Safety and Effectiveness Study of GT801 Injection in Adults With Relapsed or Refractory CD19-positive B-cell Blood Cancers and Autoimmune Hemolytic Anemia

What this Trial Is About

Researchers are studying the safety and effectiveness of GT801 injection in adults who have relapsed or refractory CD19-positive B-cell blood cancers, including acute lymphoblastic leukemia, chronic lymphocytic leukemia, non-Hodgkins lymphoma, and autoimmune hemolytic anemia. This early phase 1 study aims to understand how well the treatment works and its side effects in this group of patients. Participants will receive the GT801 injection as the study treatment. The study focuses on one group receiving this intervention. The treatment schedule and dosing details are not specified, but safety and response to the treatment will be monitored over a period of time, including up to 12 months after infusion. During the study, participants will be closely monitored for side effects and treatment responses through various assessments. Researchers will measure the proportion of participants experiencing dose-limiting toxicity within 28 days and track adverse events up to 3 months after infusion. They will also evaluate overall response rates, duration of response, progression-free survival, and other outcome measures related to both the blood cancers and autoimmune hemolytic anemia for up to 12 months. The study includes regular follow-up visits and evaluations to gather this information.

A Clinical Study Evaluating the Safety and Efficacy of GT801 Injection in Adult Patients With Relapsed/Refractory CD19-positive B-cell Hematologic Malignancies and Autoimmune Hemolytic Anemia