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

Seres Therapeutics

Status and phase: Completed; Phase 1

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation

Treatments: Drug: SER-155; Drug: Vancomycin Pre-Treatment; Drug: SER-155 Placebo; Drug: Vancomycin Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04995653

SER-155-001

Details and patient eligibility

About

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

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Cohort 1 - Open Label Study

Experimental group

Description:

Vancomycin \& SER-155

Treatment:

Drug: Vancomycin Pre-Treatment

Drug: SER-155

Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study

Experimental group

Description:

Vancomycin \& SER-155 OR Vancomycin placebo \& SER-155 placebo

Treatment:

Drug: Vancomycin Placebo

Drug: SER-155 Placebo

Drug: Vancomycin Pre-Treatment

Drug: SER-155