Study of GT719 Injection for Adults 18 to 75 Years With Relapsed or Refractory CD19-Positive B-cell Leukemia or Lymphoma

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and behavior of GT719 Injection, a biological treatment, in adults with relapsed or refractory CD19-positive B-cell non-Hodgkin lymphoma and B-acute lymphoblastic leukemia. This early phase 1 clinical trial includes a dose escalation and an expansion phase. The study will enroll 34 participants to understand how the treatment works in these blood cancers. Participants will receive the GT719 Injection as the study treatment. The trial involves a single treatment group receiving this injection to assess its effects and safety. The study includes monitoring after the infusion, focusing on adverse events, dose tolerance, and the behavior of infused cells over time. During the study, participants will be closely observed for any side effects and treatment responses. Researchers will assess adverse events within 28 days and monitor overall response, duration of response, survival rates, and infused cell activity up to 12 months. Participants will undergo medical exams, lab tests, and imaging as needed to track these outcomes and ensure safety throughout the trial, which runs until December 2027.

A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in Adult Participants With Relapsed/Refractory CD19-positive B-cell Malignant Hematological Tumors