Safety Study of CC312 in Autoimmune Disease Patients

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

November 8, 2024

Primary Completion Date

November 8, 2026

Study Completion Date

November 8, 2026

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

Trial Locations (1)

300030

RECRUITING

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CytoCares Inc

INDUSTRY