Assessment Schedule.  
A repriming cycle should occur: 
• For the second GEN3013 full dose onward (ie, C2D1), if the interval between the previous 
dose of GEN3013 and next planned dose exceeds 6 weeks.  
During the repriming cycle, CRS prophylaxis must be resumed with 3 consecutive days of 
corticosteroids beginning at each GEN3013 dose, until at least 1 full dose of GEN3013 is 
administered without subsequent occurrence of CRS Grade ≥2 (see Section 6.2.2). 
Once the full repriming cycle is completed, the subject should resume treatment with Day 1 of the 
next planned cycle (subsequent to the cycle during which the dosing was delayed). For example, 
if the subject experiences a 7-week delay after C3D1, the subject should receive a repriming cycle, 
then continue treatment at C4D1. GEN3009 dose will continue as scheduled. 
If GEN3013 dose is delayed, withheld, or discontinued during the combination treatment period, 
GEN3009 can be continued if approved by the sponsor’s medical monitor. 
Refer to Section 7.4.3 for information about dose modifications due to AEs. 

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7.4.3 
Dose Modification Guidelines for Toxicity Management 
Refer to Section 6.2.1 and Section 6.2.2 for requirements on premedication, and Section 6.3, 
Section 6.6.1, Section 7.5, Appendix 13, and Appendix 14 for guidance on prevention and 
management of specific AEs.  
7.4.3.1 
Cytopenias (All Cohorts) 
GEN3009 and/or GEN3013 dose (regardless of being monotherapy or combination therapy) will 
be held for up to 4 weeks for the following hematologic laboratory results: 
Table 25 Dose Modification Rules for Cytopenias 
Laboratory Parameter 
Laboratory Value 
Hold GEN3009 and/or GEN3013 Dose 
Resume GEN3009 and/or GEN3013 
Dose 
Platelet counta 
<50 × 109/L 
≥50 × 109/L 
Neutrophil count 
<0.5 × 109/L 
≥0.5 × 109/L 
Hemoglobin 
<8 g/dL (<5 mmol/L) 
≥8 g/dL (>5 mmol/L) 
No dose-reduction is allowed for GEN3009 or GEN3013, but a repriming cycle may be needed if the interval 
between the previous dose of GEN3013 and next planned dose exceeds 6 weeks. 
a. In subjects with CLL having platelets ≥30×109/L (30,000/µL) can be dosed after the 
consultation with the sponsor’s medical monitor. 
Note: If the investigator deems any of the above cytopenias are secondary to bone marrow 
involvement by the disease, continuation of study treatment can be discussed with the sponsor’s 
medical monitor. Transfusion with blood products (eg, RBC, platelets) and/or administration with 
G-CSF is permitted if needed. G-CSF must be used in case of ≥Grade 3 neutropenia during Dose 
Escalation and safety run in parts of the study. See Sections 6.6.1 and 7.5.1. 
7.4.3.2 
Cytokine Release Syndrome (the GEN3009 + GEN3013 Combination Cohort)  
CRS has been reported with the use of GEN3013. To date, CRS is not a known/identified risk with 
GEN3009. Refer to Section 7.5.2 and Appendix 13 for guidelines for grading and supportive care 
for CRS management. 
CRS must be graded according to the ASTCT grading for CRS (Lee et al., 2019). 

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Table 26 GEN3013 Dose Modification for Cytokine Release Syndrome (GEN3009 + 
GEN3013 Combination Cohort) 
CRS  
ASTCT Grade 
Dose Modification 
Grade 1 
• 
Hold GEN3013 (and GEN3009 if given in combination) until resolution of CRS 
event and treat the subject (see Appendix 13) 
Grade 2 
• 
Hold GEN3013 (and GEN3009 if given in combination) until resolution of CRS 
event and treat the subject. 
• 
If Grade 2 or higher CRS occurs with the second full dose or beyond, 
administer CRS prophylaxis with the next dose until a GEN3013 dose is given 
without subsequent CRS (of any grade) 
Grade 3 lasting less than 
72 hours 
• 
Hold GEN3013 (and GEN3009 if given in combination) until resolution of CRS 
event and treat the subject. 
• 
Continue with the next planned GEN3013 dose at the planned date and 
hospitalize the subject for at least 72 hours following this GEN3013 
administration. 
• 
If Grade 2 or higher CRS occurs with the second full dose or beyond, 
administer CRS prophylaxis with the next dose until a GEN3013 dose is given 
without subsequent CRS (of any grade) 
Grade 3 lasting longer 
than 72 hours 
• 
Permanently discontinue administration of GEN3013 and treat the subject (see 
Appendix 13)  
Grade 3, second 
occurrence (ie, 2 separate 
Grade 3 events) 
• 
Permanently discontinue administration of GEN3013 even if each event 
resolved to Grade 2 within 72 hours, and treat the subject (see Appendix 13) 
Grade 4 CRS 
• 
Permanently discontinue administration of GEN3013 and treat the subject (see 
Appendix 13) 
7.4.3.3 
Tumor Lysis Syndrome (All Cohorts) 
In cases of TLS, hold GEN3009 and/or GEN3013 (regardless of being monotherapy or 
combination therapy) until the TLS has resolved.  
TLS should be reported as an AE, using the National Cancer Institute Common Terminology 
Criteria for Adverse Events (CTCAE) Version 5.0 grading, whereas clinical TLS should be 
reported as an AESI, using Cairo-Bishop grading (see Appendix 4). 
Refer to Section 7.5.4 for prevention and management of TLS. 
7.4.3.4 
Immune Effector Cell-Associated Neurotoxicity Syndrome (GEN3009 + 
GEN3013 Combination Cohort) 
ICANS has been reported with the use of GEN3013. To date, ICANS is not a known/identified 
risk with GEN3009. See Table 27 for information on GEN3013 dose modification for ICANS. 
Refer to Section 7.5.3 for supportive care and Appendix 13 grading of ICANS. 

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Table 27 GEN3013 Dose Modification for ICANS (GEN3009 + GEN3013 Combination 
Cohort) 
ICANS 
ASTCT Grade 
Dose Modification 
Grade 1 or 2 
• 
Hold GEN3013 (and GEN3009 if given in combination) until resolution of 
ICANS to Grade 0 and treat the subject appropriately. 
Grade 3 or 4 
• 
Permanently discontinue administration of GEN3013 and treat the subject 
appropriately. 
7.4.3.5 
All Other AEs Related to GEN3009 and/or GEN3013 
Relationship assessment will be based on the Investigator’s judgement.  
Table 28 Dose Modification for All Other GEN3009 and/or GEN3013-Related AEs 
CTCAE Grade 
Dose Modification 
Grade 1  
• 
Continue study drug 
Grade 2  
• 
Continue study drug  
Grade 3* 
• 
First episode: May hold treatment until improvement to ≤ Grade 2 or resolution to 
baseline.  
• 
Second episode of the same AE considered related to study drug: Hold treatment 
until improvement to ≤ Grade 2 or resolution to baseline and permanently 
discontinue if no improvement within 14 days unless otherwise agreed upon with the 
sponsor’s medical monitor. 
Grade 4a 
• 
First episode: Hold treatment until improvement to ≤ Grade 2 or resolution to 
baseline. 
• 
Second episode of same AE considered related to study drug: Permanently 
discontinue study drug unless otherwise agreed upon with the sponsor’s medical 
monitor. 
a. This may exclude any asymptomatic isolated laboratory abnormalities without any clinical consequences such 
as hypoalbuminemia, hypophosphatemia, hyponatremia, etc. 
7.5 
Management of Specific Adverse Events 
7.5.1 
Neutropenia and Other Cytopenias (All Cohorts) 
G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity, 
such as febrile neutropenia and neutropenia, when clinically indicated or at the investigator’s 
discretion.  
• In case of ≥ Grade 3 neutropenia, use of growth factors is mandated during Dose Escalation 
and Safety Run-in parts of the study.  
Neutropenic fever should be evaluated immediately for any potential underlying reason (eg, blood 
cultures, imaging, etc) and managed based on local institutional guidelines ensuring appropriate 
anti-infective prophylaxis. 
For other cytopenias, blood or platelet transfusion should be given based on local institutional 
guidelines.  
Complete blood counts should be monitored until count recovery. 

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7.5.2 
Supportive Care for Cytokine Release Syndrome (Expansion GEN3009 + 
GEN3013 Combination Cohort Only) 
Rescue medication in terms of an antidote to reverse the action of GEN3013 is not available. 
Potential adverse effects of GEN3013 have to be treated symptomatically. For treatment of CRS 
patients should receive supportive care according to Appendix 13.  
The supportive care can include, but is not limited to:  
• Infusion of saline  
• Systemic glucocorticosteroid, antihistamine, antipyretic  
• Support for blood pressure (vasopressin, vasopressors)  
• Support for low-flow and high-flow oxygen and positive pressure ventilation 
• Monoclonal antibody against IL-6R, IL-6 or IL-1 (eg, tocilizumab, siltuximab, and/or 
anakinra)  
• Blood product support, analgesics, skin and mouth care, etc, should be according to local 
guidelines and investigator’s discretio. 
7.5.3 
Supportive Care for Immune Effector Cell-Associated Neurotoxicity Syndrome 
(Expansion GEN3009 + GEN3013 Combination Cohort Only) 
Close monitoring of mental status during treatment is important to secure a timely start of 
supportive care as needed. Supportive care can include, but is not limited to:  
• Initiation of IV hydration  
• Withhold oral intake  
• Avoid medications that cause central nervous system depression  
• Initiation of corticosteroids  
• Anti-cytokine therapy  
• Anti-convulsive therapy 
7.5.4 
Tumor Lysis Syndrome Prevention and Management (All Cohorts) 
To prevent TLS, all subjects should receive appropriate hydration and allopurinol according to 
local standards or available guidelines (Coiffier et al., 2008). Subjects who are considered to have 
an increased risk for TLS, eg, due to the type of lymphoma, the tumor burden (bulky disease and/or 
elevated lactate dehydrogenase), renal impairment and/or elevated uric acid should be considered 
for hydration and prophylactic treatment with a uric acid-lowering agent as well as frequent 
monitoring. If signs of TLS occur, supportive therapy, including rasburicase, may be used as 
clinically indicated at the investigator’s discretion. In addition, close monitoring of laboratory 
parameters to allow for early diagnosis of a possible TLS is recommended.  
For details, refer to Table 4 and Table 15 for the minimum sampling time points for tumor lysis. 
Definition of TLS and guidance for grading of TLS events are provided in Appendix 4.  

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7.5.5 
Tumor Flare Reaction Management (All Cohorts) 
Subjects in this trial should be monitored for tumor flare reaction (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, diffuse rash, and in some cases 
increase in the peripheral blood lymphocyte counts. TFR will be assessed according to the 
following criteria: 
• Grade 1: Mild pain not interfering with function 
• Grade 2: Moderate pain; pain or analgesics interfering with function, but not interfering 
with activities of daily living (ADL) 
• Grade 3: Severe pain; pain or analgesics interfering with function and interfering with ADL  
• Grade 4: disabling  
• Grade 5: death 
Treatment of TFR is up to the discretion of the investigator depending upon the severity and 
clinical situation. It is suggested that ≥Grade 2 TFR be treated with corticosteroids at the 
investigator’s discretion. NSAIDs (ie, ibuprofen 400 to 600 mg orally every 4 to 6 hours as needed) 
and/or narcotic analgesics for pain management may also be administered as needed. In mild to 
moderate cases, it is suggested that GEN3009 and/or GEN3013 be continued along with 
symptomatic treatment as indicated above. 
 

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8 
DISCONTINUATION, FOLLOW-UP AND COMPLETION 
8.1 
Discontinuation of Treatment 
A subject’s trial drug may be discontinued for any of the following reasons: 
• Unacceptable AE requiring treatment discontinuation (refer to Section 7)* 
• Subject non-compliance 
• Sponsor decision 
• Subject request to discontinue treatment* 
• Pregnancy 
• Clinical progression* 
• Disease progression according to response criteria 
• Other 
*Imaging should continue to be performed until evidence of radiographic disease progression 
despite treatment discontinuation. When a subject discontinues trial drug, they are to remain on 
trial and are to be followed until death, initiation of subsequent therapy, or any other reason listed 
in Section 8.2. 
Subjects should be examined regularly according to the protocol schedule, or more frequently, as 
needed. If the decision to discontinue trial drug treatment occurs around the time of the next 
planned treatment administration visit, the assessment schedule for the treatment discontinuation 
visit should be followed. Subjects should be followed for safety within 30 days of the last 
administration of trial drug in GEN3009 monotherapy cohorts and 60 days of the last 
administration of trial drug in GEN3009 + GEN3013 combination cohort 
8.2 
Withdrawal from the Trial 
Subjects are to be withdrawn from the trial (Dose Escalation or Expansion) for the following 
reasons: 
• Death 
• Lost to follow-up (refer to Section 8.4) 
• The investigator or sponsor believes (eg, that for safety or tolerability reasons [eg, AE]) it is in 
the best interest of the subject to discontinue the trial intervention 
• Subject withdraws consent from the trial 
• Other 
If the subject withdraws consent for disclosure of future information, the sponsor may retain and 
continue to use any data collected or generated before such a withdrawal of consent. A subject 
may choose to discontinue from any future trial assessments (eg, dosing, imaging, blood sampling, 
etc) but agree to remain in the trial and to be followed for survival follow-up, without withdrawal 
of consent. If a subject withdraws consent from the trial, they may request destruction of any 
samples (including those collected for biomarker testing) taken and not tested, and the investigator 
must document this in the site trial records. When a subject withdraws consent, the reason for 
withdrawal is to be documented in the source document. Trial drug assigned to the withdrawn 
subject may not be assigned to another subject. Subjects who withdraw will not be replaced. The 

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investigator and sponsor will make every effort to ensure subject data are followed for completion 
of all trial safety assessments including the safety follow-up visit and survival follow-up (refer to 
Table 3, Table 6, and Table 11) at the time of trial discontinuation.  
8.3 
Safety Follow-up Visit 
Subjects discontinuing from treatment for any reason will have a safety follow-up visit 30 days 
after the last dose of trial drug in GEN3009 monotherapy cohorts and 60 days after the last 
administration of trial drug in the GEN3009 + GEN3013 combination cohort. If the subject 
initiates new anti-lymphoma therapy after the discontinuation of treatment, the safety follow-up 
visit should be performed prior to starting new anti-cancer therapy. Once the safety follow-up visit 
is completed, the subject will move into survival status follow up (refer to Section 9.3.6). 
8.4 
Lost to Follow-Up 
For subjects whose status is unclear because they fail to appear for trial visits without stating an 
intention to withdraw consent, the investigator should show “due diligence” by contacting the 
subject, family, or family physician as agreed in the ICF and by documenting in the source 
documents steps taken to contact the subject, eg, dates of telephone calls, registered letters, etc. A 
subject should not be considered lost to follow up until due diligence has been completed 
(minimum of 3 documented attempts).  
 

