MedTrace Logo

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

NCT06348797 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-05-16

No results posted yet for this study

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.

Conditions

  • Small Cell Lung Cancer Extensive Stage

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.

Sponsors & Collaborators

  • Chengdu Brilliant Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Sichuan University

    lead OTHER

Principal Investigators

  • You Lu, MD · West China Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-03
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06348797 on ClinicalTrials.gov