Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04995653
Other study ID # SER-155-001
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date November 24, 2021
Est. completion date October 2024

Study information

Verified date January 2024
Source Seres Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date October 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Allogeneic Hematopoietic Stem Cell Transplantation

Intervention

Drug:
Vancomycin Pre-Treatment
Four times daily dosing with Vancomycin
Vancomycin Placebo
Four times daily dosing with Vancomycin Placebo
SER-155
Once daily dosing with SER-155
SER-155 Placebo
Once daily dosing with SER-155 placebo

Locations

Country Name City State
United States Harvard Medical School - Massachusetts General Hospital Cancer Center Boston Massachusetts
United States University of North Carolina Chapel Hill Chapel Hill North Carolina
United States University of Chicago Medical Center Chicago Illinois
United States City of Hope Duarte California
United States University of Florida - Division of Hematology & Oncology Gainesville Florida
United States Banner Health - MD Anderson Medical Center Gilbert Arizona
United States Mayo Clinic - Jacksonville Jacksonville Florida
United States University of California, Los Angeles - Division of Hematology-Oncology Marina Del Rey California
United States Memorial Sloan Kettering Cancer Center New York New York
United States Mayo Clinic - Rochester Rochester Minnesota
United States Mayo Clinic - Scottsdale Scottsdale Arizona
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Georgetown (MedStar Health) Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
Seres Therapeutics, Inc. Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability of SER-155, including incidence and severity of adverse events, serious adverse events, or adverse events of special interest Incidence and severity of participants with adverse events, serious adverse events, or adverse events of special interest Day 100
Primary Engraftment of SER-155 Prevalence of SER-155 strains in subject stool measured before and after treatment courses Day 100
Secondary Abundance of Enterococcus and Enterobacteriaceae Day 100
Secondary Combined and individual incidence of bloodstream infections, gastrointestinal infections, and acute Graft-versus Host Disease Day 100
Secondary Incidence and duration of febrile neutropenia Day 100
See also
  Status Clinical Trial Phase
Recruiting NCT03294824 - Non Randomized Comparative Study With Control
Recruiting NCT04098653 - Decitabine + BUCY vs BUCY Conditioning Regimen for Myeloid Tumors Undergoing Allo-HSCT Phase 2/Phase 3
Recruiting NCT03256071 - Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT Phase 2/Phase 3
Terminated NCT02653196 - A Multi-Institutional Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Malignant Neuro-Epithelial and Other Solid Tumors Early Phase 1
Terminated NCT00429039 - A Study to Accelerate Immune System Recovery Following Stem Cell Transplantation Phase 2
Recruiting NCT06028828 - Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation Phase 2
Recruiting NCT05084027 - Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT Phase 2
Recruiting NCT04123392 - Decitabine + BUCY vs BUCY Conditioning Regimen for TP53+ Myeloid Tumors Undergoing Allo-HSCT Phase 2/Phase 3
Recruiting NCT05596968 - The Gut Microbiome and Sorafenib Maintenance Therapy in FLT3-ITD Positive AML After Allo-HSCT
Recruiting NCT05596981 - The Gut Microbiome in FLT3-ITD+ AML Undergoing Allo-HSCT With Or Without Sorafenib Maintenance After Allo-HSCT
Recruiting NCT05601895 - The Gut Microbiome in FLT3- AL Undergoing Allo-HSCT With Or Without Sorafenib Maintenance
Recruiting NCT03357172 - Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation N/A
Completed NCT02250300 - MLN9708 for the Prophylaxis of Chronic Graft-versus-host Disease in Patient Undergoing Allogeneic Transplantation Phase 1/Phase 2
Recruiting NCT04372524 - Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
Recruiting NCT03593161 - Humor Therapy and Distress After Allogeneic Stem Cell Transplantation N/A
Recruiting NCT05379569 - Comparative Study of BFC and BuCy Conditioning Regimen for Allo-PBSCT in Acute B-cell ALL Phase 4
Not yet recruiting NCT03902041 - The Prospective Randomized Controlled Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic HSCT
Completed NCT02270346 - Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients N/A
Recruiting NCT03297528 - Chemotherapy and DLI for Prevention of Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant Phase 2
Completed NCT01879072 - Prospective Cohort for the Evaluation of Biomarkers Following HCT (BMT CTN 1202)