NCT07246304

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for early_phase_1

Timeline
32mo left

Started Nov 2025

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Nov 2025Nov 2028

First Submitted

Initial submission to the registry

November 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

November 30, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

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

Keywords

Small Cell Lung Cancer ( SCLC )CAR-T Cell TherapyDLL3

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Efficacy of TC-D101 CAR-T cells

    Up to 24 months

Other Outcomes (2)

  • 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

Study Arms (1)

TC-D101 CAR-T Cell Therapy

EXPERIMENTAL

Following lymphodepletion chemotherapy, participants will receive Following lymphodepletion chemotherapy, participants will receive TC-D101 CAR-T Cell CAR-T

Biological: TC-D101 CAR-T

Interventions

TC-D101 CAR-TBIOLOGICAL

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

Also known as: Fludarabine, Cyclophosphamide
TC-D101 CAR-T Cell Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Jinling Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

fludarabineCyclophosphamide

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Central Study Contacts

Tangfeng LV

CONTACT

+862580863234njzyjg80863256@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 24, 2025

Study Start

November 30, 2025

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2028

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)