Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IL-15 Enhanced Engineered NK Cells | Experimental | Single arm. Patients receive IL-15 enhanced engineered NK cells after lymphodepletion chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IL-15 enhanced engineered NK cells | Drug | Genetically engineered NK cells expressing IL-15. Administered intravenously. See protocol for dose details. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose-Limiting Toxicity (DLT) | Within 28 days after first infusion |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Expansion and persistence of IL-15 enhanced engineered NK cells and cytokine levels | Baseline (Day 0), Day 1, Day 3, Day 7, Day 14, Day 28, then every 4 weeks through 6 months, then every 12 weeks through 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinqiao Hospital | Chongqing | China |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
IL-15 enhanced engineered NK cells in patients with refractory relapsed or metastatic solid tumors.
Not provided
Not provided
Not provided
Not provided
| IL-15 Enhanced Engineered NK Cells | Biological | Genetically engineered NK cells expressing IL-15 |
|
| 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 |