Feasibility Study of Locally Manufactured CAR T-Cell Therapy for B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia in Adults

What this Trial Is About

Researchers are evaluating the feasibility and safety of locally manufacturing CAR T-cell products for patients with B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia who have limited treatment options. The study aims to demonstrate that these locally produced CAR T-cells can be reliably created and safely administered, following a Phase 2a trial design. The trial focuses on patients with specific CD19-positive lymphomas or leukemia who have failed previous therapies or have no curative options available. Participants undergo a sequence of procedures including eligibility screening, informed consent, and collection of their T-cells through apheresis. These cells are processed and modified using the CliniMACS Prodigy device to create CAR T-cells targeting CD19. Patients then receive lymphodepleting chemotherapy followed by an intravenous infusion of their own CAR T-cells on day 0. The first three patients will be closely monitored in the hospital for two weeks to assess treatment safety, with ongoing clinical follow-up and laboratory monitoring extending up to 15 years. Throughout the study, patients will have regular assessments including flow cytometry testing to monitor CAR T-cell levels at day 30 and 100, clinical evaluations monthly to day 100, and then less frequent follow-ups up to 15 years or until death. Safety evaluations focus on detecting toxicities such as cytokine release syndrome and neurological effects. Data from all participants will be reported anonymously to a national registry. The care provided aligns with standard practices used for commercially available CAR T-cell products, with additional study-specific monitoring for research purposes.

Local Manufacture of CAR T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia