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
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|
|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|
Experimental: MaaT033 treatment
A Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule
Drug: MaaT033 capsule
- 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
- 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
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
|Contact: John Weinberg, Dr||+33(0)firstname.lastname@example.org|
|Contact: Benoit Levast||+33(0)email@example.com|
|Contact: Sylvain Thepot, Dr|
|Principal Investigator: Sylvain Thepot, Dr|
|Contact: Thomas Cluzeau, Pr|
|Principal Investigator: Thomas Cluzeau, Pr|
|APHP St Antoine||Recruiting|
|Contact: Florent Malard, Dr|
|Principal Investigator: Florent Malard|
|Contact: Christian Recher, Pr|
|Principal Investigator: Christian Recher|
|Principal Investigator:||Christian Recher, Pr||IUCT|