OncoMatch/Clinical Trials/NCT06238648
Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy
Is NCT06238648 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Epcoritamab for diffuse large b-cell lymphoma, not otherwise specified.
Treatment: Epcoritamab — This phase II trial compares epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy. Epcoritamab is a bispecific antibody. It works by simultaneously attaching to a molecule called CD20 on cancerous B-cells and a molecule called CD3 on effector T-cells, which are a type of immune cell. When epcoritamab binds to CD20 and CD3, it brings the two cells together and activates the T-cells to kill the cancerous B-cells. Epcoritamab may increase a patient's chances of achieving complete remission after CD19-directed CAR-T therapy, compared to standard observation.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD20 positivity
CD20 positivity as determined by assessment of tumor cells ≤ 6 months prior to registration pre- CAR-T biopsy specimen by immunohistochemistry or flow cytometry
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: CAR-T cell therapy (axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel) — CD19-directed
Patients treated with the commercially available CD19-directed CAR-T products axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel)
Cannot have received: CD20xCD3 bispecific antibody
CD20xCD3 bispecific antibody at any point prior to registration
Cannot have received: CD20-targeted monoclonal antibody (rituximab, obinutuzumab)
Exception: biosimilars
CD20-targeted monoclonal antibody (e.g., rituximab, obinutuzumab or biosimilars) ≤ 4 weeks prior to registration
Lab requirements
Blood counts
ANC ≥ 1,000/mm^3 (G-CSF allowed); Platelet count ≥ 50,000/mm^3; Hemoglobin ≥ 7.0 g/dL if asymptomatic or > 8 if symptomatic; transfusion support allowed
Kidney function
Calculated creatinine clearance must be ≥ 45 mL/min using the Crockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 x ULN unless due to Gilbert's syndrome, non-hepatic origin, or lymphoma involvement of the liver and total bilirubin ≤ 5 x ULN; ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement)
ANC ≥ 1,000/mm^3, G-CSF allowed; Platelet count ≥ 50,000/mm^3; Hemoglobin ≥ 7.0 g/dL if asymptomatic or > 8 if symptomatic; transfusion support allowed; Total bilirubin ≤ 1.5 x ULN unless due to Gilbert's syndrome or of non-hepatic origin or lymphoma involvement of the liver and total bilirubin is ≤ 5 x ULN; ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement); Calculated creatinine clearance must be ≥ 45 mL/min using the Crockcroft-Gault formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
- Siteman Cancer Center at Washington University · St Louis, Missouri
- Hackensack University Medical Center · Hackensack, New Jersey
- Memorial Sloan Kettering Cancer Center · New York, New York
- UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina
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