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...
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NKX019 is an investigational chimeric antigen receptor natural killer (CAR NK) cell therapy being studied for immune-mediated diseases and B-cell cancers. In clinical trials it is being evaluated for lupus nephritis, systemic sclerosis, non-Hodgkin lymphoma, and other autoimmune and hematologic conditions. It is not yet approved and remains in Phase 1 clinical development.
NKX019 targets CD19, a protein found on the surface of B cells. By directing natural killer cells to CD19-expressing cells, the therapy aims to deplete pathogenic B cells involved in autoimmune diseases and B-cell malignancies. This mechanism is being studied across both oncology and autoimmune indications.
NKX019 is being developed by Nkarta, Inc., a biopharmaceutical company traded on Nasdaq under the ticker NKTX. The company is conducting Phase 1 clinical trials of NKX019 in the United States, Australia, and Puerto Rico for autoimmune diseases and B-cell cancers.
NKX019 is in Phase 1 clinical development. It is an investigational therapy and has not received FDA approval. The ongoing trials are early-stage studies designed to evaluate safety and preliminary efficacy in immune-mediated diseases and B-cell cancers.
NKX019 is being studied in three Phase 1 trials. NCT06733935 (Ntrust-2) enrolls 240 participants with systemic sclerosis and other autoimmune conditions. NCT06557265 (Ntrust-1) enrolls 120 participants with lupus nephritis and membranous nephropathy. NCT05020678 enrolls 150 participants with B-cell cancers including non-Hodgkin lymphoma.
NKX019 is not a CAR T-cell therapy. It is an allogeneic chimeric antigen receptor natural killer (CAR NK) cell therapy, meaning it uses natural killer cells rather than T cells. It is being studied for similar indications as CAR T therapies, including B-cell cancers and autoimmune diseases.