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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 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. The trial reports 20 study locations across 14 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05643638
The ClinicalTrials.gov registry entry for NCT05643638 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cynata Therapeutics Limited, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
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