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A phase 1 trial of an intravenously (IV) administered allogenic CAR-T for metastatic and progressive locally advanced solid malignancies

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Trial Profile

A phase 1 trial of an intravenously (IV) administered allogenic CAR-T for metastatic and progressive locally advanced solid malignancies

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 16 Mar 2021

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At a glance

  • Drugs Programmed cell death protein 1 gamma-delta chimeric antigen receptor T cell therapy-Kiromic (Primary)
  • Indications Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Kiromic

    • Most Recent Events

    • 09 Mar 2021 According to a Kiromic Biopharma media release, expected timeline for planned two IND resubmissions is 2Q-2021, expected review and return by the FDA post IND submissions is 30 days, expected timeline of first-in-human dosing is 3Q-2021, expected timeline of first-in-human safety and efficacy data from the trial is 4Q-2021.
    • 09 Mar 2021 According to a Kiromic Biopharma media release, the company announced today the planned resubmission of two investigational new drug (IND) applications with the U.S. Food and Drug Administration (FDA).The revised INDs have protocols which retain approximately 80% of the original INDs.
    • 24 Dec 2020 New trial record

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