Nanobody-Based Anti-CD5 CAR-T for Relapsed/Refractory T-ALL/LBL
A Phase I Dose-Escalation and Phase II Study of Nanobody-Based CD5-Targeted CAR-T Cells for the Treatment of Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL) - The CONQUER Trial
Peking University People's Hospital
30 participants
Feb 14, 2025
INTERVENTIONAL
Conditions
Summary
To observe the safety and efficacy of Nanobody-Based CD5-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed T-ALL/LBL.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Phase I: Eligible patients will receive a single infusion of CD5-targeted CAR-T cells at one of three dose levels (0.5 × 10⁶ cells/kg, 1.0 × 10⁶ cells/kg, or 2.0 × 10⁶ cells/kg) following fludarabine and cyclophosphamide (FC) lymphodepleting chemotherapy. A 3+3 dose-escalation design will be used to determine the recommended Phase II dose (RP2D) based on safety, dose-limiting toxicities (DLTs), and preliminary efficacy. Phase II: Patients will receive CD5-targeted CAR-T cells at the RP2D following FC lymphodepleting chemotherapy.
Locations(1)
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NCT06874946