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Also known as NKX101 - CAR NK cell therapy, NKX101- CAR NK cell therapy
NKX101 · 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 allogeneic CAR NK cell therapy being developed by Nkarta, Inc. for relapsed or refractory acute myeloid leukemia (AML). It is an off-the-shelf cell therapy given intravenously and is currently in Phase 1 clinical development.
NKX101 is being studied for the treatment of relapsed or refractory acute myeloid leukemia (AML) in adults. The Phase 1 trial also enrolls patients with myelodysplastic syndromes (MDS) and refractory MDS. It is investigational and has not been approved for any indication.
NKX101 targets NKG2D, a receptor expressed on natural killer cells. The therapy is engineered so that its CAR NK cells recognize NKG2D ligands on tumor cells, directing an immune response against the cancer cells in relapsed or refractory AML.
NKX101 is being developed by Nkarta, Inc., a clinical-stage biotechnology company. Nkarta trades on the Nasdaq under the ticker symbol NKTX. The company is the sponsor of the ongoing Phase 1 study of NKX101 in AML and MDS.
NKX101 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The single ongoing Phase 1 trial is active but not currently recruiting participants.
NKX101 is being evaluated in one Phase 1 trial, NCT04623944, titled "NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS." The study is active but not recruiting, has an estimated enrollment of 61 participants, and is conducted in the United States.
Yes. NKX101 is also referred to as NKX101 CAR NK cell therapy or NKX101 - CAR NK cell therapy. These names describe the same investigational allogeneic CAR NK cell product developed by Nkarta for relapsed or refractory AML and MDS.