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CompletedNCT04995653Updated Oct 1, 2024

A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT

A Phase 1 interventional study of Vancomycin Pre-Treatment and Vancomycin Placebo in Allogeneic Hematopoietic Stem Cell Transplantation, sponsored by Seres Therapeutics, Inc.. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.

Sponsored by Seres Therapeutics, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jul 2024, 2 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

An Open-Label and Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of SER-155 in Adults Undergoing Hematopoietic Stem Cell Transplantation to Reduce the Risk of Infection and Graft vs. Host Disease

Read the detailed description

This is a Phase 1b randomized, double-blind, placebo-controlled, multiple dose, multicenter study designed to evaluate the safety, efficacy, and microbiome alterations associated with SER-155 dosing, after microbiome conditioning with oral vancomycin, in adult subjects aged ≥18 years who are undergoing Hematopoietic Stem Cell Transplantation (HSCT).

02

Conditions studied

  • Allogeneic Hematopoietic Stem Cell Transplantation

Keywords

  • Microbiome
  • stem cell transplant
03

In context

Lead sponsor

Seres Therapeutics, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male and female subjects ≥ 18 years of age undergoing HSCT.
  • Planning to undergo allogeneic hematopoietic stem cell transplantation from a human leukocyte antigen matched related donor, haploidentical related donor, HLA-matched unrelated donor, or HLA 1-antigen mismatched unrelated or related donor, with either bone marrow or peripheral blood stem cells as a graft source, and with any conditioning regimen

Exclusion criteria

Exclusion Criteria:

  • Severe colitis of any etiology or active/currently-treated inflammatory bowel disease (IBD) or total colectomy.
  • Evidence of relapse or progression of hematologic malignancy (minimal residual disease is allowed).
  • Transplant using umbilical cord blood or ex vivo T-cell-depleted HSCT
  • Receipt of chimeric antigen receptor T-cell (CAR-T) therapy.
  • Received a fecal microbiota transplant (FMT) or any live microbial therapeutic within 3 months prior to Screening.
  • Known allergy or intolerance to oral vancomycin.
  • Concomitant participation or participation within 14 days or 5 half-lives of another investigational unapproved treatment, whichever is longer.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Cohort 1 - Open Label Study

    Vancomycin \& SER-155

    Drug: Vancomycin Pre-Treatment · Drug: SER-155

  • Experimental
    Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study

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

    Drug: Vancomycin Pre-Treatment · Drug: Vancomycin Placebo · Drug: SER-155 · Drug: SER-155 Placebo

Interventions

  • DrugVancomycin Pre-Treatment

    Four times daily dosing with Vancomycin

  • DrugVancomycin Placebo

    Four times daily dosing with Vancomycin Placebo

  • DrugSER-155

    Once daily dosing with SER-155

  • DrugSER-155 Placebo

    Once daily dosing with SER-155 placebo

06

What researchers measure

Primary outcomes

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

    Incidence and severity of participants with adverse events, serious adverse events, or adverse events of special interest

    Time frame: Day 100

  2. Engraftment of SER-155

    Prevalence of SER-155 strains in subject stool measured before and after treatment courses

    Time frame: Day 100

Secondary outcomes

  1. Abundance of Enterococcus and Enterobacteriaceae

    Time frame: Day 100

  2. Combined and individual incidence of bloodstream infections, gastrointestinal infections, and acute Graft-versus Host Disease

    Time frame: Day 100

  3. Incidence and duration of febrile neutropenia

    Time frame: Day 100

07

Study locations

13 sites
  • Banner Health - MD Anderson Medical Center
    Gilbert, Arizona 85234, United States
  • Mayo Clinic - Scottsdale
    Scottsdale, Arizona 85259, United States
  • City of Hope
    Duarte, California 91010, United States
  • University of California, Los Angeles - Division of Hematology-Oncology
    Marina Del Rey, California 90292, United States
  • Georgetown (MedStar Health)
    Washington, District of Columbia 21044, United States
  • University of Florida - Division of Hematology & Oncology
    Gainesville, Florida 32610, United States
  • Mayo Clinic - Jacksonville
    Jacksonville, Florida 32224, United States
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
  • Harvard Medical School - Massachusetts General Hospital Cancer Center
    Boston, Massachusetts 02114, United States
  • Mayo Clinic - Rochester
    Rochester, Minnesota 55905, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • University of North Carolina Chapel Hill
    Chapel Hill, North Carolina 27514, United States
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04995653
Lead sponsor
Seres Therapeutics, Inc.
Collaborators
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Aug 9, 2021
Start date
Nov 24, 2021
Primary completion
Jul 23, 2024
Completion
Jul 23, 2024
Last update
Oct 1, 2024

Study contacts

Doris Ponce, MD
principal investigator · MSKCC
Bina Tejura, MD
study director · Seres Therapeutics, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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