SER-155 for Bone Marrow Transplant Complications

Recruiting in Palo Alto (17 mi)

+15 other locations

Overseen byDoris Ponce, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Seres Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Doris Ponce, MD

Principal Investigator

MSKCC

Bina Tejura, MD

Principal Investigator

Seres Therapeutics, Inc.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 or older and planning to have a stem cell transplant from a donor.

Exclusion Criteria

Known allergy or intolerance to oral vancomycin

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

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

See 4 more

Treatment Details

Interventions

SER-155 (Microbiome Modulator)

Trial OverviewThe 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.

Participant Groups

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