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MTP-101-C for Immune-related Colitis and Dermatitis

This study is investigating MTP-101-C, a freeze-dried, encapsulated product made from healthy donor fecal microbiota (gut bacteria), for people with immune-related colitis (inflammation of the colon) or immune-related dermatitis (skin inflammation). These conditions are caused by certain cancer treatments and have not responded to steroids. The study aims to see if MTP-101-C can help reverse these conditions. We are looking for 30 participants, aged 18 and older, who can swallow oral medication. The main goals are to track any side effects and determine safe dosage levels. This study is currently recruiting participants.

Study design
This is an interventional study with a planned enrollment of 30 participants. The study does not specify a phase.
What's involved
You would take MTP-101-C for 28 days, during which your steroid medication would be gradually reduced. Biospecimens will be collected periodically.
Compensation
Not stated in the trial record.
Follow-up
Your condition will be assessed after completing MTP-101-C treatment (around day 28-35) and again at 6 weeks (around day 42-49).

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

NCT06499896

Healthy-donor Microbiome MTP-101-C in Steroid Relapse/Refractory Immune-related Cutaneous Adverse Events (irCAEs) and Immune-mediated Colitis (IMC)

Withdrawn
PHASE2Ages 18+InterventionalTreatment
Diwakar Davar
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:MTP-101-C

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over Up to 2 months
+1 more outcome measured

Conditions

Immune-mediated Colitis (IMC)
Immune-related Dermatitis

Explore related trials

Immune-Mediated ColitisImmune-related Dermatitis

NCT06499896

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvaniano site contact published

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

  • Diwakar M Davar, MD, PhD · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Able to swallow oral medication.
The participant provides written informed consent for the trial.
Willingness to use contraception for duration of trial participation. Male participants: A male participant must agree to use a contraception per protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
Clinically confirmed inflammatory irCAE or endoscopically confirmed IMC. Cohort 1 (irCAE): Patients with maculopapular rash, psoriasiform, lichenoid eruptions or bullous pemphigoid of at least grade 3 severity per CTCAE grading system (i.e. \>30% BSA with moderate or severe symptoms) during Screening.
Prior receipt of anti-PD(L)1 and/or anti-CTLA-4 singly or in combination with other approved or investigational agents including chemotherapy or targeted therapy.
Receipt of high-dose systemic corticosteroids defined as 1-2mg/kg prednisone equivalent daily (either oral or intravenous) with a taper over 4-6 weeks as defined by society consensus guidelines102-105; AND
No receipt of biologic such as but not limited to (dupilumab, rituximab) prior to enrollment.
NOTE: Patients must have received steroids to be eligible.
NOTE: Steroid "resistant" disease: patients whose symptoms responded (reduction in a CTCAE grade) initially but who developed recurrence upon steroid taper or discontinuation.
NOTE: Steroid "refractory" disease: patients whose symptoms have not clinically improved by a CTCAE grade in ≥48 hours or maximum of 14 days.
Receipt of high-dose systemic corticosteroids defined as 1-2mg/kg prednisone equivalent daily (either oral or intravenous) with a taper over 4-6 weeks as defined by society consensus guidelines102-105; AND
No receipt of biologic such as but not limited to (TNFα inhibitor infliximab OR α₄β₇ integrin inhibitor vedolizumab) prior to enrollment.
Patients must have received steroids to be eligible.
Steroid "resistant" disease: patients whose symptoms responded (reduction in a CTCAE grade) initially but who developed recurrence upon steroid taper or discontinuation.
Steroid "refractory" disease: patients whose symptoms have not clinically improved by a CTCAE grade in ≥48 hours or maximum of 14 days.
Patient may have received any number of lines of prior systemic therapy.
Patient with any solid tumor or hematologic malignancy are eligible.
Patient must not be receiving concurrent radiation therapy.
Willingness to undergo cohort-specific evaluation.
Cohort 1: Dermatologic evaluation, and skin biopsy evaluation prior to and after MTP-101-C administration.
Cohort 2: GI evaluation, and endoscopic evaluation including colonoscopies prior to and after MTP-101-C administration.
Willingness to undergo correlative blood and stool sampling.
Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2.
Patients with ECOG PS 2 wherein the decline in PS from baseline is deemed secondary to IMC may be enrolled at the discretion of Sponsor-Investigator.
Patients with ECOG PS 2 wherein PS is at baseline and deemed secondary to disease are excluded.
Have adequate organ function per specimens must be collected within 7 days prior to the start of study treatment.

Exclusion

Multiple irAEs besides irCAE or IMC.
Patients with concurrent ≥Grade 3 irAEs besides irCAE or IMC that necessitate systemic immune suppression are not candidates for this trial.
Patients with irCAE and/or IMC that are not otherwise clarified in Section 5.1.5 (irCAE including alopecia etc.) are not candidates for this trial.
Patients with concomitant irAEs that are well controlled (≤Grade 1 or Grade 2 on repletion medication) may be enrolled at the discretion of Sponsor-Investigator.
Diagnosis of immunodeficiency, immunosuppression or any other form of immunosuppressive therapy besides steroids/biologics within 7 days prior to the first dose of MTP-101-C treatment.
Patients at high risk of MDRO colonization including: nursing home residence, age \>85, underlying diseases (dementia, poorly controlled diabetes, chronic wounds), in-dwelling medical devices (urinary catheters, feeding tubes, PEG tubes) and a prior history of MDRO colonization.
Contraindication to endoscopy (cohort 2 only).
Contraindication to MTP-101-C administration.
Any prior head/neck and/or abdominal surgery resulting in potentially altered absorption of orally administered FMT pills.
Active bacterial infection requiring systemic antibiotic therapy.
Received live vaccines within 30 days prior to the first dose of study treatment and while participating in the study

What this trial measures

  • Incidence of adverse events (AEs)Up to 2 months

    Incidence of adverse events (AEs) in ICB-treated cancer patients treated with MTP-101-C.

  • Incidence of Dose-Limiting Toxicities (DLTs)Up to 2 months

    Incidence of dose-limiting toxicities (DLTs) in ICB-treated cancer patients treated with MTP-101-C. DLT is defined as any adverse event(s) (AEs) considered possibly, probably, or definitely related to MTP-101-C, which occur during the treatment phase. During DLT monitoring period, no further accrual will be permitted. Any patient who has started the studied treatment will be evaluable for safety. AEs will be considered DLTs if deemed related to study therapy: Hematologic: Grade 4 neutropenia, Febrile neutropenia, Grade ≥ 3 neutropenic infection, Grade ≥ 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia. Non-hematologic: Grade ≥ 3 toxicities (non-laboratory), Grade ≥ 3 nausea, vomiting or diarrhea despite maximal medical intervention, Grade 4 aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Other (non-AST/ALT) non-hematologic Grade ≥ 3 laboratory value if the abnormality leads to overnight hospitalization