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

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


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


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).

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


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
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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