Study of IOMAB-ACT Followed by CAR-T Cell Therapy for Patients Relapsed or Refractory (Diffuse Large B-cell Lymphoma
This study tests a new treatment approach for patients whose diffuse large B-cell lymphoma has not responded to previous treatments or has returned after treatment. Patients will receive a radioactive antibody injection followed by CAR-T cell therapy, which uses immune cells modified in the laboratory to fight cancer.
Key Objective: The study is testing whether adding a radioactive antibody before CAR-T cell therapy improves how well the treatment works and how safe it is for patients with hard-to-treat lymphoma.
Who to Consider: Patients with diffuse large B-cell lymphoma that has relapsed or stopped responding to standard treatments should consider this trial.
Trial Parameters
Brief Summary
This study is being done to determine the safety, efficacy and tolerability of a single 50 mCi dose of 131I-Apamistamab given prior to CAR-T cell infusion in patients with Relapsed or refractory (R/R) Diffuse large B-cell lymphoma (DLBCL).
Eligibility Criteria
Inclusion Criteria: 1. Patients with diffuse large B-cell lymphoma (de novo or DLBCL transformed from an indolent lymphoma (follicular lymphoma, chronic lymphocytic leukemia \[Richter syndrome\]) or high-grade B-cell lymphoma (HGBL): ("DLBCL patients") * Defined as relapsed or refractory DLBCL or high-grade B-cell lymphoma (HGBL) following at least one or more prior chemoimmunotherapy regimen (with at least one course including an anthracycline and CD20-directed therapy) following diagnosis of de novo DLBCL/HGBL or DLBCL arising from indolent lymphoma and requiring further treatment and deemed to be candidates for standard of care CAR-T therapy. This includes patients with primary refractory disease (failure to achieve complete response (CR) to first-line therapy), relapsed disease within 12 months of first line chemoimmunotherapy or relapsed/refractory disease after 2 or more prior lines of systemic therapy. * Patients must have at least one FDG-avid (PET-avid) measurable lesion. * Re