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A Study of SER-155 for Diarrhea in People on Immunotherapy

This study is looking into SER-155, an experimental treatment made of 16 different types of beneficial bacteria, to see if it can safely treat diarrhea in people who are receiving immunotherapy. The diarrhea must be considered likely related to the immunotherapy. Researchers want to find out if SER-155 causes few or mild side effects. You may be able to join if you are over 18, have received immunotherapy within the last 180 days, and are experiencing moderate to severe diarrhea. The study aims to enroll 15 participants. The study's current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 15 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-related side effects for up to 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06801067

A Study of SER-155 to Treat Diarrhea in People on Immunotherapy

Recruiting
PHASE1Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~15 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:SER-155

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with treatment-related adverse events of special interest
Measured over 1 year
+1 more outcome measured

Conditions

Diarrhea
Enterocolitis

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NCT06801067

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited protocol activities)

    Rockville Centre, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

    Commack, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • David Faleck, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

David Faleck, MD
[email protected]
212-639-8286
Email the study team

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Eligibility criteria

Inclusion

Age \> 18 years
Receipt of ICI (single-agent or combination) within the 180 days preceding screening.
Grade 2 - 3 diarrhea (i.e., increase of at least 4 bowel movements a day above baseline during the screening window), deemed by the treating provider as likely related to ICI therapy, with or without concomitant symptoms of grade 1 - 2 colitis (e.g.
Able to swallow oral medication
Individuals of childbearing potential willing to use a highly effective method of contraception (failure rate of \<1% per year when used consistently and correctly) for 30 days after the last dose of SER-155.
Willing to provide written informed consent, comply with the protocol, and understand the potential risks and benefits of study enrollment and treatment.

Exclusion

Active GI infection, including untreated viral, bacterial or fungal cause(s) of diarrhea.
Received immunosuppressive therapies for suspected or confirmed irEC, including systemic corticosteroids (either oral or intravenous) and/or infliximab, vedolizumab or ustekinumab
Grade 3 colitis symptoms, i.e. severe abdominal pain or peritoneal signs
Admitted to the hospital for irEC
Prednisone (or steroid equivalent) dose \> 10 mg a day for a non-GI irAE at time of screening
Pre-existing inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or microscopic colitis
Pregnant or lactating women
Any condition that requires ongoing prophylactic or therapeutic antibacterial antibiotics
Severe neutropenia, as defined by an absolute neutrophil count (ANC) \< 500 cells/mm\^3, at time of screening
Treatment with investigational medications used for diarrhea/colitis treatment and microbiome therapeutics within 30 days prior to enrollment
Known allergy or intolerance to oral vancomycin
Unable to comply with the protocol requirements
Any condition that in the opinion of the investigator may increase the risk of study participation and/or may interfere with the interpretation of study results

What this trial measures

  • Proportion of participants with treatment-related adverse events of special interest1 year

    Proportion of participants with treatment-related adverse events of special interest, i.e. blood stream infection

  • Proportion of patients with treatment-related adverse events1 year

    Proportion of patients with treatment-related adverse events