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DRUG:

NKX019

i
Other names: NKX019 , NKX 019, NKX-019
Associations
Trials
Company:
Nkarta Therap
Drug class:
CD19 inhibitor, IL-15 stimulant, OX40 agonist
Related drugs:
Associations
Trials
5ms
New P1 trial
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cyclophosphamide • NKX019
9ms
Trial primary completion date
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cyclophosphamide • NKX019
over1year
FIRST IN HUMAN DATA OF NKX019, AN ALLOGENEIC CAR NK FOR THE TREATMENT OF RELAPSED/REFRACTORY (R/R) B-CELL MALIGNANCIES (EHA 2023)
Following 3 days of lymphodepletion (LD) with fludarabine at 30 mg/m 2 /d and cyclophosphamide at 300 mg/m 2 /d, patients received NKX019 at 3 dose levels (3 × 10 8 , 1 × 10 9 , or 1.5 × 10 9 CAR + NK cells/dose x 3 doses on days 0, 7, and 14 of a 28-day cycle). These preliminary data suggest that NKX019 has a manageable safety profile with monotherapy activity across multiple histologies of B-cell NHL. Enrollment into the expansion cohorts is currently ongoing and will evaluate the RP2D in multiple cohorts: (1) CAR-T naïve LBCL, (2) CAR-T exposed LBCL, and (3) in combination with rituximab to evaluate for enhanced anti-tumor activity via ADCC. NK cell, Cellular therapy, Non-Hodgkin's lymphoma
P1 data
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IL15 (Interleukin 15)
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Rituxan (rituximab) • cyclophosphamide • fludarabine IV • NKX019
almost2years
NKX019-101: NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With B-cell Cancers (clinicaltrials.gov)
P1, N=150, Recruiting, Nkarta Inc. | N=60 --> 150 | Trial completion date: Jul 2038 --> Dec 2038 | Trial primary completion date: Jul 2023 --> Dec 2023
Enrollment change • Trial completion date • Trial primary completion date
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CD19 (CD19 Molecule)
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cyclophosphamide • NKX019
2years
NKX019, an Off-the-Shelf CD19 CAR-NK Cell, mediates improved anti-tumor activity and persistence in combination with CD20-directed therapeutic mAbs (SITC 2022)
CD20-targeted mAbs such as rituximab (RTX) and obinutuzumab (OBI), can mediate antibody-dependent cellular cytotoxicity (ADCC), a key effector mechanism of NK cells. Conclusions This study demonstrates increased activity and persistence of NKX019 when used in combination with approved CD20-targeted mAbs, RTX and OBI, against B cell malignancies. A first-in -human Phase I clinical trial of NKX019 in combination with RTX is planned.
Combination therapy
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CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule) • IL15 (Interleukin 15)
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CD19 expression
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Rituxan (rituximab) • Gazyva (obinutuzumab) • NKX019
3years
A Phase 1 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects with B-Cell Malignancies (ASH 2021)
NKX019 will be administered on Days 0, 7, and 14 of a 28-day cycle following standard fludarabine/cyclophosphamide lymphodepletion (Table). Subjects will be assessed for efficacy using disease-specific criteria: Lugano classification with LYRIC refinement for pseudo-progression (NHL), 2018 International Workshop (IW) criteria (CLL), 6th IW criteria (Waldenström macroglobulinemia [WM]), and National Comprehensive Cancer Version 1.2020 (B-ALL) (Cheson 2006, Cheson 2014, Hallek 2018, Owen 2013, Brown 2020). Enrollment across multiple sites in the US and Australia is expected to start in the second half of 2021.
Clinical • P1 data
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CD19 (CD19 Molecule) • IL2 (Interleukin 2)
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CD19 expression
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cyclophosphamide • fludarabine IV • NKX019
over3years
Clinical • New P1 trial
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CD19 (CD19 Molecule)
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NKX019
4years
[VIRTUAL] Preclinical evaluation of NKX019, a CD19-targeting CAR NK Cell (SITC 2020)
A first-in-human trial of NKX019 in B cell malignancies is planned for 2021. Ethics Approval The animal procedures described in this abstract were conducted in accordance with Explora BioLabs Animal Care and Use Protocol approved by Explora BioLabs Institutional Animal Care and Use Committee.
Preclinical
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CD19 (CD19 Molecule) • IL2 (Interleukin 2) • IL18 (Interleukin 18)
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CD19 expression
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NKX019
4years
[VIRTUAL] Preclinical evaluation of NKX019, a CD19-targeting CAR NK Cell (SITC 2020)
A first-in-human trial of NKX019 in B cell malignancies is planned for 2021. Ethics Approval The animal procedures described in this abstract were conducted in accordance with Explora BioLabs Animal Care and Use Protocol approved by Explora BioLabs Institutional Animal Care and Use Committee.
Preclinical
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CD19 (CD19 Molecule) • IL2 (Interleukin 2) • IL18 (Interleukin 18)
|
CD19 expression
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NKX019