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Safety and Tolerability Evaluation of MaaT033 (CIMON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04150393
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
MaaT Pharma

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.


Condition or disease Intervention/treatment Phase
Hematologic Diseases Chemotherapy Effect Drug: MaaT033 capsule Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Intervention Model: Sequential Assignment
Intervention Model Description: 3+3 design dose escalation
Masking: None (Open Label)
Primary Purpose: Supportive Care
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)
Actual Study Start Date : October 20, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: MaaT033 treatment
A Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule
Drug: MaaT033 capsule
Oral capsule




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or Female
  2. Age ≥ 18 years
  3. 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
  4. Patients healthy enough to likely receive their consolidation or second cycle of chemotherapy after induction chemotherapy
  5. Patients healthy enough to likely receive HSCT
  6. Informed written consent
  7. Patient recovered from neutropenia

Exclusion Criteria:

  1. Acute promyelocytic leukemia (AML-M3)
  2. AML secondary to myeloproliferative disorder or chronic myelomonocytic leukemia (CMML)
  3. Acute myeloid leukemia BCR-ABL1+
  4. Active CNS leukemia
  5. Patients with a life expectancy of <70 days according to investigator's opinion, or subject to therapeutic limitations
  6. Confirmed or suspected intestinal ischemia
  7. Confirmed or suspected toxic megacolon or gastrointestinal perforation
  8. Active uncontrolled infection according to the attending physician
  9. Any gastro-intestinal bleeding in the past 3 months
  10. Any history of gastro-intestinal surgery in the past 3 months
  11. Any history of inflammatory bowel disease
  12. Any counter-indication to swallow capsules
  13. Enrollment in another trial that may interfere with this study
  14. Known allergy or intolerance to trehalose, maltodextrin or PEG
  15. Women of childbearing potential without efficient contraceptive protection
  16. Pregnant or breastfeeding
  17. Patients with EBV-negative serology
  18. 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;
  19. Exclusion period of a previous study
  20. Administrative or legal supervision
  21. Confirmed positive result to SARS-CoV-2 nasopharyngeal test at screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04150393


Contacts
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Contact: John Weinberg, Dr +33(0)660907942 jweinberg@maat-pharma.com
Contact: Benoit Levast +33(0)660907942 blevast@maat-pharma.com

Locations
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France
CHU Angers Recruiting
Angers, France
Contact: Sylvain Thepot, Dr         
Principal Investigator: Sylvain Thepot, Dr         
CHU Nice Recruiting
Nice, France
Contact: Thomas Cluzeau, Pr         
Principal Investigator: Thomas Cluzeau, Pr         
APHP St Antoine Recruiting
Paris, France
Contact: Florent Malard, Dr         
Principal Investigator: Florent Malard         
IUCT Recruiting
Toulouse, France
Contact: Christian Recher, Pr         
Principal Investigator: Christian Recher         
Sponsors and Collaborators
MaaT Pharma
Investigators
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Principal Investigator: Christian Recher, Pr IUCT
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Responsible Party: MaaT Pharma
ClinicalTrials.gov Identifier: NCT04150393    
Other Study ID Numbers: MPOH05
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MaaT Pharma:
microbiota
microbiotherapy
Additional relevant MeSH terms:
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Hematologic Diseases