Safety Phase I Evaluation of MaaT033, a Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule, In HeMatOlogy Malignant Patients Under iNtensive Chemotherapy (CIMON)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Occurrence of MaaT033-related, treatment-emergent (serious) adverse events, grade >3, as assessed by CTCAE v4.0
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Pregnant or breastfeeding
- •Patients with EBV-negative serology
- •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;
- •Exclusion period of a previous study
- •Administrative or legal supervision
- •Confirmed positive result to SARS-CoV-2 nasopharyngeal test at screening
研究组 & 干预措施
MaaT033 treatment
A Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule
干预措施: MaaT033 capsule (Drug)
结局指标
主要结局
Occurrence of MaaT033-related, treatment-emergent (serious) adverse events, grade >3, as assessed by CTCAE v4.0
时间窗: 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
次要结局
- Dose regimen evaluation(From treatment start (V1, end of aplasia) to the end of the study (end of consolidation or up to 10 weeks))