Active — Not RecruitingPhase 2

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

United States, Australia, France60 participantsStarted 2024-03-04

Plain-language summary

This study is a prospective randomized placebo-controlled phase 2 study to compare CYP-001 plus corticosteroids (CS) to placebo plus CS in allogeneic hematologic stem cell transplant recipients with HR-aGvHD. Severity of GvHD will be assessed at screening and throughout the study using Mount Sinai Acute GvHD International Consortium (MAGIC) guidelines. Eligible subjects will be randomized to receive either CYP-001 IV infusion on Days 0 and 4 or placebo on the same days. All subjects will receive ongoing CS therapy as appropriate per institutional guidelines. Subjects will have study visits up to Day 100 during the Primary Evaluation Period. During the Follow-Up Period, subjects will have study visits up to 24 months.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Undergone allogeneic hematopoietic stem cell transplant (HSCT) * 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 Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall response rate (ORR)

Timeframe: 28 days

Trial details

NCT IDNCT05643638

SponsorCynata Therapeutics Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-17

View on ClinicalTrials.gov More Graft Versus Host Disease, Acute trials