Open
Actively Recruiting
A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT
About
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
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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 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:
- 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.
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Study Stats
Protocol No.
23-000582
Category
Other Cancer
Principal Investigator
Contact
Location
- UCLA Westwood