Phase 1 and 2 Study of Epo-R-CD19 and CD22 Targeted CAR T-Cell Therapy for Relapsed or High-Risk B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating a new T cell therapy for patients with high risk or relapsedrefractory B cell lymphoma, a type of blood cancer. This phase 1 and 2 trial aims to determine the recommended dose and assess the safety and effectiveness of CAR T-cells targeting CD19 and sometimes CD22 antigens on lymphoma cells. The study also explores how adding Epo-R to the CAR T-cells may help the cells survive and expand better in patients previously treated with chemotherapy. The study includes several parts screening, cell collection and preparation, lymphodepletion before infusion, and the CAR T-cell infusion itself. Patients undergo leukapheresis to collect T cells, which are modified and expanded in the lab based on their tumors antigen profile. The first 3-6 patients will participate in a safety run-in to determine the best dose, followed by a phase 2 portion where 20 patients receive the treatment at the recommended dose. Monitoring includes frequent blood tests and PET-CT scans to evaluate response. Participants will be closely followed through scheduled visits on days 0, 7, 14, 21, 28, then monthly up to 6 months, and yearly thereafter for up to 15 years. Assessments include imaging to check disease status and blood tests to measure CAR T-cell levels. Safety monitoring focuses on potential side effects like cytokine release syndrome and neurological symptoms. Long-term follow-up helps understand the treatments lasting effects and patient outcomes.

Antigen Targeted T Cell Therapy for Relapsed/Refractory B Cell Lymphomas