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9 
TRIAL ASSESSMENTS 
9.1 
Demography and Baseline Assessments 
9.1.1 
Demographics 
Demographic details will be assessed and recorded at screening. 
9.1.2 
Disease Status 
A subject’s history relating to the underlying disease, including primary diagnosis, date of 
diagnosis, as well as disease status at trial entry, prior evidence of CD20 positivity (the GEN3013 
+ GEN3009 combination arm), and staging criteria (ie, Ann Arbor staging for B-cell NHL [refer 
to Appendix 5] and Rai or Binet staging for CLL/SLL [refer to Appendix 6]) will be recorded at 
screening. 
9.1.3 
Medical History 
Any medical condition (signs, symptoms, and diagnosis) occurring prior to first GEN3009 and/or 
GEN3013 dose should be documented as medical history. Medical conditions that occur after the 
ICF is signed and prior to the first GEN3009 and/or GEN3013 dose should only be reported as 
AEs if they were assessed by the investigator to be caused by a protocol-mandated procedure (ie, 
tumor biopsy and/or CT scan), including washout or discontinuation of prior medications. 
Any medical history/current medical condition that worsens after the first dose of GEN3009 and/or 
GEN3013 will be documented as an AE. See additional details in Section and 10.2. 
9.1.4 
Concomitant Medication and Procedures 
Any medication or therapy (including OTC or prescription medicines, vitamins, and/or herbal 
supplements, vaccinations, and blood transfusions) other than GEN3009 is considered 
concomitant medication and must be recorded. Relevant prior concomitant medication 
administered and/or procedures during the trial must be recorded from <21 days prior to the first 
dose of GEN3009 and up to 30 days after the last dose of GEN3009 in the monotherapy arms and 
60 days after the last dose of GEN3009 + GEN3013 in the combination arm. The subject must be 
instructed to notify the investigational site about any new medications he or she takes after the 
start of the trial drug. The medical monitor should be contacted if there are any questions regarding 
concomitant or prior therapy/procedures. 
9.1.5 
Prior Cancer Therapy and Surgery 
Administration of prior treatment for B-cell NHL, including surgery, radiotherapy, chemo-
radiotherapy, systemic treatment regimens etc, from the time of the initial diagnosis until 
enrollment in this trial will be documented.  
In addition, the best response, reason for discontinuation, dates of administration, and progression 
should be reported for anti-cancer therapies.  

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9.2 
Efficacy Assessment 
9.2.1 
Definition of Measurable and Assessable Disease  
Eligible subjects with B-cell NHL must have at least 1 measurable site of disease (refer to inclusion 
criteria Section 5.1) for disease evaluations. Measurable sites of lymphoma are defined as lymph 
nodes, lymph node masses, or extranodal sites. The measurement must be determined by imaging 
evaluation by the local radiologist. Up to 6 measurable sites will be followed as indicator (target) 
lesions for each subject. All other sites of disease will be considered assessable by objective 
evidence of disease (ie, radiographic imaging, bone marrow assessment, physical examination, or 
other procedures as necessary), but is not measurable (nontarget) as defined above. Examples of 
accessible disease may include bone marrow involvement, bone lesions, effusions, or thickening 
of bowel wall. 
9.2.2 
Evaluations 
Efficacy assessments will be conducted as specified in the visit assessment schedules (refer to 
Table 2, Table 3, Table 5, Table 6, Table 10, and Table 11 will include the following: imaging 
assessments (including hepatic involvement and splenic involvement [size by vertical: cranial to 
caudal]), bone marrow assessment (as applicable), physical exam including constitutional 
symptoms, ECOG performance status, MRD status, and other procedures as necessary. All 
efficacy assessments should be conducted throughout the trial until disease progression, the start 
of new anti-cancer therapy, death or withdrawal of consent from trial participation, whichever 
occurs first. 
Response assessment for B-cell NHL will be according to revised response criteria (Cheson et 
al., 2014) (refer to Appendix 7) and for CLL according to the iwCLL (Hallek et al., 2018) (refer 
to Appendix 8). 
9.2.2.1 
Radiographic Assessment 
For B-cell NHL excluding CLL, an 18F-FDG-PET CT (or CT/MRI and FDG-PET when PET CT 
not available) must be performed at screening (ie, within 3 weeks prior to the first dose of 
GEN3009). For subjects with FDG-avid tumors at screening, all subsequent disease assessments 
will be performed with FDG-PET CT using the 5-point scale (Barrington et al., 2014). For subjects 
with 
non-avid 
or 
variably 
FDG-avid 
tumors, 
CT 
scan 
with 
IV 
contrast 
of 
neck/chest/abdomen/pelvis/additional known lesions will be performed. The CT component of the 
PET CT may be used in lieu of a standalone CT/MRI, only if the CT component is of similar 
diagnostic quality as a contrast enhanced CT performed without PET. If contrast enhanced PET 
CT is not available, a standalone diagnostic CT/MRI and a standard FDG-PET should be 
performed. If independent CT and PET scanners are used, and the subject is receiving both scans 
on the same day, the PET must be performed prior to the CT with IV contrast so as to not 
compromise PET results. The PET CT acquisition methodology (eg, administration of intravenous 
contrast) should remain consistent between screening and subsequent assessments for any given 
subject. 
For CLL, CT/MRI must be performed at screening (ie, within 3 weeks prior to the first dose of 
GEN3009) and subsequent response assessments. 

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MRI may be used to evaluate sites of disease that cannot be adequately imaged using CT (in cases 
where MRI is desirable, the MRI must be obtained at screening and at all subsequent response 
evaluations). For all other sites of disease, MRI studies do not replace the required neck, chest, 
abdomen, and pelvic CT scans. 
In monotherapy cohorts, an MRI or CT scan of the brain (with lumbar puncture) at screening and 
during the course of trial should be performed if clinically indicated. In the combination cohort 
with GEN3013, an MRI or CT scan of the brain is mandatory during screening within 21 days of 
C1D1, and lumbar puncture is required only if clinically indicated and required within 21 days of 
C1D1.  
Imaging assessment schedules in both the Dose Escalation and Expansion are: at screening, on 
Cycle 2 (Week 6), Cycle 3 (Week 12), Cycle 5 (Week 18), Cycle 6 (Week 24), Cycle 9 (Week 
36), Cycle 12 (Week 48), and every 24 weeks (Cycle 18, 24, etc.) thereafter until confirmation of 
disease progression is assessed by the investigator, the start of new anti-cancer therapy, withdrawal 
of consent, or death, whichever occurs first. All assessments will be determined from the first dose 
date and will follow the counting of calendar days and not the dosing cycles. Refer to Table 29 for 
details. Refer to Appendix 9 for PET positivity evaluation. 
Additional imaging assessments may be performed at any time during the trial at the investigator’s 
discretion to support the efficacy evaluations for a subject as necessary. Clinical suspicion of 
disease progression at any time requires a physical examination and imaging assessments to be 
performed promptly rather than waiting for the next scheduled imaging assessment.  
Table 29 Imaging Assessments During Dose Escalation and Expansion 
Subject Diagnosis 
Imaging 
Screening 
On-treatment Assessment 
B-cell NHL 
FDG-PET CT  
Required within 3 weeks 
(ie, 21 days) before 
Cycle 1 Day 1 
Required at: 
Cycle 2 (Week 6±7 days), 
Cycle 3 (Week 12±7 days), 
Cycle 5 (Week 18±7 days), 
Cycle 6 (Week 24±14 days),  
Cycle 9 (Week 36±14 days) 
Cycle 12 (Week 48±14 days) 
then every 24 weeks thereafter 
(ie, Cycle 18, 24, 36±14 days, 
etc) until confirmation of 
disease progression, start of 
new anti-cancer therapy, 
withdrawal of consent, or 
death, whichever comes first 
 
 
 
B-cell NHL including CLL CT/MRI (neck, chest, 
abdomen, and pelvis) 
 
Note: For subjects 
with non-avid or 
variably FDG-avid 
tumors, CT scan with 
IV contrast of 
neck/chest/abdomen/p
Required within 3 weeks 
(ie, 21 days) before 
Cycle 1 Day 1 
Required at: 
Cycle 2 (Week 6±7 days), 
Cycle 3 (Week 12±7 days),  
Cycle 5 (Week 18±7 days), 
Cycle 6 (Week 24±14 days),  
Cycle 9 (Week 36±14 days) 
Cycle 12 (Week 48±14 days) 

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Subject Diagnosis 
Imaging 
Screening 
On-treatment Assessment 
elvis/additional known 
lesions will be 
performed 
MRI may be used to 
evaluate sites of 
disease that cannot be 
adequately imaged 
using CT 
then every 24 weeks thereafter 
(ie, Cycle 18, 24, 36±14 days, 
etc.) until confirmation of 
disease progression, start of 
new anti-cancer therapy, 
withdrawal of consent, or 
death, whichever comes first 
B-cell NHL including CLL CT/MRI of brain 
1. Required at screening 
if clinically indicated to 
rule out CNS 
involvement in 
GEN3009 monotherapy 
cohorts 
2. Required at screening 
in all subjects in 
GEN3009 + GEN3013 
combination cohort 
Required as clinically indicated 
9.2.2.2 
Bone Marrow Assessment  
For all CLL subjects and B-cell NHL subjects with bone marrow involvement, fresh bone marrow 
biopsy and bone marrow aspirate must be obtained at screening (ie, within 3 weeks prior to the 
first dose of GEN3009) and at the time of CR or as clinically indicated. However, archival bone 
marrow biopsy obtained as routine SOC taken within 28 days before the first dose of GEN3009 is 
acceptable. Fresh bone marrow aspirate is mandatory at screening.  
• Bone marrow evaluation must include morphological examination and either flow cytometry 
or immunohistochemistry (IHC). 
• For CLL subjects and B-cell NHL subjects with bone marrow involvement, a portion of the 
bone marrow aspirate collected at screening and to confirm CR will be used for MRD 
assessments.  
• For B-cell NHL subjects with no bone marrow involvement at baseline, no bone marrow for 
MRD is required.  
• If a subject is MRD-positive in the bone marrow but maintains CR, an additional bone marrow 
aspirate will be collected after 3 months, if clinically feasible. 
A bone marrow biopsy with aspirate from CLL subjects should be obtained during the trial for the 
following:  
• To confirm a CR or nodular partial remission that is supported by physical examination 
findings, laboratory evaluations and radiographic evaluations (Hallek et al., 2018); 
• If progression is only shown in 1 parameter to confirm cytopenic progression (ie, neutropenia, 
anemia, and/or thrombocytopenia and to distinguish from autoimmune and treatment-related 
cytopenias). 
Refer to Table 30 for details.  

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Table 30 Bone Marrow Biopsy and Aspirate Collection During Dose Escalation and 
Expansion 
Subject 
Diagnosis 
Procedure 
Screening 
On-treatment Assessment 
• 
CLL 
 
• 
Lymphomas 
with bone 
marrow 
involvement 
• 
Bone Marrow 
Aspirate 
• 
Fresh bone marrow 
aspirate is required. 
• 
Bone marrow aspirate is required at 
the time of CR or as clinically 
indicated.  
• 
If at CR, bone marrow has MRD, 
additional aspirate will be collected 
after 3 months, if clinically feasible 
• 
For CLL only: bone marrow biopsy 
is required to confirm nodular 
partial remission; or if progression 
is shown in 1 parameter to confirm 
cytopenic progression  
• 
Bone Marrow 
Biospy 
• 
Fresh bone marrow 
biopsy is required. 
Archival bone 
marrow biopsy 
obtained as routine 
standard of care 
within 28 days of 
Cycle 1 Day 1 is 
acceptable 
9.2.2.3 
Minimal Residual Disease Assessment (MRD) 
MRD will be assessed by tracking the presence of DNA that encodes the B cell receptor (BCR) 
expressed specifically by the cancer cells. The DNA sequence of this BCR will be identified in the 
tumor biopsy that is requested at screening and/or in bone marrow aspirate using next-generation 
sequencing (NGS) (see Figure 2). After start of treatment, blood samples are requested at fixed 
timepoints and at time of CR to assess whether the amount of cancer DNA is declining, as a 
potential measure of (early) response, and to assess MRD.  
As an exploratory analysis, when a subject reaches a CR by FDG-PET (or by CT/MRI for non-
FDG avid disease) and having bone marrow involvement documented at screening, a portion of 
the aspirate collected to confirm CR will be used to assess MRD. Subjects having no bone marrow 
involvement at screening will not require further bone marrow examination for MRD. 

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Figure 2 MRD Assesment by Tracking Malignant Clonotype 
 
9.2.3 
Assessment of Disease Response and Progressive Disease  
9.2.3.1 
Assessment of Response 
Tumor response according to imaging assessment as described in visit assessment schedules (refer 
to Table 2, Table 3, Table 5, Table 6, Table 10, and Table 11) will be performed by the 
investigators at the site to make decisions for continuation of treatment.  
For B-cell NHL, tumor response will be determined according to Recommendations for Initial 
Evaluation, Staging, and Response Assessment of Hodgkin Lymphoma and Non-Hodgkin 
Lymphoma (Cheson et al., 2014) (refer to Appendix 7 and Appendix 10). For timepoints when 
FDG-PET assessment (metabolic response) is available, the FDG-PET (metabolic response) 
assessment trumps the CT-response in FDG-avid histologies. For timepoints when only CT is 
available, following a prior FDG-PET assessment, CT assessments may be affected by the prior 
PET CT assessment (eg, CT-based PR at current timepoint, with no worsening, does not preclude 
prior FDG-PET CR [metabolic response] and response can stay as CR). 
For CLL, response will be assessed per guidelines for diagnosis, indications for treatment, 
response assessment and supportive management of CLL (Hallek et al., 2018) (refer to Appendix 
8). 
For response assessment, imaging studies including FDG-PET CT, CT or MRI will be performed 
on Cycle 2 (Week 6), Cycle 3 (Week 12), Cycle 5 (Week 18), Cycle 6 (Week 24), Cycle 9 (Week 
36), Cycle 12 (Week 48), and every 24 weeks (Cycle 18, 24, etc) thereafter until disease 
progression, the start of a new anti-cancer therapy, withdrawal of consent, or death, whichever 
occurs first. 

