Safety and Effectiveness of Autologous and Donor-Derived CD7 CAR T-Cell Therapy for Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia and Lymphoma in a Multi-Center, Open-Label Phase 12 Trial

What this Trial Is About

Researchers are evaluating the safety and effectiveness of CD7 CAR T-cell therapy for patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma rr T-ALLT-LBL. This multi-center, open-label, non-randomized phase III trial includes patients who have limited treatment options after standard therapies and aims to understand how well these therapies work and their side effects. Participants will receive one of three types of CD7 CAR T-cell treatments depending on their history autologous cells from their own blood, donor cells from a previous hematopoietic stem cell transplant HSCT, or donor cells from a new donor. The trial involves infusion of these specially prepared cells and follows patients closely to observe their response and any toxicities. During the study, patients will be monitored for dose-limiting toxicities within 21 days after infusion in phase I and overall response at about 3 months in phase II. Additional follow-up will track safety, survival, remission duration, and immune cell levels for up to two years after treatment. The trial enrolls patients aged 1 to 70 years and involves regular assessments including laboratory tests and clinical evaluations over this period.

Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Malignancies