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

This Phase 2 study is testing a healthy-donor fecal microbiome transplant capsule (MTP-101-C) as a treatment for cancer patients who develop serious immune-related side effects from checkpoint immunotherapy — specifically severe skin reactions (irCAE) or severe colitis (IMC) — that have not responded to steroids. When cancer immunotherapy activates the immune system to fight tumors, it can sometimes trigger these gut or skin complications that are difficult to treat; modifying the gut microbiome may help calm the overactive immune response. Adults with a confirmed Grade 3 or higher skin rash or endoscopically confirmed colitis caused by PD-1 or CTLA-4 immunotherapy drugs, who have already tried steroids but not yet used biologics like infliximab, are eligible. Participation involves taking oral capsules containing donor gut bacteria daily for 4 weeks, tapering off steroids, and undergoing skin or bowel endoscopy evaluations before and after treatment. This summary was prepared with AI assistance to help patients understand the study in plain language.