NCT07193810

A Study of CC312 for Relapsed/Refractory Autoimmune Diseases

Exploratory Clinical Study on the Safety and Preliminary Efficacy of CC312 in the Treatment of Relapsed/Refractory Autoimmune Diseases

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: CytoCares Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, multiple ascending dose investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CC312 in adult patients with relapsed or refractory autoimmune diseases.

Conditions

• SLE - Systemic Lupus Erythematosus
• IIM- Idiopathic Inflammatory Myopathies
• SSc-Systemic Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	CC312	The priming dose of CC312 will be administered intravenously on Day -3, followed by safety and tolerability evaluations on Day -1 (3 days post-first dose). The first therapeutic dose of CC312 will be administered on Day 1, with subsequent doses administered on Day 4, 8, and 11. Corresponding safety and tolerability assessments will be performed with each dose. Based on the evaluation of clinical efficacy, B-cell depletion, and safety/tolerability profile at the end of Day 14, the dose for the subsequent therapeutic dosing will be determined (maintained or escalated). Thereafter, therapeutic dosing will be administered on Days 15, 18, 22, and 25, accompanied by scheduled safety and tolerability assessments.

Timeline

• Start date: 2025-09-23
• Primary completion: 2027-09-29
• Completion: 2027-09-29
• First posted: 2025-09-26
• Last updated: 2026-04-14

Locations

1 site across 1 country: China