A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of CYP-001 in Combination with Corticosteroids vs Corticosteroids Alone for the Treatment of High-Risk Acute Graft Versus Host Disease
Categories (click each to see list of all clinical trials associated with that category): BMT/GVHD (ONC), Cellular Therapy Support Service - Other CAR (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Bhatt, Vijaya
Eligibility: https://clinicaltrials.gov/study/NCT05643638?term=NCT05643638&rank=1
Summary
The primary objective of this study is to assess efficacy of CYP-001 in subjects with HR-aGvHD by Overall Response Rate (ORR) at Day 28
The secondary objectives of the study are:
1. To assess additional responses and long-term efficacy outcomes
2. To assess Overall Survival (OS)
3. To assess Event-Free survival (EFS)
4. To assess Non-Relapse Mortality (NRM)
5. To assess Failure Free Survival
6. To assess the incidence of Malignancy Relapse/Progression (MR)
7. To measure the incidence of chronic GvHD
8. To assess the cumulative steroid dose until Day 100
9. To evaluate changes in Subject Reported Outcomes
10. To evaluate the safety and tolerability of CYP-001 in subjects with SR-aGvHD