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

Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04995653
• Other study ID #: SER-155-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 24, 2021
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: Seres Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allogeneic Hematopoietic Stem Cell Transplantation

Intervention

Drug:
• Vancomycin Pre-Treatment
Four times daily dosing with Vancomycin
• Vancomycin Placebo
Four times daily dosing with Vancomycin Placebo
• SER-155
Once daily dosing with SER-155
• SER-155 Placebo
Once daily dosing with SER-155 placebo

Locations

Country	Name	City	State
United States	Harvard Medical School - Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina
United States	University of Chicago Medical Center	Chicago	Illinois
United States	City of Hope	Duarte	California
United States	University of Florida - Division of Hematology & Oncology	Gainesville	Florida
United States	Banner Health - MD Anderson Medical Center	Gilbert	Arizona
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	University of California, Los Angeles - Division of Hematology-Oncology	Marina Del Rey	California
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	Mayo Clinic - Scottsdale	Scottsdale	Arizona
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Georgetown (MedStar Health)	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Seres Therapeutics, Inc.	Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Engraftment of SER-155	Prevalence of SER-155 strains in subject stool measured before and after treatment courses	Day 100
Secondary	Abundance of Enterococcus and Enterobacteriaceae		Day 100
Secondary	Combined and individual incidence of bloodstream infections, gastrointestinal infections, and acute Graft-versus Host Disease		Day 100
Secondary	Incidence and duration of febrile neutropenia		Day 100