A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT
Purpose
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
Condition
- Allogeneic Hematopoietic Stem Cell Transplantation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- There are 2 parts or cohorts for the trial. Cohort 1 is an open-label study. Cohort 2 is double-blind, randomized, placebo-controlled study.
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort 1 - Open Label Study |
Vancomycin & SER-155 |
|
|
Experimental Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study |
Vancomycin & SER-155 OR Vancomycin placebo & SER-155 placebo |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Seres Therapeutics, Inc.
Study Contact
Detailed Description
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).