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In the Dose Escalation and Expansion (including safety run-in), response assessment will be 
conducted locally by investigators.  
As local palliative radiotherapy on non-target lesions is permitted (refer to Section 6.6), if given 
during the trial, these lesions should no longer be included in the response assessment. 
9.2.3.2 
Progressive Disease 
Imaging findings suggestive of progressive disease (PD) despite evidence of clinical benefit have 
been described with immunomodulatory agents, eg, tumor flare or pseudo-progression (Cheson et 
al., 2016). Currently, the potential for similar effect of GEN3009 is unknown, but should be taken 
into consideration when evaluating imaging during the trial. Accordingly, an increase in the size 
of previously involved lymph nodes, especially at the beginning of GEN3009 treatment, may 
represent pseudo-progression and may not be designated as PD, unless there is continued increase 
in size on subsequent imaging studies or confirmed with biopsies. Hence, in order to avoid 
premature termination, subjects can remain on the GCT3009-01 trial at investigator and subject 
discretion until the response or lack thereof is confirmed on subsequent imaging. 
9.3 
Clinical Safety Assessments 
9.3.1 
Physical Examination 
The investigator or qualified designee will perform a full physical examination according to SOC 
during the screening period and report any relevant findings as medical history. Report any medical 
conditions as an AE if they were assessed by the investigator to have been caused by a protocol-
mandated procedure (eg, tumor biopsy and/or CT scan), including washout or discontinuation of 
prior medications. After the first dose of trial drug, report any new or worsening findings since the 
last assessment as AEs. The time points for full physical examinations are described in Table 2, 
Table 3, Table 5, Table 6, Table 10, Table 11, and Table 15. 
In addition to the above, the physical examination should evaluate the presence of palpable lymph 
nodes and tumor masses. Specifically, the bidimensional diameters of the largest palpable lymph 
nodes in each of the following sites should be documented: cervical, axillary, and inguinal. To 
assess for enlargement, the dimensions of the liver and spleen below their respective costal 
margins, as assessed by palpation, should also be documented.  
Height (without shoes) rounded to nearest centimeter, and body weight will be measured as 
described in Table 2, Table 5, and Table 10. Investigators should pay special attention to clinical 
signs related to previous serious illnesses. 
9.3.1.1 
Immune Effector Cell-Associated Neurotoxicity Syndrome Assessment 
(GEN3009 + GEN3013 Combination Cohort only) 
Assessment for neurotoxicity must be performed during therapy with GEN3013 by the trial site 
staff. An assessment according to ICANS evaluation (Lee et al., 2019) should be performed as 
indicated in Table 10, Table 10, and Table 15. ICANS assessment must be performed daily in case 
of unscheduled hospitalization due to symptoms associated with CRS. Finally, additional ICANS 
assessment should always be performed when clinically indicated. 
ICANS is a disorder characterized by a pathologic process involving the CNS following any 
immune therapy that results in the activation or engagement of endogenous or infused immune 

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effector cells, including T cells. Symptoms can be progressive and may include aphasia, altered 
level of consciousness, impairment of cognitive skills, motor weakness, seizures, and cerebral 
edema (Lee et al., 2019). 
The grading of ICANS requires assessment of the 10-point immune effector cell-associated 
encephalopathy (ICE) score as well as evaluation of 4 other neurological domains: level of 
consciousness, seizures, motor symptoms, and signs of raised intracranial pressure/cerebral edema, 
which may occur with or without encephalopathy (see Appendix 14 for additional details). 
Overall ICANS grade is determined by the most severe event of the neurotoxicity domains (ICE 
score, level of consciousness, seizure, motor findings, raised intracranial pressure/cerebral edema) 
not attributable to any other cause. For example: subject with an ICE score of 3 who has a 
generalized seizure is classified as having Grade 3 ICANS. 
A subject with an ICE score of 0 may be classified as having Grade 3 ICANS if the subject is 
awake with global aphasia. But a subject with an ICE score of 0 may be classified as having Grade 
4 ICANS if the subject is unarousable. 
Depressed level of consciousness should not be attributable to another cause (eg, sedating 
medication). 
Tremors and myoclonus associated with immune effector cell therapies may be graded according 
to CTCAE, but they do not influence ICANS grading. 
Intracranial hemorrhage with or without associated edema is not considered a neurotoxicity feature 
and is excluded from ICANS grading. It may be graded according to CTCAE. 
9.3.2 
Vital Signs 
Vital signs (body temperature, blood pressure, heart rate, respiratory rate, and oxygen saturation) 
should be measured with the subject in a sitting position. Within each visit, preferably the same 
equipment shall be used for vital sign measurements. On infusion days, vital signs should be 
assessed as indicated in Table 2, Table 3, Table 5, Table 6, Table 10, Table 11, and Table 15. On 
non-infusion days, vital signs should be assessed any time during the visit. 
More frequent examinations may be performed at the discretion of the Investigator and if 
medically indicated. 
9.3.3 
Electrocardiograms 
The ECGs will be recorded digitally at the sites by using the standard 12-leads as outlined in Table 
2, Table 3, Table 5, Table 6, Table 10, Table 11, and Table 15. ECGs will be performed in 
accordance with the ECG manual issued by the vendor. The digital ECGs will be transmitted from 
the sites electronically to a central laboratory for a measurement of the cardiac intervals and 
morphologic assessment by a central cardiologist. 
An overall interpretation of the ECGs will be performed by the investigator, or the investigator 
may delegate this task to a cardiologist, if applicable. The investigator ECG interpretation must be 
done using the paper ECG reading from the ECG machine by signing and dating the print out. In 
case of discrepancy between central and the investigator ECG readings, the central reading will be 
used for trial analysis purposes. 
For the ECG recordings, the subjects must be resting and in a supine or reclined position for at 
least 10 minutes. ECGs should be done in triplicate, 5 minutes apart (±5 minutes). In case any 

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irregularity (eg, vomiting or cough) occurs during the recording of the ECG, the ECG should be 
repeated. 
9.3.4 
ECOG Performance Status 
The ECOG performance status will be assessed by the investigator as indicated in Table 2, Table 
3, Table 5, Table 6, Table 10, Table 11, and Table 15. Performance status will be scored using the 
ECOG performance status scale index (refer to Appendix 11). 
9.3.5 
Constitutional Symptoms (B Symptoms) 
Constitutional symptoms will be evaluated at screening and before GEN3009 administration as 
indicated in Table 2, Table 3, Table 5, Table 6, Table 10, Table 11, and Table 15. Constitutional 
symptoms include night sweats, weight loss > 10% over 6 months, and extreme fatigue and/or 
fever without infection. 
9.3.6 
Survival Status 
Survival status will be assessed every 3 months via telephone contact, email, or on-site visit, after 
the last administration of GEN3009 and/or GEN3013 and will continue until the subject dies or 
withdraws from the trial. Data will be collected as reported by the subject regarding disease status, 
new anti-lymphoma treatment, any other malignancy other than the disease under study (ie, a 
second primary malignancy), and survival status, if available. If the subject is not available for this 
assessment, the response should be entered as “lost to follow up” (Section 8.4). 
9.4 
Clinical Laboratory Assessments 
9.4.1 
Laboratory Parameters 
The laboratory parameters listed in Table 31 must be performed as indicated in the visit assessment 
schedules (refer to Table 2, Table 3, Table 5, Table 6, Table 10, Table 11, and Table 15). Any 
local or central laboratory values leading to a dose modification/delay should be recorded as an 
AE (Section 10.2.5). 
Laboratory abnormalities are to be recorded as AEs also if considered clinically relevant by the 
investigator (see Section 10.2.5). 
Local Laboratory Assessments 
Local laboratory values for hematology, biochemistry and coagulation must be obtained within 
3 days prior to the first dose of each subject and reviewed by the investigator prior to the first dose 
to ensure that the subject is still eligible. For the subsequent doses, these laboratory values must 
be obtained within 1 day, preferably on the same day prior to each GEN3009 and/or GEN3013 
administration, and reviewed by the investigator prior to each administration to ensure the subject 
can be dosed in line with the dosing instructions as defined in the protocol. As this is a FIH trial, 
the timing of safety laboratory assessments may be adjusted during the trial based on emerging 
data.  
Additional local laboratory values may be obtained at the discretion of the investigator and used 
for other clinical treatment decisions of the subject. 
Local laboratory assessments outlined in Table 31 must be recorded. 

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Central Laboratory Assessments 
Central laboratory assessments include immunophenotyping for lymphocytes (Section 9.8.3.1), 
PK (Section 9.5), immunogenicity assessments (ADAs) (Section 9.6), and cytokine measurements 
(Section 9.8.3.2). Additional biopsy and blood samples for exploratory biomarker analyses will be 
collected (refer to Sections 9.8.2 and 9.8.3) and shipped for centralized testing. 

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Table 31 Protocol-Required Laboratory Assessments 
Local Laboratory Assessments 
Test Category 
Test Name 
Hematology 
Hemoglobin, hematocrit, white blood cells including differential (neutrophils, 
basophils, eosinophils, lymphocytes [both percent and absolute]), monocytes 
(absolute values for differential are preferred), reticulocytes and platelets. 
Reporting the proportion of prolymphocytes is desirable when these are 
present. 
 
Quantitative 
lymphocyte subsets 
B cells, T cells, and NK cells (both absolute and percent) 
Biochemistry 
Albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate 
aminotransferase (AST), bicarbonate, lactate dehydrogenase (LDH), calcium, 
chloride, magnesium, inorganic phosphorus (phosphate), sodium, potassium, 
creatinine, total bilirubin, blood urea nitrogen (BUN) or urea, uric acid, 
glucose (non-fasting), total protein, C-reactive protein (CRP), D-dimer, 
ferritin. 
 
Tumor lysis sample includes uric acid, potassium, inorganic phosphorus 
(phosphate), calcium and creatinine. 
Coagulation 
Prothrombin time (PT), international normalized ratio (INR), activated partial 
thromboplastin time (APTT), fibrinogen 
Serology 
Hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb). 
If positive serology, PCR for HBV-DNA to be performed. 
Hepatitis C virus (HCV) antibody. If positive serology PCR for HCV RNA to 
be performed. 
 
Cytomegalovirus (CMV) serology (IgG and IgM) at screening. If positive, 
further surveillance, ie, PCR for CMV-DNA to be performed at the 
investigator’s discretion. Note: HIV testing is required at screening only if 
required per local health authorities or institutional standards. . 
Additional tests 
Beta2-microglobulin (at screening only). 
 
Immunoglobulins: IgA, IgG and IgM (at screening, at start of each cycle, and 
at the treatment discontinuation visit). 
Urinalysis 
pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte 
esterase, specific gravity. 
Pregnancy test 
For female subjects with childbearing potential, a serum pregnancy test (beta-
hCG) must be performed at screening; urine OR serum pregnancy test must 
be performed at the start of each cycle, at the treatment discontinuation visit, 
and safety follow up visit. 
DLBCL or CLL 
For subjects with DLBCL, major biologically distinct molecular subtypes 
(germinal center B-cell (GCB) and activated B-cell [ABC]), MYC positivity 
(IHC and FISH data), chromosomal rearrangements of MYC plus BCL2 
(double-hit lymphoma) and overexpression of MYC and BCL2 proteins 
(double-expressor lymphoma) will be collected. 
For subjects with CLL/SLL, FISH data for del(13q), del(11q), del(17p), and 
DNA sequencing for TP53 and IGHV mutational status will be collected. 
Bone marrow biopsy 
and/or aspirate 
For subject response assessments, perform locally. 

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Each serum sample for ADA evaluation will be divided into 2 aliquots (one for ADA analysis and 
a back-up). Plasma concentrations of GEN3009 or GEN3013 will be analyzed (refer to Section 
9.5) and those data will be used for interpretation of the ADA data. 
The ADA samples may additionally be used to evaluate safety or efficacy aspects that address 
concerns arising during or after the trial period for further characterization of immunogenicity. 
Samples may be stored according to local regulations at a facility selected by the sponsor to enable 
further analysis of immune responses to GEN3009 or GEN3013. 
Genetic analyses will not be performed on these serum samples. Subject confidentiality will be 
maintained. 
The detection and titer characterization of ADAs will be performed using validated, specific and 
sensitive Electrochemiluminescence Immunoassay (ECLIA) methods and the titer of confirmed 
positive samples will be reported. The analysis will be performed under the supervision of the 
sponsor at an assay CRO. Neutralization characterization of ADAs will be performed at sponsor 
laboratories using appropriate methods. 
9.7 
Tumor Biopsy 
During both Dose Escalation and Expansion, for subjects with accessible tumors, tumor samples 
are required for biomarker assessments. A fresh lymph node biopsy is preferable at screening and 
the biopsy can be a whole lymph node or core biopsy. A fine needle biopsy will not be sufficient. 
An archival lymph node tumor biopsy, which is the most recently collected lymph node biopsy 
after most recent therapy prior to enrollment, is also acceptable if taken within 6 months of C1D1 
(Table 32).  
During Expansion two fresh core tumor biopsies at C2D1 (±1 week) for GEN3009 + GEN3013 
cohorts and C2D15 (±1 week) for GEN3009 monotherapy cohorts are mandatory for all patients 
with accessible tumors, where it is considered feasible without a high risk of complications for the 
patient based on the discretion of the investigator. Additionally, where feasible, a biopsy should 
be collected at the end of treatment visit. All tumor biopsies should be formalin-fixed, paraffin-
embedded. Tumor biopsies will be examined as described in Section 9.2.2.3 and 9.8.2.  
Table 32 Tumor Biopsy Collection During Dose Escalation and Expansion  
Subject Diagnosis 
Requirement 
 
B-cell NHL, SLL or 
CLL 
Fresh whole lymph node biopsy or fresh core tumor biopsies (2 cores ) is required. If a 
fresh biopsy is not clinically feasible, an archival lymph node biopsy (FFPE) is 
acceptable, which is the most recently collected lymph node biopsy after most recent 
therapy prior to enrollment, if taken within 6 months of Cycle 1 day 1. 
9.8 
Biomarkers 
Biomarker investigations in this trial will include safety markers, candidate predictive biomarkers, 
which may predict outcome to the treatment, and pharmacodynamic biomarkers. Biomarker 
assessments performed in the Dose Escalation and Expansion will focus on complement activation 
(primarily as pharmacodynamics marker), circulating cytokine levels (as safety assessment), CD37 
versus membrane complement regulatory protein (mCRP) expression on leukocyte subsets (as 
candidate predictive markers for treatment efficacy), frequencies of (CD37-expressing) expressing 
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10 
SAFETY MONITORING AND ADVERSE EVENT REPORTING 
10.1 
Adverse Event Definitions 
10.1.1 
Definition of Adverse Events 
An AE is any untoward medical occurrence in a clinical trial subject, temporally associated with 
the use of a medicinal product, whether or not considered related to the medicinal product. An AE 
can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal 
product. 
AEs (including laboratory abnormalities that constitute AEs) should be described using a diagnosis 
whenever possible, rather than individual underlying signs and symptoms. When a clear diagnosis 
cannot be identified, each sign or symptom should be reported as a separate AE. 
10.1.2 
Definition of Serious Adverse Events 
An SAE is defined as an AE that meets 1 of the following criteria: 
• Is fatal or life-threatening1 
• Results in persistent or significant disability/incapacity 
• Constitutes a congenital anomaly/birth defect 
• Is medically significant, ie, defined as an event that jeopardizes the subject or may require 
medical or surgical intervention to prevent 1 of the outcomes listed above. Medical and 
scientific judgment must be exercised in deciding whether an AE is “medically significant” 
• Requires inpatient hospitalization or prolongation of existing hospitalization2 (Planned 
hospitalization for observation following GEN3009 and/or GEN3013 (GEN3009 + GEN3013 
cohort 4 only) administration during Cycle 1 should not be reported as an SAE). 
1The term “life-threatening” in the definition of “serious” refers to an event in which the subject was at risk of death 
at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more 
severe. 
2Hospitalizations for the following reasons should not be reported as SAEs: 
• 
Routine treatment or monitoring of the underlying disease, not associated with any deterioration in the condition 
• 
Solely due to progression of the underlying cancer 
• 
Elective or pre-planned treatment for a pre-existing condition that is unrelated to the underlying disease and has 
not worsened since signing the informed consent 
• 
Social reasons and respite care in the absence of any deterioration in the subject’s general condition 
• 
Treatment on an emergency outpatient basis that does not result in hospital admission and involves an event not 
fulfilling any of the definitions of an SAE given above is not an SAE. 
10.1.3 
Definition of Adverse Events of Special Interest 
AESIs are defined as events (serious or non-serious) which are of scientific and medical concern 
specific to the sponsor’s product or program, for which ongoing monitoring and rapid 

