Study of CD7 CAR-T Cell Therapy Followed by Allogeneic Stem Cell Transplant for Adults with Relapsed or Refractory CD7 Positive Blood Cancers

What this Trial Is About

Researchers are evaluating the safety of a treatment involving CD7 CAR-T cells followed by allogeneic hematopoietic stem cell transplantation allo-HSCT for patients with CD7-positive relapsed or refractory malignant hematologic diseases. This single-arm, open-label, phase III study aims to assess safety outcomes and is sponsored by Zhejiang University. The trial focuses on patients with specific types of acute leukemia that are resistant to or have relapsed after standard treatments. Participants will receive an infusion of CD7 CAR-T cells designed to target cancer cells expressing CD7. This treatment is followed by allo-HSCT as a bridging therapy to further support recovery. The study includes monitoring of the CAR-T cell expression, cytokine levels related to CAR-T therapy, and various survival and remission outcomes over time, with evaluations scheduled from weeks to months after treatment. During the study, participants will undergo assessments including adverse event monitoring up to 28 days after CAR-T infusion, laboratory tests, and evaluations of remission and survival status up to two years post-treatment. Researchers will also monitor bone marrow transplantation success and minimal residual disease over extended follow-up periods. The total participation time and detailed evaluation schedules are designed to thoroughly understand the safety and effects of this combined treatment approach.

CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases