Evaluation of CID-103 Safety and Effectiveness in Adults with Active and Chronic Antibody-Mediated Kidney Transplant Rejection

What this Trial Is About

Researchers are studying CID-103, a new anti-CD38 monoclonal antibody, to evaluate its safety and effectiveness in adults with active and chronic antibody-mediated rejection ABMR following kidney transplant. This global Phase 12 trial aims to find a safe dose range and assess clinical efficacy to provide potential new treatment options for people who do not respond well to current therapies. The study has two parts Part A tests increasing doses of CID-103 to assess safety, tolerability, and find the optimal dose, while Part B enrolls about 40 participants to further evaluate safety and effectiveness at that dose. CID-103 is administered by intravenous infusion, starting with a priming dose of 150 mg in the first week, then continued at the target dose. Treatment may last up to 12 months, followed by a post-treatment safety follow-up period. Participants will undergo regular assessments including biopsies, laboratory tests, and monitoring for adverse events and immune responses. The main outcomes measured include safety events, serious adverse events, antibody development, and biopsy-proven resolution of rejection activity. The study lasts up to 65 weeks, during which kidney function, protein levels, donor-specific antibodies, and other markers will be closely monitored to evaluate treatment effects and participant safety.

A Two Part Dose-escalation Safety and Efficacy Study of CID-103 in Adults With Active and Chronic Active Renal Allograft Antibody Mediated Rejection (ABMR).