RecruitingEarly Phase 1NCT07246304

TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC

A Preliminary Exploratory Clinical Study of TC-D101 in the Treatment of DLL3-Positive Relapsed/Refractory Primary Small Cell Lung Cancer


Sponsor

TCRCure Biopharma Ltd.

Enrollment

24 participants

Start Date

Nov 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-D101 CAR-T cells in patients with DLL3-positive Relapsed/Refractory primary small cell lung cancer(r/r SCLC) who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in SCLC.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new cell therapy called TC-D101 for people with relapsed or treatment-resistant small cell lung cancer (SCLC) whose tumors express a protein called DLL3. TC-D101 is a type of engineered immune cell designed to find and kill cancer cells that carry DLL3. **You may be eligible if...** - You are 18 to 75 years old - You have small cell lung cancer that has come back or stopped responding to treatment - Your tumor cells test positive for the DLL3 protein - You have not had success with or are not suitable for standard therapies - You have a life expectancy of at least 3 months and are in adequate general health **You may NOT be eligible if...** - Your tumor does not test positive for DLL3 - You have active or uncontrolled infections - You have had severe autoimmune disease or are on systemic immune-suppressing drugs - You have untreated brain metastases 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

BIOLOGICALTC-D101 CAR-T

TC-D101 CAR-T treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.


Locations(1)

The Jinling Hospital

Nanjing, Jiangsu, China

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NCT07246304


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