Clinical trial · Interventional
Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor business decision to terminate the study early
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A: HMO 9.0 g and B. infantis
- description
- 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).
- interventionNames
- Drug: B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010)
- type
- EXPERIMENTAL
- label
- Cohort B: HMO 4.5 g and B. infantis
- description
- HMO will be administered at 4.5 g orally BID, and B. infantis will be administered orally BID (total of 43 days of dosing).
- interventionNames
- Drug: B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010)
- type
- NO_INTERVENTION
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed informed consent prior to initiation of any study-specific procedure or treatment. 2. Male and female participants 18 to 75 years of age at the time of informed consent. 3. Planning to receive a first allo-HCT. 4. Able to comply with protocol requirements. Exclusion Criteria: 1. Participants with prior bowel resection resulting in colostomy 2. Serious medical or psychiatric illness likely to interfere with participation in study. 3. 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. 4. Female participants who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
References
Publications (0)
Data not yet available