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NCT05643638 · ClinicalTrials.gov registry record · Phase 2
A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD
A Phase 2 study of Graft Versus Host Disease, Acute, sponsored by Cynata Therapeutics Limited.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 20
- Study locations
NCT05643638: Recruiting Phase 2 study of Graft Versus Host Disease, Acute, sponsored by Cynata Therapeutics Limited.
NCT05643638 is a Phase 2 study of Graft Versus Host Disease, Acute that is actively recruiting participants, run by Cynata Therapeutics Limited. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05643638, a Phase 2 study of Graft Versus Host Disease, Acute, is actively recruiting participants, sponsored by Cynata Therapeutics Limited.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
ORR is defined as the proportion of subjects demonstrating a complete response (CR) or partial response (PR) without requirement for additional systemic therapies for an earlier progression, a mixed response or a nonresponse.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- DRUG Corticosteroids
- BIOLOGICAL CYP-001: Cymerus induced pluripotent stem cell (iPSC)-derived mesenchymal stem cells (MSCs)
Study Locations (20)
Other
- Hospital Claude Huriez - Lille
- Hôpital Necker Enfants Malades - Paris
- Hôpital Universitaire Pitié-Salpêtrière - Paris
- Azienda Ospedaliero Universitaria delle Marche - Ancona
Arizona
- Banner MD Anderson - Phoenix
- Mayo Clinic Hospital - Phoenix
Florida
- Mayo Clinic Hospital - Jacksonville
- Memorial healthcare System - Pembroke Pines
New South Wales
- Royal Prince Alfred Hospital - Sydney
- Westmead Hospital - Westmead
Arkansas
- University of Arkansas Medical Center - Little Rock
Georgia
- BMT Group of Georgia - Atlanta
Illinois
- Northwestern University - Evanston
Michigan
- Karmanos Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-03-04 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What NCT05643638 shows while recruiting
NCT05643638 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Graft Versus Host Disease, Acute appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05643638 names 20 study sites across 14 states, led by Other, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT05643638 about?
NCT05643638 is a clinical study titled "A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD". 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 A...
What is the current status of trial NCT05643638?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-03-04. Estimated completion is 2027-12.
What conditions does trial NCT05643638 study?
This clinical trial studies the following conditions: Graft Versus Host Disease, Acute.
What interventions are being tested in trial NCT05643638?
The interventions under investigation include: Placebo (BIOLOGICAL), Corticosteroids (DRUG), CYP-001: Cymerus induced pluripotent stem cell (iPSC)-derived mesenchymal stem cells (MSCs) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05643638?
This trial is sponsored by Cynata Therapeutics Limited, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05643638 being conducted?
This trial has 20 study locations across Arizona, Arkansas, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05643638's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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