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

  • Interventional
  • Recruiting
  • NCT04995653
Eligibility Details Visit Clinicaltrials.gov

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 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).

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 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.

At a Glance

National Government IDNCT04995653

IRB#IRB21-0908

Lead SponsorSeres Therapeutics, Inc.

Lead PhysicianSatyajit Kosuri

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting