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    Association details:
    Biomarker:HER-2 overexpression
    Cancer:Solid Tumor
    Drug:CT-0508 (HER2 inhibitor, Macrophage stimulant)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    CARISMA Press Release
    Title:

    CARISMA Therapeutics Announces U.S. Food and Drug Administration Grants Fast Track Designation to CT-0508 for the Treatment of Patients with Solid Tumors

    Published date:
    09/22/2021
    Excerpt:
    CARISMA Therapeutics Inc...announced today that that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M) for the treatment of patients with solid tumors....It is currently being evaluated in a first-in-human Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers do not have any approved HER2-targeted therapies or who do not respond to treatment.
    Trial ID:
    NCT04660929
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

    Excerpt:
    ...Assess the safety and tolerability of CT-0508 by estimating the frequency and severity of adverse events in subjects with HER2 overexpressing solid tumors.`...
    Trial ID:
    NCT04660929