Primary Objective: To evaluate the safety and efficacy of CHT105 Injection in subjects with relapsed/refractory autoimmune diseases. Secondary Objective:To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of CHT105 Injection. Indication: Immune Thrombocytopenia (ITP)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Single-dose administration and Multiple-dose administration, administered dose:2\*10\^8 CAR-T cells,6\*10\^8 CAR-T cells,1.8\*10\^9 CAR-T cells,3.6\*10\^9 CAR-T cells.
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Types, severity, and frequency of adverse events (AEs)
Time frame: Throughout the study period, up to 52 weeks.
Complete response rate and partial response rate
Time frame: Week 12,Week 24
Peripheral blood CAR copy number
Time frame: Day 1,Day 4,Day 7,Day 10,Day 21
Peripheral blood lymphocyte subsets
Time frame: Day 1,Day 4,Day 7,Day 10,Week 2,Week 3,Week 4,Week 8,Week 12,Week 24,Week 36,Week 52
Autoantibodies
Time frame: Day 1,Day 7,Week 2,Week 3,Week 4,Week 8,Week 12,Week 24,Week 36,Week 52
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