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Corticosteroid

Microbiome Treatment for Colitis (FMT-ELIMINATE Trial)

Phase 2

Waitlist Available

Led By Diwakar M Davar, MD, PhD

Research Sponsored by Diwakar Davar

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior receipt of anti-PD(L)1 and/or anti-CTLA-4 therapy

Patients with steroid relapsed/refractory Grade ≥3 irCAE or IMC

Must not have

Active bacterial infection requiring systemic antibiotic therapy

Prior head/neck and/or abdominal surgery affecting absorption of FMT pills

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if a treatment called hdFMT can help reverse side effects from cancer immunotherapy that don't respond to steroids or other drugs. The study will investigate how specific bacteria in the

Who is the study for?

This trial is for individuals with immune-related skin issues like eczema or colitis that haven't improved after steroid treatment. Participants should have these conditions due to cancer immunotherapy and must not respond well to other biologic treatments.

What is being tested?

The study tests MTP-101-C, a healthy-donor microbiome therapy, on patients who didn't get better from steroids or biologics for their skin problems or colitis caused by cancer treatments.

What are the potential side effects?

While the side effects of MTP-101-C are not detailed here, similar microbiome therapies can cause digestive upset, potential infection risks, and immune reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have previously received immunotherapy targeting PD-1, PD-L1, or CTLA-4.

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I have had a severe immune-related side effect from cancer treatment that didn't improve with steroids.

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I am not currently undergoing radiation therapy.

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I am able to care for myself and up to walking around.

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I have not taken any biologic drugs before joining this study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on antibiotics for a bacterial infection.

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I've had surgery on my head/neck or abdomen that affects how I absorb pills.

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I have severe side effects from immunotherapy, not including skin or muscle issues.

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I have not taken immunosuppressive therapy in the last 7 days.

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I cannot undergo endoscopy due to health reasons.

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I cannot take MTP-101-C due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Dose-Limiting Toxicities (DLTs)

Incidence of adverse events (AEs)

Secondary study objectives

Patient Reported Outcomes - FACIT-general

Patient Reported Outcomes - FACT-ICM

Resolution of IMC following MTP-101-C in steroid relapsed/refractory IMC (cohort 2)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: MTP-101-C (Cohort 2: Steroid R/R biologic-naive colitis)Experimental Treatment1 Intervention

Patients given MTP-101-C (encapsulated fecal microbiota, containing \~5 x 1011 bacteria derived from healthy donors). Dosing: 5 capsules/day (Day 1); 2 capsules/day (D2-D28)

Group II: MTP-101-C (Cohort 1: Steroid R/R biologic-naive dermatitis)Experimental Treatment1 Intervention

Patients given MTP-101-C (encapsulated fecal microbiota, containing \~5 x 1011 bacteria derived from healthy donors). Dosing: 5 capsules/day (Day 1); 2 capsules/day (D2-D28)

0 / 11Eligibility criteria met