Hematologic DiseasesPhase 1CIMONNCT04150393
Safety and Tolerability Evaluation of MaaT033
A Phase 1 study testing MaaT033 capsule in people with Hematologic Diseases and Chemotherapy Effect, run by MaaT Pharma at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Diseases, Chemotherapy Effect
- What is being tested?
- MaaT033 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesFrance
- Study dates
- 20 Oct 2020to 13 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
About this study
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)
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.
Read more
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.
- Conditions
- Hematologic Diseases, Chemotherapy Effect
- Being tested
- MaaT033 capsule
- Keywords
- microbiota, microbiotherapy
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaaT033 capsuleDrug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| MaaT033 treatment | Experimental | A Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule Receives: Drug: MaaT033 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From treatment start (V1, end of aplasia) to the end of the study (end of consolidation or up to 10 weeks)
Secondary outcomes (1)
Dose regimen evaluation
Activity assessment of the different dose regimens defined as bacterial "engraftment" of the product
Measured: From treatment start (V1, end of aplasia) to the end of the study (end of consolidation or up to 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start20 Oct 2020
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 3+3 design dose escalation
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaaT Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Recher, Pr, Principal investigator, IUCT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150393
- Sponsor's protocol ID
- MPOH05
- Acronym
- CIMON
- Status last verified
- Apr 2022
- First submitted
- 25 Oct 2019
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malard F, Thepot S, Cluzeau T, Carre M, Lebon D, Bories P, Legrand O, Schwarz M, Loschi M, Meunier M, Joris M, Gasc C, Jouve J, Levast B, Plantamura E, Prestat E, Sabourin A, Gaugler B, Dore J, Recher C, Mohty M. Gut microbiota restoration with oral pooled fecal microbiotherapy after intensive chemotherapy: the phase 1b CIMON trial. Blood Adv. 2025 Aug 12;9(15):3739-3749. doi: 10.1182/bloodadvances.2024015571.
PubMed 40197991
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04150393
- Acronym / sponsor ID
- CIMON / MPOH05
- Conditions
- Hematologic Diseases, Chemotherapy Effect
- Keywords
- microbiota, microbiotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- MaaT PharmaIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3 design dose escalation
| Arm | Type | Receives |
|---|---|---|
| MaaT033 treatment | Experimental | Drug: MaaT033 capsuleA Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaaT033 capsuleOral capsule | Drug | MaaT033 treatment |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Derived from this study: PubMed 40197991Malard F, Thepot S, Cluzeau T, Carre M, Lebon D, Bories P, Legrand O, Schwarz M, Loschi M, Meunier M, Joris M, Gasc C, Jouve J, Levast B, Plantamura E, Prestat E, Sabourin A, Gaugler B, Dore J, Recher C, Mohty M. Gut microbiota restoration with oral pooled fecal microbiotherapy after intensive chemotherapy: the phase 1b CIMON trial. Blood Adv. 2025 Aug 12;9(15):3739-3749. doi: 10.1182/bloodadvances.2024015571.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Recher, Pr principal investigator
IUCT
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MaaT033 capsule in people with Hematologic Diseases and Chemotherapy Effect, run by MaaT Pharma at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04150393, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.