A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD
Public ClinicalTrials.gov record NCT05643638. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05643638
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 65 participants
Conditions and interventions
Conditions
Interventions
- CYP-001: Cymerus induced pluripotent stem cell (iPSC)-derived mesenchymal stem cells (MSCs) Biological
- Placebo Biological
- Corticosteroids Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 4, 2024 (Actual)
- Primary completion
- Mar 17, 2026 (Actual)
- Completion
- Jun 17, 2026 (Actual)
- Last update posted
- Oct 22, 2026
2024 – 2026
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson | Phoenix | Arizona | 85012 | — |
| Mayo Clinic Hospital | Phoenix | Arizona | 85288 | — |
| University of Arkansas Medical Center | Little Rock | Arkansas | 72205 | — |
| Mayo Clinic Hospital | Jacksonville | Florida | 32224 | — |
| Memorial healthcare System | Pembroke Pines | Florida | 33026 | — |
| BMT Group of Georgia | Atlanta | Georgia | 30342 | — |
| Northwestern University | Evanston | Illinois | 60208 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| University Of Nebrasaka Medical Center | Omaha | Nebraska | 68198 | — |
| Weill Cornell Medicine - New York Presbyterian Hospital | New York | New York | 10065 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Penn State Health | Hershey | Pennsylvania | 17033 | — |
| University of Utah | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05643638, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 22, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05643638 live on ClinicalTrials.gov.