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
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
- 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.