Clinical trial NCT04995653: A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allogeneic Hematopoietic Stem Cell Transplantation
Keywords: Microbiome
stem cell transplant
Lead sponsor: Seres Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Memorial Sloan Kettering Cancer Center
First posted: 2021-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability of SER-155, including incidence and severity of adverse events, serious adverse events, or adverse events of special interest
timeFrame: Day 100
measure: Engraftment of SER-155
timeFrame: Day 100
Secondary outcomes:
measure: Abundance of Enterococcus and Enterobacteriaceae
timeFrame: Day 100
measure: Combined and individual incidence of bloodstream infections, gastrointestinal infections, and acute Graft-versus Host Disease
timeFrame: Day 100
measure: Incidence and duration of febrile neutropenia
timeFrame: Day 100
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner Health - MD Anderson Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic - Scottsdale
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: Marina Del Rey
country: United States
facility: University of California, Los Angeles - Division of Hematology-Oncology
state: California
city: Washington
country: United States
facility: Georgetown (MedStar Health)
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida - Division of Hematology & Oncology
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Boston
country: United States
facility: Harvard Medical School - Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: MSKCC
name: Doris Ponce, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seres Therapeutics, Inc.
name: Bina Tejura, MD
role: STUDY_DIRECTOR
References: