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    Home > Active Ingredient News > Blood System > Universal CAR-NK for relapsed/refractory acute myeloid leukemia (AML), 3/5 cases achieved CR

    Universal CAR-NK for relapsed/refractory acute myeloid leukemia (AML), 3/5 cases achieved CR

    • Last Update: 2022-05-25
    • Source: Internet
    • Author: User
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    On April 25, U.
    S.
    time, Nkarta Therapeutic (later known as Nkarta) announced the latest clinical data on the company’s two CAR-NK pipelines, NKX101 (targeting NKG2D) and NKX019 (targeting CD19), in the treatment of hematological tumors

    .

    On April 25, U.
    S.
    time, Nkarta Therapeutic (later known as Nkarta) announced the latest clinical data on the company’s two CAR-NK pipelines, NKX101 (targeting NKG2D) and NKX019 (targeting CD19), in the treatment of hematological tumors

    .

    NKX101 is Nkarta's first pipeline, a virus-transfected engineered allogeneic CAR-NK cell product targeting NKG2D ligands to prepare NK cells from the peripheral blood of healthy donors.
    It is a "universal" CAR-NK cell.
    therapy

    .
    Since NKG2D ligands are selectively overexpressed in various cancer cells (among which, 80%-100% of AML samples were found to express NKG2D ligands), NKX101 can be used to treat a variety of hematological malignancies and solid tumors

    .

    In this clinical trial evaluating NKX101 in the treatment of relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), all subjects (21 patients) had experienced multiple prior treatments and Among the patients with multiple relapses and poor prognosis, 20 had been treated with the BCL-2-targeted drug Venetoclax, and 4 had been treated with allogeneic hematopoietic stem cell transplantation
    .
    A total of 5 dose levels were tested in the Phase I clinical trial of NKX101: 1.
    5x10
    8 , 3x10 8 , 4.
    5x10
    8 , 10x10 8 , and 15x10 8 , respectively, as 2 infusions (days 0 and 7) or two infusions over a week 3 infusions during the week (days 0, 7, and 14)
    .

    Leukemia Stem Cells 8 8 8 8 8

    From the published data, NKX101 treatment was well tolerated, and no CAR-T -like toxicities, such as cytokine release syndrome (CRS) and neurotoxicity, were observed at any dose; neither graft-versus-host was observed GvHD and NKG2D CAR-NK-related AEs; more serious adverse events were observed, including myelosuppression, infection , etc.
    , which were related to chemotherapy lymphadenopathy and the disease itself; at the highest dose (15x10
    8  CAR-NK cells) , 3 infusions), no dose-limiting toxicity was observed in the study
    .

    CAR -T infection8

    The most intriguing clinical data is that high-dose ( 10x108 or 15x108 CAR  -NK cells, 3 infusions) showed a good response in AML, with 3 CRs in 5 subjects, of which 2 had minimal MRD.
    Residual lesions were negative

    .
    A case study showed that after 3 infusions of 10x10 8  CAR-NK cells, NKX101 was detectable after each dose for approximately 20 days
    .

    The most intriguing clinical data is that high-dose ( 10x108 or 15x108 CAR  -NK cells, 3 infusions) showed a good response in AML, with 3 CRs in 5 subjects, of which 2 had minimal MRD.
    Residual lesions were negative

    .
    8 8 8

    The data released by Nkarta demonstrated the good tolerability, safety and high activity of NKG2D CAR-NK in the treatment of AML
    .
    Previously, Nkarta has reported preclinical research results of local infusion of NKX101 in the treatment of liver cancer and metastatic bowel cancer, and its potential in the treatment of solid tumors is also worth looking forward to

    .

    In fact, as early as 2018, Celyad developed CYAD-01/02 (a CAR-T cell therapy targeting NKG2D ligands), and reported that some patients with r/r AML receiving NKG2D CAR-T therapy had obtained Complete relief
    .
    At the 62nd ASH Annual Meeting in December 2020, Celyad presented clinical data on CYAD-02 for the treatment of AML in 9 patients treated with CYAD-02 (up from 100 million to 300 million at a maximum dose of 10 100 million, 3 infusions every 2 weeks, 3 patients in each dose group, pretreated with CYFLU chemotherapy), 7 were clinically evaluated, 4 showed anti-AML/MDS effect (4/7= 57%), including one mCR and three SD

    .
    However, one case of grade 4 CRS occurred in the lowest dose group, and one case of grade 3 CRS occurred in the highest dose group, and the severe CRS response rate was higher (2/9=22.
    22%)

    .
    However, Nkarta's NKX101 not only has outstanding therapy, but also has better safety, which is worthy of encouragement

    .



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