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    DRUG:

    STK-009/SYNCAR-001

    i
    Other names: STK-009/SYNCAR-001, STK 009/SYNCAR 001, STK009/SYNCAR001
    Associations

    News

    Trials
    Company:
    Synthekine
    Drug class:
    CD19-targeted CAR-T immunotherapy, IL-2 stimulant
    Related drugs:
    Associations

    News

    Trials
    1m
    A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease (clinicaltrials.gov)
    P1, N=48, Active, not recruiting, Synthekine | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    STK-009/SYNCAR-001
    8ms
    STK-009-101: Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies (clinicaltrials.gov)
    P1, N=36, Active, not recruiting, Synthekine | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CD19 (CD19 Molecule)
    |
    cyclophosphamide • fludarabine IV • STK-009/SYNCAR-001
    11ms
    Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With Severe, Refractory Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1, N=42, Recruiting, Synthekine | Initiation date: Dec 2024 --> Mar 2025
    Trial initiation date
    |
    STK-009/SYNCAR-001
    1year
    Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects with Severe, Refractory Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1, N=42, Recruiting, Synthekine | Initiation date: Sep 2024 --> Dec 2024
    Trial initiation date • CAR T-Cell Therapy
    |
    STK-009/SYNCAR-001
    1year
    Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With Severe, Refractory Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1, N=42, Recruiting, Synthekine | Not yet recruiting --> Recruiting
    Enrollment open • CAR T-Cell Therapy
    |
    STK-009/SYNCAR-001
    over1year
    Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With Severe, Refractory Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1, N=42, Not yet recruiting, Synthekine
    New P1 trial • CAR T-Cell Therapy
    |
    STK-009/SYNCAR-001
    almost2years
    Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies (clinicaltrials.gov)
    P1, N=36, Recruiting, Synthekine | Trial primary completion date: Jun 2024 --> Jun 2026
    Trial primary completion date • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    cyclophosphamide • fludarabine IV • STK-009/SYNCAR-001
    almost2years
    Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies (clinicaltrials.gov)
    P1, N=36, Recruiting, Synthekine
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    cyclophosphamide • fludarabine IV • STK-009/SYNCAR-001
    2years
    Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies (clinicaltrials.gov)
    P1, N=36, Recruiting, Synthekine | Initiation date: Feb 2023 --> Jun 2022
    Trial initiation date • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    cyclophosphamide • fludarabine IV • STK-009/SYNCAR-001
    2years
    Engineered human IL-2/IL-2Rß orthogonal pairs selectively enhance anti-GPC3 CAR T cells in vivo to drive complete responses in solid epithelial tumor models (SITC 2023)
    Importantly, STK-009 induced the expression of cytotoxic machinery, pro-survival, and proliferative genes in tumor-infiltrating SYNCAR-002 (figure 3). Conclusions These findings validate that the orthogonal IL-2 platform has the potential to improve the efficacy and durability of CAR T therapy for solid tumor targets such as GPC3 by selectively expanding CAR-T cells in vivo and activating CAR-T cells in a hostile tumor microenvironment.
    Preclinical • CAR T-Cell Therapy • IO biomarker
    |
    CD19 (CD19 Molecule) • GPC3 (Glypican 3) • IL2 (Interleukin 2)
    |
    CD19 expression • GPC3 expression
    |
    STK-009/SYNCAR-001
    over2years
    A Phase 1 study to evaluate the safety and tolerability of a combination autologous CD19 CAR T cell therapy (SYNCAR-001) and orthogonal IL-2 (STK-009) in subjects with relapsed or refractory CD19 expressing hematologic malignancies (NCT05665062) (AACR 2023)
    Secondary endpoints include assessments of response, pharmacokinetics, and immunogenicity. Exploratory endpoints include assessment of immune cell populations, and relevant gene/protein expression, as well as persistence, phenotype, and functionality of SYNCAR-001 in the peripheral blood and/or bone marrow in response to STK-009.
    Clinical • P1 data • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule) • IL2 (Interleukin 2)
    |
    CD19 expression
    |
    STK-009/SYNCAR-001
    almost3years
    Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies (clinicaltrials.gov)
    P1, N=36, Recruiting, Synthekine
    New P1 trial • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    cyclophosphamide • fludarabine IV • STK-009/SYNCAR-001