Study of Safety and Effectiveness of CD19-CAR.p40-T Cell Therapy in Adults Aged 18 to 75 with Relapsed or Refractory CD19-Positive Blood Cancers

What this Trial Is About

This research aims to evaluate the safety and effectiveness of autocrine p40-expressing CD19-targeted chimeric antigen receptor T cells CD19-CAR.p40-T in patients with relapsed or refractory CD19-positive blood cancers such as B cell lymphoma, acute lymphoblastic leukemia, and acute myeloid leukemia. These cancers have shown resistance or relapse after prior treatments, and this investigational therapy is designed to improve T-cell persistence and antitumor activity by genetically modifying the patients own T cells. Participants will first receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide on three consecutive days before the CAR-T cell infusion. Then, 72 hours after chemotherapy, a single intravenous infusion of the CD19-CAR.p40-T cells will be given. This study is a Phase III, single-arm trial that includes initial screening, leukapheresis to collect T cells, cell manufacturing, treatment, and follow-up. Throughout the study, participants will be closely monitored for safety concerns including cytokine release syndrome, neurotoxicity, infections, and blood-related toxicities. Disease response will be assessed using disease-specific criteria, and blood samples will be collected to track the expansion and persistence of the infused CAR-T cells. The primary safety evaluation will cover 30 days after treatment, with secondary assessments of clinical responses up to 2 years. The total study duration allows detailed observation of treatment effects and adverse events.

Efficacy and Safety of CD19-CAR.p40-T in Patients With Relapsed/Refractory CD19-Positive Hematologic Malignancies