An Open-Label Phase 1 Study to Investigate the Safety and Efficacy of CYP-001 for the Treatment of Adults With Steroid-Resistant Acute Graft Versus Host Disease

Trial Profile

An Open-Label Phase 1 Study to Investigate the Safety and Efficacy of CYP-001 for the Treatment of Adults With Steroid-Resistant Acute Graft Versus Host Disease

Recruiting
Phase of Trial: Phase I

Latest Information Update: 15 Nov 2017

At a glance

  • Drugs CYP 001 (Primary)
  • Indications Graft-versus-host disease
  • Focus Adverse reactions
  • Sponsors Cynata Therapeutics
  • Most Recent Events

    • 15 Nov 2017 According to a Cynata Therapeutics media release, enrollment of first cohort (A) has been completed. Eighth patient has been dosed, once this patient in Cohort A reaches Day 28, it will trigger a review by the independent Data Safety and Monitoring Board (DSMB).
    • 05 Jul 2017 According to a company media release, the FDA clarified that Cynata may submit a request for "Regenerative Medicine Advanced Therapy" (RMAT) designation for CYP-001 to treat GvHD once preliminary results from this clinical trial are available, assuming those results support such a request.
    • 02 Mar 2017 Planned primary completion date changed from 1 Oct 2017 to 1 Dec 2017.
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