IL-15 Enhanced NK Cell Therapy for Solid Tumors

Early Phase 1Not Yet RecruitingNCT07621471

Genovn Therapeutics (Suzhou) Co., Ltd.12 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors Metastatic Cancer

Interventions

IL-15 enhanced engineered NK cellsDRUG

Genetically engineered NK cells expressing IL-15. Administered intravenously. See protocol for dose details.

IL-15 Enhanced Engineered NK CellsBIOLOGICAL

Genetically engineered NK cells expressing IL-15

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18-70 years; 2. ECOG 0-1; 3. histopathologically confirmed metastatic or recurrent solid tumors (breast, liver, lung, etc.); 4. failed prior standard therapy; 5. \>=1 measurable lesion per RECIST 1.1; 6. adequate bone marrow, liver, kidney, and coagulation function; 7. recovered from prior treatment toxicities; 8. signed informed consent. Exclusion Criteria: 1. Pregnancy/lactation; 2. other malignancy within 5 years (except cured localized tumors); 3. active autoimmune disease or immunodeficiency; 4. uncontrolled cardiovascular disease or infection; 5. active TB; 6. positive HBsAg/HBcAb or HCV antibody (unless viral load undetectable); 7. positive syphilis antibody; 8. major surgery or vaccination within 28 days; 9. prior cell therapy; 10. severe allergy to study drugs; 11. investigator judged unsuitable.

Locations (1)

Xinqiao Hospital

Chongqing, China

Outcomes

Primary Outcomes

Incidence of Dose-Limiting Toxicity (DLT)

Time frame: Within 28 days after first infusion

Secondary Outcomes

Objective Response Rate (ORR)

Time frame: Every 4 weeks for the first 6 months, then every 12 weeks through 24 months

Duration of Response (DOR)

Time frame: From date of first documented response until date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Progression-Free Survival (PFS)

Time frame: From date of enrollment until date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Overall Survival (OS)

Time frame: From date of enrollment until date of death from any cause, assessed up to 24 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.