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

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.

Timeline

Start

2017-03-01

Primary completion

2018-08-28

Completion

2020-06-30

Outcome

Met primary endpoint

release “CYP-001, its lead Cymerus™ mesenchymal stem cell (MSC) product candidate, met all clinical endpoints in a Phase 1 trial” cynata.com ↗

release “CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease” cynata.com ↗

Publications

• Kelly K, Bloor AJC, Griffin JE, Radia R, Yeung DT, Rasko JEJ. Two-year safety outcomes of iPS cell-derived mesenchymal stromal cells in acute steroid-resistant graft-versus-host disease. Nat Med. 2024 Jun;30(6):1556-1558. doi: 10.1038/s41591-024-02990-z. Epub 2024 May 22.
• Bloor AJC, Patel A, Griffin JE, Gilleece MH, Radia R, Yeung DT, Drier D, Larson LS, Uenishi GI, Hei D, Kelly K, Slukvin I, Rasko JEJ. Production, safety and efficacy of iPSC-derived mesenchymal stromal cells in acute steroid-resistant graft versus host disease: a phase I, multicenter, open-label, dose-escalation study. Nat Med. 2020 Nov;26(11):1720-1725. doi: 10.1038/s41591-020-1050-x. Epub 2020 Sep 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mesenchymoangioblast-derived mesenchymal stem cells	Unknown	1e+06 cells/kg	Intravenous
Subject	Mesenchymoangioblast-derived mesenchymal stem cells	Unknown	2e+06 cells/kg	Intravenous

Indications