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A Multicentre, Randomized, Double-Blinded, Phase 2b Study Evaluating the Efficacy and Safety of MaaT033, an Oral, Pooled Microbiome Ecosystem Therapy in Patients Undergoing Allogenic Hematop... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6408; P2b Exclusion criteria comprise non-myeloablative conditioning regimen, conventional myeloablative conditioning regimen, in-vitro T-cell depletion, alloHCT with cord blood cells, alloHCT from an unrelated donor with = 3/10 HLA-mismatches, use of alemtuzumab, vedolizumab or abatacept for GvHD prophylaxis, history of chronic digestive disease...Exploratory endpoints will describe the impact of MaaT013 on immune recovery, the nutritional status of the patients, and resource utilization...The study is approved in France and Germany; expansion to other countries is planned for 2024. Study start is expected in September 2023.
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Enrollment open, Trial completion date, Trial primary completion date: ARES: MaaT013 as Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients (clinicaltrials.gov) - Jun 24, 2022 P3, N=75, Recruiting, A Phase 3 trial is currently ongoing to confirm these results in ruxolitinib-refractory patients (NCT04769895). Not yet recruiting --> Recruiting | Trial completion date: Mar 2024 --> Sep 2024 | Trial primary completion date: May 2023 --> Sep 2023
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Enrollment closed, Trial completion date, Trial primary completion date: HERACLES: Treatment of Steroid Refractory Gastro-intestinal Acute GVHD afteR AllogeneiC HSCT With fEcal Microbiota tranSfer (clinicaltrials.gov) - May 21, 2020 P2, N=32, Active, not recruiting, The overall response rate was 82% with the off-the-shelf MaaT013 product, shown to be safe and effective in these immunocompromised patients with severe conditions, warranting further exploration of the full ecosystem microbiota restoration approach. Recruiting --> Active, not recruiting | Trial completion date: Sep 2020 --> Dec 2020 | Trial primary completion date: Sep 2019 --> Jan 2020
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