Drugs / NKX019
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06518668 | Jul 2024 → Dec 2026 expected | systemic lupus erythematosus | Hospital for Special Surgery, New York | Enrolling by invitation | No outcome recorded |
| Phase 1 | NCT05020678 | Aug 2021 → Mar 2025 overdue | B-cell acute lymphoblastic leukemia, Waldenstrom macroglobulinemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, large B-cell lymphoma +1 | Nkarta, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06733935 | Nov 2024 → Oct 2028 expected | anti-neutrophil cytoplasmic antibody-associated vasculitis, idiopathic inflammatory myopathy, rheumatoid arthritis, systemic sclerosis | Nkarta, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06557265 | Jun 2024 → Apr 2027 expected | idiopathic membranous glomerulonephritis, lupus nephritis | Nkarta, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-04-15 | Nkarta, Inc. | Regulatory Nkarta Announces FDA Agreement on Outpatient Dosing of NKX019 in Autoimmune Disease, Expanding Access to Community Rheumatology Centers nkartatx.com ↗
Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biotechnology company developing engineered natural killer (NK) cell therapies to treat autoimmune diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on key changes to the ongoing Ntrust-1 and Ntrust-2 clinical trials. |
| 2025-10-22 | Nkarta, Inc. | Results Nkarta Announces Poster Presentation at Upcoming American College of Rheumatology (ACR) Convergence Meeting nkartatx.com ↗
Nkarta will present clinical data showing that the company’s investigational therapy, NKX019, achieved robust pathogenic B-cell depletion followed by reconstitution of the B cell compartment, consistent with immune reset in participants with non-Hodgkin lymphoma. |
| 2024-12-05 | Nkarta, Inc. | Regulatory Nkarta Announces IND Clearance of Investigator-Sponsored Trial in Myasthenia Gravis and Opening of Enrollment for Ntrust-2 nkartatx.com ↗
Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced the opening of Ntrust-2 to enrollment and the IND clearance for an investigator-sponsored trial (IST) that will evaluate NKX019, Nkarta’s allogeneic, CD19-directed chimeric antigen receptor (CAR) NK-cell therapy, in patients with myasthenia gravis (MG). |
| 2024-06-27 | Nkarta, Inc. | Regulatory Nkarta Initiates Clinical Trial of NKX019 in Lupus Nephritis with First Patient in Screening and Announces Pipeline Expansion to Additional Autoimmune Indications nkartatx.com ↗
The company also announced the clearance by the U.S. Food and Drug Administration (FDA) of its second Investigational New Drug (IND) application for NKX019 in autoimmune disease. |
| 2023-10-17 | Nkarta, Inc. | Regulatory Nkarta Receives FDA Clearance of IND Application for NKX019 in Lupus Nephritis nkartatx.com ↗
Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced the clearance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to evaluate NKX019, its allogeneic, CD19-directed CAR NK cell therapy candidate, for the treatment of lupus nephritis. |
| 2023-06-10 | Nkarta, Inc. | Results Nkarta Presents NKX019 Clinical Data at the European Hematology Association 2023 Congress and 17th International Conference on Malignant Lymphoma nkartatx.com ↗
7 of 10 r/r NHL patients achieved complete response (70% CR rate) following treatment with NKX019 monotherapy at 1 billion and 1.5 billion CAR NK cells per dose in the Phase 1 dose escalation study |
| 2022-12-05 | Nkarta, Inc. | Results Nkarta Announces Updated Clinical Data on Anti-CD19 Allogeneic CAR-NK Cell Therapy NKX019 for Patients with Relapsed or Refractory Non-Hodgkin Lymphoma nkartatx.com ↗
Seven of ten patients treated at the higher dose levels in a three-dose regimen showed a complete response (70% CR), including two patients with aggressive large B cell lymphoma (LBCL), one patient with mantle cell lymphoma (MCL), and one patient with marginal zone lymphoma (MZL). |
| 2022-11-07 | Nkarta, Inc. | Results Nkarta Presents Data Supporting Engineered NK Cell Based Combination Therapies and Next Generation Commercial-Scale Manufacturing Platform at SITC 37th Annual Meeting nkartatx.com ↗ |
| 2022-04-25 | Nkarta, Inc. | Results Nkarta Announces Positive Preliminary Dose Finding Data for Two Lead Engineered Natural Killer Cell Programs nkartatx.com ↗
5 of 6 patients with relapsed / refractory NHL treated with a three-dose regimen consisting of 1B CAR NK cells per dose achieved response (83% ORR) and 3 of 6 achieved complete response (50% CR rate); responses included DLBCL |
| 2021-04-28 | Nkarta, Inc. | Regulatory Nkarta Receives NKX019 IND Clearance from U.S. Food and Drug Administration for Treatment of Relapsed/Refractory B Cell Malignancies nkartatx.com ↗
Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that the U.S. Food & Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to study NKX019 in patients with relapsed or refractory B cell malignancies. |
| 2020-11-09 | Nkarta, Inc. | Results Nkarta Announces Presentation of Preclinical Data on NKX019, Engineered NK Cell Therapy Candidate Targeting CD19, at the Annual Meeting of the Society for Immunotherapy of Cancer nkartatx.com ↗
Cryopreserved NKX019 demonstrated potent, targeted anti-tumor activity in vitro and in vivo across different CD19-expressing cancer models for B cell lymphoma and acute lymphoblastic leukemia. |
| 2019-11-18 | Nkarta, Inc. | Results Nkarta Therapeutics Presents Preclinical Data for CD19 CAR NK Program nkartatx.com ↗
In a series of in vitro and in vivo experiments, Nkarta scientists identified a CAR construct containing an OX40 co-stimulatory domain as optimal for further development. |
All press releases naming this drug 18 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NKX019 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06733935 ↗ |
| Modality | Cell therapy | “allogeneic CAR NK product” NCT05020678 ↗ |
| Route | Intravenous | “Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK)” NCT05020678 ↗ |
| Target | CD19 | “CD19-Directed CAR NK” NCT06518668 ↗ |