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

a study on Allogeneic Hematopoietic Cell Transplantation Bone Marrow Transplant Hematopoietic Cell Transplantation Stem Cell Transplant Graft Versus Host Disease

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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

Official Title

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)

Details

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).

Keywords

Allogeneic Hematopoietic Stem Cell Transplantation, Microbiome, stem cell transplant, Vancomycin, Vancomycin Pre-Treatment, SER-155, Open Label Study

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • University of California, Los Angeles - Division of Hematology-Oncology accepting new patients
    Marina Del Rey California 90292 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seres Therapeutics, Inc.
ID
NCT04995653
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 75 study participants
Last Updated