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NCT05643638RECRUITINGIRB Ready

A Study of CYP-001 in Combination with Corticosteroids in Adults with High-risk AGvHD

Sponsored by Cynata Therapeutics Limited

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 60 participants interested
2% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

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

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

60 participants

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Gender

ALL

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Sponsor

Cynata Therapeutics Limited

Study Locations

Choose your preferred location or select flexible during enrollment

COMPLETED

Phoenix

Arizona

Location available
View Phoenix location page
RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
RECRUITING

Little Rock

Arkansas

Location available
View Little Rock location page
RECRUITING

Jacksonville

Florida

Location available
View Jacksonville location page
RECRUITING

Pembroke Pines

Florida

Location available
View Pembroke Pines location page
RECRUITING

Atlanta

Georgia

Location available
View Atlanta location page
RECRUITING

Evanston

Illinois

Location available
View Evanston location page
RECRUITING

Detroit

Michigan

Location available
View Detroit location page
RECRUITING

Omaha

Nebraska

Location available
View Omaha location page

๐Ÿ“ And 4 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Graft versus Host Disease Treatment in Phoenix?

Join others in Arizona exploring innovative treatment options through clinical research

Graft versus Host Disease Treatment Options in Phoenix, Arizona

If you're searching for Graft versus Host Disease treatment in Phoenix, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Phoenix, Phoenix, Little Rock and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Graft versus Host Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 60 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Graft versus Host Disease?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Graft versus Host Disease

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Graft versus Host Disease Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05643638. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.