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

Hematologic Malignancy Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06102213
• Other study ID #: 22-CT-001
• Status: Recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms

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