Study of CD5 CAR-T Cell Therapy for Relapsed or Refractory CD5 T-lymphoblastic Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of CD5 CAR-T cell therapy in patients with relapsed or refractory CD5-positive T-cell non-Hodgkin lymphoma, also known as T-lymphoblastic lymphoma. This early phase 1 clinical study builds upon previous research confirming the safety of this therapy, aiming to further assess its effectiveness and gather additional safety data by expanding the number of participants to 30. Participants in this study will receive CD5 CAR-T cells through intravenous infusion. The treatment follows a dose escalation design with three dose levels tested using the standard 33 method. This approach helps determine the appropriate dosage while monitoring for safety and treatment response over time. During the study, patients will be closely monitored for dose-limiting toxicities up to 28 days after treatment and treatment-emergent adverse events for up to two years. Researchers will assess the overall response rate within 12 weeks, duration of remission up to one year, progression-free survival up to two years, and overall survival up to one year after infusion. Various laboratory tests, imaging, and clinical evaluations will be conducted to track patient progress and safety throughout the study period.

Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-lymphoma