Last updated on June 2018

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


Brief description of study

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.

Detailed Study 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 Study Identifier: NCT02923375

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Matthew Henderson

Sydney Local Health District
Sydney, Australia

Matthew Henderson

Royal Adelaide Hospital
Adelaide, Australia

Matthew Henderson

NHS Foundation Trust
Bristol, United Kingdom

Matthew Henderson

NHS Trust
Leeds, United Kingdom

Matthew Henderson

NHS Foundation Trust
Liverpool, United Kingdom

Matthew Henderson

NHS Foundation Trust
Manchester, United Kingdom

Matthew Henderson

NHS Foundation Trust
Nottingham, United Kingdom