Hematologic MalignancyPhase 2NCT06102213
Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation
A Phase 2 study testing B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010) in people with Hematologic Malignancy, run by Prolacta Bioscience at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to 12 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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)
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
- Being tested
- B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010)
- Keywords
- allo-hct, microbiome, gut engraftment
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010)Drug
PBCLN-010: Human Milk Oligosaccharides (HMO). PBCLN-014: B. infantis.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of safety and tolerability measures assessed through adverse events, serious adverse events, and adverse events of special interest per treatment group
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion,180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start18 Sep 2023
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Why it stopped: Sponsor business decision to terminate the study early
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolacta Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102213
- Sponsor's protocol ID
- 22-CT-001
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06102213
- Acronym / sponsor ID
- 22-CT-001
- Conditions
- Hematologic Malignancy
- Keywords
- allo-hct, microbiome, gut engraftment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor business decision to terminate the study early
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Prolacta BioscienceIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Cohort A: HMO 9.0 g and B. infantis | Experimental | Drug: B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010)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). |
| Cohort B: HMO 4.5 g and B. infantis | Experimental | Drug: B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010)HMO will be administered at 4.5 g orally BID, and B. infantis will be administered orally BID (total of 43 days of dosing). |
| Cohort C | No intervention | –Participants in this cohort will not receive any study drug |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010)PBCLN-010: Human Milk Oligosaccharides (HMO). PBCLN-014: B. infantis. | Drug | Cohort A: HMO 9.0 g and B. infantis, Cohort B: HMO 4.5 g and B. infantis |
Primary outcome
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
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
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
4 secondary outcomes
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
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
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
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
Results and safety
The study was stopped early (reason given: Sponsor business decision to terminate the study early). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: Yes. To be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing B. infantis (PBCLN-014) and Human Milk Oligosaccharides (HMO) (PBCLN-010) in people with Hematologic Malignancy, run by Prolacta Bioscience at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor business decision to terminate the study early). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.