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

This is a multi-center, open-label, non-randomized, phase 1/2 study of anti-CD5 CAR-T cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian optimal interval (BOIN) 12 design will be used to explore the optimal biological dose (OBD) from starting dose level 1: 1×10\^6 (±20%) to dose level 2: 2×10\^6 (±20%) in three cohorts (autologous, previous-transplant-donor or newly matched donor-derived CD5 CAR T cells). If the manufactured cells are not sufficient to meet the preassigned standard dose criteria, patients will be given infusion at a low dose level of 5×10

Trial Details

NCT ID
NCT07070323
Phase
PHASE1 / PHASE2
Sponsor
Beijing GoBroad Hospital
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Autologous CD5 CAR T-cells
  • Previous stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells
  • Newly matched donor-derived CD5 CAR T-cells
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806
  • Chengdu, Sichuan, China|30.66667,104.06667

Key Eligibility Criteria

  • Only patients who meet all the following criteria can be included:
  • 1\. Candidates with relapse or refractory CD5+ T-cell malignancies, who have progressed after treatment with all standard therapies or been intoler…

For full eligibility, visit ClinicalTrials.gov.

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