A Study of CYP-001 for the Treatment of Steroid-Resistant Acute Graft Versus Host Disease

General Information

Summary The purpose of this study is to assess the safety, tolerability and efficacy of two infusions of CYP-001 in adults with steroid-resistant GvHD.
Description This is a multi-centre, open label, dose escalation study to assess the safety, tolerability and efficacy of two infusions of CYP-001, in adults who have steroid-resistant GvHD. Participants will receive standard of care treatment throughout the study, according to local procedures. The first eight participants will be enrolled in Cohort A and receive a CYP-001 dose of 1 million cells per kg, up to a maximum dose of 100 million cells, on Day 0 and Day 7. Subject to a safety review of data from Cohort A, an additional eight participants will be enrolled into Cohort B and receive a CYP-001 dose of 2 million cells/kg, up to a maximum dose of 200 million cells, on Day 0 and Day 7. The primary evaluation period concludes for each participant 100 days after the first dose of CYP-001. Participants will have study visits on Days 0, 3, 7, 14, 21, 28, 60 and 100. Subsequently, participants will enter a long term follow-up period, which concludes 2 years after the first dose of CYP-001.
Clinical trials phase Phase 1
Start date (estimated) 2017-03-01
End date (estimated) 2020-05-31
Clinical feature
Label Graft Versus Host Disease
Link http://purl.obolibrary.org/obo/NCIT_C3063
Description A reaction, which may be fatal, in an immunocompromised subject (host) who has received an antigenically incompatible tissue transplant (graft) from an immunocompetent donor. The reaction is secondary to the activation of the transplanted cells against those host tissues that express an antigen not expressed by the donor, and is seen most commonly following bone marrow transplantation; acute disease is seen after 5-40 days, and chronic disease occurs weeks to months after transplantation.

Administrative Information

NCT Number NCT02923375
EudraCT Number 2016-000070-38
Other study identifiers
Name CYP-GvHD-P1-01
Source weblink https://clinicaltrials.gov/ct2/show/NCT02923375
Regulatory body approval
Country
Public contact
Email info@cynata.com
First name Kilian
Last name Kelly
Country
Australia
Sponsors Cynata Therapeutics Limited

Cell Line

Recruitment

Recruitment Status Active, not recruiting
Estimated number of participants 16