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SER-155 for Allogeneic Bone Marrow Transplant

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Chicago Medical Center, Chicago, ILAllogeneic Bone Marrow TransplantSER-155 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new drug to see if it can reduce the risk of infection and graft vs. host disease in adults undergoing stem cell transplantation.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

4 Primary · 8 Secondary · Reporting Duration: Day 365

Day 100
Abundance of Enterococcus and Enterobacteriaceae
Combined and individual incidence of bloodstream infections, gastrointestinal infections, and acute Graft-versus Host Disease
Engraftment of SER-155
Incidence and duration of febrile neutropenia
Safety and tolerability of SER-155, including incidence and severity of adverse events, serious adverse events, or adverse events of special interest
To assess engraftment: prevalence of SER-155 strains in subject stool measured before and after treatment courses through Day 100 with SER-155
To assess the proportion of participants with an adverse events, serious adverse events, or adverse events of special interest through Day 100 after SER-155
To evaluate the individual incidence of the Acute Graft-versus-Host Disease among recipients of SER-155 compared to placebo
To evaluate the individual incidence of the bloodstream infections among recipients of SER-155 compared to placebo
To evaluate the individual incidence of the gastrointestinal infections among recipients of SER-155 compared to placebo
Day 365
To evaluate overall survival among recipients of SER-155 compared to placebo
To evaluate the individual incidence and duration of febrile neutropenia

Trial Safety

Safety Progress

1 of 3

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Trial Design

2 Treatment Groups

Cohort 1 - Open Label Study
1 of 2
Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study
1 of 2

Experimental Treatment

75 Total Participants · 2 Treatment Groups

Primary Treatment: SER-155 · Has Placebo Group · Phase 1

Cohort 1 - Open Label StudyExperimental Group · 2 Interventions: Vancomycin Pre-Treatment, SER-155 · Intervention Types: Drug, Drug
Cohort 2 - Randomized, Double-Blind, Placebo-Controlled StudyExperimental Group · 4 Interventions: Vancomycin Pre-Treatment, Vancomycin Placebo, SER-155, SER-155 Placebo · Intervention Types: Drug, Drug, Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 365

Who is running the clinical trial?

Seres Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
905 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterOTHER
1,845 Previous Clinical Trials
589,940 Total Patients Enrolled
Doris Ponce, MDPrincipal InvestigatorMSKCC
Bina Tejura, MDStudy DirectorSeres Therapeutics, Inc.
2 Previous Clinical Trials
32 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Could you elaborate on the research that has been done concerning SER-155?

"Presently, there are 55 SER-155 trials in progress. Of these studies, 6 have reached the third phase of clinical trial testing. Although a majority of these evaluations take place near Jupiter, Florida, there are 315 other locations running trials for this medication." - Anonymous Online Contributor

Unverified Answer

How many research sites are conducting this experiment?

"In addition to Mayo Clinic - Scottsdale in Scottsdale, Arizona, University of Florida - Division of Hematology & Oncology in Gainesville, Washington and Fred Hutchinson Cancer Research Center in Seattle Massachusetts; 8 other clinical sites are participating this trial." - Anonymous Online Contributor

Unverified Answer

What is the current size of the patient cohort for this investigation?

"To satisfactorily complete this clinical trial, a total of 75 participants must be recruited that meet the selection criteria. Patients can join the study at Mayo Clinic - Scottsdale in Scottsdale, Arizona and University of Florida - Division of Hematology & Oncology in Gainesville, Washington." - Anonymous Online Contributor

Unverified Answer

Are there any available opportunities for participants in this experiment?

"Confirmed. According to clinicaltrials.gov, this medical trial has been open for recruitment since November 24th 2021 and was last updated on the 7th of November 2022 - it is still actively seeking participants." - Anonymous Online Contributor

Unverified Answer

What medical conditions has SER-155 proven to be most effective in treating?

"SER-155 is a clinically approved treatment for staphylococcal infections, the various illnesses caused by staphylococci, and enterocolitis resulting from Staphylococcus aureus." - Anonymous Online Contributor

Unverified Answer

Are there any documented hazards to taking SER-155?

"Due to the initial stage of clinical research, SER-155's safety rating is estimated to be 1 on a scale from 1 to 3. This is because there are limited studies confirming its efficacy and safety." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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