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

Completed · Phase 1 · Has a placebo group

Conditions studied: Allogeneic Hematopoietic Stem Cell Transplantation

In brief

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

Key facts

Study ID

NCT04995653

Run by

Seres Therapeutics, Inc.

People needed

60

Starts

2021-11-24

Expected to finish

2024-07-23

Last updated by the study team

2024-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.