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Phase III registration trial of T-Guard for for the second-line treatment of steroid-resistant acute graft-versus-host-disease in patients following hematopoietic stem cell transplantation

Trial Profile

Phase III registration trial of T-Guard for for the second-line treatment of steroid-resistant acute graft-versus-host-disease in patients following hematopoietic stem cell transplantation

Planning
Phase of Trial: Phase III

Latest Information Update: 20 Dec 2018

At a glance

  • Drugs Anti-CD3-ricin chain A conjugate/anti-CD7-ricin chain A conjugate (Primary)
  • Indications Graft-versus-host disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Xenikos
  • Most Recent Events

    • 20 Dec 2018 According to a Xenikos media release, the company plans to file an Investigational New Drug application in 2019 for the conduct of this trial. The trial design is based on input received from the U.S. Food and Drug Administration at the End-of-Phase 2 meeting.
    • 16 Nov 2018 According to Xenikos media release, the trial is expected to support future regulatory filings for marketing approval.
    • 24 May 2018 New trial record
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