Actively Recruiting
Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC)
Led by Beijing Biotech · Updated on 2026-03-18
60
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at the time of consent
- Histologically or cytologically confirmed small cell lung cancer (SCLC) that is metastatic, extensive-stage, or unresectable, and relapsed or refractory after at least one prior systemic regimen including platinum-based therapy unless contraindicated
- At least one measurable lesion per RECIST v1.1
- ECOG performance status 0 to 1
- Adequate organ function including hematologic, renal, hepatic, and cardiac parameters as defined in the protocol
- Life expectancy of at least 12 weeks
- Tumor tissue available for antigen profiling of DLL3, CD56/NCAM1, and GD2
- Negative pregnancy test for persons of childbearing potential and agreement to use effective contraception during the study
You will not qualify if you...
- Active or uncontrolled central nervous system metastases or leptomeningeal disease (treated or stable CNS metastases may be allowed)
- Prior CAR-T, CAR-NK, or other gene-modified cellular therapy within 6 months or prior therapy against investigational target antigens that would interfere with safety or efficacy assessment
- Allogeneic hematopoietic stem cell transplant within 6 months or active graft-versus-host disease
- Active uncontrolled infection including HIV, hepatitis B or C with viremia, or tuberculosis
- Clinically significant cardiovascular disease such as recent myocardial infarction within 6 months, uncontrolled arrhythmia, or left ventricular ejection fraction less than 45%
- Active autoimmune disease requiring systemic immunosuppression or chronic corticosteroid use over 10 mg/day prednisone equivalent (unless for physiologic replacement)
- Concurrent malignancy needing active treatment (some exceptions apply for certain skin or in situ cancers)
- Pregnant or breastfeeding
- Any condition that would make participation unsafe or interfere with compliance as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
Seni S Lu, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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