NCT07246304

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
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: TCRCure Biopharma Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	TC-D101 CAR-T	TC-D101 CAR-T treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.

Timeline

• Start date: 2025-11-30
• Primary completion: 2027-11-30
• Completion: 2028-11-30
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: China