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

NCT06102213 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: 22-CT-001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

allo-hct; microbiome; gut engraftment

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

Cohort A: HMO 9.0 g and B. infantis

EXPERIMENTAL

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)

Cohort B: HMO 4.5 g and B. infantis

EXPERIMENTAL

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)

Cohort C

NO INTERVENTION

Participants in this cohort will not receive any study drug

Interventions

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

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

Cohort A: HMO 9.0 g and B. infantis; Cohort B: HMO 4.5 g and B. infantis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to initiation of any study-specific procedure or treatment.
• Male and female participants 18 to 75 years of age at the time of informed consent.
• Planning to receive a first allo-HCT.
• Able to comply with protocol requirements.

You may not qualify if:

• Participants with prior bowel resection resulting in colostomy
• Serious medical or psychiatric illness likely to interfere with participation in study.
• 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.
• Female participants who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.

Sponsors & Collaborators

• Prolacta Bioscience: lead

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Health Maintenance Organizations

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Managed Care Programs; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Prepaid Health Plans; Group Practice; Professional Practice; Organization and Administration; Health Services Administration; Delivery of Health Care; Patient Care Management

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Unblinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3 cohorts: Cohort A and B receive combination study drug in difference doses (Cohort A receives HMO 9.0 g and B. infantis; Cohort B received HMO 4.5 g and B. infantis) Cohort C does not receive study drug

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 26, 2023
• Study Start: September 18, 2023
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: August 19, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: To be determined
• Access Criteria: To be determined

Locations

US (1)