Safety and Effectiveness of Humanized CD19 CAR-T Cell Therapy for Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkins Lymphoma in Patients Aged 3 to 75 Years

What this Trial Is About

This research aims to evaluate humanized CD19 CAR-T cell therapy for patients with relapsed or refractory CD19-positive B-cell blood cancers, including acute lymphoblastic leukemia B-ALL and B-cell non-Hodgkins lymphoma B-NHL. The study is an early-phase, open-label, single-center trial designed to explore the safety of different dose levels of this therapy. It enrolls two groups of patients with a total of 72 participants, focusing mainly on dose-related safety outcomes. Participants receive humanized CD19 CAR-T cells through intravenous infusion. The study uses a 33 dose escalation design with three dose levels to determine the appropriate dosing. There is only one treatment arm where participants get this experimental CAR-T cell therapy. The study duration includes follow-up for up to two years after infusion to monitor safety and treatment effects. During the study, participants undergo various assessments including monitoring for dose-limiting toxicities up to 28 days post-infusion and tracking adverse events for up to two years. Researchers will evaluate overall response rates, survival outcomes, quality of life, and functional scores at multiple time points over two years. The study involves regular medical evaluations, laboratory tests, and quality of life questionnaires to closely observe participants health and treatment impact throughout the trial period.

A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL