Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06450041 | NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial | PHASE2 | RECRUITING | 62 | — | — | Dec 16, 2024 | Dec 1, 2038 | Mar 23, 2026 | 13 | United States |
The response evaluation is based on central review or site review (when central review is not available) of patient diagnostic assessments. Response is determined by the NANT response criteria v2.0 (https://doi.org/10.1002/pbc.26940). 1. Complete response 2. Partial response 3. Minor response 4. Stable response 5. Progressive disease 6. Early death from malignant disease 7. Early death from toxicity Evaluable response patients have received sufficient therapy (1) and have sufficient response evaluation data to assess best overall response (2) including patients in categories f and g 1. is defined as at least 75% of all therapeutic agents in course 1, or less than 75% in course 1 due to clinical signs of tumor progression or therapy related toxicity. 2. is defined as presence of a disease evaluation for each of the 3 disease parameters (bone, soft tissue, bone marrow) at one or more timepoints after enrollment. Best Overall Response Rate = (a+b+c)/ (a+b+c+d+e+f+g).
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Patients will be treated with chemoimmunotherapy (temozolomide, irinotecan, GM-CSF, and dinutuximab) plus UD TGFβi NK cells. |
| Name | Type | Description |
|---|---|---|
| Universal Donor (UD) TGFβi NK Cells | DRUG | Patients will receive a dose of 1x108 UD TGFβi NK cells/kg per treatment cycle on day 8 of each cycle |
| Temozolomide | DRUG | Enteral or IV daily on days 1-5 of each cycle For patients ≥ 0.5 m2: 100 mg/m2/dose For patients \< 0.5 m2: 3.3 mg/kg/dose MAXIMUM dose = 200 mg |
| Irinotecan | DRUG | 50mg/m2/dose IV daily on days 1-5 of each cycle |
| Dinutuximab | DRUG | 17.5mg/m2/dose IV daily on days 2-5 of each cycle |
| GM-CSF | DRUG | 250mcg/m2/dose subcutaneous (preferred) or IV daily on days 6-12 of each cycle |
Inclusion Criteria: * Patients must be ≥ 1 year and ≤31 years of age at the time of enrollment on the study. * Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholami...