A Phase 1b Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of SER-155 in Adults Undergoing Hematopoietic Stem Cell Transplantation (HSCT) to Reduce the Risk of Infection and Graft vs. Host Disease (GvHD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 13
- 主要终点
- Engraftment of SER-155
研究概览
简要总结
An Open-Label and Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of SER-155 in Adults Undergoing Hematopoietic Stem Cell Transplantation to Reduce the Risk of Infection and Graft vs. Host Disease
详细描述
This is a Phase 1b randomized, double-blind, placebo-controlled, multiple dose, multicenter study designed to evaluate the safety, efficacy, and microbiome alterations associated with SER-155 dosing, after microbiome conditioning with oral vancomycin, in adult subjects aged ≥18 years who are undergoing Hematopoietic Stem Cell Transplantation (HSCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 and female subjects ≥ 18 years of age undergoing HSCT.
- •Planning to undergo allogeneic hematopoietic stem cell transplantation from a human leukocyte antigen matched related donor, haploidentical related donor, HLA-matched unrelated donor, or HLA 1-antigen mismatched unrelated or related donor, with either bone marrow or peripheral blood stem cells as a graft source, and with any conditioning regimen
排除标准
- •Severe colitis of any etiology or active/currently-treated inflammatory bowel disease (IBD) or total colectomy.
- •Evidence of relapse or progression of hematologic malignancy (minimal residual disease is allowed).
- •Transplant using umbilical cord blood or ex vivo T-cell-depleted HSCT
- •Receipt of chimeric antigen receptor T-cell (CAR-T) therapy.
- •Received a fecal microbiota transplant (FMT) or any live microbial therapeutic within 3 months prior to Screening.
- •Known allergy or intolerance to oral vancomycin.
- •Concomitant participation or participation within 14 days or 5 half-lives of another investigational unapproved treatment, whichever is longer.
研究组 & 干预措施
Cohort 1 - Open Label Study
Vancomycin & SER-155
干预措施: SER-155 (Drug)
Cohort 1 - Open Label Study
Vancomycin & SER-155
干预措施: Vancomycin Pre-Treatment (Drug)
Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study
Vancomycin & SER-155 OR Vancomycin placebo & SER-155 placebo
干预措施: Vancomycin Pre-Treatment (Drug)
Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study
Vancomycin & SER-155 OR Vancomycin placebo & SER-155 placebo
干预措施: Vancomycin Placebo (Drug)
Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study
Vancomycin & SER-155 OR Vancomycin placebo & SER-155 placebo
干预措施: SER-155 (Drug)
Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study
Vancomycin & SER-155 OR Vancomycin placebo & SER-155 placebo
干预措施: SER-155 Placebo (Drug)
结局指标
主要结局
Engraftment of SER-155
时间窗: Day 100
Prevalence of SER-155 strains in subject stool measured before and after treatment courses
Safety and tolerability of SER-155, including incidence and severity of adverse events, serious adverse events, or adverse events of special interest
时间窗: Day 100
Incidence and severity of participants with adverse events, serious adverse events, or adverse events of special interest
次要结局
- Incidence and duration of febrile neutropenia(Day 100)
- Abundance of Enterococcus and Enterobacteriaceae(Day 100)
- Combined and individual incidence of bloodstream infections, gastrointestinal infections, and acute Graft-versus Host Disease(Day 100)