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

  • STATUS
    Recruiting
  • End date
    May 10, 2025
  • participants needed
    70
  • sponsor
    Seres Therapeutics, Inc.
Updated on 4 October 2022

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

Description

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

Details
Condition Allogeneic Hematopoietic Stem Cell Transplantation
Treatment Vancomycin Pre-Treatment, Vancomycin Placebo, SER-155, SER-155 Placebo
Clinical Study IdentifierNCT04995653
SponsorSeres Therapeutics, Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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 sibling, haploidentical related donor, or HLA-matched unrelated
donor with either bone marrow or peripheral blood stem cells as a graft source, and with
any conditioning regimen

Exclusion Criteria

Has 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 1 month or 5 half-lives of another
investigational treatment
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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