Last updated on October 2017

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
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Matthew Henderson

Royal Adelaide Hospital
Adelaide, Australia
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Matthew Henderson

NHS Foundation Trust
Bristol, United Kingdom
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Matthew Henderson

NHS Trust
Leeds, United Kingdom
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Matthew Henderson

NHS Foundation Trust
Liverpool, United Kingdom
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Matthew Henderson

NHS Foundation Trust
Manchester, United Kingdom
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Matthew Henderson

NHS Foundation Trust
Nottingham, United Kingdom
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