A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT
- Interventional
- Recruiting
- NCT04995653
Contact Information
A Phase 1b Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of SER-155 in Adults Undergoing Hematopoietic Stem Cell Transplantation (HSCT) to Reduce the Risk of Infection and Graft vs. Host Disease (GvHD)
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 is a Phase 1b randomized, double-blind, placebo-controlled, multiple dose, multicenter
study designed to evaluate the efficacy, safety and microbiome alterations associated with
SER-155 dosing, after pre-treatment with vancomycin, in adult subjects older than 18 years
who are undergoing Hematopoietic Stem Cell Transplantation (HSCT).
Gender
All
Age Group
18 Years and up
Accepting 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 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.
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.