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A Multi-center Randomized, Double Blinded Phase IIb Trial Evaluating Oral Pooled Fecal Microbiotherapy MaaT033 to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)

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Trial Profile

A Multi-center Randomized, Double Blinded Phase IIb Trial Evaluating Oral Pooled Fecal Microbiotherapy MaaT033 to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 24 Jan 2025

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At a glance

  • Drugs MaaT 033 (Primary)
  • Indications Haematological malignancies; Transplant rejection
  • Focus Registrational; Therapeutic Use
  • Acronyms PHOEBUS
  • Sponsors MaaT Pharma

    • Most Recent Events

    • 21 Jan 2025 According to a MaaT Pharma media release, company is expecting the routine DSMB review for ongoing safety, conducted every six months, as well as a DSMB assessing mortality imbalance between arms, respectively at 60 patients (expected in Q1 2025) and at 120 patients (expected in Q3 2025), after 90 days of follow-up post Allo-HSCT.
    • 21 Jan 2025 According to a MaaT Pharma media release, Phase 2b trial is progressing well, with 80 patients enrolled as of end of December 2024.
    • 21 Jan 2025 According to a MaaT Pharma media release, the DSMB completed its second safety assessment of the Phase 2b trial PHOEBUS and recommended continuation of the trial without modification.The routine DSMB, which convenes every six months, is composed of 5 independent experts, reviewed safety data on 59 patients (cutoff date as of October 31st, 2024) and concluded that MaaT033 is well tolerated and has an acceptable safety profile.

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