What side effects are associated with this type of intervention?

Common treatments for blood cancers include chemotherapy, radiation therapy, and hematopoietic cell transplantation (HCT). Treatments involving modulation of the gut microbiome, such as the use of human milk oligosaccharides (HMO) and Bifidobacterium infantis (B. infantis), aim to reduce gastrointestinal (GI) domination by harmful bacteria. Known side effects of these microbiome-modulating treatments can include gastrointestinal upset, such as bloating, gas, and diarrhea. Additionally, there is a potential risk of systemic infections, particularly in immunocompromised patients. More broadly, side effects of blood cancer treatments can include fatigue, nausea, increased risk of infections, and organ toxicity.

What prior FDA approvals exist?

FDA-approved treatments for blood cancers include a variety of chemotherapies, targeted therapies, and immunotherapies. Commonly approved drugs include tyrosine kinase inhibitors like imatinib for chronic myeloid leukemia, monoclonal antibodies like rituximab for non-Hodgkin lymphoma, and CAR T-cell therapies such as tisagenlecleucel for acute lymphoblastic leukemia. While modulation of the gut microbiome is an emerging area of research, specific FDA approvals for blood cancer treatments using this approach are not yet established. Current research, such as the study involving HMO and B. infantis, aims to explore the potential benefits of microbiome modulation in improving outcomes for patients undergoing treatments like allo-HCT.

What other types of research exist?

Promising novel alternatives for modulating the gut microbiome in blood cancer patients include: 1) Fecal Microbiota Transplantation (FMT), which has shown potential in restoring healthy microbiota and reducing pathogenic bacteria. 2) Next-generation probiotics, such as Akkermansia muciniphila and Faecalibacterium prausnitzii, which are being studied for their anti-inflammatory properties and ability to enhance gut barrier function. 3) Synbiotics combining prebiotics and multiple probiotic strains tailored to individual microbiome profiles, which may offer more comprehensive modulation of the gut environment.

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PBCLN-014 + PBCLN-010 for Blood Cancer

Phase 2

Waitlist Available

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 up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of special sugars (HMO) and beneficial bacteria (B. infantis) to help improve gut health in patients who have received a type of stem cell transplant. These patients often have problems with harmful bacteria in their gut. The treatment aims to feed good bacteria so they can grow and reduce the harmful ones.

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.

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.

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 ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for blood cancers include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target cancer cell pathways, reducing damage to normal cells. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Modulating the gut microbiome, as studied with HMO and B. infantis, aims to reduce gastrointestinal domination by harmful bacteria (pathobionts), potentially improving treatment outcomes and reducing complications. This approach is significant for blood cancer patients as it may enhance the efficacy of treatments and improve overall gut health, which is often compromised during cancer therapy.

Combination Therapy of TGF-β Blockade and Commensal-derived Probiotics Provides Enhanced Antitumor Immune Response and Tumor Suppression.