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

Small Cell Lung Cancer ( SCLC )CAR-T Cell Therapy

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

Inclusion Criteria10

Participants must voluntarily provide written informed consent.
Aged 18-75 years (inclusive).
Life expectancy ≥ 3 months.
ECOG performance status 0-1.
Failed or unsuitable for standard therapy.
At least one measurable lesion per RECIST 1.1.
DLL3-positive r/r SCLC confirmed by immunohistochemistry.
Adequate organ and bone marrow function.
Effective contraception required for participants of childbearing potential.
Adequate venous access for leukapheresis.

Exclusion Criteria10

Primary CNS malignancy or uncontrolled CNS metastases.
Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ).
Active autoimmune disease or history of autoimmune disease.
Immunodeficiency, including HIV positivity.
Bleeding disorders (inherited or acquired).
Clinically significant cardiovascular disease.
Active infection (including tuberculosis, hepatitis B/C, syphilis).
Pregnant or breastfeeding women.
Clinically significant ascites . 10 Uncontrolled pleural effusion or pericardial effusion.
\. Prior cell or gene therapy. 12. Severe drug hypersensitivity history. 13. Investigator-assessed unsuitability for trial participation.