Phase 2 Study of WU-CART-007, an Anti-CD7 CAR-T Cell Therapy, for Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

What this Trial Is About

Researchers are evaluating the effectiveness of WU-CART-007, an anti-CD7 allogeneic CAR-T cell therapy, in patients with Relapsed or Refractory RR T-Cell Acute Lymphoblastic Leukemia T-ALL and Lymphoblastic Lymphoma LBL, as well as in those in remission but still testing positive for Minimal Residual Disease MRD. This Phase 2, single-arm, multi-center, open-label study aims to assess the therapys ability to induce a complete MRD-negative response in these patients. Participants will receive a single intravenous infusion of WU-CART-007 following lymphodepletion. The study involves one treatment group receiving this CAR-T cell product. The treatment will be monitored over time to evaluate response rates and complete remission status. During the study, patients will be closely observed and assessed for treatment response, including composite complete response and MRD response rates over a 24-month period. Evaluations will include clinical examinations, laboratory tests, and monitoring for safety and efficacy. The entire study spans from the start date in January 2025 through to completion in December 2028, with primary outcome assessment planned at 24 months.

A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)