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Also known as NKX101 - CAR NK cell therapy
NKX101- CAR NK cell therapy · 1 trial · 4 indications
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...
NKX101 is an investigational CAR NK cell therapy being studied for the treatment of relapsed or refractory acute myeloid leukemia (AML) in adults. It is also being evaluated in patients with myelodysplastic syndromes (MDS). The therapy is administered intravenously and is currently in Phase 1 clinical development.
NKX101 is being developed by Nkarta, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol NKTX. The company is conducting clinical trials of NKX101 in the United States for the treatment of relapsed or refractory AML and MDS.
NKX101 is currently in Phase 1 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, and it is designed to evaluate the safety and efficacy of NKX101 in adults with AML or MDS.
NKX101 is being studied in a Phase 1 clinical trial with the identifier NCT04623944. This trial is titled 'NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS' and is being conducted in the United States. The trial is enrolling adults aged 18 years and older and is not yet completed.
Yes, NKX101 is also referred to as NKX101 - CAR NK cell therapy. Both names refer to the same investigational cell therapy being developed by Nkarta, Inc. for the treatment of relapsed or refractory AML and MDS.