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

NCT07480213 PHASE1, PHASE2 RECRUITING

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).

Details

Lead sponsor	Beijing Biotech
Phase	PHASE1, PHASE2
Status	RECRUITING
Enrolment	60
Start date	Mon Feb 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Apr 17 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Small Cell Lung Cancer (SCLC)
• Relapsed/Refractory SCLC
• SCLC, Extensive Stage

Interventions

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

Countries

China