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

Phase 1

Completed

• Conditions: Allogeneic Hematopoietic Stem Cell Transplantation
• Interventions: Drug: Vancomycin Pre-Treatment; Drug: SER-155; Drug: Vancomycin Placebo; Drug: SER-155 Placebo

• Registration Number: NCT04995653
• Lead Sponsor: Seres Therapeutics, Inc.

Brief 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

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 Timeline

• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-08-09
• Study Start: 2021-11-24
• Primary Completion: 2024-07-23
• Study Completion: 2024-07-23
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study	SER-155 Placebo	Vancomycin \& SER-155 OR Vancomycin placebo \& SER-155 placebo
Cohort 1 - Open Label Study	SER-155	Vancomycin \& SER-155
Cohort 1 - Open Label Study	Vancomycin Pre-Treatment	Vancomycin \& SER-155
Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study	Vancomycin Pre-Treatment	Vancomycin \& SER-155 OR Vancomycin placebo \& SER-155 placebo
Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study	Vancomycin Placebo	Vancomycin \& SER-155 OR Vancomycin placebo \& SER-155 placebo
Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study	SER-155	Vancomycin \& SER-155 OR Vancomycin placebo \& SER-155 placebo

Primary Outcome Measures

Name	Time	Method
Engraftment of SER-155	Day 100	Prevalence of SER-155 strains in subject stool measured before and after treatment courses
Safety and tolerability of SER-155, including incidence and severity of adverse events, serious adverse events, or adverse events of special interest	Day 100	Incidence and severity of participants with adverse events, serious adverse events, or adverse events of special interest

Secondary Outcome Measures

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

Trial Locations

Locations (13)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Banner Health - MD Anderson Medical Center; 🇺🇸 Gilbert, Arizona, United States

City of Hope; 🇺🇸 Duarte, California, United States

University of California, Los Angeles - Division of Hematology-Oncology; 🇺🇸 Marina Del Rey, California, United States

Mayo Clinic - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

University of Florida - Division of Hematology & Oncology; 🇺🇸 Gainesville, Florida, United States

University of North Carolina Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Georgetown (MedStar Health); 🇺🇸 Washington, District of Columbia, United States

Mayo Clinic - Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Harvard Medical School - Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic - Rochester; 🇺🇸 Rochester, Minnesota, United States

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States