Phase I Study to Find Safe Dose and Evaluate Effectiveness of GF-CART01 CD2019 CAR T Cell in Adults 18-70 with Relapsed or Refractory B-Cell Blood Cancers

What this Trial Is About

Researchers are evaluating the safety, persistence, and clinical activity of GF-CART01, a type of CAR T cell therapy, in adults aged 18 to 70 who have relapsed or refractory B-cell blood cancers and have not responded to at least two prior standard treatments or stem cell transplantation. This Phase I trial uses a traditional dose-escalation design to find the maximum tolerated dose and recommended dose for future studies, focusing on dose-limiting toxicities and preliminary effectiveness. Participants will receive different dose levels of GF-CART01, which consists of CAR-positive viable T cells targeting CD19 and CD20 markers on tumor cells. The study follows a 33 dose-escalation scheme to carefully monitor safety and establish the best dose for further research. The intervention is administered once, after which participants will be observed over time to assess treatment impact and persistence. During the study, participants will undergo various assessments including monitoring for side effects, blood tests to track the behavior and persistence of GF-CART01 cells, and imaging scans to evaluate tumor response. Safety and tolerability will be followed up to one year after cell infusion. Researchers will also study pharmacokinetics and the feasibility of producing the therapy. The overall study duration extends until late 2027, with key outcomes measured from the day of infusion through one year post-treatment.

A Study to Evaluate the Safety and Clinical Activity of GF- CART01 (CD20/19 CAR T Cell) in Subjects With Relapsed or Refractory B-Cell Hematological Malignancies