Safety and Tolerability Evaluation of MaaT033

Chemotherapy Effect Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04150393
• Other study ID #: MPOH05
• Status: Completed
• Phase: Phase 1
• Start date: October 20, 2020
• Est. completion date: December 13, 2021

Study information

• Verified date: April 2022
• Source: MaaT Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy Effect
• Hematologic Diseases

Intervention

Drug:
• MaaT033 capsule
Oral capsule

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Nice	Nice
France	APHP St Antoine	Paris
France	IUCT	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
MaaT Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From treatment start (V1, end of aplasia) to the end of the study (end of consolidation or up to 10 weeks)
Secondary	Dose regimen evaluation	Activity assessment of the different dose regimens defined as bacterial "engraftment" of the product	From treatment start (V1, end of aplasia) to the end of the study (end of consolidation or up to 10 weeks)