NCT07621471Not yet recruitingPhase 1
A Single-Arm Clinical Study of IL-15 Enhanced Engineered NK Cells for Refractory Relapsed/Metastatic Solid Tumors
Genovn Therapeutics (Suzhou) Co., Ltd.1 site in 1 country12 target enrollmentStarted: July 1, 2026Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 12
- Locations
- 1
Study Overview
Brief Summary
A single-arm, Phase 1 study evaluating safety, tolerability, and preliminary efficacy of IL-15 enhanced engineered NK cells in patients with refractory relapsed or metastatic solid tumors.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-70 years;
- •histopathologically confirmed metastatic or recurrent solid tumors (breast, liver, lung, etc.);
- •failed prior standard therapy;
- •>=1 measurable lesion per RECIST 1.1;
- •adequate bone marrow, liver, kidney, and coagulation function;
- •recovered from prior treatment toxicities;
- •signed informed consent.
Exclusion Criteria
- •Pregnancy/lactation;
- •other malignancy within 5 years (except cured localized tumors);
- •active autoimmune disease or immunodeficiency;
- •uncontrolled cardiovascular disease or infection;
- •positive HBsAg/HBcAb or HCV antibody (unless viral load undetectable);
- •positive syphilis antibody;
- •major surgery or vaccination within 28 days;
- •prior cell therapy;
- •severe allergy to study drugs;
- •investigator judged unsuitable.
Investigators
Study Sites (1)
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