Metastatic Cancer, Solid Tumors
Conditions
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.
Interventions
DRUGIL-15 enhanced engineered NK cells
Genetically engineered NK cells expressing IL-15. Administered intravenously. See protocol for dose details.
BIOLOGICALIL-15 Enhanced Engineered NK Cells
Genetically engineered NK cells expressing IL-15
Sponsors
Genovn Therapeutics (Suzhou) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
IL-15 enhanced engineered NK cells in patients with refractory relapsed or metastatic solid tumors.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Dose-Limiting Toxicity (DLT) | Within 28 days after first infusion |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | Every 4 weeks for the first 6 months, then every 12 weeks through 24 months |
| Duration of Response (DOR) | 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) | 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) | From date of enrollment until date of death from any cause, assessed up to 24 months |
Countries
China
Outcome results
None listed