TriangleNCT03625037 · CITED IN SOURCE DOCUMENTS
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE1, PHASE2
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-09-09
The purpose of this trial is to measure the following in participants with relapsed and/or refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20): * The dose schedule for epcoritamab * The side effects seen with epcoritamab * What the body does with epcoritamab once it is administered * What epcoritamab does to the body once it is administered * How well epcoritamab works against relapsed and/or refractory B-cell lymphoma The trial consists of 3 parts: * a dose-escalation part (Phase 1, first-in-human \[FIH\]) * an expansion part (Phase 2a) * a dose-optimization part (OPT) (Phase 2a) The trial time for each participant depends on which trial part the participant enters: * For the dose-escalation part, each participant will be in the trial for approximately 1 year, which is made up of 21 days of screening, 6 months of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant). * For the expansion and dose-OPT parts, each participant will be in the trial for approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant). Participation in the study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends. All participants will receive active drug, and no participants will be given placebo.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Main Inclusion Criteria - Escalation Part (recruitment completed) * Documented CD20+ mature B-cell neoplasm 1. DLBCL - de novo or transformed 2. HGBCL 3. PMBCL 4. FL 5. MCL 6. SLL 7. MZL (nodal, extranodal or mucosa associated) * Relapsed and/or refractory disease following treatment with an anti-CD20 monoclonal antibody (e.g. rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue. * Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2. * Participants must have measurable disease by computed tomography (CT), magnetic resonance imaging (MRI) or Positron emission tomography-Computed tomography (PET-CT) scan * Acceptable renal function. * Acceptable liver function. Main Inclusion Criteria - Expansion \& Dose-OPT Parts * Documented CD20 positive mature B cell neoplasm or CD20+ MCL. * DLBCL, de novo or transformed (including double hit or triple hit). * PMBCL * FL grade 3B * Histologic confirmed FL * MZL * SLL * MCL (prior Bruton's tyrosine kinase inhibitor \[BTKi\] or intolerant to BTKi) * At least 2 therapies including an anti-CD20 monoclonal antibody containing chemotherapy combination regimen. * Either failed prior autologous hematopoietic stem cell transplantation (HSCT) or ineligible for autologous stem cell transplantation due to age or comorbidities. * At least 1 measurable site of disease based on CT, MRI or PET-CT scan with involvement of 2 or more clearly demarcated lesions and or nodes. Main Exclusion Criteria - All Parts * Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening. * Known past or current malignancy other than inclusion diagnosis. * Aspartate aminotransferase (AST), and/or alanine transaminase (ALT) \>3 × upper limit of normal. * Total bilirubin \>1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin. * Estimated Creatinine clearance (CrCl) \<45 milliliters (mL)/min. * Known clinically significant cardiovascular disease. * Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment). Past coronavirus disease 2019 (COVID-19) infection may be a risk factor. * Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy. * Seizure disorder requiring therapy (such as steroids or anti-epileptics). * Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20. * Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first epcoritamab administration. * Eligible for curative intensive salvage therapy followed by high dose chemotherapy with HSCT rescue. * Autologous HSCT within 100 days prior to first epcoritamab administration, or any prior allogeneic HSCT or solid organ transplantation. * Active hepatitis B (deoxyribonucleic acid \[DNA\] polymerase chain reaction \[PCR\]-positive) or hepatitis C (ribonucleic acid \[RNA\] PCR-positive infection). Participants with evidence of prior hepatitis B (HBV) but who are PCR-negative are permitted in * Known human immunodeficiency virus (HIV) infection. * Exposed to live or live attenuated vaccine within 4 weeks prior to signing Informed consent form (ICF). * Pregnancy or breast feeding. * Participant is known or suspected of not being able to comply with the study protocol or has any condition for which, participation would not be in the best interest of the participant. * Contraindication to all uric acid lowering agents. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Epcoritamab will be administered by subcutaneous injections in cycles of 28 days.
- intervention Names
- Biological: Epcoritamab
- label
- Epcoritamab
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Epcoritamab
- description
- Administered as specified in the treatment arm.
- name
- Epcoritamab
- other Names
- GEN3013
- DuoBody®-CD3xCD20
- EPKINLY™
- type
- BIOLOGICAL
Study design
- allocation
- NA
- intervention Model
- SEQUENTIAL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 666
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- To determine the MTD and/or RP2D to be studied in the Expansion part. DLT will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
- measure
- Dose-Escalation: Dose Limiting Toxicity (DLT)
- time Frame
- During the first cycle (28 days)
- description
- An AE is any untoward medical occurrence in a clinical trial participant, 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.
- measure
- Dose-Escalation: Number of Participants with Adverse Events (AEs)
- time Frame
- From first dose until the end of the safety follow-up period (Up to 1 year)
- description
- ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria.
