What side effects are associated with this type of intervention?

Common treatments for bone marrow transplantation include chemotherapy, radiation therapy, and immunosuppressive drugs. These treatments can lead to side effects such as infections, graft-versus-host disease (GVHD), organ damage, and gastrointestinal issues. For microbiome therapeutics like SER-155, which aim to modulate gut microbiota and immune response, potential side effects may include gastrointestinal disturbances, such as diarrhea or constipation, and possible infections due to changes in the gut flora. It is essential to monitor patients closely for these side effects to manage them effectively.

What prior FDA approvals exist?

FDA approvals for treatments related to bone marrow transplants include various drugs aimed at reducing infection and graft-versus-host disease (GVHD). While specific microbiome therapeutics like SER-155 are still under study, other approved treatments include antibiotics, antifungals, and immunosuppressive agents such as tacrolimus and cyclosporine. These drugs help manage the immune response and prevent complications post-transplant. Additionally, probiotics and prebiotics are being explored for their potential to modulate gut microbiota and improve transplant outcomes.

What other types of research exist?

Promising alternatives to SER-155 for bone marrow transplant patients include: 1) Probiotics and synbiotics, which have shown potential in modulating gut microbiota and reducing inflammation. 2) Reduced-intensity conditioning (RIC) regimens, which have demonstrated benefits in reducing GVHD and improving overall survival rates. 3) BRAF inhibitors like vemurafenib combined with rituximab, which are used in specific cases of hematologic malignancies and may offer benefits in managing post-transplant complications.

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Microbiome Modulator

SER-155 for Bone Marrow Transplant Complications

Phase 1

Waitlist Available

Led By Doris Ponce, MD

Research Sponsored by Seres Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Received a fecal microbiota transplant (FMT) or any live microbial therapeutic within 3 months prior to Screening

Transplant using umbilical cord blood or ex vivo T-cell-depleted HSCT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 100

Summary

This trial is testing SER-155, a treatment for adults receiving stem cell transplants. It aims to reduce infections and Graft vs. Host Disease by first removing harmful gut bacteria with an antibiotic and then introducing beneficial bacteria. The study will evaluate if this approach is safe and effective.

Who is the study for?

Adults over 18 planning to undergo a bone marrow transplant from various donor types, with any conditioning regimen. Not for those who've had CAR-T therapy, vancomycin allergy, certain transplants like umbilical cord blood or T-cell-depleted HSCT, active severe colitis/IBD, recent investigational treatments, hematologic malignancy relapse/progression (except minimal residual disease), or recent live microbial therapeutics.

What is being tested?

The study is testing SER-155 and its placebo in adults undergoing stem cell transplantation. It's designed to see if SER-155 can reduce infection risk and graft vs. host disease compared to placebo. Participants will also receive either vancomycin pre-treatment or its placebo before the main intervention.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions related to immune system modulation such as infections or allergic responses due to SER-155 or the vancomycin pre-treatment.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a fecal transplant or live microbial treatment in the last 3 months.

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I am receiving a transplant with umbilical cord blood or T-cell-depleted stem cells.

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I have received CAR-T cell therapy.

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I have severe colitis, IBD, or have had my entire colon removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 100

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 100

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 100 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Engraftment of SER-155

Safety and tolerability of SER-155, including incidence and severity of adverse events, serious adverse events, or adverse events of special interest

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2 - Randomized, Double-Blind, Placebo-Controlled StudyExperimental Treatment4 Interventions

Vancomycin \& SER-155 OR Vancomycin placebo \& SER-155 placebo

Group II: Cohort 1 - Open Label StudyExperimental Treatment2 Interventions

Vancomycin \& SER-155

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vancomycin Pre-Treatment

2021

Completed Phase 1

~60

SER-155

2021

Completed Phase 1

~60

SER-155 Placebo

2021

Completed Phase 1

~60

Vancomycin Placebo

2021

Completed Phase 1

~60

0 / 4Eligibility criteria met

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 Bone Marrow Transplant (BMT) patients, such as microbiome therapeutics like SER-155, work by modulating the gut microbiota to enhance immune function and reduce complications like infections and Graft vs. Host Disease (GVHD). These treatments aim to create a balanced gut environment that supports a healthy immune response, which is critical for BMT patients as it can significantly impact the success of the transplant and the patient's overall recovery. By reducing the risk of infections and GVHD, these therapies help improve patient outcomes and quality of life post-transplant.