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communication by the investigator to the sponsor may be appropriate. Such events may require 
further investigation in order to characterize and understand them.  
AESIs are defined on the basis of an ongoing review of the safety data. AESIs are discussed further 
in Section 10.3 and in the IB.  
10.1.4 
Definition of Infusion-Related Reactions 
IRRs are defined as any AEs occurring during infusion or where the onset of the event occurs 
within 24 hours after the ended infusion. For IRRs, the causality of the event should be judged as 
“related” by the investigator.  
Investigators should consider the clinical picture and isolated events, such as “fatigue,” occurring 
within 24 hours after the end of infusion, and assess whether they do or do not constitute an IRR. 
10.2 
Adverse Event Reporting 
All AEs, whether serious or nonserious (see definition in section 10.1.2), will be documented from 
the first dose of GEN3009 and/or GEN3013 (GEN3009 + GEN3013 cohort only) until 30 days 
after the last GEN3009 and 60 days after the last dose of GEN3013, subject withdrew consent, 
subject started new anti-cancer treatment, or the subject died, whichever comes first. Refer to the 
electronic case report form (eCRF) completion guidelines for additional information on reporting 
and stepwise guidance.  
Medical conditions (signs, symptoms, and diagnoses) that occur after the ICF is signed and prior 
to the first GEN3009 and/or GEN3013 dose should only be reported as AEs if they were assessed 
by the investigator to be caused by a protocol-mandated procedure (ie, tumor biopsy and/or CT 
scan), including washout or discontinuation of prior medications.  
The investigator will use the CTCAE Version 5.0 (NCI, 2017) to describe the intensity of AEs, 
except for TLS (refer to Appendix 4), CRS (refer to Appendix 13) and ICANS (refer to Appendix 
14). Changes in intensity of an ongoing AE should be assessed at each visit or more frequent if 
deemed necessary and must be reported. 
SAEs still ongoing after the safety follow-up visit(s) should be followed on a regular basis 
according to the investigator’s clinical judgment until the event has been resolved or until the 
investigator assesses it as chronic and all queries have been resolved. Only SAEs judged by the 
investigator as related to GEN3009 (all cohorts) and/or GEN3013 (the combination cohort only) 
should be reported after the safety follow-up visit. 
The investigator must assess whether or not the event is related to the trial drug. The relationship 
is to be judged using the following terms: 
• Related 
• Not related 
If the relationship changes over time, the last judgment by the investigator should be reported. 
Relatedness has to be assessed and reported from the first time the event is being reported. 
A suspected adverse reaction is one in which there is a reasonable possibility that the trial drug 
caused the AE; this means there is evidence to suggest a causal relationship between the trial drug 
and the AE (ie, considered related). 
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• Final assessment of AEs must be performed by a medically qualified person, ie, a medical 
doctor. 
• All AEs that occur during the AE reporting period must be reported in a timely manner in the 
eCRF, whether or not the event is treatment-related. 
• All AEs must be assessed at each visit (or more frequently, if necessary). 
10.2.1 
Pre-existing Condition 
In this trial, a pre-existing condition (ie, a disorder that was present before the AE reporting period 
has started and noted on the medical history form) is not to be reported as an AE. If, however, a 
pre-existing condition worsens during the treatment period, the event must be reported as an AE 
in a timely manner in the eCRF. 
10.2.2 
Diagnosis 
The diagnosis/cause of an AE should be recorded rather than the symptoms of the AE. If no 
diagnosis is available each sign and symptom should be recorded as individual AEs. 
10.2.3 
Disease Progression or Death 
Progression of malignancy, if only documented by use of an appropriate method (as per CT/PET 
or MRI criteria), with no clinical symptoms, should not be reported as an AE or SAE. However, 
all hospitalizations and deaths caused by clinical manifestations of disease progression should be 
reported as SAEs.  
10.2.4 
Unrelated Procedures 
Diagnostic and therapeutic non-invasive and invasive procedures, such as surgery, should not be 
reported as AEs. A medical condition for which an unscheduled procedure was performed, should 
however be reported if it meets the definition of an AE. For example, an acute appendicitis should 
be reported as the AE and not the appendectomy. 
10.2.5 
Laboratory Test Abnormalities 
Laboratory abnormalities that are considered clinically significant, ie, induce clinical signs or 
symptoms, require concomitant therapy, or require changes in trial drug should be recorded as an 
AE in a timely manner in the eCRF. Whenever possible, a diagnosis, rather than a symptom should 
be provided (eg, anemia instead of low hemoglobin, neutropenia instead of decreased neutrophil 
count). Laboratory abnormalities that meet the criteria for AEs should be followed until they have 
returned to normal or an adequate explanation of the abnormality is found. When an abnormal 
laboratory or test result corresponds to a sign/symptom of an already reported AE, it is not 
necessary to separately record the laboratory/test result as an additional event. 
10.3 
Adverse Events of Special Interest 
The following are considered AESIs: 
GEN3009:  

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• IRRs 
GEN3009 + GEN3013  
• IRRs 
• CRS 
• Clinical TLS 
• ICANS 
AESIs are to be entered in the eCRF and reported to the safety CRO within 24 hours if they meet 
seriousness criteria or entered in eCRF within 72 hours if not serious. 
10.4 
Events Requiring Immediate Reporting 
10.4.1 
Serious Adverse Events  
All SAEs occurring during the safety reporting period must be reported from the trial site to the 
sponsor no later than 24 hours following:  
• the subject visit at which such AE was reported, noted or recognized,  
• the principal investigator’s or any investigator personnel’s receipt of the test results,  
• other information at, or from which, such development was reported, noted, or recognized. 
Grade 3 and 4 abnormal laboratory test values, if deemed serious (refer to Section 10.1.2), must 
be reported as SAEs when these are assessed as clinically significant by the reporting investigator. 
Refer to the eCRF completion guidelines for additional information on reporting and stepwise 
guidance. 
10.4.2 
Serious Adverse Events With Onset After Ended Trial Participation 
Information on any SAE with onset at any time after the subject has terminated trial participation 
that is suspected to be related to the trial drug by the investigator should be collected and emailed 
to the safety CRO. 
10.4.3 
Overdose and Medication Errors 
An overdose is defined as a subject receiving a dose of GEN3009 and/or GEN3013 (GEN3009 + 
GEN3013 cohort 4 only) in excess of 10% of that specified in this protocol. All cases of overdose, 
whether associated with an AE or not, must be reported to the sponsor within 24 hours of 
knowledge of the event. Overdose of concomitant medication should only be reported if associated 
with AEs, whether serious or not. 
Medication errors (including infusion rate errors) and uses outside what is foreseen in the protocol, 
including misuse and abuse of the product, should be reported to the sponsor within 24 hours of 
knowledge of the event. 
Overdose and/or medication errors with GEN3009 and/or GEN3013 (GEN3009 + GEN3013 
cohort 4 only) must be recorded as an AE , whether associated with an AE or not, within 24 hours 
after awareness. 

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Refer to the eCRF completion guidelines for additional information on reporting and stepwise 
guidance. 
Overdose, medication errors, misuse, and abuse do not automatically make an AE serious, but if 
the consequences are serious, for example death or hospitalizations, the event is serious and must 
be reported as an SAE. 
Rescue medication to reverse the action of GEN3009 and/or GEN3013 (GEN3009 + GEN3013 
cohort 4 only) is not available. In case of overdose, medication errors, misuse, and/or abuse of trial 
drug, subjects should be monitored closely for potential side effects of GEN3009 and/or GEN3013 
(GEN3009 + GEN3013 cohort 4 only) and receive supportive care according to local guidelines 
for the management of the potential side effects. 
In the event of an overdose, the investigator should: 
• Contact the medical monitor immediately. 
• Closely monitor the subject for any AE/SAE and laboratory abnormalities, and ensure timely 
reporting of those, until GEN3009 and/or GEN3013 (GEN3009 + GEN3013 cohort 4 only) 
can no longer be detected systemically. 
• Obtain a plasma sample for PK analysis if requested by the medical monitor (determined on a 
case-by-case basis). 
• Document the quantity of the excess dose as well as the duration of the overdose. 
10.4.4 
Pregnancy 
Pregnancy is not allowed in this trial. However, if any pregnancy occurs during trial participation, 
the pregnancy must be reported. Pregnant trial subjects must be withdrawn from treatment 
immediately, whereas male subjects may continue in the trial should pregnancy of female partners 
occur. In this case, a separate informed consent will be obtained from the female partner for 
collection of information regarding the pregnancy. 
All reports of pregnancy in female subjects or partners of male subjects must be reported on a 
pregnancy form to sponsor or designee within 24 hours of learning of its occurrence. The 
pregnancy must be followed up to determine outcome (including premature termination) and status 
of mother and child. The child must be followed at least to the age of 1 month. Pregnancy 
complications and elective terminations must be reported as an AE or SAE. Spontaneous abortions 
must be reported as an SAE. Any SAE occurring in association with a pregnancy brought to the 
investigator’s attention after the subject has completed the trial and considered by the investigator 
as possibly related to the GEN3009 and/or GEN3013 (GEN3009 + GEN3013 cohort 4 only), must 
be promptly reported to the sponsor or designee. 
10.4.5 
Timelines for Immediate Reporting 
All SAEs, events of overdose and/or medication errors with GEN3009 and/or GEN3013 
(GEN3009 + GEN3013 cohort 4 only), serious AESIs, and pregnancy must be reported to the 
sponsor within 24 hours after sites’ awareness. Completed Safety Reporting documents must be 
forwarded to the safety CRO within 24 hours. 

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10.5 
Suspected Unexpected Serious Adverse Reactions 
The sponsor has a legal responsibility to notify, as appropriate and according to local regulations, 
both the local regulatory authority and other regulatory agencies about the safety of the product 
under clinical investigation. Prompt notification of SAEs by the investigator to the sponsor is 
essential so that legal obligations and ethical responsibilities towards the safety of subjects are 
met. 
The sponsor will ensure that all relevant information about suspected unexpected serious adverse 
reactions (SUSARs) is recorded and reported as soon as possible, but within a maximum of 15 days 
(fatal or life-threatening SUSARs within a maximum of 7 days) of first knowledge by the sponsor 
or designee, to the competent regulatory authorities and/or to the ethics committee according to 
the applicable local regulatory requirements. Relevant follow-up information of fatal or life-
threatening SUSARs will be communicated subsequently within an additional 8 days. 
The investigator should be aware of local reporting regulations to the IEC/IRB. The sponsor or the 
safety CRO will either supply the investigator with the reports which should be passed on to the 
IEC/IRB or report directly to the IEC/IRB, depending on local regulations. 
10.6 
Follow Up on Adverse Events 
All AEs should be followed until they are resolved, until the end of the safety follow-up period, 
or the start of new anti-cancer treatment, whichever comes first. However, GEN3009 and/or 
GEN3013 (GEN3009 + GEN3013 cohort 4 only) related AESIs qualifying for safety reporting 
and all SAEs (independent of causality) still ongoing after the safety follow-up visit must be 
followed on a regular basis, according to the investigator’s clinical judgment, until the event has 
been resolved or until the investigator assesses it as chronic and all queries have been resolved. 
10.7 
Warnings and Precautions 
No evidence available at the time of the approval of this trial protocol indicated that special 
warnings or precautions were appropriate, other than those noted in the IB. Additional safety 
information collected between IB updates will be communicated in the form of investigator 
notifications. This information will be included in the subject informed consent and should be 
discussed with the subject during the trial as needed. 
10.8 
Data Monitoring Committee 
This trial will institute a DMC, which will function independently of all other individuals 
associated with the conduct of this clinical trial, including the investigators participating in the 
trial. The functions and responsibilities of the DMC will be described in the DMC charter, which 
will be signed by the DMC. 
During the Dose Escalation, the DMC will review the totality of the data and monitor safety for 
the trial on a quarterly basis or more frequently as defined in the DMC charter (escalation). 
During the Expansion of the trial, the DMC will review the totality of the data at pre-specified 
intervals as defined in the DMC charter (expansion). The DMC will evaluate the safety profile 
with particular emphasis on any safety signals. 
The DMC will also be available on an ad hoc basis, ie, to advise and recommend actions in relation 
to urgent safety signals, mitigation plans, etc or if requested by the DEC or sponsor SC.  

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The DMC will provide written feedback following periodic reviews and ad-hoc reviews. If a DMC 
meeting is scheduled, it will include both an open and closed session to discuss available data. 
During the open session, sponsor employees and investigators could participate together with the 
DMC. During the closed session, only DMC members will participate. The sponsor SC will 
hereafter meet to evaluate the recommendations provided by the DMC. 
10.9 
Dose Escalation Committee and the Safety Committee 
In the Dose Escalation (monotherapy cohorts) and safety run-in (combination cohort) parts of the 
trial, subject safety will be monitored by the DEC and the sponsor SC. The sponsor SC is a cross-
functional committee chaired by Global Drug Safety & Pharmacovigilance (GDS&PV) and 
consists of project-specific staff such as the Medical Director, Medical Scientist, Safety Physician 
and Safety Scientist, Regulatory Lead, Non-clinical Safety Representative, Head of Medical 
Department, Head of GDS&PV, Head of Regulatory Affairs, and Head of Pharmacology. The 
DEC will be chaired by the sponsor medical monitor and membership will include at a minimum 
the trial principal investigators, members of the sponsor medical and safety departments, as well 
as additional staff as appropriate. 
The DEC will meet throughout the Dose Escalation and the safety run-in, after completion of the 
DLT evaluation period (ie, 28 days) by subjects enrolled in each dose level cohort. Dose escalation 
decisions will be proposed by the DEC in conjunction with the participating investigators. The 
DEC will convene when all subjects in a DL cohort complete the DLT evaluation period to make 
a decision regarding further dose escalation and when a decision regarding RP2D must be made. 
The sponsor SC will meet immediately following DEC meetings and DMC periodic reviews to 
evaluate the recommendations from the DEC and DMC and determine how to proceed. The 
sponsor SC will monitor all available treatment-emergent data to ensure subject safety. The 
sponsor SC is responsible for ensuring that participation in the trial is safe for trial subjects, 
evaluating the outcome of ongoing safety surveillance, evaluating outcomes of DEC and DMC 
meetings, performing benefit-risk assessments, evaluating regulatory impact of decisions made, 
and for ensuring that appropriate actions are taken when new safety issues emerge. 

