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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 14, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
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."

Trial Locations (1)

100044

RECRUITING

Peking University People's Hospital, Beijing

All Listed Sponsors
collaborator

Hebei Senlang Biotechnology Inc., Ltd.

INDUSTRY

lead

Peking University People's Hospital

OTHER

NCT06874946 - Nanobody-Based Anti-CD5 CAR-T for Relapsed/Refractory T-ALL/LBL | Biotech Hunter | Biotech Hunter