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RECRUITING
NCT06874946
PHASE1/PHASE2

Nanobody-Based Anti-CD5 CAR-T for Relapsed/Refractory T-ALL/LBL

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

3 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-02-14

Completion Date

2027-12-31

Last Updated

2025-03-13

Healthy Volunteers

No

Interventions

BIOLOGICAL

CD5-targeted CAR-T cells

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)

Peking University People's Hospital

Beijing, Beijing Municipality, China