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Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC)
Sponsor: Beijing Biotech
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
EB-DART-NK01 (DLL3/CD56 CAR-NK cells)
EB-DART-NK01 (DLL3/CD56 CAR-NK cells)
Lymphodepleting chemotherapy
(fludarabine + cyclophosphamide)
Locations (1)
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China