Phase 12 Study of Nanobody CD5-CAR T Cell Therapy for Relapsed or Refractory CD5 T-Cell Malignancies

What this Trial Is About

Researchers are evaluating the safety and effectiveness of anti-CD5 CAR-T cell therapy in patients with relapsed or refractory CD5-positive T-cell malignancies who have limited treatment options. This multi-center, open-label, non-randomized phase 12 study aims to determine the optimal biological dose and assess the therapys impact on cancer in these patients. The study includes three groups based on the source of the CAR T cells autologous, previous stem-cell transplant donor-derived, or newly matched donor-derived cells. Participants will receive a lymphodepleting treatment followed by an infusion of CD5 CAR T cells from one of the three sources. The study will explore different doses, starting from 1 million cells per kilogram to 2 million cells per kilogram, with a lower dose option if cell production is insufficient. The trial involves a dose-finding phase phase 1 to evaluate safety and a phase 2 to assess treatment response. Participants will be monitored closely for side effects and treatment response, with assessments including adverse event tracking up to two years and evaluation of tumor response at 3 months after infusion. Additional outcome measures include pharmacokinetics, progression-free survival, and overall survival. The total study duration includes monitoring for safety and effectiveness for up to two years after treatment infusion.

A Multicenter, Open-Label, Non-Randomized, Single-Arm Clinical Study of Nanobody CD5-CAR T Cell Therapy for Refractory/Relapsed T Lymphocyte Malignancies