A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD

General Information

Summary A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of CYP-001 in Combination With Corticosteroids (CS) vs CS Alone for the Treatment of High-Risk Acute Graft Versus Host Disease
Clinical trials phase Phase 2
Start date (estimated) 2023-08-31
End date (estimated) 2026-12-31
Clinical feature
Label Graft versus host disease
Link http://www.orpha.net/ORDO/Orphanet_39812
Description A rare disease that occurs after allogeneic hematopoietic stem cell transplant and is a reaction of donor immune cells against host tissues. Activated donor T cells damage host epithelial cells after an inflammatory cascade that begins with the preparative regimen.

Administrative Information

NCT number NCT05643638
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05643638
Other study identifiers
Name CYP-GvHD-P2-01
Source weblink https://clinicaltrials.gov/ct2/show/NCT05643638
Public contact
Email clinical@cynata.com
Public email clinical@cynata.com
First name Cynata Therapeutics Limited
Last name Cynata Therapeutics Limited
Phone +61 3 7067 6940
Sponsors Cynata Therapeutics Limited


Which differentiated cell type is used
Label Mesenchymal Stem Cell
Link http://purl.obolibrary.org/obo/NCIT_C43423
Description An undifferentiated stromal cell with the ability to develop into the cells that form distinct mesenchymal tissues; such as bone, muscle, connective tissue, blood vessels, and lymphatic tissue.


Recruitment Status Recruiting
Estimated number of participants 60