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Trial record 1 of 1 for:    SER-155
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A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04995653
Recruitment Status : Recruiting
First Posted : August 9, 2021
Last Update Posted : November 10, 2022
Sponsor:
Collaborator:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Seres Therapeutics, Inc.

Study Description
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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

Condition or disease Intervention/treatment Phase
Allogeneic Hematopoietic Stem Cell Transplantation Drug: Vancomycin Pre-Treatment Drug: Vancomycin Placebo Drug: SER-155 Drug: SER-155 Placebo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 24, 2021
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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: Vancomycin Placebo
Four times daily dosing with Vancomycin Placebo

Drug: SER-155
Once daily dosing with SER-155

Drug: SER-155 Placebo
Once daily dosing with SER-155 placebo


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of SER-155, including incidence and severity of adverse events, serious adverse events, or adverse events of special interest [ Time Frame: Day 100 ]
    Incidence and severity of participants with adverse events, serious adverse events, or adverse events of special interest

  2. Engraftment of SER-155 [ Time Frame: Day 100 ]
    Prevalence of SER-155 strains in subject stool measured before and after treatment courses


Secondary Outcome Measures :
  1. Abundance of Enterococcus and Enterobacteriaceae [ Time Frame: Day 100 ]
  2. Combined and individual incidence of bloodstream infections, gastrointestinal infections, and acute Graft-versus Host Disease [ Time Frame: Day 100 ]
  3. Incidence and duration of febrile neutropenia [ Time Frame: Day 100 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 sibling, haploidentical related donor, HLA-matched unrelated donor, or HLA 1-antigen mismatched unrelated 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04995653


Contacts
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Contact: Bina Tejura, MD 617-945-9626 clinicalstudies@serestherapeutics.com

Locations
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United States, Arizona
Mayo Clinic - Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Nandita Khera, MD         
United States, Florida
University of Florida - Division of Hematology & Oncology Not yet recruiting
Gainesville, Florida, United States, 32610
Contact: Nosha Farhadfar, MD         
Mayo Clinic - Jacksonville Not yet recruiting
Jacksonville, Florida, United States, 32224
Contact: Hemant Murthy, MD         
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Satyajit Kosuri, MD         
United States, Massachusetts
Harvard Medical School - Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Zachariah DeFilipp, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Doris Ponce, MD         
United States, Washington
Fred Hutchinson Cancer Research Center Not yet recruiting
Seattle, Washington, United States, 98109
Contact: David Fredricks, MD         
Sponsors and Collaborators
Seres Therapeutics, Inc.
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Doris Ponce, MD MSKCC
Study Director: Bina Tejura, MD Seres Therapeutics, Inc.
More Information
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Responsible Party: Seres Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04995653    
Other Study ID Numbers: SER-155-001
First Posted: August 9, 2021    Key Record Dates
Last Update Posted: November 10, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seres Therapeutics, Inc.:
Microbiome
stem cell transplant
Additional relevant MeSH terms:
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Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents