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

NCT07246304 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-11-24

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

TC-D101 CAR-T

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

Sponsors & Collaborators

  • The Jinling Hospital

    collaborator UNKNOWN

  • TCRCure Biopharma Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2027-11-30
Completion
2028-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07246304 on ClinicalTrials.gov