A Randomized, Open-Label, Multicenter, Phase 2a Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Rate of gut engraftment of B. infantis through Day 180 among recipients of PBCLN-010 in combination with PBCLN-014 compared with standard of care (SOC) (control cohort).
研究概览
简要总结
This is a Phase 2a, open-label, multicenter study to evaluate the safety and efficacy of HMO (PBCLN-010) and B. infantis (PBCLN-014) on the gut microbiome and GI domination by pathobionts in participants receiving allo-HCT.
Approximately 60 participants will be enrolled in this study, and all participants will undergo screening assessments up to 28 days before the first study drug dose (D 7). Participants meeting all the eligibility criteria based on the screening assessments will be enrolled and randomly assigned to 1 of the 3 cohorts:
- Cohort A (HMO 9.0 g and B. infantis) BID
- Cohort B (HMO 4.5 g and B. infantis) BID
- Cohort C (Control Cohort): Participants in this cohort will not receive any study drug.
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
- None
盲法说明
Unblinded
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to initiation of any study-specific procedure or treatment.
- •Male and female participants 18 to 75 years of age at the time of informed consent.
- •Planning to receive a first allo-HCT.
- •Able to comply with protocol requirements.
排除标准
- •Participants with prior bowel resection resulting in colostomy
- •Serious medical or psychiatric illness likely to interfere with participation in study.
- •History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions.
- •Female participants who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
研究组 & 干预措施
Cohort A: HMO 9.0 g and B. infantis
HMO will be administered at 9.0 g orally twice a day (BID), and B. infantis will be administered orally twice a day (BID) (total of 43 days of dosing).
干预措施: B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010) (Drug)
Cohort B: HMO 4.5 g and B. infantis
HMO will be administered at 4.5 g orally BID, and B. infantis will be administered orally BID (total of 43 days of dosing).
干预措施: B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010) (Drug)
结局指标
主要结局
Rate of gut engraftment of B. infantis through Day 180 among recipients of PBCLN-010 in combination with PBCLN-014 compared with standard of care (SOC) (control cohort).
时间窗: Through study completion,180 days
Duration of gut engraftment of B. infantis through Day 180 among recipients of PBCLN-010 in combination with PBCLN-014 compared with standard of care (SOC) (control cohort).
时间窗: Through study completion,180 days
Incidence and severity of safety and tolerability measures assessed through adverse events, serious adverse events, and adverse events of special interest per treatment group
时间窗: before treatment, during treatment, or ≤ 56 days after cessation of treatment
次要结局
- Measures of safety and tolerability by physical examinations examined by cohort to assess the effect of oral administration of PBCLN-010 in combination with PBCLN-014(Dosing period, 43 days)
- Measuring cases of acute graft versus host disease (aGvHD) to determine the cumulative incidence or rate of acute graft versus host disease (aGvHD) at D180(Through study completion,180 days)
- Measuring the incidence of bloodstream infections, use of anti-infective agents, frequency/length of hospitalizations stays to evaluate the incidence of the infection and other safety events among recipients of study drug compared with SOC(Through study completion,180 days)
- Measuring temperature ≥ 38.0°C (100.4°F) sustained over a 1-hour period concurrent with ANC < 500 cells/mm3 to determine the incidence and duration of febrile neutropenia(Day -7 through neutrophil engraftment)