Safety and Tolerability Evaluation of MaaT033

NCT04150393 | Completed Phase 1 DMC

• 1 other identifier: MPOH05
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

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.

Conditions

Hematologic Diseases; Chemotherapy Effect

Keywords

microbiota; microbiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Dose regimen evaluation

  From treatment start (V1, end of aplasia) to the end of the study (end of consolidation or up to 10 weeks)

Study Arms (1)

MaaT033 treatment

EXPERIMENTAL

A Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule

Drug: MaaT033 capsule

Interventions

MaaT033 capsule DRUG

Oral capsule

MaaT033 treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MaaT Pharma: lead

Study Sites (4)

CHU Angers

Angers, France

Location

CHU Nice

Nice, France

Location

APHP St Antoine

Paris, France

Location

IUCT

Toulouse, France

Location

Related Publications (1)

• 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.

  PMID: 40197991 DERIVED

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Christian Recher, Pr

  IUCT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3+3 design dose escalation

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 4, 2019
• Study Start: October 20, 2020
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)