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

August 16, 2024 updated by: Prolacta Bioscience

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A: HMO 9.0 g and B. infantis
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).
Drug: B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010)
PBCLN-010: Human Milk Oligosaccharides (HMO). PBCLN-014: B. infantis.
Experimental: Cohort B: HMO 4.5 g and B. infantis
HMO will be administered at 4.5 g orally BID, and B. infantis will be administered orally BID (total of 43 days of dosing).
Drug: B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010)
PBCLN-010: Human Milk Oligosaccharides (HMO). PBCLN-014: B. infantis.
No Intervention: Cohort C
Participants in this cohort will not receive any study drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of safety and tolerability measures assessed through adverse events, serious adverse events, and adverse events of special interest per treatment group
Time Frame: before treatment, during treatment, or ≤ 56 days after cessation of treatment
before treatment, during treatment, or ≤ 56 days after cessation of treatment
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).
Time Frame: Through study completion,180 days
Through study completion,180 days
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).
Time Frame: Through study completion,180 days
Through study completion,180 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Dosing period, 43 days
Dosing period, 43 days
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
Time Frame: Through study completion,180 days
Through study completion,180 days
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
Time Frame: Day -7 through neutrophil engraftment
Day -7 through neutrophil engraftment
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
Time Frame: Through study completion,180 days
Through study completion,180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prolacta Bioscience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Actual)

August 12, 2024

Study Completion (Actual)

August 12, 2024

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 16, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-CT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

To be determined

IPD Sharing Time Frame

To be determined

IPD Sharing Access Criteria

To be determined

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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