Clinically diagnosed with acute GvHD requiring systemic therapy with corticosteroids.
HR-aGvHD must meet one of the following clinical features within 72 hours prior to randomization: (a) high-risk as per Refined Minnesota Criteria; OR (b) One of the following: (i) isolated stage 2 involvement of the lower GI tract; (ii) Stage 1 lower GI tract disease with skin involvement
Evidence of myeloid engraftment post allogeneic HSCT
Life expectancy of at least one month
You may not be if
Received any systemic treatment for aGvHD other than corticosteroids +/- calcineurin inhibitors
Chronic GvHD or overlap syndrome with both acute and chronic features of GvHD
Relapsed primary malignancy since
received more than one allogeneic HSCT
Clinically significant respiratory, renal or cardiac disease
Cholestatic disorders or sinusoidal obstructive syndrome/veno-occlusive disease of the liver
Any active uncontrolled infection requiring treatment and likely to impact on the ability of the subject to participate in the trial.
Known infection with CMV, EBV, HHV-6, HBV, HCV, HIV or Tuberculosis. If the treatment for CMV, EBV, HHV-6, HBV, HCV has commenced the subject is eligible.
Known sensitivity to dimethylsulfoxide (DMSO) or any other component of CYP-001.
Received any investigational treatment agent within 30 days or within 5 half-lives of Screening, whichever is greater.
