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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

  • 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
There are 2 parts or cohorts for the trial. Cohort 1 is an open-label study. Cohort 2 is double-blind, randomized, placebo-controlled study.
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 - Open Label Study 		Vancomycin & SER-155
  • Drug: Vancomycin Pre-Treatment
    Four times daily dosing with Vancomycin
  • Drug: SER-155
    Once daily dosing with SER-155
Experimental
Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study 		Vancomycin & SER-155 OR Vancomycin placebo & SER-155 placebo
  • Drug: Vancomycin Pre-Treatment
    Four times daily dosing with Vancomycin
  • Drug: Vancomycin Placebo
    Four times daily dosing with Vancomycin Placebo
  • Drug: SER-155
    Once daily dosing with SER-155
  • Drug: SER-155 Placebo
    Once daily dosing with SER-155 placebo

Recruiting Locations

Harvard Medical School - Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
Contact:
Investigator Site

More Details

Status
Recruiting
Sponsor
Seres Therapeutics, Inc.

Study Contact

Bina Tejura, MD
617-945-9626
clinicalstudies@serestherapeutics.com

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.