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11 
STATISTICS 
Statistical analyses will be performed by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be used to analyze the efficacy and safety data is 
outlined below. Specific details will be provided in the statistical analysis plan (SAP). 
In general, data from the Dose Escalation and Expansion (including safety run-in) parts, from 
GEN3009 monotherapy and GEN3009 + GEN3013 combination therapy will be summarized 
separately.  
In the reporting of the Dose Escalation and safety run-in, tables will report by cohort while in the 
Expansion tables will report by indication. 
Milestone analyses will be timed as follows: 
Dose Escalation and Safety Run-in: 
• At the end of the DLT observation period for the last dosed subject in a dose-escalation 
cohort, a DEC report will be created to support the decision for escalation/de-escalation. 
Expansion: 
• An analysis will be performed when all subjects have sufficient data to evaluate response 
(and safety) in expansion. 
• Additional analysis, such as supporting regular DMC meetings, may also be performed 
during the trial. 
• The final analysis across all indications will be conducted at the end of the trial, up to 
5 years after the last subject’s first treatment in the trial. 
11.1 
Analysis Sets 
11.1.1 
Full Analysis Set 
The full analysis set (FAS) and safety set are defined in the same way and comprise all subjects to 
whom trial drug has been assigned and who received at least 1 dose of trial drug. Subjects will be 
analyzed according to actual treatment received. 
11.1.2 
Dose-Determining Analysis Set 
In GEN3009 Dose Escalation, the dose-determining set (DDS) consists of all subjects from the 
safety set who have either received between 80% and 125% of the planned dose and have 
completed the DLT observation period, or have experienced a DLT during Cycle 1. A treated 
subject who discontinues due to toxicity during the DLT observation period should be included in 
the DDS, regardless of the amount of dose received. This constitutes an evaluable subject for the 
determination of MTD statistical analyses. Subjects enrolled in parallel cohorts during escalation 
will not be included in DDS, but will be reported in the FAS for decision making. 
In GEN3009 + GEN3013 safety run-in, the DDS includes all FAS subjects in the safety run-in part 
who meet the minimum exposure criterion and have sufficient safety evaluations or experience a 
DLT during the DLT observation period. The DLT observation period consists of the 4 weeks, ie, 
28 days, following the first GEN3009 dose. 
A subject will meet the minimum exposure criterion if the subject takes at least 3 out of 4 pre-
planned GEN3009 doses and one full dose of GEN3013 within the first cycle .  

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11.1.3 
Pharmacokinetic Analysis Set 
The PK analysis set will include all subjects who receive at least 1 dose of trial drug and who 
provide at least 1 evaluable PK sample. 
11.1.4 
Immunogenicity Analysis Set 
The immunogenicity analysis set will include all subjects who receive at least 1 dose of trial drug 
and have a baseline and at least 1 evaluable on-treatment ADA sample. 
11.1.5 
Response Evaluable Set 
The response evaluable set (RES) will consist of all subjects who: 
• receive at least 1 dose of trial drug; 
• have measurable disease at baseline; and 
• have at least 1 post-baseline disease evaluation or die within 60 days of first trial treatment. 
11.2 
Subject Demographics and Baseline Characteristics 
Demographic and other baseline data including disease characteristics will be listed and 
summarized descriptively for the FAS. 
Categorical data will be presented as frequencies and percentages. For continuous data, mean, 
standard deviation, median, minimum, and maximum will be presented. 
Relevant medical histories and current medical history at baseline will be summarized by system 
organ class and preferred term, by DL and expansion cohort. 
11.3 
Treatments 
The safety set will be used for the analyses below. Categorical data will be summarized as 
frequencies and percentages. For continuous data, mean, standard deviation, median, 25th and 75th 
percentiles, minimum, and maximum will be presented.  
The duration of exposure in months to GEN3009 and combination with GEN3013, as well as the 
dose intensity (computed as the ratio of actual cumulative dose received and actual duration of 
exposure) will be summarized by means of descriptive statistics.  
The number of subjects with dose adjustments and the reasons will be summarized, and all dosing 
data will be listed. 
Concomitant medications will be summarized. 
11.4 
Primary Objectives 
The primary objectives of the Dose Escalation and Expansion safety run-in are to: 
• Determine the MTD and/or determine the RP2D 
• Establish the safety profile 
The primary objective of the Expansion is to: 

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• Evaluate (preliminary) anti-tumor efficacy 
11.4.1 
Primary Endpoints 
11.4.1.1 Escalation and Safety Run-in in Expansion  
11.4.1.1.1 DLTs and AEs 
• Number of DLTs during the DLT period (initial 28 days of treatment).  
• Summary tables for AEs will include only AEs that started or worsened during the on-treatment 
period (the TEAEs). 
• The incidence of TEAEs (new or worsening from baseline) will be summarized by system 
organ class and/or preferred term, severity (CTCAE grade), type of AE, and relationship to 
GEN3009 (Dose Escalation) or GEN3009 + GEN3013 (safety run-in). 
• SAEs, non-serious AEs, and AESIs during the on-treatment period will be tabulated. 
• All deaths (on treatment and post treatment) will be summarized. 
• All AEs, deaths and SAEs (including those from the pre and post-treatment periods) will be 
listed and those collected during the pre-treatment and post-treatment periods will be flagged. 
Further summaries of AEs will be specified in the SAP. 
11.4.1.1.2  Severity of Changes in Laboratory Values 
Grading of laboratory values will be assigned programmatically as per the CTCAE Version 5.0. 
The calculation of CTCAE grades will be based on the observed laboratory values only; clinical 
assessments will not be taken into account. 
CTCAE Grade 0 will be assigned for all non-missing values not graded as 1 or higher. 
For laboratory tests where grades are not defined by the CTCAE, results will be categorized as 
low/normal/high based on laboratory normal ranges. 
For laboratory tests where grades are defined by the CTCAE: 
• Worst post-baseline CTCAE grade (regardless of the baseline status). Each subject will be 
counted only once for the worst grade observed post-baseline. 
• Shift tables using CTCAE grades to compare baseline to the worst on-treatment value. 
For laboratory tests where grades are not defined by the CTCAE: 
• Shift tables using the low/normal/high (low and high) (or other project-specific) 
classification to compare baseline to the worst on-treatment value. 
In addition to the above mentioned tables and listings, other exploratory analyses, eg, figures 
plotting time course of raw or change in laboratory tests over time or box plots might be specified 
in the analysis plan. 
11.4.1.1.3 Frequency of Dose Interruptions, Delays and Dose Intensity 
See Section 11.3. 

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11.4.1.2 Expansion 
For all efficacy analyses the FAS will be used. The RES may also be used for presentation of 
results, in particular for responder rates while the trial is ongoing.  
For GEN3009 monotherapy cohorts in Expansion (R/R DLBCL, FL and CLL cohorts), ORR will 
be determined per (Cheson et al., 2014) for lymphomas and per (Hallek et al., 2018) for CLL. 
Subjects with PR and CR are considered as responders while all other categories, including “not 
evaluable,” are considered as non-responders. ORR will be calculated together with its 95% CI. 
For GEN3009 + GEN3013 R/R DLBCL cohort, CR rate will be summarized. CR rate is defined 
as the proportion of patients with CR. Analysis will be based on response assessment by Lugano 
(Cheson et al., 2014). 
11.4.2 
Statistical Hypothesis, Model, and Method of Analysis 
Results will be presented using descriptive statistics. No formal statistical hypotheses are 
formulated in this trial. Any P values will be considered as hypothesis-generating results to be 
considered for future trials. 
11.5 
Secondary Safety Objectives 
11.5.1 
Other Safety Data 
11.5.1.1 ECG 
12-lead ECGs including PR, QRS, QT, QTcF, and RR intervals will be obtained for each subject 
during the trial in accordance with Table 2 and Table 3 (Dose Escalation), Table 5, Table 6, 
Table 10, Table 11, and Table 15 (Dose Expansion). ECG data will be read and interpreted 
centrally. Categorical analysis of QT/QTc interval data based on the number of subjects meeting 
or exceeding predefined limits in terms of absolute QT/QTc intervals or changes from baseline 
will be presented. In addition, a listing of these subjects will be produced. 
11.5.1.2 Vital Signs 
Data on vital signs will be tabulated and listed; notable values will be flagged. 
11.6 
Pharmacokinetics 
Individual curves of plasma concentration of GEN3009 or GEN3013 versus time after end of 
infusion will be presented for all subjects, including information on actual administered dose. All 
available data will be shown in these figures. Concentrations below the limit of quantification will 
be marked separately. 
PK parameters (Table 33) will be calculated based on non-compartmental methods and will be 
calculated separately for Cycle 1 and Cycle 2. Elimination half-life (T1/2) and parameters based on 
T1/2 (area under the curve [AUC]inf, CL) will be calculated only if a sufficient number of 
observations are available above LLOQ.  
The relation between derived PK parameters and covariates such as actual dose, weight and dose, 
and selected laboratory parameters will be evaluated graphically. 

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If deemed applicable compartmental modeling approaches to parameter estimation will be applied.  
Descriptive statistics of PK endpoints will include arithmetic and geometric means, standard 
deviations, CV%, median, minimum and maximum. 
Further exploratory analyses of PK data may be performed. 
Table 33 Non-compartmental Pharmacokinetic Parameters 
AUC0-7days 
The AUC from time zero to Day 7 (mass × time × volume-1) 
AUCinfa 
The AUC from time zero to infinity (mass × time × volume-1) 
AUClast 
The AUC from time zero to last quantifiable measurement (mass × time × volume-1) 
Cmax 
The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration 
after single dose administration (mass × volume-1) 
Tmax 
The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug 
concentration after single dose administration (time) 
Ctrough 
Observed concentration at the end of the dosing interval (mass × volume-1) 
T1/2a 
The elimination half-life associated with the terminal slope (λz) of a semi logarithmic 
concentration-time curve (time) 
CLa 
The total body clearance of drug from the plasma (volume × time-1) 
a 
Calculated only if feasible.  
11.6.1 
Pharmacodynamics 
The FAS will be used to summarize the pharmacodynamic parameters. 
Selected cytokine results will be summarized by cytokine and time point. Median cytokine results, 
and their standard errors, may be plotted by time and cytokine. 
11.7 
Immunogenicity of GEN3009/GEN3013 
Immunogenicity analysis samples will be scored ADA positive or ADA negative and subsequently 
reported. From positive ADA samples, titer values and neutralizing antibody scores (positive or 
negative) will be determined and reported. ADA negative samples with drug on board above the 
drug tolerance limits of the ADA method will be scored inconclusive due to possible drug 
interference. The association between positive/non-positive ADA and PK (predose, AUC, Cmax), 
major safety signals (CTCAE ≥Grade 3) and efficacy information (change in tumor size by CT 
scan) may be explored. 
11.8 
Secondary Efficacy Objectives 
The secondary efficacy objectives are to: 
• Further evaluate the anti-tumor activity of GEN3009 or the combination of GEN3009 + 
GEN3013 
• Evaluate clinical efficacy 
11.8.1 
Definition of Response 
11.8.1.1 Response in B-cell NHL Other Than CLL 
Objective and best response will be classified according to the Recommendations for Initial 
Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The 

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Lugano Classification (Cheson et al., 2014). Subjects with PR and CR are considered as responders 
while all other categories, including “not evaluable,” are considered as non-responders. Subjects 
with CR, PR, or SD are considered to be in disease control. 
11.8.1.2 Response in CLL/SLL 
Assessment of response to therapy will be classified according to iwCLL guideline (Hallek et al., 
2018) and should include careful physical examination and evaluation of the blood and bone 
marrow. To define the response to therapy, 2 groups of parameters need to be assessed and 
documented: parameters of group A assess the lymphoid tumor load and constitutional symptoms; 
parameters of group B assess the hematopoietic system. 
Any response to therapy (eg, CR, PR) should be sustained for at least 2 months before using this 
response in the assessment. In addition, where appropriate, a further assessment of response (ie, 
marrow assessment) may be performed at least 2 months after the subject has cleared MRD from 
the peripheral blood. 
CR and PR are considered clinically beneficial; all others (eg, SD, nonresponse, PD, death from 
any cause) will be rated as a treatment failure (Hallek et al., 2018). 
11.8.1.3 Definitions of Relapsed/Refractory 
Relapsed disease is defined as disease responding (CR or PR) to therapy that have progressed 
≥6 months after completion of therapy. Refractory disease is defined as disease not responding to 
therapy that have progressed or disease responding to therapy that have progressed during therapy 
or within 6 months (<6 months) of completion of therapy. For CLL, “relapsed disease” is defined 
as evidence of disease progression in a subject who has previously achieved a CR or PR for ≥6 
months. “Refractory disease” is defined as treatment failure (not achieving a CR or PR) or as 
progression within 6 months from the last dose of therapy. 
11.8.2 
Duration of Response 
DoR only applies to subjects whose best objective response is CR or PR and is defined as the 
number of days from the first documentation of objective tumor response (CR or PR) to the date 
of first PD or death.  
DoR will be censored and summarized in the same way as PFS (section 11.8.4). The detailed 
censoring rules are specified in the SAP. 
11.8.3 
Time to Response 
TTR is defined as the time from C1D1 to first documentation of objective tumor response (CR or 
PR). Descriptive statistics will be presented. 
11.8.4 
Progression-free Survival 
PFS is defined as the number of days from C1D1 to of the first documented progression or death 
due to any cause.  
PFS will be censored if no PFS event is observed before the first to occur between: (i) the analysis 
cut-off date, and (ii) the date when a new anti-neoplastic therapy is started. The censoring date will 

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be the date of the last adequate tumor assessment prior to cut-off/start of new anti-neoplastic 
therapy. The detailed censoring rules are specified in the SAP.  
PFS will be derived for all subjects and presented graphically as well as summarized using survival 
analysis methods.  
The quartile estimates of PFS from the Kaplan Meier product limit algorithm will be presented. 
The 2-sided 95% confidence interval will be presented as well. The number of events may be 
small, and thereby limit use of the Kaplan Meier method to provide reliable information. In this 
case, descriptive statistics (eg, n, mean, standard deviation, median, minimum and maximum) for 
PFS will be presented. 
11.8.5 
Overall Survival 
Overall survival (OS) is defined as the number of days from Day 1 of Cycle 1 to death due to any 
cause. If a subject is not known to have died, then OS will be censored at the latest date the subject 
was known to be alive (on or before the cut-off date)  
11.8.6 
Minimal Residual Disease 
The rate of MRD-negativity is defined as the proportion of patients with at least 1 MRD-negative 
sample. Duration of MRD-negativity is defined as the number of days from the first documentation 
of MRD-negativity to the date of MRD status change (not MRD-negativity). 
11.9 
Exploratory Endpoints 
Only descriptive analyses will be performed on exploratory endpoints. Further details for the 
specific endpoints will be defined in the SAP. 
11.10 
Interim Analyses 
No formal interim analysis is planned for this trial. 
11.11 
Sample Size Calculation 
Sample size for the Dose Escalation is expected to be up to 90 subjects based on simulations of 
the mBOIN design in order to provide adequate information for MTD estimation and the planning 
and design of future trials. The expected number of subjects depends on the true relationship 
between dose and DLT probability but is expected to lie between 30 to 40 subjects in realistic 
scenarios. Approximately 49 additional subjects may be recruited to DLS below the MTD where 
it is found relevant to further explore the PK, toxicity, and efficacy. 
Table 34 shows 4 different scenarios for the probability of a subject having a DLT at the 10 DLs. 
For each scenario the total expected number of subjects, when following the mBOIN design, is 
shown in the rightmost column. The mBOIN design method behaves as intended with most 
subjects exposed to the DLs with DLT probability close to the target DLT rate and fewer subjects 
exposed in total if the toxicity is high at the lowest DLs. 

