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

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Keywords

Microbiome, stem cell transplant

Brief 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

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).

Emily Walsh, Jonathan U. Peled, Doris M. Ponce, Satyajit Kosuri, Nandita Khera et al. (20 authors)

Journal of Clinical Oncology2025-05-28

10.1200/jco.2025.43.16_suppl.6554

Biomarkers in a phase 1b study of investigational microbiome therapeutic SER-155 in adults undergoing allogeneic hematopoietic cell transplantation (allo-HCT).

Doris M. Ponce, Swarna Pandian, Marcel R.M. van den Brink, Satyajit Kosuri, Nandita Khera et al. (18 authors)

Journal of Clinical Oncology2024-06-01

10.1200/jco.2024.42.16_suppl.6554

Impact of Investigational Microbiome Therapeutic SER-155 on Pathogen Domination: Initial Results from a Phase 1b Study in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation (HCT)

Jonathan U. Peled, Marcel R.M. van den Brink, Doris M. Ponce, Satyajit Kosuri, Nandita Khera et al. (19 authors)

Blood2023-11-02

10.1182/blood-2023-188885

A phase 1b study to evaluate the efficacy, safety, and pharmacokinetics of an investigational microbiome therapeutic, SER-155, in adults undergoing hematopoietic stem cell transplantation.

Doris M. Ponce, Satyajit Kosuri, Nandita Khera, Zachariah DeFilipp, Mary‐Jane Lombardo et al. (10 authors)

Journal of Clinical Oncology2023-06-011 citations

10.1200/jco.2023.41.16_suppl.tps7080

A phase 1b 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 versus host disease (NCT04995653).

Doris M. Ponce, Mary‐Jane Lombardo, Christopher B. Ford, Jonathan U. Peled, Marcel R.M. van den Brink et al. (6 authors)

Journal of Clinical Oncology2022-06-012 citations

10.1200/jco.2022.40.16_suppl.tps7074

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGVancomycin Pre-Treatment

Four times daily dosing with Vancomycin

DRUGVancomycin Placebo

Four times daily dosing with Vancomycin Placebo

DRUGSER-155

Once daily dosing with SER-155

DRUGSER-155 Placebo

Once daily dosing with SER-155 placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability of SER-155, including incidence and severity of adverse events, serious adverse events, or adverse events of special interest	Day 100	Incidence and severity of participants with adverse events, serious adverse events, or adverse events of special interest
Engraftment of SER-155	Day 100	Prevalence of SER-155 strains in subject stool measured before and after treatment courses

Secondary

Measure	Time frame
Abundance of Enterococcus and Enterobacteriaceae	Day 100
Combined and individual incidence of bloodstream infections, gastrointestinal infections, and acute Graft-versus Host Disease	Day 100
Incidence and duration of febrile neutropenia	Day 100

Countries

United States

Outcome results

None listed