Clinical trial · Interventional
IL-15 Enhanced NK Cell Therapy for Solid Tumors
A Single-Arm Clinical Study of IL-15 Enhanced Engineered NK Cells for Refractory Relapsed/Metastatic Solid Tumors
NCT07621471CI-TRIAL-00113300not yet recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IL-15 enhanced engineered NK cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IL-15 Enhanced Engineered NK Cells
- description
- Single arm. Patients receive IL-15 enhanced engineered NK cells after lymphodepletion chemotherapy.
- interventionNames
- Drug: IL-15 enhanced engineered NK cells
- Biological: IL-15 Enhanced Engineered NK Cells
Primary outcomes (1)
- measure
- Incidence of Dose-Limiting Toxicity (DLT)
- timeFrame
- Within 28 days after first infusion
Secondary outcomes (4)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Every 4 weeks for the first 6 months, then every 12 weeks through 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.