Feasibility Study of CD19-Directed CAR T-Cell Therapy for Relapsed or Refractory B-Lineage Leukemia and Lymphoma

What this Trial Is About

Researchers are evaluating the feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed or refractory B-lineage leukemia and lymphoma. This phase II, open-label, single-arm, multi-center study focuses on patients who have these specific blood cancers that have either returned or not responded to previous treatments. The study includes several phases screening for eligibility and enrollment preparatory steps such as bridging therapy if needed, collection of immune cells through leukapheresis, manufacturing of CAR T-cells, and lymphodepletion treatment followed by a single infusion of the anti-CD19 CAR T-cells. After treatment, participants will have follow-up visits for up to 24 months to monitor efficacy and safety. Participants will undergo evaluations including disease assessments, safety monitoring, and response measurements over the 24-month follow-up phase. Researchers will track how well the protocol can be followed, the overall response rate within six months, and any treatment-related toxicities. The total study duration includes all phases from screening through extended follow-up, providing detailed monitoring of treatment effects and patient health.

CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol