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Phase Ib CIMON trial of MaaT033 receives positive first DSMB safety review in patients with AML and MDS
On December 22, 2020, the first analysis of the phase Ib CIMON trial (NCT04150393) was announced. This ongoing trial is investigating the safety and tolerability of MaaT033, a microbiome capsule, in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) who had received high-intensity chemotherapy. Review of the first patient cohort by an independent data safety and monitoring board (DSMB) confirmed the absence of safety issues and recommended continuation of the trial.1
MaaT0331
- An off-the-shelf, oral microbiome biotherapeutic, consisting of a pooled-donor, full ecosystem of high microbial species diversity and richness
- Designed to restore the gut microbiome and re-establish immune system homeostasis that is disrupted by cancer, chemotherapy, and associated prophylactic treatments, in an attempt to improve clinical outcome
CIMON (NCT04150393)1,2
- An open-label, phase Ib trial of MaaT033 in 27 adult patients, across four centers in France, with AML and high-risk MDS who underwent intensive chemotherapy
- Start date: October 20, 2020
- Estimated completion: December 2021
- Primary outcome: Safety and tolerability
- Secondary outcome: Dose regimen evaluation
For more information on how the gut microbiome affects the immune system and response to cancer therapy, watch the AML Hub animated video here.
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