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 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Four times daily dosing with Vancomycin
Four times daily dosing with Vancomycin Placebo
Once daily dosing with SER-155
Banner Health - MD Anderson Medical Center
Gilbert, Arizona, United States
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States
City of Hope
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
Engraftment of SER-155
Prevalence of SER-155 strains in subject stool measured before and after treatment courses
Time frame: Day 100
Abundance of Enterococcus and Enterobacteriaceae
Time frame: Day 100
Combined and individual incidence of bloodstream infections, gastrointestinal infections, and acute Graft-versus Host Disease
Time frame: Day 100
Incidence and duration of febrile neutropenia
Time frame: Day 100
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Once daily dosing with SER-155 placebo
Duarte, California, United States
University of California, Los Angeles - Division of Hematology-Oncology
Marina del Rey, California, United States
Georgetown (MedStar Health)
Washington D.C., District of Columbia, United States
University of Florida - Division of Hematology & Oncology
Gainesville, Florida, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Harvard Medical School - Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
...and 3 more locations