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Table 34 Modified BOIN Design Characteristics 
Simulation Scenario 
Probability of DLT, Expected Number of Subjects at Each Dose Level  
Expected 
Number of 
Subjects 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
1 Prob(DLT) 
0% 
1% 
1% 
2% 
3% 
4% 
5% 
10% 
20% 
30% 
 
Num of subjects 
1.0 
1.1 
1.1 
3.2 
3.4 
3.5 
3.8 
5.1 
5.9 
4.6 
32.7 
2 Prob(DLT) 
0% 
1% 
1% 
2% 
3% 
4% 
5% 
20% 
25% 
35% 
 
Num of subjects 
1.0 
1.1 
1.1 
3.3 
3.4 
3.5 
4.9 
6.2 
4.7 
2.9 
32.0 
3 Prob(DLT) 
0% 
1% 
1% 
2% 
3% 
4% 
5% 
20% 
40% 
60% 
 
Num of subjects 
1.0 
1.0 
1.1 
3.3 
3.3 
3.5 
5.0 
7.3 
4.8 
1.0 
31.3 
4 Prob(DLT) 
0% 
1% 
1% 
2% 
3% 
4% 
5% 
10% 
12% 
15% 
 
Num of subjects 
1.0 
1.0 
1.1 
3.2 
3.4 
3.5 
3.8 
4.3 
4.4 
6.6 
32.2 
 

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12 
DATA HANDLING AND RECORD KEEPING 
12.1 
Source Documentation 
Source documents provide evidence for the existence of the subject and substantiate the integrity 
of the data collected. Source documents are filed at the investigator’s site. At a minimum, the type 
and level of detail of source data available for a subject should be consistent with that commonly 
documented at the trial site as a basis for standard medical care. Specific details required as source 
data for the trial will be reviewed with the investigator before the trial, described in the monitoring 
guidelines (or equivalent), and captured in a source data verification log at site.  
For each subject, the investigator must indicate in the hospital/medical source records that the 
subject participates in this trial and the date of obtaining the informed consent. The records should 
document data on the condition of the subject at the time the subject is enrolled in the trial to enable 
verification of eligibility. Signed and dated ICFs will be stored and archived according to local 
requirements. In addition, the following information, at the minimum, will also be recorded in the 
hospital/medical source records for each subject: 
• 
Subject’s name and date of birth  
• 
Screening/randomization number 
• 
Trial identification 
• 
Eligibility of participation in the trial (inclusion/exclusion) 
• 
Medical history 
• 
Date of each visit 
• 
Any assessment performed, ie, results of safety and efficacy parameters  
• 
Concomitant medications 
• 
Occurrence of any AEs/SAEs (including description and duration) 
• 
Receipt, dilution, dispensing and return of IMP 
• 
Status of the subject at the end of trial 
• 
Reason for discontinuation/withdrawal, if applicable 
Any worksheets used to capture data to facilitate completion of the eCRF will become part of the 
subject’s source documentation. 
An electronic source system may be utilized, which contains data maintained in a hospital medical 
record to document medical care (eg, electronic source documents) as well as the clinical trial-
specific data fields as determined by the protocol. This data is electronically extracted for use by 
the sponsor. If the electronic source system is utilized, references made to the case report form 
(CRF) in the protocol include the electronic source system but information collected through the 
electronic source system may not be limited to that found in the CRF. Data in this system may be 
considered source documentation. 
The author of an entry in the source should be identifiable. 

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Information included in the subject’s hospital records may be subject to local regulations. If there 
is a discrepancy between local requirements and the protocol, local regulations should be followed. 
12.2 
Case Report Form Completion 
CRF data will be transcribed into an electronic data capture (EDC) system by trial-site personnel 
from the source documents. Both EDC and other electronically captured trial data are transmitted 
in a secure manner to the sponsor within agreed upon timeframes. 
Data relating to the trial must be documented and reported in English. Trial site personnel must 
complete the CRF as soon as possible after the data are available and preferably within 5 days. 
Source data and the CRFs should be available for review at the next scheduled monitoring visit. 
All eCRF entries, response to queries, corrections, and alterations must be made by the investigator 
or other authorized trial-site personnel. The completed eCRF must be verified and approved by 
the investigator or qualified physician who is a subinvestigator and who is delegated this task on 
the Delegation of Authority Form. 
Corrections to the eCRF after data entry can be done as follows: 
• Trial-site personnel can make corrections in the EDC tool at their own initiative or as a response 
to an auto query (generated by the EDC tool) 
• The monitor can generate a query for resolution by the trial-site personnel 
• The sponsor or designee can generate a query for resolution by the trial-site personnel 
12.3 
Data Quality Management 
Steps to be taken to ensure the accuracy and reliability of data include the selection of qualified 
investigators and appropriate trial sites, review of protocol procedures with the investigator and 
trial-site personnel before the trial, periodic monitoring visits by the sponsor, and direct 
transmission of clinical laboratory data from a central laboratory, ECG data from the ECG vendor, 
and review of radiographic scans, pathology reports (as applicable) from the central imaging 
vendor (Expansion only) into the sponsor’s database. Written instructions will be provided for 
collection, handling, storage, and shipment of samples. 
Guidelines for eCRF completion will be provided with trial-site personnel before the first subject 
is dosed. The sponsor/CRO will review eCRFs for accuracy and completeness during on-site 
monitoring visits and after transmission to the sponsor; any discrepancies will be resolved with 
the investigator or designee, as appropriate. After upload of the data into the trial database they 
will be verified for accuracy and consistency with the data sources. 
12.4 
Record Retention 
In compliance with the ICH GCP guidelines, the investigator/institution will maintain all eCRFs 
and all source documents, as well as a source document location list, that support the data collected 
from each subject, as well as all trial documents as specified in ICH GCP guideline Section 8, 
Essential Documents for the Conduct of a Clinical Trial, and all trial documents as specified by 
the applicable regulatory requirement(s). The investigator/institution will take measures to prevent 
accidental or premature destruction of these documents. 
Essential documents must be retained for 25 years after end of trial. These documents will be 
retained for a longer period if required by the applicable regulatory requirements. It is the 

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responsibility of the sponsor to inform the investigator/institution as to when these documents no 
longer need to be retained. 
If the responsible investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the trial records, custody must be transferred to a qualified and trained 
person who will accept the responsibility. The sponsor must be notified in writing of the name and 
address of the new custodian. Under no circumstance shall the investigator relocate or dispose of 
any trial documents before having obtained written approval from the sponsor. 
If it becomes necessary for the sponsor or the appropriate regulatory authority to review any 
documentation relating to this trial, the investigator/institution must permit access to such reports.  

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13 
ETHICS 
13.1 
Trial-Specific Design Considerations 
Thorough scientific evaluation of any promising treatment before market authorization is an 
ethical requirement. In the continuing search for medications with improved efficacy and safety 
profiles, it is necessary to fully investigate and understand new products before public exposure. 
This trial is being conducted to evaluate the safety and multiple-dose PK of GEN3009 
monotherapy and GEN3009 + GEN3013 combination therapy in subjects with relapsed, 
progressive and/or refractory B-cell NHL. The results of this trial will provide useful information 
on the PK of GEN3009 and/or GEN3013. These data will assist in developing dosage adjustment 
guidance for future trials. 
As with all clinical and PK trials, there are risks associated with venipuncture and multiple blood 
sample collection. To avoid multiple venipunctures, which may cause additional discomfort, the 
use of IV indwelling catheters is permitted in this trial. The blood sample collection scheme was 
designed to collect the minimum number of blood samples that accurately and completely describe 
the PK of GEN3009 and GEN3013. Additionally, there are medical risks related to obtaining fresh 
biopsies. To mitigate such risks, fresh biopsies in this trial are performed only where it is 
considered feasible without a high risk of complications for the subject based on the discretion of 
the investigator. 
Potential subjects will be fully informed of the risks and requirements of the trial and, during the 
trial, subjects will be given any new information that may affect their decision to continue 
participation. They will be told that their consent to participate in the trial is voluntary and may be 
withdrawn at any time with no reason given and without penalty or loss of benefits to which they 
would otherwise be entitled. Only subjects who are fully able to understand the risks, benefits, and 
potential AEs of the trial, and provide their consent voluntarily will be enrolled. 
13.2 
Regulatory Ethics Compliance 
13.2.1 
Investigator Responsibilities 
The investigator is responsible for ensuring that the trial is performed in accordance with the 
protocol, current ICH guidelines on GCP, and applicable regulatory and country-specific 
requirements.  
GCP is an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting trials that involve the participation of human subjects. Compliance with this standard 
provides public assurance that the rights, safety, and well-being of trial subjects are protected, 
consistent with the principles that originated in the Declaration of Helsinki, and that the trial data 
are credible. 
13.2.2 
Independent Ethics Committee or Institutional Review Board 
This trial will be undertaken only after the IEC/IRB has given full approval of the final protocol, 
amendments (if any, excluding the ones that are purely administrative, with no consequences for 
subjects, data, or trial conduct), the ICF, applicable recruiting materials, and subject compensation 
programs, and the sponsor has received a copy of this written approval. This approval letter must 
be dated and must clearly identify the IEC/IRB and the documents being approved. 

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Approval for the collection of samples for research and for the corresponding ICF must be obtained 
from the IEC/IRB, as required by local regulations. Approval for the protocol can be obtained 
independent of this optional research component.  
For all protocol amendments (excluding the ones that are purely administrative, with no 
consequences for subjects, data, or trial conduct), the amendment and applicable ICF revisions 
must be submitted promptly to the IEC/IRB for review and approval before implementation of the 
change(s) unless the amendment is issued to eliminate immediate hazards to trial subjects.  
Where applicable, interim reports on the trial and/or review(s) of trial progress will be submitted 
by the investigator to the IEC/IRB at intervals stipulated in its guidelines. 
At the end of the trial, the investigator (or sponsor where required) will notify the IEC/IRB about 
the trial completion. 
13.2.3 
Informed Consent 
The ICFs that are used must be approved by the sponsor and by the reviewing IEC/IRB and be in 
a language that the subject can read and understand. The informed consent should be in accordance 
with principles that originated in the Declaration of Helsinki 2013, current ICH guidelines, 
applicable regulatory requirements, and sponsor policy. 
It is the personal responsibility of the investigator or an authorized member of the trial-site 
personnel to explain to potential subjects the aims, methods, reasonably anticipated benefits, and 
potential hazards of the trial, and any discomfort participation in the trial may entail. Subjects will 
be informed that their participation is voluntary and that they may withdraw consent to participate 
at any time without justifying the reason. They will be informed that choosing not to participate 
will not affect the care the subject will receive for the treatment of their disease. Finally, they will 
be told that the investigator will maintain a subject identification register for the purposes of long-
term follow up if needed and that their records may be accessed by health authorities and 
authorized sponsor personnel without violating the confidentiality of the subject, to the extent 
permitted by the applicable laws or regulations. By signing the ICF, the subject is authorizing such 
access, and agrees to allow their trial physician to re-contact the subject for the purpose of 
obtaining consent for additional safety evaluations, including scans, if needed. 
The subject will be given sufficient time to read the ICF and the opportunity to ask questions. After 
this explanation and before entry into the trial, consent should be appropriately recorded by means 
of the subject's personally dated signature. After having obtained the consent, a copy of the ICF 
must be given to the subject. 
A separate ICF will be used for the required DNA/RNA research component of the trial if required 
by local regulations.  
13.2.4 
Privacy of Personal Data 
The collection and processing of personal data from subjects enrolled in this trial will be limited 
to those data that are necessary to fulfill the purpose and the objectives of the trial. These data 
must be collected and processed with adequate precautions to ensure confidentiality and 
compliance with applicable data privacy protection laws and regulations. Appropriate technical 
and organizational measures to protect the personal data against unauthorized disclosures or 
access, accidental or unlawful destruction, or accidental loss or alteration must be put in place. 

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Sponsor personnel whose responsibilities require access to personal data agree to keep the identity 
of subjects confidential. 
The informed consent obtained from the subject includes explicit consent for the processing of 
personal data for the purpose of the trial and for the investigator/institution to allow direct access 
to his or her original medical records (source data/documents) for trial-related monitoring, audit, 
IEC/IRB review, and regulatory inspection. This consent also addresses the transfer of the data to 
other entities and to other countries. 
The subject has the right to request, through the investigator, access to his or her personal data and 
the right to request rectification of any data that are not correct or complete. Furthermore, the 
subject has the right to withdraw consent at any time throughout the duration of the trial. Personal 
data collected prior to the subject’s withdrawal will still be used but no new personal data will be 
collected or processed for trial purposes unless it relates to reportable safety events. Reasonable 
steps will be taken by the investigator to respond to such requests, taking into consideration the 
nature of the request, the conditions of the trial, the applicable laws and regulations, and the 
investigator’s obligations stated in the clinical trial agreement, including the data processor 
agreement. 
13.2.5 
Return of Exploratory Research Data to Subjects and Investigators 
Exploratory biomarker research is not conducted under standards appropriate for the return of data 
to subjects or investigators. In addition, the sponsor cannot make decisions as to the significance 
of any findings resulting from exploratory research. Therefore, exploratory research data will not 
be returned to subjects or investigators, unless required by law or local regulations. Privacy and 
confidentiality of data generated in the future on stored samples will be protected by the same 
standards applicable to all other clinical data. 

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14 
ADMINISTRATIVE PROCEDURES 
14.1 
Protocol Amendments 
Neither the investigator nor the sponsor will modify this protocol without a formal amendment by 
the sponsor. All protocol amendments must be issued by the sponsor and signed and dated by the 
investigator. Protocol amendments must not be implemented without prior IEC/IRB approval, or 
when the relevant competent authority has raised any grounds for non-acceptance, except when 
necessary to eliminate immediate hazards to the subjects, in which case the amendment must be 
promptly submitted to the IEC/IRB and relevant competent authority. Documentation of 
amendment approval by the investigator and IEC/IRB must be provided to the sponsor. When the 
change(s) involve(s) only logistic or administrative aspects of the trial, the IRB (and IEC where 
required) only needs to be notified. 
During the course of the trial, in situations where a departure from the protocol is unavoidable, the 
investigator or other physician in attendance will contact the appropriate sponsor representative 
(refer to contact information page[s] provided separately). Except in emergency situations, this 
contact should be made before implementing any departure from the protocol. In all cases, contact 
with the sponsor must be made as soon as possible to discuss the situation and agree on an 
appropriate course of action. The data recorded in the eCRF and source documents will reflect any 
departure from the protocol, and the source documents will describe this departure and the 
circumstances requiring it. 
14.2 
Regulatory Documentation 
14.2.1 
Regulatory Approval/Notification 
This protocol and any amendment(s) must be submitted to the appropriate regulatory authorities 
in each respective country, if applicable. A trial may not be initiated until all local regulatory 
requirements are met. 
14.3 
Subject Identification, Enrollment, and Screening Logs 
The investigator agrees to assign a unique subject identification to protect the subject’s identity 
and to permit easy identification of each subject during and after the trial. All reports and 
communications relating to the trial will identify subjects by the unique subject identifier and year 
of birth or age.  
The investigator must complete a subject screening and enrollment log, which reports on all 
subjects who consent to be on trial, are screened, screen failed, including those who meet eligibility 
for inclusion in the trial. The subject identification log will be treated as confidential and will be 
filed by the investigator in the trial file. The screening and enrollment logs will be reviewed by the 
sponsor or designee for completeness. 
14.4 
Monitoring 
The sponsor will use a combination of remote and on-site monitoring to monitor this trial. The 
sponsor or delegate will perform on-site monitoring visits as frequently as necessary. The monitor 
will record dates of the visits in a trial-site visit log that will be kept at the trial site. In the Dose 
Escalation the first post-initiation visit will be made as soon as possible after enrollment has begun. 

