A Phase 2 Study of Odronextamab in Relapsed/ Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Before and After Chimeric Antigen Receptor (CAR) T-Cell Therapy
Joseph Tuscano
Summary
This 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.
Description
PRIMARY OBJECTIVE: I. To assess anti-tumor activity of odronextamab + CAR T-cell therapy in in patients with relapsed or refractory (R/R) DLBCL. SECONDARY OBJECTIVES: I. To evaluate the toxicities of odronextamab + CAR T-cell therapy in patients with R/R DLBCL. II. To further assess anti-tumor activity of odronextamab + CAR T-cell therapy in patients with R/R DLBCL. OUTLINE: Patients receive odronextamab intravenously (IV) over 1-4 hours on days 1, 2, 8, 9, 15, and 16 of cycle 1, on days 1, 8, and 15 of cycles 2-4 then on days 1 and 15 of subsequent cycles until achievement of durable co…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Aged ≥ 18 at the time of consent * Patients must have histologically or cytologically confirmed relapsed/ refractory (R/R) diffuse large B-cell lymphoma (DLBCL); transformed follicular lymphoma patients are eligible * Patients must have failed at least 2 prior therapies * Life expectancy ≥ 3 months * Candidate for any Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T cell therapy as per institutional guidelines * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%) * Leukocytes ≥ 2,500/µL * Absolute neutrophil cou…
Interventions
- BiologicalChimeric Antigen Receptor T-Cell Therapy
Receive CAR T-cell therapy
- BiologicalOdronextamab
Given IV
Location
- University of California Davis Comprehensive Cancer CenterSacramento, California