Actively Recruiting
Phase 1 Study of KAN-004 Treatment for Patients with Immune-Related Diarrhea or Colitis
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2026-04-13
21
Participants Needed
1
Research Sites
104 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the safety and tolerability of KAN-004 for patients with immune-related colitis irColitis and diarrhea caused by antitumor drugs. This Phase I clinical trial focuses on individuals who have developed irColitis related to immune checkpoint inhibitor treatment. The study is sponsored by the Centre hospitalier de lUniversite9 de Montre9al CHUM and aims to understand how well patients tolerate this new biological treatment. KAN-004 is a biological treatment containing a mix of bacteria from healthy donors, prepared as a powder inside capsules for oral intake. Participants with non-steroid refractory irColitis will receive this treatment. The trial includes a 6-week treatment period during which the safety and side effects of KAN-004 will be closely monitored. During the study, participants will take KAN-004 capsules and provide blood and stool samples for analysis. Researchers will track any treatment-emergent adverse events to evaluate safety and tolerability. Participants must be accessible for treatment and follow-up visits, and the study lasts at least 6 weeks. The trial will continue until the planned end date in 2030, with regular assessments throughout the treatment period.
CONDITIONS
Brief Title
KAN-004 for Immune-Related Diarrhea or Colitis
Research Team
W
Wiam Belkaid, PhD
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