NCT06888960

Safety Study of CC312 in Autoimmune Disease Patients

An Exploratory Clinical Study on the Safety of CC312 in Treating Patients With Refractory Autoimmune Diseases

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

Summary

This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune diseases. The trial also assesses pharmacokinetics (PK) and preliminary efficacy. CC312 is a trispecific T cell engager (TriTE) that targets the B cell surface antigen CD19, the T cell antigen CD3, and the T cell co-stimulatory molecule CD28. Given its mechanism of action, which is similar to the "biopharmaceutical version" of CAR-T, there is a higher risk of cytokine release syndrome (CRS) at the onset of infusion administration. Therefore, a lower priming dose will be administered before the therapeutic dosing phase to mitigate this risk and ensure safety, followed by a therapeutic dose to achieve and maintain efficacy. The study is divided into three dose groups, with 3-6 subjects enrolled in each group, resulting in a total of 9-18 subjects in the study. A "3+3" dose escalation design is employed to systematically evaluate the safety and determine the optimal dose of CC312.

Conditions

• Systemic Lupus Erythematosus (SLE)
• Idiopathic Inflammatory Myopathy (IIM)
• Systemic Sclerosis (SSc)
• Rheumatoid Arthritis (RA)
• Primary Immune Thrombocytopenia (ITP)
• Autoimmune Hemolytic Anemia

Interventions

Type	Name	Description
BIOLOGICAL	CC312	After a 28-day screening period, subjects who meet the inclusion and exclusion criteria will be enrolled for baseline assessments and biological sample collection prior to the guided administration period. The guided dose of CC312 will be administered via IV infusion on Day -3, followed by safety and tolerability assessments on the third day after the initial administration (i.e., Day -1). The therapeutic dose of CC312 will be administered via IV infusion on Day 1, with subsequent infusions scheduled on Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25. Comprehensive safety and tolerability assessments will be conducted at each of these time points.

Timeline

• Start date: 2024-11-08
• Primary completion: 2026-11-08
• Completion: 2026-11-08
• First posted: 2025-03-21
• Last updated: 2025-09-17

Locations

1 site across 1 country: China