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A Phase 1 Dose-ranging Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MRG-106 Following Local Intratumoral, Subcutaneous, and Intravenous Administration in Subjects With Various Lymphomas and Leukemias

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Trial Profile

A Phase 1 Dose-ranging Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MRG-106 Following Local Intratumoral, Subcutaneous, and Intravenous Administration in Subjects With Various Lymphomas and Leukemias

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Feb 2022

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At a glance

  • Drugs Cobomarsen (Primary) ; Cobomarsen (Primary) ; Cobomarsen (Primary) ; Cobomarsen (Primary)
  • Indications Adult T-cell leukaemia-lymphoma; Chronic lymphocytic leukaemia; Cutaneous T-cell lymphoma; Diffuse large B cell lymphoma; Mycosis fungoides
  • Focus Adverse reactions; First in man
  • Sponsors miRagen Therapeutics; Viridian Therapeutics

    • Most Recent Events

    • 19 Nov 2020 Status changed from active, no longer recruiting to completed.
    • 05 Aug 2020 According to a miRagen Therapeutics media release, the company plans to meet with the FDA and receive guidance on the Company's proposed clinical path in this indication before the end of 2020.
    • 07 May 2020 According to a miRagen Therapeutics media release, the Company would expect to meet with the FDA in the third quarter of 2020. However, as the FDA prioritizes its efforts on COVID-19, it is uncertain if the meeting will occur on the standard FDA timeline. The Company therefore cannot provide assurances that the meeting will occur as originally expected in the third quarter of 2020.
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