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

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07246304

Enrollment

Registered

2025-11-24

Start date

2025-11-30

Completion date

2028-11-30

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Small Cell Lung Cancer ( SCLC ), CAR-T Cell Therapy, DLL3

Brief 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.

Detailed description

This study is designed as a single-arm, open-label, single-dose clinical trial to evaluate the safety and efficacy of TC-D101 CAR-T cell therapy in patients with r/r SCLC. The study protocol consists of five main stages: (1) patient screening, (2) collection of peripheral blood mononuclear cells (PBMCs), (3) lymphodepletion chemotherapy, (4) TC-D101 CAR-T cell infusion, and (5) post-infusion follow-up.

Interventions

BIOLOGICALTC-D101 CAR-T

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Participants must voluntarily provide written informed consent. 2. Aged 18-75 years (inclusive). 3. Life expectancy ≥ 3 months. 4. ECOG performance status 0-1. 5. Failed or unsuitable for standard therapy. 6. At least one measurable lesion per RECIST 1.1. 7. DLL3-positive r/r SCLC confirmed by immunohistochemistry. 8. Adequate organ and bone marrow function. 9. Effective contraception required for participants of childbearing potential. 10. Adequate venous access for leukapheresis.

Exclusion criteria

1. Primary CNS malignancy or uncontrolled CNS metastases. 2. Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ). 3. Active autoimmune disease or history of autoimmune disease. 4. Immunodeficiency, including HIV positivity. 5. Bleeding disorders (inherited or acquired). 6. Clinically significant cardiovascular disease. 7. Active infection (including tuberculosis, hepatitis B/C, syphilis). 8. Pregnant or breastfeeding women. 9. Clinically significant ascites . 10 Uncontrolled pleural effusion or pericardial effusion. 11\. Prior cell or gene therapy. 12. Severe drug hypersensitivity history. 13. Investigator-assessed unsuitability for trial participation.

Design outcomes

Primary

Measure	Time frame	Description
Safety of TC-D101 CAR-T cells	Up to 24 months	The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.

Secondary

Measure	Time frame	Description
Efficacy of TC-D101 CAR-T cells	Up to 24 months	Optimal objective response rate (ORR)

Other

Measure	Time frame	Description
To investigate the Cmax of TC-D101 CAR-T cells in the peripheral blood after infusion	Up to 24 months	—
To assess TC-D101 CAR-T cell trafficking into tumor tissues after infusion	Up to 24 months	To detect TC-D101 CAR-T cell number in tumor tissues after infusion

Countries

China

Contacts

Primary ContactTangfeng LV

njzyjg80863256@163.com+862580863234

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026