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Corticosteroid

CYP-001 + 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

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.
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.
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
Select...
I have had a stem cell transplant from a donor.
Select...
My condition meets the high-risk criteria for acute GvHD as defined, including specific GI and skin involvement.
Select...
I have acute GvHD and need steroids for treatment.
Select...
My bone marrow transplant from a donor is successful.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
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

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
~18 spots leftby Apr 2025
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