Adaptive Phase 1/2 testing dual-target CAR‑NK cells for relapsed or refractory small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multi-center adaptive Phase 1/2 trial gives allogeneic off-the-shelf CAR‑NK cell products that target two antigens to adults with relapsed or refractory extensive-stage SCLC. Three dual-target constructs (DLL3/CD56, DLL3/GD2, and CD56/GD2) are evaluated in parallel during a modified 3+3 dose-escalation to determine the maximum tolerated dose or recommended Phase 2 dose. Tumor antigen profiling by immunohistochemistry guides baseline characterization and an interim composite assessment of safety, manufacturability, in vivo persistence, and early antitumor activity selects one construct to move into a Phase 2 expansion cohort. Participants receive lymphodepleting chemotherapy (for example fludarabine and cyclophosphamide) before CAR‑NK infusion(s), and repeat dosing may be used to support NK persistence.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 1 prior systemic regimen (must include a platinum-based regimen unless contraindicated).
* At least one measurable lesion per RECIST v1.1.
* ECOG performance status 0 to 1.
* Adequate organ function (hematologic, renal, hepatic, and cardiac) as defined in the protocol (examples: ANC \>= 1.0 x10\^9/L, platelets \>= 75 x10\^9/L, creatinine clearance \>= 50 mL/min, AST/ALT \<= 3 x ULN, total bilirubin \<= 1.5 x ULN).
* Life expectancy \>= 12 weeks.
* Tumor tissue available (archival or fresh) for antigen profiling (DLL3, CD56/NCAM1, GD2).
* Negative pregnancy test for persons of childbearing potential; agreement to use effective contraception for the protocol-defined duration.

Exclusion Criteria:

* Active or uncontrolled CNS metastases or leptomeningeal disease (treated/stable CNS metastases may be allowed per protocol).
* Prior treatment with CAR-T, CAR-NK, or other gene-modified cellular therapy within 6 months (or any prior therapy directed against the investigational target antigens if it would confound safety/efficacy assessment).
* Allogeneic hematopoietic stem cell transplant within 6 months or active graft-versus-host disease.
* Active uncontrolled infection, including uncontrolled HIV, active hepatitis B or C with viremia, or active tuberculosis.
* Clinically significant cardiovascular disease (e.g., recent myocardial infarction within 6 months, uncontrolled arrhythmia, LVEF \< 45%).
* Active autoimmune disease requiring systemic immunosuppression; chronic systemic corticosteroid use \> 10 mg/day prednisone equivalent (unless for physiologic replacement).
* Concurrent malignancy requiring active treatment (exceptions may apply for certain non-melanoma skin cancers or in situ cancers).
* Pregnant or breastfeeding.
* Any condition that, in the investigator's opinion, would make participation unsafe or interfere with compliance.

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Seni S Lu, Phd
• Email: Seni-Lu@beijing-biotech.com
• Phone: +86 13076790030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.