Allogeneic Hematopoietic Stem Cell TransplantationPhase 1NCT04995653
A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT
A Phase 1 study testing Vancomycin Pre-Treatment and SER-155 in people with Allogeneic Hematopoietic Stem Cell Transplantation, run by Seres Therapeutics, Inc. at 13 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation
- What is being tested?
- Vancomycin Pre-Treatment and SER-155
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 13 sitesUnited States
- Study dates
- 24 Nov 2021to 23 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Harvard Medical School - Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27514
University of Chicago Medical Center
Chicago, Illinois, 60637
City of Hope
Duarte, California, 91010
University of Florida - Division of Hematology & Oncology
Gainesville, Florida, 32610
Banner Health - MD Anderson Medical Center
Gilbert, Arizona, 85234
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
University of California, Los Angeles - Division of Hematology-Oncology
Marina del Rey, California, 90292
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85259
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Georgetown (MedStar Health)
Washington D.C., District of Columbia, 21044
About this study
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)
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
Read the 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).
- Being tested
- Vancomycin Pre-Treatment, Vancomycin Placebo, SER-155, SER-155 Placebo
- Keywords
- Microbiome, stem cell transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin Pre-TreatmentDrug
Four times daily dosing with Vancomycin
Vancomycin PlaceboDrug
Four times daily dosing with Vancomycin Placebo
SER-155Drug
Once daily dosing with SER-155
SER-155 PlaceboDrug
Once daily dosing with SER-155 placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Open Label Study | Experimental | Vancomycin \& SER-155 Receives: Drug: Vancomycin Pre-Treatment; Drug: SER-155 |
| Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study | Experimental | Vancomycin \& SER-155 OR Vancomycin placebo \& SER-155 placebo Receives: Drug: Vancomycin Pre-Treatment; Drug: Vancomycin Placebo; Drug: SER-155; Drug: SER-155 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 100
Engraftment of SER-155
Prevalence of SER-155 strains in subject stool measured before and after treatment courses
Measured: Day 100
Secondary outcomes (3)
Abundance of Enterococcus and Enterobacteriaceae
Measured: Day 100
Combined and individual incidence of bloodstream infections, gastrointestinal infections, and acute Graft-versus Host Disease
Measured: Day 100
Incidence and duration of febrile neutropenia
Measured: Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start24 Nov 2021
- Primary completion23 Jul 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seres Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor
- Investigators
- Doris Ponce, MD, Principal investigator, MSKCCBina Tejura, MD, Study director, Seres Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995653
- Sponsor's protocol ID
- SER-155-001
- Status last verified
- Sep 2024
- First submitted
- 13 Jul 2021
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04995653
- Acronym / sponsor ID
- SER-155-001
- Keywords
- Microbiome, stem cell transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seres Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Open Label Study | Experimental | Drug: Vancomycin Pre-Treatment, Drug: SER-155Vancomycin \& SER-155 |
| Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study | Experimental | Drug: Vancomycin Pre-Treatment, Drug: Vancomycin Placebo, Drug: SER-155, Drug: SER-155 PlaceboVancomycin \& SER-155 OR Vancomycin placebo \& SER-155 placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vancomycin Pre-TreatmentFour times daily dosing with Vancomycin | Drug | Cohort 1 - Open Label Study, Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study |
| Vancomycin PlaceboFour times daily dosing with Vancomycin Placebo | Drug | Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study |
| SER-155Once daily dosing with SER-155 | Drug | Cohort 1 - Open Label Study, Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study |
| SER-155 PlaceboOnce daily dosing with SER-155 placebo | Drug | Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study |
Primary outcome
Safety and tolerability of SER-155, including incidence and severity of adverse events, serious adverse events, or adverse events of special interest
Time frame: Day 100
Incidence and severity of participants with adverse events, serious adverse events, or adverse events of special interest
Engraftment of SER-155
Time frame: Day 100
Prevalence of SER-155 strains in subject stool measured before and after treatment courses
3 secondary outcomes
Abundance of Enterococcus and Enterobacteriaceae
Time frame: Day 100
Combined and individual incidence of bloodstream infections, gastrointestinal infections, and acute Graft-versus Host Disease
Time frame: Day 100
Incidence and duration of febrile neutropenia
Time frame: Day 100
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris Ponce, MD principal investigator
MSKCC
Bina Tejura, MD study director
Seres Therapeutics, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vancomycin Pre-Treatment and SER-155 in people with Allogeneic Hematopoietic Stem Cell Transplantation, run by Seres Therapeutics, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of SER-155, including incidence and severity of adverse events, serious adverse events, or adverse events of special interest (time frame: Day 100). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.