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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06102213
Other study ID # 22-CT-001
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 18, 2023
Est. completion date October 24, 2025

Study information

Verified date October 2023
Source Prolacta Bioscience
Contact Greg McKenzie, PhD
Phone 626.599.9260
Email GMcKenzie@prolacta.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 24, 2025
Est. primary completion date August 29, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States The University of Texas MD Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Prolacta Bioscience

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and severity of safety and tolerability measures assessed through adverse events, serious adverse events, and adverse events of special interest per treatment group before treatment, during treatment, or = 56 days after cessation of treatment
Primary 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). Through study completion,180 days
Primary 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). Through study completion,180 days
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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