NCT06102213

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Prolacta Bioscience · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

• Hematologic Malignancy

Interventions

Type	Name	Description
DRUG	B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010)	PBCLN-010: Human Milk Oligosaccharides (HMO). PBCLN-014: B. infantis.

Timeline

• Start date: 2023-09-18
• Primary completion: 2024-08-12
• Completion: 2024-08-12
• First posted: 2023-10-26
• Last updated: 2024-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study