Safety and Effectiveness of CAR-T Cell Therapy for Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma with Central Nervous System Involvement

What this Trial Is About

Researchers are evaluating CAR-T cell therapy in patients with relapsed or refractory central nervous system CD19-positive B-cell hematological cancers. These include acute lymphoblastic leukemia and B-cell non-Hodgkins lymphoma. This single-center, open-label, early-phase study aims primarily to explore the safety of this therapy with a focus on dose-related safety aspects. Participants will receive CAR-T cells by intravenous infusion following a dose-escalation design with three dose levels. Two groups of 36 patients each will be enrolled. The study also involves surgical placement of an Ommaya reservoir catheter into the brains fourth ventricle to assist treatment delivery. Dose escalation follows a standard 33 model. During the study, participants will be monitored for dose-limiting toxicity up to 28 days after infusion and for treatment-emergent adverse events up to two years. Researchers will assess response rates, overall survival, event-free survival, disease control, and quality of life using various clinical and psychological scales over periods up to two years. The total participation time can extend to two years with multiple evaluations and safety monitoring.

A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Malignancies