A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT
NCT ID: NCT04995653
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2021-11-24
2024-07-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1 - Open Label Study
Vancomycin \& SER-155
Vancomycin Pre-Treatment
Four times daily dosing with Vancomycin
SER-155
Once daily dosing with SER-155
Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study
Vancomycin \& SER-155 OR Vancomycin placebo \& SER-155 placebo
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Seres Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Doris Ponce, MD
Role: PRINCIPAL_INVESTIGATOR
MSKCC
Bina Tejura, MD
Role: STUDY_DIRECTOR
Seres Therapeutics, Inc.
Locations
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Banner Health - MD Anderson Medical Center
Gilbert, Arizona, United States
Mayo Clinic - Scottsdale
Scottsdale, 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
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
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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SER-155-001
Identifier Type: -
Identifier Source: org_study_id
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