Phase 1 Study of CD19-Directed CAR-T Cell Therapy IC191563 for Adults With Relapsed or Refractory B Cell Malignancies

What this Trial Is About

Researchers are evaluating the effects of a new type of immunotherapy called CD-19 directed chimeric antigen receptor CAR-T cell therapy, known as IC191563, for patients with B cell cancers that have returned or not responded to previous treatments. This phase I trial aims to find the highest safe dose of these modified T cells, which are designed to help the immune system recognize and fight cancer cells. The study also looks at the safety, side effects, and effectiveness of this treatment. Participants receive a chemotherapy regimen including cyclophosphamide and fludarabine or bendamustine before receiving the IC191563 CAR-T cells through an intravenous infusion. The treatment process includes bone marrow biopsy and aspiration, CT and PET scans, MRI, and blood and tumor sample collection. The study follows a dose-escalation design to assess the best tolerated dose of the CAR-T cells. During the trial, patients are closely monitored for treatment effects and side effects like neurotoxicity and cytokine release syndrome. Follow-up visits occur on day 60, every 3 months up to 3 years, every 6 months from years 3 to 5, and then yearly for up to 15.5 years. Researchers measure response rates, duration of response, progression-free survival, and minimal residual disease, along with safety and biological markers related to the treatment.

CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies