Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NKX019 · 3 trials · 16 indications
Incidence of DLTs will be evaluated
Incidence and severity of treatment-emergent adverse events will be evaluated
Incidence of clinically significant laboratory abnormalities will be evaluated
DLTs are defined as adverse events attributable to NKX019 treatment that occur during Cycle 1 and meet protocol-specified criteria
Percentage of subjects with complete and partial response. Response to treatment will be assessed based on: Lugano classification with LYRIC refinement for subjects with NHL (except CLL/SLL and WM); 2018 iwCLL guidelines for subjects with CLL/SLL; Version 1.2020 NCCN for subjects with B-ALL; consensus criteria from the 6th International Workshop on Waldenström Macroglobulinemia for subjects with WM.
| Arm | Type | Description |
|---|---|---|
| NKX019 - CAR NK cell therapy | EXPERIMENTAL | Phase 1/2: NKX019 plus fludarabine and cyclophosphamide |
| Name | Type | Description |
|---|---|---|
| NKX019 | DRUG | NKX019 is an investigational allogeneic CD19-Directed CAR NK |
| Fludarabine | DRUG | Lymphodepletion |
| Cyclophosphamide | DRUG | Lymphodepletion |
| Fludarabine, Cyclophosphamide | DRUG | For Lymphodepletion |
General Inclusion Criteria: 1. Age ≥18 and ≤75 2. Signed informed consent form and ability to adhere to the study visit schedule and comply with other protocol requirements 3. Women of childbearing potential must have negative pregnancy tests at screening and baseline, and agree to abstinence or ac...
NKX019 is an investigational allogeneic chimeric antigen receptor natural killer cell (CAR NK) therapy being studied in adults with B-cell cancers and autoimmune diseases. In clinical trials, it is being evaluated for non-Hodgkin lymphoma, lupus nephritis, systemic sclerosis, and other immune-mediated conditions. It is not yet approved and remains in Phase 1 clinical development.
NKX019 is an allogeneic chimeric antigen receptor natural killer cell (CAR NK) therapy. It is designed to use natural killer cells engineered with a chimeric antigen receptor to target and eliminate disease-causing cells. The specific molecular target is not disclosed in the available information.
NKX019 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 NKX019 in the United States, Australia, and Puerto Rico.
NKX019 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. Clinical trials are ongoing or active but not recruiting in some cases, with studies evaluating the therapy in B-cell cancers and autoimmune diseases.
NKX019 is being studied in three clinical trials. NCT05020678 evaluates it in adults with B-cell cancers including non-Hodgkin lymphoma. NCT06557265 (Ntrust-1) studies it in lupus nephritis and primary membranous nephropathy. NCT06733935 (Ntrust-2) studies it in systemic sclerosis and other immune-mediated diseases.
NKX019 is a type of chimeric antigen receptor natural killer cell (CAR NK) therapy, specifically an allogeneic CAR NK product. It is not known by any other drug name. The therapy is being investigated for its potential in treating hematologic cancers and autoimmune conditions.