This study is a prospective single-arm open-label clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune disease. A total of 30 subjects will be enrolled in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
GT719 Injection
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
RECRUITINGProportion of participants experiencing dose limiting toxicity
Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion
Time frame: 28 days
Incidence of treatment-emergent adverse events
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards
Time frame: 2 years
Efficacy outcomes for SLE
SLE response index 4 (SR-4) response
Time frame: 14 days; 1, 2, 3 and 6 Months post GT719 infusion
Efficacy outcomes for Systemic Sclerosis
ACR-CRISS score (CRISS score≥0.6 improvment, \<0.6 no improvment)
Time frame: 14 days; 1, 2, 3, and 6 months post GT719 infusion
Efficacy outcomes for Inflammatory Myopathy
Total Improvement Score (TIS)
Time frame: 14 days; 1, 2, 3, and 6 months post GT719 infusion
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