What's the purpose of this trial?
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
This trial is currently open and accepting patients.
What will happen during the trial?
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).
You may be able to join this trial if you:
The following criteria is a partial list of reasons why patients may be
eligible to participate in this clinical trial. Further evaluation with a medical professional is
required.
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.
Additional Trial Information
Phase 1
Enrollment: 75 patients (estimated)
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