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Recruiting Phase 1/2

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

NCT07480213 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2026-02-02
Last updated
2026-03-18

Condition(s) studied

Small Cell Lung Cancer (SCLC)Relapsed/Refractory SCLCSCLC, Extensive Stage

Investigational drug(s) / intervention(s)

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

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

Lymphodepleting chemotherapy: (fludarabine + cyclophosphamide)

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of dose-limiting toxicities (DLTs) — 28 Days
  • Maximum tolerated dose (MTD) — 12 months

Trial sites (1)

FacilityCityRegionStatus
Peking University Shenzhen Hospital Shenzhen Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07480213 on ClinicalTrials.gov ↗ ← All trials in China