Phase 1b2 Study of Autologous CD19-Directed CAR T-cell Therapy for Relapsed or Refractory Aggressive Lymphoma and Acute Lymphoblastic Leukemia in Patients Aged 2 to 70

What this Trial Is About

This research investigates the use of autologous CD19-directed chimeric antigen receptor CAR T-cells in patients with relapsed or refractory aggressive lymphoma or acute lymphoblastic leukemia ALL. The study evaluates the safety and dosing of these CAR T-cells, which are engineered immune cells targeting CD19 on cancer cells. The trial is conducted in two phases Phase 1b for dose finding and Phase 2 for dose expansion, involving patients aged 2 to 70 years who meet specific disease and health criteria. Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine on three days before the CAR T-cell infusion. On day 0, a single intravenous dose of the CAR T-cells is administered. During Phase 1b, three dose levels are tested to find the recommended dose for Phase 2. All patients receive the same conditioning chemotherapy before CAR T-cell treatment to prepare their bodies for this therapy. Throughout the study, patients undergo monitoring for treatment-related side effects, dosing toxicities, and CAR T-cell levels in blood or bone marrow for up to three years. Researchers assess response rates by measuring complete or partial remission of disease. Participants will have various evaluations including imaging, laboratory tests, and clinical assessments to track safety, treatment effects, and overall health during and after the therapy.

Anti-CD19, Dual Co-stimulatory (4-1BB, CD3ζ) Chimeric Antigen Receptor T-cells in Patients With Relapsed/Refractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)