RecruitingPhase 1Phase 2NCT07480213

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

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


Sponsor

Beijing Biotech

Enrollment

60 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy called dual-target CAR-NK cells — engineered natural killer cells that attack two targets on cancer cells at once — for people with small cell lung cancer (SCLC) that has come back or stopped responding to treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed small cell lung cancer that has spread or is unresectable, and has returned or stopped responding after at least one round of chemotherapy (including a platinum-based drug) - You have at least one measurable tumor - Your overall health is good (ECOG 0–1) - Your heart, kidneys, liver, and blood counts meet required levels - You are willing to use contraception during and after the study **You may NOT be eligible if...** - Cancer has spread to your brain in an uncontrolled way - You previously received CAR-T, CAR-NK, or similar gene-modified cell therapy within 6 months - You had a bone marrow transplant within the past 6 months or have active graft-versus-host disease - You have an active uncontrolled infection (including HIV, active hepatitis B/C, or tuberculosis) - You have significant heart disease - You have an active autoimmune disease requiring high-dose steroids - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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

DRUGLymphodepleting chemotherapy

(fludarabine + cyclophosphamide)


Locations(1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

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NCT07480213