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RECRUITING
NCT07480213
PHASE1/PHASE2

Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC)

Sponsor: Beijing Biotech

View on ClinicalTrials.gov

Summary

This study is an open-label, multi-center, adaptive Phase 1/2 trial evaluating the safety, feasibility, and preliminary antitumor activity of allogeneic dual-target CAR-NK cell products in adults with relapsed or refractory small cell lung cancer (SCLC). Three candidate dual-target constructs (DLL3/CD56, DLL3/GD2, and CD56/GD2) will be assessed during dose escalation; a pre-specified interim assessment will select the most suitable construct to proceed into an expansion cohort at the recommended Phase 2 dose (RP2D).

Official title: A Phase 1/2 Adaptive Dose-Escalation and Expansion Study of Dual-Targeting Chimeric Antigen Receptor Natural Killer (CAR-NK) Cells Directed Against DLL3, CD56 (NCAM1), and/or GD2 in Adults With Relapsed/Refractory Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-02-02

Completion Date

2028-04-17

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

BIOLOGICAL

EB-DART-NK01 (DLL3/CD56 CAR-NK cells)

EB-DART-NK01 (DLL3/CD56 CAR-NK cells)

DRUG

Lymphodepleting chemotherapy

(fludarabine + cyclophosphamide)

Locations (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China