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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04623944 | NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS | PHASE1 | ACTIVE NOT_RECRUITING | 61 | — | — | Sep 21, 2020 | Jul 1, 2039 | Dec 27, 2024 | 8 | United States |
Incidence, nature, and severity of treatment related adverse events will be evaluated. An adverse event is any unfavorable and unintended sign including clinically significant abnormal laboratory findings, symptom or disease.
Responses will be assessed per modified ELN criteria and will include complete and partial remission with and without varying degrees of hematologic recovery
| Arm | Type | Description |
|---|---|---|
| NKX101 - CAR NK cell therapy | EXPERIMENTAL | All subjects in Part 1 will receive lymphodepletion with fludarabine/cyclophosphamide followed by 3 or 2 (Regimen A or B, respectively) weekly doses of NKX101. Subjects in Part 2 will receive lymphodepletion with either fludarabine/cyclophosphamide or fludarabine/cytarabine (ara-C), or if the optional arm is opened, lymphodepletion with fludarabine/cyclophosphamide and decitabine, followed by 3 weekly doses of NKX101. Part 2: unrelated off-the-shelf donor derived NKX101 will be used. |
| Name | Type | Description |
|---|---|---|
| NKX101 - CAR NK cell therapy | BIOLOGICAL | NKX101 is an investigational allogeneic CAR NK product targeting NKG2D ligands on cancer cells. Part 2 will use the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of NKX101 as determined in Part 1. |
Inclusion Criteria: * General: * ECOG performance status ≤2 * Disease related: * For AML subjects: * Previously treated relapsed/refractory AML, including subjects with MRD+ disease * Received at most 3 lines of previous anti-leukemia therapy * For subjects with targetable fms-li...