Phase 12 Study of BCOR and ZC3H12 Gene Knock-out CD19-targeting CAR-T Cell Therapy for Adults with Relapsed or Refractory B-cell Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new CAR-T cell therapy called CAR19TIF cells in adults with refractory or relapsed B-cell lymphoma. This Phase 12, single-center study focuses on CAR-T cells modified by knocking out BCOR and ZC3H12 genes, aiming to create more functional and long-lasting immune cells. The trial addresses different types of B-cell Non-Hodgkins lymphomas, including diffuse large B-cell lymphoma and follicular lymphoma, among others. The study has two phases. In Phase 1, between 6 and 18 patients will receive varying doses of CAR19TIF cells following chemotherapy with fludarabine and cyclophosphamide to prepare the body. Dose levels start at 5x105 cellskg, with possible adjustments up or down based on safety and effectiveness, using a staggered schedule with 28 days between infusions for safety. Phase 2 will enroll 10 to 12 patients, treated at the recommended Phase 2 dose established from Phase 1 results. Participants will undergo multiple assessments including monitoring for adverse events, response to treatment, and survival over periods up to 24 months. Blood tests will track levels of CAR-T cells and related markers, while scans will assess tumor response. Safety monitoring includes checking for dose-limiting toxicities within 28 days of infusion. The study aims to gather detailed data on tolerability, pharmacokinetics, clinical responses, and long-term outcomes, with follow-up lasting up to two years after treatment.

BCOR and ZC3H12 Genes Knock-out CD19-targeting CAR-T Cell Therapy in r/r B Cell Lymphoma