Back to resultsSafety and Tolerability Evaluation of MaaT033 (CIMON)
Primary Purpose
Hematologic Diseases, Chemotherapy Effect
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
MaaT033 capsule
Sponsored by
About this trial
This is an interventional supportive care trial for Hematologic Diseases focused on measuring microbiota, microbiotherapy
Eligibility 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
Sites / Locations
- CHU Angers
- CHU Nice
- APHP St Antoine
- IUCT
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MaaT033 treatment
Arm Description
A Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Dose regimen evaluation
Activity assessment of the different dose regimens defined as bacterial "engraftment" of the product
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04150393
Brief Title
Safety and Tolerability Evaluation of MaaT033
Acronym
CIMON
Official Title
Safety Phase I Evaluation of MaaT033, a Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule, In HeMatOlogy Malignant Patients Under iNtensive Chemotherapy (CIMON)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
December 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MaaT Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Diseases, Chemotherapy Effect
Keywords
microbiota, microbiotherapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
3+3 design dose escalation
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MaaT033 treatment
Arm Type
Experimental
Arm Description
A Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule
Intervention Type
Drug
Intervention Name(s)
MaaT033 capsule
Intervention Description
Oral capsule
Primary Outcome Measure Information:
Title
Occurrence of MaaT033-related, treatment-emergent (serious) adverse events, grade >3, as assessed by CTCAE v4.0
Description
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)
Secondary Outcome Measure Information:
Title
Dose regimen evaluation
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Recher, Pr
Organizational Affiliation
IUCT
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
Country
France
Facility Name
CHU Nice
City
Nice
Country
France
Facility Name
APHP St Antoine
City
Paris
Country
France
Facility Name
IUCT
City
Toulouse
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Tolerability Evaluation of MaaT033
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