RecruitingPhase 1NCT06348797

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

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)


Sponsor

Sichuan University

Enrollment

28 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new type of cell therapy called CAR-T — where your own immune cells are engineered in a lab to fight cancer — for people with small cell lung cancer (SCLC) that has come back or stopped responding to treatment. **You may be eligible if...** - You have small cell lung cancer that came back or got worse after at least one round of platinum-based chemotherapy - You are between 18 and 70 years old - You are in reasonably good health overall (able to carry out light activity) - You have at least one measurable tumor outside the brain - Your HIV, hepatitis B, hepatitis C, and syphilis tests are negative - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - You have active or unstable brain metastases - You have a history of autoimmune disease (such as lupus or rheumatoid arthritis) - You had a serious infection in the past 4 weeks - You had a heart attack or stroke in the past 3 months - You have previously received DLL3-targeted therapy or any CAR-T cell therapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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

DRUGα-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

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NCT06348797


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