Phase 12 Study of CD5 CAR T Cell Therapy for Patients Aged 1 to 70 Years With Relapsed or Refractory CD5 T-Cell Cancers

What this Trial Is About

Researchers are evaluating anti-CD5 CAR-T cell therapy in patients with CD5-positive relapsed or refractory T-cell malignancies who have limited options after standard treatments. This phase 12, multi-center, open-label, non-randomized study aims to find the best biological dose and assess safety, tolerability, and effectiveness of the therapy. The study enrolls up to 54 participants aged 1 to 70 years with specific T-cell cancers including acute lymphoblastic leukemia and other T-cell malignancies. Participants receive one of three types of CD5 CAR T-cell infusions after a lymphodepleting regimen autologous cells from their own blood, donor cells from a previous stem-cell transplant donor, or cells from a newly matched donor. Dose levels are carefully adjusted based on a Bayesian optimal interval design, ranging from a low dose if cell numbers are limited to higher levels. The treatment is given once and closely monitored. During the study, participants will be followed for adverse events and dose-limiting toxicities within the first month after infusion. Response to treatment is assessed at around three months. Long-term monitoring for up to two years includes survival, disease progression, and pharmacokinetics of the CAR T cells. Participants undergo blood tests, bone marrow or cerebrospinal fluid analysis, and clinical evaluations to measure safety and treatment effects throughout the study period.

CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-cell Malignancies