A Phase 1 interventional study of MaaT033 capsule in Hematologic Diseases and Chemotherapy Effect, sponsored by MaaT Pharma. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-12.
Sponsored by MaaT Pharma · Phase 1, Interventional, and Supportive care
Richness and diversity of gut microbiota are increasingly found to be associated with cancer outcomes. Moreover, an adequately responsive immune system seems to rely on the existence of a functioning gut ecosystem that includes the microbiota and its natural environment.
Cancer by itself, but also cancer treatments - in particular chemotherapy - induce gut dysbiosis, impair the constant reparation mechanisms of the gut epithelium, disrupt immune homeostasis, and stunt immune responsiveness.
The objective of MaaT033 is to (1) prevent the decay of the gut ecosystem (dysbiosis) to preserve immune homeostasis, (2) restore and optimize the gut ecosystem to full functionality including its role in repairing the gut epithelium and healthy gut barrier, and (3) maintain a restored gut ecosystem and fully functional immune homeostasis.
Restoring the full gut ecosystem and its associated microbiota could become an important therapeutic option to improve clinical outcomes and control adverse events of conventional approaches, including immunotherapy in cancer patients.
As a first step, MaaT033 capsules containing lyophilized, pooled, full-ecosystem microbiota in its natural environment are to be tested for their safety and tolerability in hematological malignant patients, who are exposed to intensive rounds of chemotherapy and antibiotics.
460 studies on the registry are indexed under Hematologic Diseases; 105 are open to participants now.
This study's enrollment of 21 is below the median of 50 across 274 interventional studies indexed under Hematologic Diseases.
Browse Hematologic Diseases studies →MaaT Pharma is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
A Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule
Drug: MaaT033 capsule
Oral capsule
Occurrence of MaaT033-related, treatment-emergent (serious) adverse events, grade >3, as assessed by CTCAE v4.0
Evaluation of safety and tolerability of MaaT033 in patients with hematologic malignancies
Time frame: From treatment start (V1, end of aplasia) to the end of the study (end of consolidation or up to 10 weeks)
Dose regimen evaluation
Activity assessment of the different dose regimens defined as bacterial "engraftment" of the product
Time frame: From treatment start (V1, end of aplasia) to the end of the study (end of consolidation or up to 10 weeks)
Plan to share: No
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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MaaT Pharma