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

Prolacta Bioscience

Status and phase: Terminated; Phase 2

Conditions: Hematologic Malignancy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06102213

22-CT-001

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 3 patient groups

Cohort A: HMO 9.0 g and B. infantis

Experimental group

Description:

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).

Treatment:

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

Cohort B: HMO 4.5 g and B. infantis

Experimental group

Description:

HMO will be administered at 4.5 g orally BID, and B. infantis will be administered orally BID (total of 43 days of dosing).

Treatment:

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

Cohort C

No Intervention group

Description:

Participants in this cohort will not receive any study drug