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

Phase 2

Recruiting

• Conditions: Graft Versus Host Disease, Acute

• Registration Number: NCT05643638
• Lead Sponsor: Cynata Therapeutics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-29
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion Criteria:<br><br> - Undergone allogeneic hematopoietic stem cell transplant (HSCT)<br><br> - Clinically diagnosed with acute GvHD requiring systemic therapy with<br> corticosteroids.<br><br> - HR-aGvHD must meet one of the following clinical features within 72 hours prior to<br> randomization: (a) high-risk as per Refined Minnesota Criteria; OR (b) One of the<br> following: (i) isolated stage 2 involvement of the lower GI tract; (ii) Stage 1<br> lower GI tract disease with skin involvement<br><br> - Evidence of myeloid engraftment post allogeneic HSCT<br><br> - Life expectancy of at least one month<br><br>Exclusion Criteria:<br><br> - Received any systemic treatment for aGvHD other than corticosteroids +/- calcineurin<br> inhibitors<br><br> - Chronic GvHD or overlap syndrome with both acute and chronic features of GvHD<br><br> - Relapsed primary malignancy since<br><br> - received more than one allogeneic HSCT<br><br> - Clinically significant respiratory, renal or cardiac disease<br><br> - Cholestatic disorders or sinusoidal obstructive syndrome/veno-occlusive disease of<br> the liver<br><br> - Any active uncontrolled infection requiring treatment and likely to impact on the<br> ability of the subject to participate in the trial.<br><br> - Known infection with CMV, EBV, HHV-6, HBV, HCV, HIV or Tuberculosis. If the<br> treatment for CMV, EBV, HHV-6, HBV, HCV has commenced the subject is eligible.<br><br> - Known sensitivity to dimethylsulfoxide (DMSO) or any other component of CYP-001.<br><br> - Received any investigational treatment agent within 30 days or within 5 half-lives<br> of Screening, whichever is greater.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)

Secondary Outcome Measures

Name	Time	Method
Durable Overall response rate (ORR);Overall response rate (ORR);Complete response rate (CRR);Overall survival;Event-free survival;Time to non-relapse mortality;Failure-free survival;Time to malignancy relapse/progression;Incidence of chronic GvHD;Weekly cumulative steroid dose;Patient reported outcomes: Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) instrument;Patient reported outcomes: EuroQol 5-Dimension (EQ-5D) health-related quality of life instrument;Incidence, severity, duration of treatment-emergent adverse events