Trial | NCT04150393  Report issue

Title

Safety and Tolerability Evaluation of MaaT033
Safety Phase I Evaluation of MaaT033, a Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule, In HeMatOlogy Malignant Patients Under iNtensive Chemotherapy (CIMON)

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    21
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.
Study Started
Oct 20
2020
Primary Completion
Dec 13
2021
Study Completion
Dec 13
2021
Last Update
Apr 12
2022

Drug MaaT033 capsule

Oral capsule

MaaT033 treatment Experimental

A Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule

Criteria 

Inclusion Criteria:

Male or Female
Age ≥ 18 years
Patients diagnosed with AML defined according to WHO 2016 criteria with ≥20% leukemic blasts in the bone marrow or with high- risk myelodysplastic syndrome, receiving intensive chemotherapy
Patients healthy enough to likely receive their consolidation or second cycle of chemotherapy after induction chemotherapy
Patients healthy enough to likely receive HSCT
Informed written consent
Patient recovered from neutropenia

Exclusion Criteria:

Acute promyelocytic leukemia (AML-M3)
AML secondary to myeloproliferative disorder or chronic myelomonocytic leukemia (CMML)
Acute myeloid leukemia BCR-ABL1+
Active CNS leukemia
Patients with a life expectancy of <70 days according to investigator's opinion, or subject to therapeutic limitations
Confirmed or suspected intestinal ischemia
Confirmed or suspected toxic megacolon or gastrointestinal perforation
Active uncontrolled infection according to the attending physician
Any gastro-intestinal bleeding in the past 3 months
Any history of gastro-intestinal surgery in the past 3 months
Any history of inflammatory bowel disease
Any counter-indication to swallow capsules
Enrollment in another trial that may interfere with this study
Known allergy or intolerance to trehalose, maltodextrin or PEG
Women of childbearing potential without efficient contraceptive protection
Pregnant or breastfeeding
Patients with EBV-negative serology
Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
Exclusion period of a previous study
Administrative or legal supervision
Confirmed positive result to SARS-CoV-2 nasopharyngeal test at screening
No Results Posted