Epcoritamab in Combination With R-CHOP for Patients With Aggressive Non-Hodgkin Lymphoma

Starting soon · Phase 2

Conditions studied: Non-Hodgkin's B-cell Lymphoma, Lymphoma Non-Hodgkin, Diffuse Large B-Cell Lymphoma (DLBCL)

In brief

A Phase II, open-label, two-arm, multicenter study evaluating the combination of epcoritamab with R-CHOP chemotherapy in patients with newly diagnosed, aggressive B-cell non-Hodgkin lymphoma.

Key facts

Study ID: NCT07588698
Run by: Mwanasha Merrill, MD
People needed: 20
Starts: 2026-07-15
Expected to finish: 2029-07-31
Last updated by the study team: 2026-05-15

Who can join

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

You may qualify if…

Participants must have confirmed CD20-positive aggressive B-cell lymphoma, including de novo or transformed diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement; primary mediastinal large B-cell lymphoma (PMBCL); T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus-positive DLBCL, NOS; or follicular lymphoma grade 3b.
Measurable disease per Lugano 2014 criteria.
No prior therapy for DLBCL or FL G3B other than corticosteroids or palliative radiotherapy. Of note, a cycle of anthracycline-containing regimen (given as standard of care prior to study enrollment) is allowed, provided that patients will receive a total of six cycles of chemotherapy as part of their treatment plan. Patients who received one cycle of an anthracycline-containing regimen prior to enrollment will proceed directly to Cycle 2 on study.
Age ≥18 years
Participants must have an International Prognostic Index (IPI) score of 2-5.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
Demonstrates adequate organ function as defined below:
Adequate bone marrow function:
absolute neutrophil count platelets
1.0 × 10⁹/Litre (L) (with growth factor use allowed)
75 × 10⁹/L
Exceptions:
Patients may be enrolled despite not meeting the thresholds above if either of the following applies, provided the Absolute Neutrophil Count (ANC) is ≥0.75 × 10⁹/L:
The patient has received one prior cycle of chemotherapy off study, and cytopenias at Cycle 2, Day 1 of protocol therapy are believed to be due to recent chemotherapy, provided there is evidence of marrow recovery and no other contraindications.
The patient has documented bone marrow involvement by lymphoma, and cytopenias are believed to be disease-related rather than indicative of poor marrow reserve or unrelated pathology. In such cases, enrollment is permitted at the discretion of the investigator if the patient is otherwise eligible and deemed safe to proceed.
Adequate hepatic function:
Total bilirubin
≤2 × upper limit of normal (ULN) (unless due to Gilbert's)
Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT)
≤3 × institutional upper limit of normal
Alanine aminotransferase (ALT) Serum glutamic-pyruvic transaminase (SGPT)
≤3 × institutional upper limit of normal
Adequate renal function:
As assessed by estimated glomerular filtration rate (eGFR)
Coagulation:

You may not qualify if…

History of severe allergic or anaphylactic reactions to anti-CD20 mAb therapy or known allergy or intolerance to any component or excipient of epcoritamab.
Any prior treatment with a bispecific antibody targeting CD3 and CD20.
Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to the first dose of epcoritamab.
Requiring immunosuppressive therapy for an ongoing baseline medical condition. For corticosteroids, prednisolone >10 mg daily (or equivalent) qualifies as immunosuppressive and thus be excluded for this use. Note: corticosteroids at any dose are permitted for control of lymphoma related symptoms, including during screening, and for any adverse events (AE) management during study.
Vaccination with live vaccines within 28 days prior to the first dose of epcoritamab.
Clinically significant cardiovascular disease, including:
Myocardial infarction within 6 months prior to the first dose of epcoritamab, or unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure New York Heart Association Class III-IV), cardiac arrhythmia (NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade 3 or higher), or clinically significant electrocardiogram (ECG) abnormalities
Screening 12-lead ECG showing a baseline QT Corrected for Heart Rate using Fridericia's Formula (QTcF) >470 msec
Stroke within 6 months prior to first epcoritamab dose
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at trial enrolment or significant infections within 2 weeks prior to the first dose of epcoritamab.
Active hepatitis B Virus (HBV) (Deoxyribonucleic Acid Polymerase Chain Reaction (DNA PCR) -positive) or hepatitis C (Ribonucleic Acid Polymerase Chain Reaction (RNA PCR) -positive infection). Subjects with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy. Subjects who received treatment for Hepatitis C Virus (HCV) that was intended to eradicate the virus may participate if hepatitis C Ribonucleic acid (RNA) levels are undetectable.
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 Prostate-Specific Antigen (PSA) level < 0.1 ng/milliliter (mL)
Any curable cancer with a complete response (CR) of > 2 years duration.
Neuropathy > grade 1 with the exception of neuropathy directly related to lymphoma (e.g., direct nerve compression from tumor).
. Female who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this trial or within 12 months after the last dose of epcoritamab; female subjects must also agree not to breastfeed during the entire trial and until 12 months after the last administration of study drug.
Male who plans to father a child while enrolled in this trial or within 12 months after the last dose of epcoritamab.
Contraindication to any of the individual drugs of the R-CHOP regimen.

Where it is running

Zuckerberg San Francisco General — San Francisco, California, United States
University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.