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OncoMatch/Clinical Trials/NCT06854159

Odronextamab for the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma Before and After Chimeric Antigen Receptor T-cell Therapy

Is NCT06854159 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Chimeric Antigen Receptor T-Cell Therapy and Odronextamab for recurrent diffuse large b-cell lymphoma.

Phase 2RecruitingJoseph TuscanoNCT06854159Data as of May 2026

Treatment: Chimeric Antigen Receptor T-Cell Therapy · OdronextamabThis phase II trial tests how well odronextamab works before and after standard of care (SOC) chimeric antigen receptor (CAR) T-cell therapy in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR-T cell therapy is the SOC treatment most patients receive when other treatments have failed. CAR-T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Odronextamab is a monoclonal antibody that is called bispecific, as it individually targets 2 cell proteins, CD20 and CD3. Proteins are part of each cell in the body, which work together like little machines for the cell to function. CD20 is a protein that is found on the surface of both normal B-cells and B-cells that make up certain cancers, like DLBCL. CD3 is a protein that is found on the surface of T cells. T-cells and normal B-cells are types of white blood cells in the body and are a part of the immune system that fights infections. Odronextamab is designed to help T-cells find and kill the B-cells including the cancer cells in DLBCL. Giving odronextamab before and after CAR T-cell therapy may improve response in patients with relapsed or refractory DLBCL.

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Extracted eligibility criteria

Cancer type

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 2 prior lines

Lab requirements

Blood counts

Leukocytes ≥ 2,500/µL; ANC ≥ 1,000/µL or > 500/µL for bone marrow involvement; Platelets ≥ 50,000/µL or ≥ 25,000/µL for bone marrow involvement; Hemoglobin ≥ 8 g/dL or ≥ 7 g/dL for bone marrow involvement

Kidney function

Creatinine clearance ≥ 30 mL/min/1.73 m^2 by Cockcroft-Gault; Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 50 mL/min

Liver function

Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert disease, ≤ 4 x ULN for Gilbert syndrome excluded); AST/ALT ≤ 3 x ULN (≤ 5 x ULN for liver involvement); Alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN for liver involvement or bone metastases)

Cardiac function

Cardiac ejection fraction > 50% by echocardiogram or MUGA scan

Leukocytes ≥ 2,500/µL; ANC ≥ 1,000/µL or > 500/µL for patients with bone marrow involvement; Platelets ≥ 50,000/µL or ≥ 25,000/µL for patients with bone marrow involvement; Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert disease, ≤ 4 x ULN for Gilbert syndrome excluded); AST/ALT ≤ 3 x ULN (≤ 5 x ULN for liver involvement); Creatinine clearance ≥ 30 mL/min/1.73 m^2 by Cockcroft-Gault; Hemoglobin ≥ 8 g/dL or ≥ 7 g/dL for bone marrow involvement; Alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN for liver involvement or bone metastases); INR and aPTT ≤ 1.5 x ULN; Cardiac ejection fraction > 50% by echocardiogram or MUGA scan; Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 50 mL/min

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California Davis Comprehensive Cancer Center · Sacramento, California

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