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A Phase 1/2a Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CDK-003 in Healthy Adult Participants and Intralesionally Administered CDK-003 in Patients With Cutaneous T-cell Lymphoma (CTCL)

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Trial Profile

A Phase 1/2a Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CDK-003 in Healthy Adult Participants and Intralesionally Administered CDK-003 in Patients With Cutaneous T-cell Lymphoma (CTCL)

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 05 Sep 2022

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At a glance

  • Drugs ExoIL 12 (Primary)
  • Indications Cutaneous T-cell lymphoma; Kaposi's sarcoma; Merkel cell carcinoma; Squamous cell cancer
  • Focus Adverse reactions
  • Sponsors Codiak BioSciences

    • Most Recent Events

    • 30 Aug 2022 Status changed from recruiting to discontinued.
    • 30 Jun 2022 According to an Codiak BioSciences media release, data from trial validates 6 mcg as the intended dose for Phase 2 development. The intends to conclude the current study in the UK and transition to a U.S. IND application. The company anticipates initiating a Phase 2 trial during the first quarter of 2023 in patients with cutaneous malignancies responsive to rIL-12 in studies historically, including CTCL, Kaposi's sarcoma, Merkel cell carcinoma, and squamous cell carcinoma.
    • 30 Jun 2022 Results published in the Codiak BioSciences media release Media Release.
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