Actively Recruiting
Adaptive Phase 1/2 Study of Dual-Targeting CAR-NK Cell Therapy Directed Against DLL3, CD56, and GD2 in Adults With Relapsed or Refractory Small Cell Lung Cancer
Led by Beijing Biotech · Updated on 2026-03-18
60
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, and early antitumor effects of allogeneic dual-target CAR-NK cell products in adults with relapsed or refractory small cell lung cancer (SCLC). This open-label, multi-center Phase 1/2 trial focuses on three off-the-shelf CAR-NK therapies designed to target combinations of DLL3, CD56, and GD2 proteins commonly found on SCLC tumors. The study aims to identify the most promising dual-target CAR-NK construct to proceed to further testing. Participants will undergo screening including tumor antigen profiling to confirm target presence. The trial includes a Phase 1 dose escalation with up to three parallel arms, each testing a different CAR-NK dual-target combination (DLL3/CD56, DLL3/GD2, CD56/GD2). After lymphodepleting chemotherapy with fludarabine and cyclophosphamide, participants receive CAR-NK infusions, possibly repeated within a cycle or given in a second cycle for responders. A pre-planned interim review will select the best construct for a Phase 2 expansion cohort at the recommended dose. During the study, participants will be closely monitored for safety issues such as cytokine release syndrome and neurotoxicity, with assessments of dose-limiting toxicities and maximum tolerated dose over 12 months. Clinical follow-up for efficacy and late side effects continues for 24 months, with potential long-term monitoring for up to 15 years to watch for delayed adverse events. Researchers will evaluate tumor response, progression-free survival, and overall survival as key outcomes.
CONDITIONS
Brief 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 that is metastatic, extensive-stage, or unresectable, and relapsed or refractory after at least one prior systemic regimen including platinum-based chemotherapy unless contraindicated.
- At least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function including hematologic, renal, hepatic, and cardiac as defined in the protocol.
- Life expectancy of at least 12 weeks.
- Availability of tumor tissue for antigen profiling.
- 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 treatment with CAR-T, CAR-NK, or other gene-modified cellular therapy within 6 months or any prior therapy targeting the investigational antigens if it would affect safety or efficacy assessment.
- Allogeneic hematopoietic stem cell transplant within 6 months or presence of 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 below 45%.
- Active autoimmune disease requiring systemic immunosuppression or chronic corticosteroid use above 10 mg/day prednisone equivalent unless for hormone replacement.
- Concurrent malignancy requiring active treatment except some non-melanoma skin cancers or in situ cancers.
- Pregnant or breastfeeding individuals.
- Any condition that would make participation unsafe or interfere with compliance as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 28 days per dose escalation cycle; second cycle may be allowed in responders
Participants receive lymphodepleting chemotherapy followed by infusion(s) of dual-target CAR-NK cells. Repeat dosing within a cycle and a second cycle may be permitted for responders without prohibitive toxicity.
multiple visits including dosing on Day 0, Day 7, and Day 14 within a cycle
Duration - 24 months
Participants are monitored for safety and efficacy outcomes, including adverse events and survival, for up to 24 months after treatment.
clinical follow-up visits scheduled over 24 months
Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
Seni S Lu, Phd
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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