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

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.

Study Overview

• Status: Recruiting
• Conditions: CAR-T Cell Therapy; Small Cell Lung Cancer ( SCLC )
• Intervention / Treatment: Biological: TC-D101 CAR-T

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Tangfeng LV; Phone Number: +862580863234; Email: njzyjg80863256@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The Jinling Hospital
      • Contact: Tangfeng Hospital; Phone Number: +862580863234; Email: njzyjg80863256@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TC-D101 CAR-T Cell Therapy; Following lymphodepletion chemotherapy, participants will receive Following lymphodepletion chemotherapy, participants will receive TC-D101 CAR-T Cell CAR-T	Biological: TC-D101 CAR-T; TC-D101 CAR-T treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.; Other Names: Cyclophosphamide; Fludarabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of TC-D101 CAR-T cells	The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.	Up to 24 months
Safety of TC-D101 CAR-T cells	Incidence of DLT	Up to 1 month

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	To detect TC-D101 CAR-T cell number in tumor tissues after infusion	Up to 24 months

Collaborators and Investigators

• Sponsor: TCRCure Biopharma Ltd.
• Collaborators: The Jinling Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: DLL3; CAR-T Cell Therapy; Small Cell Lung Cancer ( SCLC )
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; Organic Chemicals; Hydrocarbons; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cyclophosphamide; fludarabine
• Other Study ID Numbers: D101-IIT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No