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At these visits, the monitor will compare the data entered into the eCRFs with the hospital or clinic 
records (source documents). The nature and location of all source documents will be identified to 
ensure that all sources of original data required to complete the eCRF are known to the sponsor 
and trial-site personnel and are accessible for verification by the sponsor trial-site contact. If 
electronic records are maintained at the trial site, the method of verification must be discussed with 
the trial-site personnel. Where allowed in accordance with local regulations, (eg, in the event of a 
national emergency) and in agreement with the investigator, remote source data verification may 
be performed. 
The investigator must permit the monitor direct access to all source data, including electronic 
medical records, and/or documents with the purpose of verifying that the data recorded in the 
eCRF are consistent with the original source data. Findings from this review of eCRFs and source 
documents will be discussed with the trial-site personnel. The sponsor expects that, during 
monitoring visits, the relevant trial-site personnel will be available, the source documentation will 
be accessible, and a suitable environment will be provided for review of trial-related documents. 
The monitor will meet/talk with the investigator on a regular basis during the trial to provide 
feedback on the trial conduct. 
In addition to on-site monitoring visits, remote contacts can occur. It is expected that during these 
remote contacts, trial-site personnel will be available to provide an update on the progress of the 
trial at the site. 
14.5 
On-Site Audits 
Representatives of the sponsor’s clinical quality assurance department may visit the trial site at 
any time during or after completion of the trial to conduct an audit of the trial in compliance with 
regulatory guidelines and company policy. These audits will require access to all trial records, 
including source documents, for inspection and comparison with the eCRFs. Subject privacy must, 
however, be respected. The investigator and trial-site personnel are responsible for being present 
and available for consultation during routinely scheduled trial-site audit visits conducted by the 
sponsor or its designees. 
Similar auditing procedures may also be conducted by agents of any regulatory body, either as part 
of a national GCP compliance program or to review the results of this trial in support of a 
regulatory submission. The investigator should immediately notify the sponsor if he or she has 
been contacted by a regulatory agency concerning an upcoming inspection. 
14.6 
Publication 
All information, including but not limited to information regarding GEN3009 and/or GEN3013 or 
the sponsor's operations (eg, patent application, formulas, manufacturing processes, basic 
scientific data, prior clinical data, formulation information) supplied by the sponsor to the 
investigator and not previously published, and any data, including pharmacogenomic or 
exploratory biomarker research data, generated as a result of this trial, are considered confidential 
and remain the sole property of the sponsor. The investigator agrees to maintain this information 
in confidence and use this information only to accomplish this trial and will not use it for other 
purposes without the sponsor's prior written consent. 
The investigator understands that the information developed in the trial will be used by the sponsor 
in connection with the continued development of GEN3009 and/or GEN3013, and thus may be 
disclosed as required to other clinical investigators or regulatory agencies. To permit the 

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information derived from the clinical trials to be used, the investigator is obligated to provide the 
sponsor with all data obtained in the trial. 
The results of the trial will be reported in a clinical trial report generated by the sponsor and will 
contain eCRF data from all trial sites that participated in the trial and direct transmission of clinical 
laboratory data from a central laboratory into the sponsor's database. Recruitment performance or 
specific expertise related to the nature and the key assessment parameters of the trial will be used 
to determine a coordinating investigator. Results of exploratory biomarker analyses performed 
after the clinical trial report (CTR) has been issued will be reported in a separate report and will 
not require a revision of the CTR. Trial subject identifiers will not be used in publication of results. 
Any work created in connection with performance of the trial and contained in the data that can 
benefit from copyright protection (except any publication by the investigator as provided for 
below) shall be the property of the sponsor as author and owner of copyright in such work. 
Consistent with Good Publication Practices and International Committee of Medical Journal 
Editors guidelines (Battisti et al., 2015; ICMJE, 2018), the sponsor shall have the right to publish 
such primary (multicenter) data and information without approval from the investigator. The 
investigator has the right to publish trial site-specific data after the primary data are published. If 
an investigator wishes to publish information from the trial, a copy of the manuscript must be 
provided to the sponsor for review at least 60 days before submission for publication or 
presentation. Expedited reviews will be arranged for abstracts, poster presentations, or other 
materials. If requested by the sponsor in writing, the investigator will withhold such publication 
for up to an additional 60 days to allow for filing of a patent application. In the event that issues 
arise regarding scientific integrity or regulatory compliance, the sponsor will review these issues 
with the investigator. The sponsor will not mandate modifications to scientific content and does 
not have the right to suppress information. For multicenter trial designs and sub-trial approaches, 
secondary results generally should not be published before the primary endpoints of a trial have 
been published. Similarly, investigators will recognize the integrity of a multicenter trial by not 
submitting for publication data derived from the individual trial site until the combined results 
from the completed trial have been submitted for publication, within 12 months of the availability 
of the final data (tables, listings, graphs), or the sponsor confirms there will be no multicenter trial 
publication. Authorship of publications resulting from this trial will be based on the guidelines on 
authorship, such as those described in the Uniform Requirements for Manuscripts Submitted to 
Biomedical Journals, which state that the named authors must have made a significant contribution 
to the design of the trial or analysis and interpretation of the data, provided critical review of the 
paper, given final approval of the final version, and agreed to be accountable for all aspects of the 
work (ICMJE, 2010).  
14.7 
Registration of Clinical Trials and Disclosure of Results 
The sponsor will register and/or disclose the existence of and the results of clinical trials as 
required by law. 

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15 
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16 
APPENDICES 

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Appendix 1 Calculation of Glomerular Filtration Rate 
Glomerular filtration rate (GFR) may be estimated based on commonly used and accepted 
formulae, ie 
,Cockroft Gault formula 
 
(140 - age) × weight × FS 
 
GFR =  
───────────────────── 
 
Serum Creatinine × 72 
Units: GFR [ml/min], age [years], weight [kg], serum creatinine [mg/dl], FS is a correction 
Factor for Sex: in males FS=1, in females FS=0.85 
Modification of Diet in Renal Disease (MDRD) formula 
GFR =  170 x Serum Creatinine-0.999 × Age-0.176 × BUN -0.170 × Albumin +0.318 x FS 
Units: GFR [ml/min], age [years], serum creatinine [mg/dl], FS is a correction Factor for Sex: 
in males FS=1, in females FS=0.762 
Variations of the MDRD formula 
GFR =  186 × Serum Creatinine-1.154 × Age-0,203 × FS 
Units: GFR [ml/min], age [years], serum creatinine [mg/dl], FS is a correction Factor for Sex: 
in males FS=1, in females FS=0.742 

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 New York Heart Association Criteria 
Class  
Subject Symptoms 
Objective Assessment 
I 
No limitation of physical activity. 
Ordinary physical activity does not cause 
undue fatigue, palpitation, dyspnea 
(shortness of breath). 
No objective evidence of cardiovascular 
disease. No symptoms and no limitation 
in ordinary physical activity. 
II 
Slight limitation of physical activity. 
Comfortable at rest. Ordinary physical 
activity results in fatigue, palpitation, 
dyspnea (shortness of breath). 
Objective evidence of minimal 
cardiovascular disease. Mild symptoms 
and slight limitation during ordinary 
activity. Comfortable at rest. 
III 
Marked limitation of physical activity. 
Comfortable at rest. Less than ordinary 
activity causes fatigue, palpitation, or 
dyspnea. 
Objective evidence of moderately severe 
cardiovascular disease. Marked limitation 
in activity due to symptoms, even during 
less-than-ordinary activity. Comfortable 
only at rest. 
IV 
Unable to carry on any physical activity 
without discomfort. Symptoms of heart 
failure at rest. If any physical activity is 
undertaken, discomfort increases. 
Objective evidence of severe 
cardiovascular disease. Severe limitations. 
Experiences symptoms even while at rest. 
 

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 Corticosteroid Dose Equivalents 
Steroid 
Approximate Equivalent 
Dose 
 
Betamethasone 
12 mg 
Long-acting 
Dexamethasone 
15 mg 
Long-acting 
Methylprednisolone 
80 mg 
Intermediate-acting 
Triamcinolone 
80 mg 
Intermediate-acting 
Prednisone 
100 mg 
Intermediate-acting 
Prednisolone 
100 mg 
Intermediate-acting 
 

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 Tumor Lysis Syndrome 
Presence of TLS is not clearly defined by CTCAE. For this trial the Cairo-Bishop classification 
will be used to define the presence of TLS. Laboratory TLS (Table 35) will not be considered as 
presence of TLS in the absence of the specified clinical complications (Coiffier et al., 2008). 
Clinical TLS should be graded according to Table 36. Individual symptoms should be graded 
according to CTCAE.  
As noted in Section 7.1, during Dose Escalation, Grade 4 TLS is considered a DLT. Refer to 
Sections 7.4.3.3 and 7.5.4 for relevant management and dose modification guidelines. 
Table 35 
Cairo-Bishop Definition of Laboratory Tumor Lysis Syndrome 
Laboratory parameter 
Value 
Change from Baseline 
Uric acid 
≥ 476 µmol/L or 8 mg/dL 
25% increase 
Potassium 
≥ 6.0 mmol/L or 6 mg/L 
25% increase 
Phosphorus 
≥ 1.45 mmol/L 
25% increase 
Calcium 
≤ 1.75 mmol/L 
25% increase 
Note: 2 or more laboratory changes within 3 days before or 7 days after treatment with GEN3009. Based on (Coiffier 
et al., 2008). 
 
Table 36 
Cairo-Bishop Definition of Clinical Tumor Lysis Syndrome and Grading 
Complication 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Grade 5 
Creatinine*† 
1.5 x ULN 
> 1.5–3.0 x ULN 
> 3.0-6.0 x ULN 
> 6.0 x ULN 
Death  
Cardiac 
arrhythmia* 
Intervention 
not indicated 
Nonurgent medical 
intervention needed 
Symptomatic and 
incompletely 
controlled medically 
or controlled with 
device (eg, 
defibrillator) 
Life-threatening (eg, 
arrhythmia 
associated with CHF, 
hypotension, 
syncope, shock)  
Seizure* 
None 
One brief 
generalized 
seizure; seizure(s) 
well controlled by 
anticonvulsants or 
infrequent focal 
motor seizures not 
interfering with 
ADL 
Seizure in which 
consciousness is 
altered; poorly 
controlled seizure 
disorder; with 
breakthrough 
generalized seizures 
despite medical 
intervention 
Seizure of any kind 
which are prolonged, 
repetitive or difficult 
to control (eg, status 
epilepticus, 
intractable epilepsy) 
* Not directly or probably attributable to GEN3009 
† If no institutional ULN is specified, ULN is defined as follows: female 105.6 µmol/L, male 114.4 µmol/L. 
Based on (Coiffier et al., 2008). 

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Appendix 5 Ann Arbor Staging 
Stage 
Area of Involvement 
I 
Single lymph node or lymph node region 
II 
Two or more lymph node regions on same side of diaphragm 
III 
Lymph node regions on both sides of the diaphragm are affected 
IV 
Disease is wide spread, including multiple involvement at 1 or more extranodal 
sites (beyond the lymph node, spleen, tonsils and Waldeyer’s ring), such as the 
bone marrow, liver or pleura 
A 
Without disease symptoms 
B 
With symptoms like night sweats, weight loss > 10% over 6 months, fever without infection 
E 
Extranodal disease 
 

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 Rai and Binet Staging 
 
Rai Staging System 
Low-risk disease 
Lymphocytosis with leukemia cells in the blood and/or marrow 
Intermediate-risk disease 
Peripheral blood lymphocytosis, enlarged lymph nodes in any 
site, and splenomegaly and/or hepatomegaly (lymph nodes being 
palpable or not) 
High-risk disease 
Disease-related anemia (as defined by a Hb level <1 g/dL) or 
thrombocytopenia (as defined by a platelet count of <100 × 
109/L) 
Hallek et al., 2018 
Binet Staging System 
Stage 
 
A 
Hb ≥10 g/dL and platelets ≥100×109/L and up to 2 areas involved 
B 
Hb ≥10 g/dL and platelets ≥100×109/L and 3 or more lymphoid 
areas involved 
C 
Hb <10 g/dL and/or a platelet count <100 × 109/L) 
Areas of involvement considered for staging include: 
1. Head and neck, including the Waldeyer ring (this counts as 1 area, even if ≥1 group of nodes is enlarged) 
2. Axillae (involvement of both axillae counts as just 1 area) 
3. Groins, including superficial femorals (involvement of both groins counts as just 1 area) 
4. Palpable spleen 
5. Palpable liver (clinically enlarged) 
Hallek et al., 2018 
 

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Appendix 7 Response Criteria for B-cell NHL by CT Scan  
Response 
Lymph Nodes 
Non-
Measurable 
Lesion 
Organ 
Enlargement 
New Lesions 
Bone Marrow 
CR 
Target 
nodes/nodal 
masses 
regression 
≤1.5 cm in 
longest 
diameter 
Absent 
Regress to 
normal 
None 
Normal by 
morphology; if 
indeterminate, 
IHC negative 
PR 
≥50% decrease 
in SPD of up to 
6 target 
measurable 
nodes and 
extranodal sites 
Absent/normal, 
regressed, but 
no increase 
Spleen 
regressed >50% 
in length 
beyond normal  
None 
Not applicable 
No response or 
SD 
<50% decrease 
in SPD of up to 
6 target 
measurable 
nodes and 
extranodal sites 
No increase 
consistent with 
progression 
No increase 
consistent with 
progression 
None 
Not applicable 
PD 
>1.5 cm and 
increase by 
≥50% from 
nadir and 
increase from 
nadir 
• 
0.5 cm for 
lesions 
≤2 cm 
• 
1.0 cm for 
lesions 
>2 cm 
New or clear 
progression of 
pre-existing 
lesions 
Spleen length 
increase of 
>50% from 
baseline or if no 
prior 
splenomegaly, 
must increase 
by at least 2 cm 
from baseline 
Regrowth of 
previously 
resolved 
lesions; new 
nodes >1.5 cm 
in any axis; new 
extranodal site 
>1.0 cm in any 
axis; assessable 
disease of any 
size 
unequivocally 
attributable to 
lymphoma 
New or 
recurrent 
involvement 
(Cheson et al., 2014)  

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Appendix 8 Response Criteria for CLL 
Group and 
Parameters 
Complete Remission 
(CR)** 
 
