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

• Status: Recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seres Therapeutics, Inc.
• Collaborator: Memorial Sloan Kettering Cancer Center
• Treatments: Vancomycin

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, or HLA-matched unrelated donor with either bone marrow or peripheral blood stem cells as a graft source, and with any conditioning regimen

Exclusion Criteria:

Has 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 1 month or 5 half-lives of another investigational treatment.