- measure
- Expansion: Overall Response Rate (ORR)
- time Frame
- Up to 1.5 years
- description
- CRS will be graded based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
- measure
- Dose-OPT DLBCL, FL and MCL: Percentage of Participants with =>Grade 2 Cytokine Release Syndrome (CRS) Events and All Grade CRS Events
- time Frame
- From first dose until 7 days after second full dose (Day 28 for DLBCL; Day 35 for FL; Day 28-35 for MCL)
- secondary Outcomes
- description
- Anti-lymphoma activity will be evaluated as number of participants with resolution of constitutional symptoms, reduction in tumor size, objective, and best response (ORR, CR and PR).
- measure
- Dose-Escalation: Number of Participants with Anti-lymphoma Activity of Epcoritamab
- time Frame
- Up to 1 year
- description
- DOR is defined as the time from the first documentation of response (CR or PR) to the date of progressive disease (PD) or death, whichever occurs earlier as assessed by the investigator.
- measure
- Dose-Escalation: Duration of Response (DOR)
- time Frame
- Up to 1 year
- description
- DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on Lugano criteria.
- measure
- Expansion: DOR
- time Frame
- Up to 1.5 years
- description
- Change from baseline in health-related quality of life over time and in relation to treatment will be evaluated using FACT-Lym scale.
- measure
- Expansion Part: Changes in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
- time Frame
- Up to 1.5 year
- description
- CRS will be graded based on ASTCT criteria.
- measure
- Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Following First Full Dose
- time Frame
- Up to 1.5 years
- description
- CRS will be graded based on ASTCT criteria.
- measure
- Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Overall
- time Frame
- Up to 1.5 years
- description
- ORR is defined as the percentage of participants achieving CR or PR assessed by investigator.
- measure
- Dose-OPT DLBCL and FL: ORR
- time Frame
- Up to 1.5 years
- description
- CR rate is defined as the percentage of participants with CR assessed by investigator.
- measure
- Dose-OPT DLBCL and FL: CR Rate
- time Frame
- Up to 1.5 years
- description
- DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier assessed by investigator.
- measure
- Dose-OPT DLBCL and FL: Duration of CR (DoCR)
- time Frame
- Up to 1.5 years
- description
- PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier assessed by investigator.
- measure
- Dose-OPT DLBCL and FL: Progression-Free Survival (PFS)
- time Frame
- Up to 1.5 years
- description
- To determine the MTD and/or RP2D to be studied in the expansion part. DLT will be graded according to NCI-CTCAE version 5.0.
- measure
- Dose-OPT DLBCL and FL: DLT
- time Frame
- During the first cycle (28 days) in each Dose-OPT Part (DLBCL, FL and MCL)
- description
- DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on Lugano criteria assessed by investigator.
- measure
- Dose-OPT DLBCL, FL and MCL: DOR
- time Frame
- Up to 1.5 years
Full study description
- brief Summary
- The purpose of this trial is to measure the following in participants with relapsed and/or refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20): * The dose schedule for epcoritamab * The side effects seen with epcoritamab * What the body does with epcoritamab once it is administered * What epcoritamab does to the body once it is administered * How well epcoritamab works against relapsed and/or refractory B-cell lymphoma The trial consists of 3 parts: * a dose-escalation part (Phase 1, first-in-human \[FIH\]) * an expansion part (Phase 2a) * a dose-optimization part (OPT) (Phase 2a) The trial time for each participant depends on which trial part the participant enters: * For the dose-escalation part, each participant will be in the trial for approximately 1 year, which is made up of 21 days of screening, 6 months of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant). * For the expansion and dose-OPT parts, each participant will be in the trial for approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant). Participation in the study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends. All participants will receive active drug, and no participants will be given placebo.
- detailed Description
- The purpose of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D), as well as to establish the safety profile of epcoritamab in participants with relapsed or refractory B-cell lymphoma. In the expansion part, additional participants will be treated with epcoritamab, at the RP2D and the purpose is to further explore and determine the safety and efficacy of epcoritamab. The dose-OPT part will evaluate alternative priming and intermediate dose regimens of epcoritamab in participants with: * Diffuse large B-cell lymphoma (DLBCL) * Follicular lymphoma (FL) * Mantle cell lymphoma (MCL) All participants will receive epcoritamab at the RP2D.
Source references
- references
- citation
- Thieblemont C, Phillips T, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Do YR, Feldman T, Gasiorowski R, Jurczak W, Kim TM, Lewis DJ, van der Poel M, Poon ML, Cota Stirner M, Kilavuz N, Chiu C, Chen M, Sacchi M, Elliott B, Ahmadi T, Hutchings M, Lugtenburg PJ. Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. J Clin Oncol. 2023 Apr 20;41(12):2238-2247. doi: 10.1200/JCO.22.01725. Epub 2022 Dec 22.
