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

NCT04995653 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: SER-155-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 13

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

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Keywords

Microbiome; stem cell transplant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Cohort 1 - Open Label Study

EXPERIMENTAL

Vancomycin \& SER-155

Drug: Vancomycin Pre-Treatment; Drug: SER-155

Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study

EXPERIMENTAL

Vancomycin \& SER-155 OR Vancomycin placebo \& SER-155 placebo

Drug: Vancomycin Pre-Treatment; Drug: Vancomycin Placebo; Drug: SER-155; Drug: SER-155 Placebo

Interventions

Vancomycin Pre-Treatment DRUG

Four times daily dosing with Vancomycin

Cohort 1 - Open Label Study; Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study

Vancomycin Placebo DRUG

Four times daily dosing with Vancomycin Placebo

Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study

SER-155 DRUG

Once daily dosing with SER-155

Cohort 1 - Open Label Study; Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study

SER-155 Placebo DRUG

Once daily dosing with SER-155 placebo

Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seres Therapeutics, Inc.: lead
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (13)

Banner Health - MD Anderson Medical Center

Gilbert, Arizona, 85234, United States

Location

Mayo Clinic - Scottsdale

Scottsdale, Arizona, 85259, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

University of California, Los Angeles - Division of Hematology-Oncology

Marina del Rey, California, 90292, United States

Location

Georgetown (MedStar Health)

Washington D.C., District of Columbia, 21044, United States

Location

University of Florida - Division of Hematology & Oncology

Gainesville, Florida, 32610, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Harvard Medical School - Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Study Officials

• Doris Ponce, MD

  MSKCC

  PRINCIPAL INVESTIGATOR

• Bina Tejura, MD

  Seres Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 9, 2021
• Study Start: November 24, 2021
• Primary Completion: July 23, 2024
• Study Completion: July 23, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)