 
Partial Remission 
(PR)** 
 
 
Progressive 
Disease (PD) 
 
 
Stable Disease 
(SD) 
 
 
Group A – assess the lymphoid tumor load and constitutional symptoms 
Lymph nodes None ≥1.5 cm 
Decrease ≥50% from 
baseline* 
Increase ≥50% 
from baseline or 
from response 
Change of -49% 
to +49%  
Liver and/or 
spleen size† 
Liver size normal; 
spleen size <13 cm 
Decrease ≥50% from 
baseline 
Increase ≥50% 
from baseline or 
from response 
Change of -49% 
to +49% 
Constitutional 
symptoms 
None 
Any 
Any 
Any 
Circulating 
lymphocyte 
count 
< 4 × 109/L 
Decrease ≥50% from 
baseline 
Increase ≥50% 
from baseline 
Change of -49% 
to +49% 
Group B – assess the hematopoietic system  
Platelet count ≥100 × 109/L (≥ 00,000 
µL) 
≥100 × 109/L (≥100,000 
µL) or increase ≥ 50% 
over baseline 
Decrease ≥50% 
from baseline 
secondary to CLL 
Change of -49% 
to +49% 
Hemoglobin 
≥11.0 g/dL 
(untransfused and 
without erythropoietin ) 
≥11.0 g/dL or increase 
of ≥50% over baseline 
Decrease of 
≥2.0 g/dL from 
baseline, 
secondary to CLL 
Increase 
<11.0 g/dL or 
<50% over 
baseline or 
decrease 
<2.0 g/dL 
Bone marrow Normocellular, no CLL 
cells, no B-lymphoid 
nodules 
Presence of CLL cells 
or B-lymphoid nodules, 
or not done 
Increase of CLL 
cells by ≥50% on 
successive 
biopsies 
No change in 
marrow 
infiltration 
*Sum of the products of 6 or fewer lymph nodes (as evaluated by CT scans and physical 
examination in clinical trials or by physical examination in general practice). 
†Spleen size is considered normal if <13 cm. There is not firmly established international 
consensus of the size of a normal liver; therefore, liver size should be evaluated by imaging and 
manual palpation and recorded. 
**CR, (all of the criteria have to be met); PD (at least 1 of the criteria of group A or group B has 
to be met); PR (for a PR, at least 2 of the parameters of group A and 1 parameter of group B need 
to improve if previously abnormal; if only 1 parameter of both groups A and B is abnormal before 
therapy, only 1 needs to improve); SD (all of the criteria have to be met; constitutional symptoms 
alone do not define PD). 
Nodular partial remission is defined as a bone marrow biopsy showing residual nodules or 
suspicious lymphocytic infiltrates in subjects who are in remission; which often indicates a 
residual disease.  
(Hallek et al., 2018) 

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Appendix 9 PET Positivity Evaluation 
Evaluation of PET positivity should be performed according to the 5-point scale (5-PS) adopted 
from the Deauville criteria described in (Barrington et al., 2014). 
The 5-PS was intended as a simple, reproducible scoring method, with the flexibility to change the 
threshold between good or poor response according to the clinical context and/or treatment 
strategy. For example, a lower level of FDG uptake might be preferred to define a so-called 
negative result in a clinical trial exploring de-escalation to avoid undertreatment. A higher level of 
uptake might be preferred to define a so-called positive result in a trial exploring escalation to 
avoid overtreatment. The 5-PS has been validated for use at interim and the end of treatment. 
The 5-PS scores the most intense uptake in a site of initial disease, if present, as follows: 
1 no uptake  
2 uptake ≤ mediastinum  
3 uptake > mediastinum 
4 uptake moderately higher than liver 
5 uptake markedly higher than liver and/or new lesions 
X new areas of uptake unlikely to be related to lymphoma 

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Appendix 10 Response Criteria for B-cell NHL by FDG-PET CT scan  
Response 
Lymph Nodes  Non-
Measurable 
Lesion 
Organ 
Enlargement 
New Lesions 
Bone Marrow 
CR 
Score 1, 2 or 3 
with or without 
a residual mass 
on 5-PS* 
Not applicable 
Not applicable 
None 
No evidence of 
FDG-avid 
disease in 
marrow  
PR 
Score 4 or 5* 
with reduced 
uptake 
compared to 
baseline and 
residual mass of 
any size  
Not applicable 
Not applicable 
None 
Residual uptake 
higher than 
uptake in 
normal marrow 
but reduced 
compared to 
baseline 
No response or 
SD 
Score 4 or 5 
with no 
significant 
change in FDG 
uptake  
Not applicable 
Not applicable 
None 
No change from 
baseline 
PD 
Score 4 or 5 
with an increase 
in intensity of 
uptake from 
baseline  
None 
- 
New FDG-avid 
foci consistent 
with lymphoma  
New or 
recurrent FDG-
avid foci 
*PET 5-PS: 1, no uptake above background; 2, uptake ≤ mediastinum; 3, uptake > mediastinum; liver; 4, 
uptake moderately > liver; 5, uptake markedly higher 
than liver and/or new lesions; X, new areas of uptake unlikely to be related to lymphoma. 
 

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 ECOG Performance Status 
Grade 
ECOG 
0 
Fully active, able to carry on all pre-disease performance without restriction 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work 
of a light or sedentary nature, eg, light house work, office work 
2 
Ambulatory and capable of all selfcare but unable to carry out any work activities. Up 
and about more than 50% of waking hours 
3 
Capable of only limited selfcare, confined to bed or chair more than 50% of waking 
hours 
4 
Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 
5 
Dead 
(Oken et al., 1982) 

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 Definition of Reproductive Potential and Contraception 
Female subjects of reproductive potential must agree to use adequate contraception during and 
for 12 months after the last GEN3009 and/or GEN3013 administration. Adequate contraception 
is defined as highly effective methods of contraception in the table that follows. Birth control 
methods are considered highly effective if they have a failure rate of less than 1% per year, when 
used consistently and correctly. 
In this trial, subjects are considered to have reproductive potential, unless they are 
postmenopausal or permanently sterile. 
• A postmenopausal state is defined as no menses, in subjects >45 years of age, for 
12 months without an alternative medical cause. A high follicle-stimulating hormone 
(FSH) level in the postmenopausal range may be used to confirm a post-menopausal state 
in subjects not using hormonal contraception or hormonal replacement therapy. However, 
in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.  
• Permanent sterilization methods include hysterectomy, bilateral salpingectomy and 
bilateral oophorectomy. 
All female subjects must agree not to donate eggs (ova, oocytes) for the purpose of assisted 
reproduction during the trial and for 12 months after receiving the last dose of GEN3009 and/or 
GEN3013. 
 
Highly Effective Methods of Contraception 
• 
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of 
ovulation1: 
o 
Oral 
o 
Intravaginal  
o 
Transdermal 
• 
Progestogen-only hormonal contraception associated with inhibition of ovulation1: 
o 
Oral 
o 
Injectable 
o 
Implantable2 
• 
Intrauterine device2 
• 
Intrauterine hormone-releasing system2 
• 
Bilateral tubal occlusion2 
• 
Vasectomized partner2, 3 
• 
Sexual abstinence4 
1 Hormonal contraception may be susceptible to interaction with GEN3009 and/or GEN3013, which may reduce 
the efficacy of the contraception method and therefore must be supplemented with a barrier method for the 
non-vasectomized male partner (preferably a condom with spermicidal foam/gel/film/cream/suppository). 
2 Contraception methods that in the context of this guidance are considered to have low user dependency. 
3 Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner 
of the female subject of reproductive potential (ie, the trial subject) and that the vasectomized partner has 
received medical assessment of the surgical success. 
4 In the context of this guidance, sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated with the trial treatment. The 

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reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the 
preferred and usual lifestyle of the subject. 
Table adapted from ‘Recommendations related to contraception and pregnancy testing in clinical trials, version 1.1.” 
(CTFG, 2020).  
 

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Appendix 13 Grading and Management of Cytokine Release Syndrome 
Harmonized definitions and grading criteria for CRS, per the American Society for 
Transplantation and Cellular Therapy (ASTCT), formerly American Society for Blood and 
Marrow Transplantation, (ASBMT), are presented below. 
Grading of Cytokine Release Syndrome  
CRS Parameter 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Grade 5 
Fever1 
>38.0°C 
>38.0°C 
>38.0°C 
>38.0°C 
Death due to 
CRS in which 
another cause is 
not the 
principal factor 
leading to this 
outcome 
With 
hypotension 
None 
Not requiring 
vasopressors 
Requiring 1 
vasopressor with 
or without 
vasopressin 
Requiring ≥ 2 
vasopressors 
(excluding 
vasopressin) 
And/or 
hypoxia2 
None 
Requiring low-
flow 
(≤6 L/minute) 
nasal cannula or 
blow-by 
Requiring high-
flow 
(>6 L/minute) 
nasal cannula, 
facemask, 
nonrebreather 
mask, or venturi 
mask 
Requiring positive 
pressure ventilation3 
(eg, CPAP, BiPAP, 
intubation and 
mechanical 
ventilation) 
Note: organ toxicities or constitutional symptoms associated with CRS may be graded according to CTCAE but 
they do not influence CRS grading. 
1. Fever is defined as temperature ≥38.0°C not attributable to any other cause, with or without constitutional 
symptoms (eg, myalgia, arthralgia, malaise). In subjects who have CRS receiving antipyretics, anticytokine 
therapy, and/or corticosteroids, fever is no longer required to grade subsequent CRS severity. In this case, CRS 
grading is driven by hypotension and/or hypoxia. 
2. CRS grade is determined by the more severe event: hypotension or hypoxia not attributable to any other cause. 
For example, a subject with temperature of 39.5°C, hypotension requiring 1 vasopressor, and hypoxia requiring 
low-flow nasal cannula is classified as Grade 3 CRS. Both systolic blood pressure and mean arterial pressure are 
acceptable for blood pressure measurement. No specific limits are required, but hypotension should be determined 
on a case-by-case basis, accounting for age and the subject’s individual baseline, ie, a blood pressure that is below 
the normal expected for an individual in a given environment. 
Intubation of a subject without hypoxia for the possible neurologic compromise of a patent airway alone or for a 
procedure is not by definition Grade 4 CRS. 
Source: (Lee et al., 2019) 
 

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Grading and Management of Cytokine Release Syndrome  
CRS 
Grade 
Defining Features of Grade 
Management 
Grade 1 
Fever with temperature ≥38°C but no 
hypotension or hypoxia 
Antipyretics and IV hydration 
Diagnostic work‐up to rule out infection 
Consider growth factors and antibiotics if 
neutropenic 
Grade 2 
Fever with hypotension not requiring 
vasopressors and/or hypoxia requiring low‐
flow nasal cannula 
Supportive care as in grade 1 
IV fluid boluses and/or supplemental oxygen 
Tocilizumab +/− dexamethasone or its equivalent of 
methylprednisolone 
Grade 3 
Fever with hypotension requiring 
1 vasopressor with or without vasopressin 
and/or hypoxia requiring high‐flow nasal 
cannula, facemask, nonrebreather mask, or 
venturi mask 
Supportive care as in grade 1 
Consider monitoring in intensive care unit 
Vasopressor support and/or supplemental oxygen 
Tocilizumab + dexamethasone 10-20 mg IV every 6 
hours or its equivalent of methylprednisolone 
Grade 4 
Fever with hypotension requiring 
2 vasopressors (excluding vasopressin) 
and/or hypoxia requiring positive pressure 
ventilation (eg, CPAP, BiPAP, intubation 
and mechanical ventilation) 
Supportive care as in grade 1 
Monitoring in intensive care unit 
Vasopressor support and/or supplemental oxygen via 
positive pressure ventilation 
Tocilizumab + methylprednisolone 1000 mg/day 
Source: (Neelapu, 2019) 
 

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 Grading of Neurotoxicity Associated with Immune Effector Cells 
Harmonized definitions and grading criteria for neurotoxicity, per the ASTCT, formerly ASBMT, 
are presented below. 
Grading for Immune Effector Cell‐associated Neurotoxicity Syndrome  
Neurotoxicity 
Domain 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Grade 5 
ICE score1 
7-9 
3-6 
0-2 
0 (subject is unrousable 
and unable to perform 
ICE) 
Death due 
to ICANS 
in which 
another 
cause is 
not the 
principal 
factor 
leading to 
this 
outcome 
Depressed 
level 
of consciousness2 
Awakens 
spontaneously 
Awakens to 
voice 
Awakens only to 
tactile stimulus 
Subject is unrousable 
or requires vigorous or 
repetitive tactile stimuli 
to arouse. Stupor or 
coma. 
Seizure 
N/A 
N/A 
Any clinical seizure 
focal or generalized 
that resolves rapidly 
or nonconvulsive 
seizures on EEG 
that resolve with 
intervention 
Life-threatening 
prolonged seizure (>5 
min); or repetitive 
clinical or electrical 
seizures without return 
to baseline in between 
Motor findings3 
N/A 
N/A 
N/A 
Deep focal motor 
weakness such as 
hemiparesis or 
paraparesis 
Elevated 
ICP/cerebral 
edema 
N/A 
N/A 
Focal/local edema 
on neuroimaging4 
Diffuse cerebral 
edema on 
neuroimaging; 
decerebrate or 
decorticate posturing; 
or cranial nerve VI 
palsy, or papilledema, 
or Cushing’s triad 
Note: ICANS grade is determined by the most severe domain event not attributable to any other cause. For example, 
a subject with an ICE score of 3 who has a generalized seizure is classified as Grade 3 ICANS. 
1. A subject with an ICE score of 0 may be classified as Grade 3 ICANS if awake with global aphasia, but a 
subject with an ICE score of 0 may be classified as Grade 4 ICANS if unarousable. 
2. Depressed level of consciousness should be attributable to no other cause (eg, no sedating medication). 
3. Tremors and myoclonus associated with immune effector cell therapies may be graded according to CTCAE 
Version 5.0, but they do not influence ICANS grading. 
4. Intracranial hemorrhage with or without associated edema is not considered a neurotoxicity feature and is 
excluded from ICANS grading. It may be graded according to CTCAE Version 5.0.  
Source: (Lee et al., 2019) 
 

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Immune Effector Cell-Associated Encephalopathy Assessment Tool  
Cognitive Domain 
Task 
Points 
ICE Scoring 
Orientation 
Orientation to year 
Orientation to month 
Orientation to city 
Orientation to hospital 
1 
1 
1 
1 
10: No impairment 
7-9 Grade 1 ICANS 
3-6 Grade 2 ICANS 
0-2: Grade 3 ICANS 
0 due to subject unarousable 
and unable to perform ICE 
assessment: Grade 4 ICANS 
Naming 
Ability to name 3 common objects 
(eg, point to clock, pen, button) 
3 
Following 
commands 
Ability to follow simple commands 
(eg, “Show me 2 fingers” or “Close 
your eyes and stick out your 
tongue”) 
1 
Writing 
Ability to write a standard sentence 
(eg, “Our national bird is the bald 
eagle”) 
1 
Attention 
Ability to count backwards from 
100 by 10 
1 
Maximum ICE score 
10 
Source: Based on (Lee et al., 2019)