Actively Recruiting
A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD
Led by Cynata Therapeutics Limited · Updated on 2025-12-05
60
Participants Needed
39
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergone allogeneic hematopoietic stem cell transplant (HSCT)
- Clinically diagnosed with acute GvHD requiring systemic therapy with corticosteroids
- High-risk acute GvHD meeting Refined Minnesota Criteria or specific lower GI tract involvement within 72 hours prior to randomization
- Evidence of myeloid engraftment after allogeneic HSCT
- Life expectancy of at least one month
You will not qualify if you...
- Received systemic treatment for aGvHD other than corticosteroids or calcineurin inhibitors
- Presence of chronic GvHD or overlap syndrome with acute and chronic features
- Relapsed primary malignancy
- 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
- Active uncontrolled infection requiring treatment that affects trial participation
- Known infection with CMV, EBV, HHV-6, HBV, HCV, HIV, or Tuberculosis unless treatment has started for CMV, EBV, HHV-6, HBV, or HCV
- Known sensitivity to dimethylsulfoxide (DMSO) or any component of CYP-001
- Received investigational treatment within 30 days or within 5 half-lives of screening, whichever is greater
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
Banner MD Anderson
Phoenix, Arizona, United States, 85012
Completed
2
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85288
Actively Recruiting
3
University of Arkansas Medical Center
Little Rock, Arkansas, United States, 72205
Actively Recruiting
4
Mayo Clinic Hospital
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
Memorial healthcare System
Pembroke Pines, Florida, United States, 33026
Actively Recruiting
6
BMT Group of Georgia
Atlanta, Georgia, United States, 30342
Actively Recruiting
7
Northwestern University
Evanston, Illinois, United States, 60208
Actively Recruiting
8
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
9
University Of Nebrasaka Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
10
Weill Cornell Medicine - New York Presbyterian Hospital
New York, New York, United States, 10065
Completed
11
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
12
Penn State Health
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
13
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
14
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Completed
15
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Completed
16
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Active, Not Recruiting
17
Hospital Claude Huriez
Lille, France
Actively Recruiting
18
Hôpital Necker Enfants Malades
Paris, France
Actively Recruiting
19
Hôpital Universitaire Pitié-Salpêtrière
Paris, France
Actively Recruiting
20
Azienda Ospedaliero Universitaria delle Marche
Ancona, Italy
Actively Recruiting
21
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Actively Recruiting
22
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Actively Recruiting
23
Istituto Clinico Humanitas
Rozzano, Italy
Actively Recruiting
24
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
Actively Recruiting
25
Ospedale dell'Angelo di Mestre
Venezia, Italy
Actively Recruiting
26
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Actively Recruiting
27
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain
Actively Recruiting
28
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Actively Recruiting
29
Hospital Universitario Ramon y Cajal
Madrid, Spain
Actively Recruiting
30
Hospital Universitato De La Princesa
Madrid, Spain
Completed
31
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
Actively Recruiting
32
Clínica Universidad de Navarra
Pamplona, Spain
Actively Recruiting
33
Anadolu Medical Center
Eskişehir, Turkey (Türkiye)
Actively Recruiting
34
Gayrettepe Florence Nightingale Hastanesi
Istanbul, Turkey (Türkiye), 34318
Completed
35
Koc University
Istanbul, Turkey (Türkiye)
Actively Recruiting
36
Memorial Bahcelievler Hospital
Istanbul, Turkey (Türkiye)
Completed
37
Izmir Medicalpark Hospital
Izmir, Turkey (Türkiye)
Actively Recruiting
38
İnonu University
Malatya, Turkey (Türkiye)
Actively Recruiting
39
Dr Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Yenimahalle, Turkey (Türkiye)
Actively Recruiting
Research Team
C
Cynata Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here