- pmid
- 36548927
- type
- RESULT
- citation
- Linton KM, Vitolo U, Jurczak W, Lugtenburg PJ, Gyan E, Sureda A, Christensen JH, Hess B, Tilly H, Cordoba R, Lewis DJ, Okada C, Hutchings M, Clausen MR, Sancho JM, Cochrane T, Leppa S, Chamuleau MED, Gernhardt D, Altintas I, Liu Y, Ahmadi T, Dinh MH, Hoehn D, Favaro E, Elliott B, Thieblemont C, Vose JM. Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study. Lancet Haematol. 2024 Aug;11(8):e593-e605. doi: 10.1016/S2352-3026(24)00166-2. Epub 2024 Jun 15.
- pmid
- 38889737
- type
- RESULT
- citation
- Sinnollareddy M, Sanghavi K, Gibiansky L, Li T, Putnins M, Mohamed MF, Patah P, Favaro E, Gupta M, Parikh A, Xu S. Exposure-Response Analyses to Inform the Optimal Epcoritamab Monotherapy Dosing Regimen in Relapsed or Refractory Follicular Lymphoma. Clin Pharmacokinet. 2026 Aug 1. doi: 10.1007/s40262-026-01661-1. Online ahead of print.
- pmid
- 42541678
- type
- DERIVED
- citation
- Li T, Tredennick A, Polhamus D, Putnins M, Liu S, Sanghavi K, Thalhauser CJ, Parikh A, Noorani B, Mohamed MF, Le Gallo C, Elliott B, Gupta M, Xu S. Epcoritamab Step-Up Dosing Regimen Selection and Optimization Using Repeated Time-to-Event Modeling for Cytokine Release Syndrome Risk Mitigation. Clin Pharmacol Ther. 2026 Aug;120(2):542-551. doi: 10.1002/cpt.70362. Epub 2026 Jul 7.
- pmid
- 42411504
- type
- DERIVED
- citation
- Danilov AV, Kambhampati Thiruvengadam S, Linton K, Cumings K, Chirikov V, Mutebi A, Bains Chawla S, Chhibber A, Rivas Navarro F, Marques Goncalves F, Wang A, Ding Z, Alshreef A, Favaro E, Hoehn D, Sureda A. Indirect comparison of epcoritamab vs chemoimmunotherapy, mosunetuzumab, or odronextamab in follicular lymphoma. Blood Adv. 2025 Aug 12;9(15):3754-3765. doi: 10.1182/bloodadvances.2024015274.
- pmid
- 40472301
- type
- DERIVED
- citation
- Thieblemont C, Karimi YH, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Jurczak W, Do YR, Gasiorowski R, Lewis DJ, Kim TM, van der Poel M, Poon ML, Feldman T, Linton KM, Sureda A, Hutchings M, Dinh MH, Kilavuz N, Soong D, Mark T, Sacchi M, Phillips T, Lugtenburg PJ. Epcoritamab in relapsed/refractory large B-cell lymphoma: 2-year follow-up from the pivotal EPCORE NHL-1 trial. Leukemia. 2024 Dec;38(12):2653-2662. doi: 10.1038/s41375-024-02410-8. Epub 2024 Sep 25.
- pmid
- 39322711
- type
- DERIVED
- citation
- Phillips T, Lugtenburg P, Kalsekar A, Mutebi A, Wang A, Blaedel J, Kosa K, Martin S, Sacchi M, Kilavuz N, Thieblemont C. Improvements in Patient-Reported Outcomes in Relapsed or Refractory Large B-Cell Lymphoma Patients Treated With Epcoritamab. Clin Lymphoma Myeloma Leuk. 2024 Mar;24(3):e78-e87.e2. doi: 10.1016/j.clml.2023.11.005. Epub 2023 Nov 27.
- pmid
- 38151388
- type
- DERIVED
- citation
- Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, Lewis DJ, Sureda Balari A, Cunningham D, Oliveri RS, Elliott B, DeMarco D, Azaryan A, Chiu C, Li T, Chen KM, Ahmadi T, Lugtenburg PJ. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021 Sep 25;398(10306):1157-1169. doi: 10.1016/S0140-6736(21)00889-8. Epub 2021 Sep 8.
- pmid
- 34508654
- type
- DERIVED
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Discovery and provenance
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- p id="_2098" tabindex="-1">Evidence (epcoritamab):</p> <div class="pdq-content-list"><ol id="_2099"><li> A phase I/II trial (<a href="/clinicaltrials/NCT03625037">NCT03625037</a>) included 157 patients with relapsed or refractory DLBCL after two or more prior lines of therapy.[<a href="#cit/section_9.40">40</a>]<div cla
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- 14 CLINICAL STUDIES 14.1 DLBCL and High-grade B-cell Lymphoma The efficacy of EPKINLY was evaluated in EPCORE NHL-1 (Study GCT3013-01; NCT03625037), an open-label, multi-cohort, multicenter, single-arm trial in 157 patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines o
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Preserved source evidence · Independent clinical review pending · Not medical advice