Safety and Tolerability Evaluation of MaaT033

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.

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Key information

Conditions

Hematologic Diseases Chemotherapy Effect Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU Angers, Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MaaT033 capsule

Drug

Oral capsule

Primary outcomes

Occurrence of MaaT033-related, treatment-emergent (serious) adverse events, grade >3, as assessed by CTCAE v4.0

Time frame: From treatment start (V1, end of aplasia) to the end of the study (end of consolidation or up to 10 weeks)

Evaluation of safety and tolerability of MaaT033 in patients with hematologic malignancies

Secondary outcomes

Dose regimen evaluation

Time frame: From treatment start (V1, end of aplasia) to the end of the study (end of consolidation or up to 10 weeks)

Activity assessment of the different dose regimens defined as bacterial "engraftment" of the product

Sponsors and collaborators

Lead sponsor

MaaT Pharma

Industry

Registry information

Official study title

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

Acronym: CIMON

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Nov 4, 2019
Registry last updated: Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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