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MaaT013 As Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients

NCT04769895 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-10-17

No results posted yet for this study

Summary

MaaT013 showed interesting results in steroids and ruxolitinib-resistant aGVHD patients with gut involvement (55% ORR at D28) and 47% and 39% OS at 6 and 12 months respectively (Malard 2020), therefore warrant being tested as salvage therapy in steroid and JAK inhibitors-resistant GI-aGvHD patients. Given the absence of an approved 3rd line strategy or 2nd line strategy in ruxolitinib intolerant patients and the extremely poor prognosis of these patients, who are mostly left with no viable therapeutic option, a single-arm open-label design was proposed.

Conditions

  • Acute Graft Versus Host Disease in Intestine
  • Steroid Refractory GVHD

Interventions

DRUG

MaaT013

MaaT013 is made of allogeneic, full-ecosystem pooled biotherapeutic intestinal microbiota

Sponsors & Collaborators

  • MaaT Pharma

    lead INDUSTRY

Principal Investigators

  • Florent Malard, MD, PhD · APHP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-25
Primary Completion
2024-11-30
Completion
2025-11-30

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Spain

Study Locations

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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 NCT04769895 on ClinicalTrials.gov