A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

Running, not enrolling · Phase 2

Conditions studied: Non-Hodgkin Lymphoma

In brief

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 496 adult participants with NHL will be enrolled in 100 sites globally. In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28 day, 21 day, or 56 day cycles dependent on the arm in combination with the anti-neoplastic agents described below: 1: Oral lenalidomide in participants (PPTS) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in PPTS with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in PPTS with newly diagnosed treatment-naïve DLBCL, or completion of treatment in 3B; 4: Oral CC-99282 in PPTS with R/R DLBCL; 5: Oral CC-99282 in PPTS with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in PPTS with R/R mantle cell lymphoma (MCL). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Key facts

Study ID: NCT05283720
Run by: Genmab
People needed: 264
Starts: 2022-06-14
Expected to finish: 2032-11-01
Last updated by the study team: 2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Diagnosis of:
- Diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma (FL) or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report:
DLBCL, not otherwise specified (NOS).
High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible.
Follicular lymphoma (FL) Grade 3B. OR
FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR
Mantle cell lymphoma (MCL) with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR).
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2, except for Arm 6A where ECOG performance status must be 0-1.
Must have 1 or more measurable disease sites:
A positron emission tomography (PET) /computed tomography (CT) scan demonstrating PET-positive lesion(s) AND
At least 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or magnetic resonance imaging (MRI).

You may not qualify if…

Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20.
Toxicities from prior anticancer therapy that have not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia. Other eligibility criteria (e.g., laboratory, cardiac criteria) must also be met.

Where it is running

Yale University School of Medicine /ID# 242089 — New Haven, Connecticut, United States
Christiana Care Health Service /ID# 242301 — Newark, Delaware, United States
Tampa General Hospital /ID# 246748 — Tampa, Florida, United States
Winship Cancer Institute of Emory University /ID# 242153 — Atlanta, Georgia, United States
University of Maryland, Baltimore /ID# 242218 — Baltimore, Maryland, United States
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144 — Kansas City, Missouri, United States
Northwell Health - Monter Cancer Center /ID# 245435 — Lake Success, New York, United States
Icahn School of Medicine at Mount Sinai /ID# 242123 — New York, New York, United States
Novant Health Presbyterian Medical Center /ID# 242148 — Charlotte, North Carolina, United States
East Carolina University - Brody School of Medicine /ID# 242506 — Greenville, North Carolina, United States
Novant Health Forsyth Medical Center /ID# 242198 — Winston-Salem, North Carolina, United States
Thomas Jefferson University Hospital /ID# 242077 — Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center /ID# 242106 — Philadelphia, Pennsylvania, United States
Thompson Cancer Survival Ctr /ID# 242150 — Knoxville, Tennessee, United States
Joe Arrington Cancer Research /ID# 242226 — Lubbock, Texas, United States
Swedish Medical Center - Seattle /ID# 242269 — Seattle, Washington, United States
MultiCare Institute for Research and Innovation /ID# 242127 — Tacoma, Washington, United States
Beijing Cancer Hospital /ID# 252303 — Beijing, Beijing Municipality, China
Fudan University Shanghai Cancer Center /ID# 252292 — Shanghai, Shanghai Municipality, China
Fakultni Nemocnice Brno - Jihlavska /ID# 242683 — Brno, Brno-mesto, Czechia
Fakultni Nemocnice Ostrava /ID# 242684 — Ostrava, Ostrava-mesto, Czechia
Vseobecna Fakultni nemocnice v Praze /ID# 242685 — Prague, Praha 17, Czechia
Fakultni nemocnice Hradec Kralove - Sokolska /ID# 241722 — Hradec Králové, Czechia
Aarhus Universitetshospital - Skejby /ID# 242670 — Aarhus, Central Jutland, Denmark
The University of Arizona Cancer Center - North Campus /ID# 242219 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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