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RECRUITING
NCT06348797
PHASE1

Phase I Clinical Study of α-PD-L1/DLL3 CAR-T in Patients With R/R SCLC

Sponsor: Sichuan University

View on ClinicalTrials.gov

Summary

A study to evaluate the safety and feasibility of α-PD-L1/4-1BB DLL3 Chimeric Antigen Receptor (CAR)-T (BHP01) in patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC) and determine the appropriate CAR-T cell dose. Next, In dose expansion phase, patients were assign two groups with/without bridge radiotherapy.

Official title: Phase I Clinical Study on Safety and Feasibility of DLL3 Targeted α-PD-L1/4-1BB Modifying Chimeric Antigen Receptor T-cells in Patients With Relapsed or Refractory Small Cell Lung Cancer (SCLC)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2025-04-03

Completion Date

2026-12-31

Last Updated

2025-05-16

Healthy Volunteers

No

Interventions

DRUG

α-PD-L1/4-1BB DLL3 CAR-T (BHP01)

Preconditioning with fludarabine, cyclophosphamide, based chemotherapy regimen at sub-clinical doses; Bridge radiotherapy with 15 Gray (Gy)/5 fractions; α-PD-L1/4-1BB DLL3 CAR-T (BHP01): the first dose was 5x10\^5/kg.

Locations (1)

West China Hospital Sichuan University

Chengdu, Sichuan, China