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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

Tracking Information
First Submitted Date  ICMJE October 25, 2019
First Posted Date  ICMJE November 4, 2019
Last Update Posted Date November 17, 2020
Actual Study Start Date  ICMJE October 20, 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2019)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2019)		 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability Evaluation of MaaT033
Official Title  ICMJE Safety Phase I Evaluation of MaaT033, a Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule, In HeMatOlogy Malignant Patients Under iNtensive Chemotherapy (CIMON)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Intervention Model Description:
3+3 design dose escalation
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Hematologic Diseases
  • Chemotherapy Effect
Intervention  ICMJE Drug: MaaT033 capsule
Oral capsule
Study Arms  ICMJE Experimental: MaaT033 treatment
A Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule
Intervention: Drug: MaaT033 capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2019)		 27
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: John Weinberg, Dr +33(0)660907942 jweinberg@maat-pharma.com
Contact: Benoit Levast +33(0)660907942 blevast@maat-pharma.com
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04150393
Other Study ID Numbers  ICMJE MPOH05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MaaT Pharma
Study Sponsor  ICMJE MaaT Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christian Recher, Pr IUCT
PRS Account MaaT Pharma
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP