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Corticosteroid

CYP-001 plus corticosteroids for Graft-versus-Host Disease

Phase 2

Recruiting

Research Sponsored by Cynata Therapeutics Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergone allogeneic hematopoietic stem cell transplant (HSCT)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial studies how well a therapy, CYP-001, plus corticosteroids can help treat graft-versus-host disease (GvHD) after stem cell transplant. Subjects will receive either the therapy or a placebo, and GvHD severity will be assessed.

Who is the study for?

This trial is for adults who've had a stem cell transplant and are now facing high-risk acute Graft-versus-Host Disease (aGvHD). They should expect to live at least another month, have specific types of lower GI tract involvement or skin issues, need corticosteroids for their aGvHD, and show signs that the new stem cells are working in their bone marrow.Check my eligibility

What is being tested?

The study tests CYP-001, which comes from special lab-grown stem cells. It's given with standard corticosteroid treatment to see if it's better than just getting a placebo with corticosteroids. Patients will be randomly chosen to get either CYP-001 or the placebo on two separate days and followed up for up to two years.See study design

What are the potential side effects?

While not specified here, treatments like CYP-001 could cause reactions where they're infused into the body, affect immune system function leading to increased infection risk or other immune-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a stem cell transplant from a donor.

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My condition meets the high-risk criteria for acute GvHD as defined, including specific GI and skin involvement.

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I have acute GvHD and need steroids for treatment.

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My bone marrow transplant from a donor is successful.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Complete response rate (CRR)

Durable Overall response rate (ORR)

Event-free survival

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CYP-001 plus corticosteroidsExperimental Treatment2 Interventions

Group II: Placebo plus corticosteroidsPlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Corticosteroids

2003

Completed Phase 4

~8270

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cynata Therapeutics LimitedLead Sponsor

3 Previous Clinical Trials

60 Total Patients Enrolled

Jolanta Airey, MDStudy DirectorCynata Therapeutics Limited

2 Previous Clinical Trials

44 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many study participants are being monitored in this research project?

"Affirmative. Clinicaltrials.gov data attests to the fact that this clinical trial was initially posted on December 31st 2023 and is currently seeking applicants. The study needs 60 participants from 4 different medical hubs."

Answered by AI

Is the enrollment period for this study still ongoing?

"Corroborating information found on clinicaltrials.gov confirms that this research is presently recruiting participants. The first post was made on December 31st, 2023 and the data were updated lastly on December 11th of the same year."

Answered by AI

Is this research being administered in multiple healthcare centers within the state?

"At the present moment, 4 sites are actively recruiting for this medical trial. These centres can be found in New york, Herston and Westmead as well as other cities with more locations to come. To reduce logistical demands, it is suggested that you choose a site closest to your residence if you decide to join in on the study."

Answered by AI

Has the FDA sanctioned the pairing of CYP-001 and corticosteroids?

"Our team at Power gauged the safety of CYP-001 plus corticosteroids to be a 2 due to it being in Phase 2, meaning that while there is some evidence for its security, there are no studies attesting to its effectiveness yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD

2024. "A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05643638.

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