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A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD

NCT05643638 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-05

No results posted yet for this study

Summary

This study is a prospective randomized placebo-controlled phase 2 study to compare CYP-001 plus corticosteroids (CS) to placebo plus CS in allogeneic hematologic stem cell transplant recipients with HR-aGvHD. Severity of GvHD will be assessed at screening and throughout the study using Mount Sinai Acute GvHD International Consortium (MAGIC) guidelines. Eligible subjects will be randomized to receive either CYP-001 IV infusion on Days 0 and 4 or placebo on the same days. All subjects will receive ongoing CS therapy as appropriate per institutional guidelines. Subjects will have study visits up to Day 100 during the Primary Evaluation Period. During the Follow-Up Period, subjects will have study visits up to 24 months.

Conditions

  • Graft Versus Host Disease, Acute

Interventions

BIOLOGICAL

CYP-001: Cymerus induced pluripotent stem cell (iPSC)-derived mesenchymal stem cells (MSCs)

Cymerus MSCs are derived from iPSCs using the proprietary Cymerus platform technology.

BIOLOGICAL

Placebo

The placebo product is identical to CYP-001, except that it contains no active agent

DRUG

Corticosteroids

All enrolled subjects in this trial must receive corticosteroids at a minimum dose of oral prednisone 2 mg/kg/day (or methylprednisolone 1.6 mg/kg/day IV) as therapy for aGvHD for at least for 72 hours post enrollment.

Sponsors & Collaborators

  • Cynata Therapeutics Limited

    lead INDUSTRY

Principal Investigators

  • Jolanta Airey, MD · Cynata Therapeutics Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2026-03-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Italy
  • Lithuania
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05643638 on ClinicalTrials.gov