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Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation

NCT06102213 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-08-19

No results posted yet for this study

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

DRUG

B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010)

PBCLN-010: Human Milk Oligosaccharides (HMO). PBCLN-014: B. infantis.

Sponsors & Collaborators

  • Prolacta Bioscience

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-18
Primary Completion
2024-08-12
Completion
2024-08-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06102213 on ClinicalTrials.gov