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

A Phase 1b Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of SER-155 in Adults Undergoing Hematopoietic Stem Cell Transplantation (HSCT) to Reduce the Risk of Infection and Graft vs. Host Disease (GvHD)

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

Study Overview

• Status: Completed
• Conditions: Allogeneic Hematopoietic Stem Cell Transplantation
• Intervention / Treatment: Drug: Vancomycin Pre-Treatment; Drug: SER-155; Drug: Vancomycin Placebo; Drug: SER-155 Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: SER-155; Once daily dosing with SER-155; Drug: Vancomycin Placebo; Four times daily dosing with Vancomycin Placebo; Drug: SER-155 Placebo; Once daily dosing with SER-155 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 100
Engraftment of SER-155	Prevalence of SER-155 strains in subject stool measured before and after treatment courses	Day 100

Secondary Outcome Measures

Outcome Measure	Time Frame
Abundance of Enterococcus and Enterobacteriaceae	Day 100
Combined and individual incidence of bloodstream infections, gastrointestinal infections, and acute Graft-versus Host Disease	Day 100
Incidence and duration of febrile neutropenia	Day 100

Collaborators and Investigators

• Sponsor: Seres Therapeutics, Inc.
• Collaborators: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Doris Ponce, MD, MSKCC; Study Director: Bina Tejura, MD, Seres Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2021
• Primary Completion (Actual): July 23, 2024
• Study Completion (Actual): July 23, 2024

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Microbiome; stem cell transplant
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: SER-155-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No