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

Clinical Trial Details

This clinical trial is for men and women with newly diagnosed with acute Graft vs Host Disease (GvHD).

The purpose of this study is to evaluate if CYP-001 can be effective to treat GvHD that has not responded to steroids.

The study drug used in this study (CYP-001) is experimental. This means that it is not an approved treatment for high-risk acute GvHD by the U.S. Food and Drug Administration (FDA) or anywhere in the world.

Participants will be randomized to receive either CYP-001 IV infusion or placebo. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

Participation is expected to last about 24 months.

Key Eligibility:

Open to men and women above the age of 18 who have been diagnosed with Acute Graft Versus Host Disease.
Participants must not have received more than one allogeneic Hematopoietic Stem Cell Transplant (HSCT).

Detailed eligibility will be reviewed when you contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Jerome Castaneda
212-746-1362
jec4027@med.cornell.edu

Primary Investigator(s)

Tsiporah B Shore, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2305026049

ClinicalTrials.gov:

NCT05643638

Status

Open to Enrollment

Age Group

Adult

Disease

Graft Versus Host Disease