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PBCLN-014 + PBCLN-010 for Blood Cancer

Q: Does this trial offer eligibility to those who fall within a younger age bracket?

Based on the prerequisites for enrollment established by this clinical trial, any potential participants must be aged between 18 and 75.

Q: Are there still open opportunities to participate in this clinical experiment?

Confirmed, this trial is actively seeking participants. It was first announced on the 18th of September 2023 and recently updated on October 20th 2023 according to clinicaltrials.gov's records.

Q: For what demographic is this clinical trial most suitable?

Eligibility for this trial is limited to those 18 and 75 years old with blood cancers. Approximately 60 participants are needed in order to complete the research project.

Q: What has the regulatory approval status been for Cohort A: HMO 9.0 g and B. infantis?

As this is a Phase 2 study, data supporting the safety of Cohort A: HMO 9.0 g and B. infantis has been gathered; however, there is no evidence for its efficacy thus far so it was assessed with a score of 2.

Q: How many people are currently engaging in this trial?

Indeed, the details present on clinicaltrials.gov indicate that this medical trial is actively recruiting patients - it was initially posted to the site on September 18th 2023 and its information has been updated as recently as October 20th of the same year. The study requires 60 participants for their research at one location.

Phase 2

Recruiting

Research Sponsored by Prolacta Bioscience

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion,180 days

Awards & highlights

Study Summary

This trial will test a drug to see how it affects the gut microbiome and GI of people receiving allo-HCT.

Who is the study for?

Adults aged 18-75 planning to receive their first allogeneic hematopoietic cell transplantation (allo-HCT) for blood cancers can join. They must be able to follow the study plan and have signed a consent form. People with prior bowel resections leading to colostomy, serious illnesses affecting study participation, or women who are pregnant or breastfeeding cannot participate.Check my eligibility

What is being tested?

The trial is testing the effects of two substances on gut health in allo-HCT recipients: HMO (PBCLN-010) and B. infantis (PBCLN-014). Participants will be divided into three groups; two will receive different doses of HMO along with B. infantis twice daily, while a control group won't get these substances.See study design

What are the potential side effects?

Potential side effects aren't specified but may relate to changes in gut microbiome and gastrointestinal issues due to the introduction of new substances like HMO and B. infantis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion,180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion,180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion,180 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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).

Incidence and severity of safety and tolerability measures assessed through adverse events, serious adverse events, and adverse events of special interest per treatment group

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).

Secondary outcome measures

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

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

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

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Cohort B: HMO 4.5 g and B. infantisExperimental Treatment1 Intervention

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

Group II: Cohort A: HMO 9.0 g and B. infantisExperimental Treatment1 Intervention

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).

Group III: Cohort CActive Control1 Intervention

Participants in this cohort will not receive any study drug

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Prolacta BioscienceLead Sponsor

16 Previous Clinical Trials

1,532 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial offer eligibility to those who fall within a younger age bracket?

"Based on the prerequisites for enrollment established by this clinical trial, any potential participants must be aged between 18 and 75."

Answered by AI

Are there still open opportunities to participate in this clinical experiment?

"Confirmed, this trial is actively seeking participants. It was first announced on the 18th of September 2023 and recently updated on October 20th 2023 according to clinicaltrials.gov's records."

Answered by AI

For what demographic is this clinical trial most suitable?

"Eligibility for this trial is limited to those 18 and 75 years old with blood cancers. Approximately 60 participants are needed in order to complete the research project."

Answered by AI

What has the regulatory approval status been for Cohort A: HMO 9.0 g and B. infantis?

"As this is a Phase 2 study, data supporting the safety of Cohort A: HMO 9.0 g and B. infantis has been gathered; however, there is no evidence for its efficacy thus far so it was assessed with a score of 2."

Answered by AI

How many people are currently engaging in this trial?

"Indeed, the details present on clinicaltrials.gov indicate that this medical trial is actively recruiting patients - it was initially posted to the site on September 18th 2023 and its information has been updated as recently as October 20th of the same year. The study requires 60 participants for their research at one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06102213.

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