Study of CC312 to Evaluate Safety and Early Effectiveness in Adults with Relapsed or Resistant Autoimmune Diseases

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and early effectiveness of CC312 in adults aged 18 to 65 with relapsed or refractory autoimmune diseases such as Systemic Lupus Erythematosus SLE, Idiopathic Inflammatory Myopathies IIM, and Systemic Sclerosis SSc. This early-phase, open-label study is investigator-initiated and sponsored by CytoCares Inc. The study involves administering CC312 intravenously in a series of doses starting with a priming dose on Day -3, followed by therapeutic doses on Days 1, 4, 8, and 11. After evaluating safety, B-cell depletion, and clinical response on Day 14, the dose may be maintained or increased, with additional doses given on Days 15, 18, 22, and 25. Safety and tolerability are assessed throughout the dosing schedule. Participants will undergo regular safety and tolerability assessments, alongside laboratory tests measuring drug levels, immune cells, antibodies, and disease activity scores such as the SLE Responder Index and modified Rodnan Skin Score. The study will monitor adverse events and dose-limiting toxicities over two years, tracking multiple disease activity markers and patient and physician global assessments. The total study duration allows for comprehensive monitoring of safety and preliminary efficacy.

A Study of CC312 for Relapsed/Refractory Autoimmune Diseases