This study is an open-label, single-arm, dose-escalation and dose-expansion clinical trial designed to evaluate the safety, efficacy and cellular pharmacokinetics of GT801 injection in patients with moderate to severe refractory autoimmune diseases.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
GT801 Injection
Renji Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGProportion of participants experiencing dose limiting toxicity
The proportion of participants with dose-limiting toxicity (DLT) occurring within 28 days after infusion
Time frame: 28 days
Adverse Events (AEs) occurring after infusion and their proportions
Adverse Events (AEs) occurring after infusion and their proportions
Time frame: 3 months
Efficacy outcomes for Systemic Lupus Erythematosus (SLE)
SLE Response index 4(SRI-4) response: Min/Max Value: Not specified; a decrease in score indicates improvment, higher scores indicate worse outcome
Time frame: 1, 2, 3 and 6 Months post GT801 infusion
Efficacy outcomes for lupus nephritis (LN)
Renal response rate
Time frame: 1, 2, 3 and 6 Months post GT801 infusion
Efficacy outcomes for membranous nephropathy (MN)
Renal response rate
Time frame: 1, 2, 3 and 6 Months post GT801 infusion
Efficacy outcomes for Idiopathic Inflammatory Myopathies (IIM)
Total lmprovement Score (TlS): Min/Max Value: Not specified; an increase in score indicates improvement, higher scores indicate better outcome.
Time frame: 1, 2, 3 and 6 Months post GT801 infusion
Efficacy outcomes for Systemic Sclerosis (SSc)
Combined Response Index in Systemic Sclerosis (CRISS): the score ranges from 0 to 1 point; a score ≥ 0.6 indicates treatment improvement, while a score \< 0.6 indicates no disease improvement.
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Time frame: 1, 2, 3 and 6 Months post GT801 infusion
Efficacy Outcomes for ANCA-Associated Vasculitis (AAV)
The proportion of subjects achieving complete remission and partial remission
Time frame: 6 and 12 Months post GT801 infusion
Efficacy Outcomes for Participants with Sjogren's Syndrome
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)response rates
Time frame: 6 and 12 Months post GT801 infusion
Efficacy Outcomes for Participants with Sjogren's Syndrome
EULAR Sjögren's Syndrome Patient-Reported Index (ESSPRI)response rates
Time frame: 6 and 12 Months post GT801 infusion
Cellular Kinetics of All Participants: Time to Peak Expansion of GT801 Cells After Infusion (Tmax)
Time to Peak Expansion (Tmax) refers to the time point at which the infused target cells proliferate to the peak quantity in the participants' bodies.
Time frame: From infusion to 12 months
Cellular Kinetics of All Participants: Expansion Peak of GT801 Cells After Infusion (Cmax)
Expansion Peak (Cmax) refers to the maximum quantity of infused GT801 cells achieved during their proliferation in the participants' bodies.
Time frame: From infusion to 12 months
Cellular Kinetics of All Participants: Area Under the Curve (AUC) of GT801 Cells After Infusion
Area Under the Curve (AUC) refers to the area enclosed by the curve of GT801 cell quantity change over time after infusion and the time axis.
Time frame: From infusion to 12 months
Cellular Kinetics of All Participants: Duration of Detectable Concentration of GT801 Cells After Infusion (Tlast)
Duration of Detectable Concentration (Tlast) refers to the time period from the infusion of GT801 cells to the last time point at which the target cells can be detected in the peripheral blood or target tissues.
Time frame: From infusion to 12 months
Pharmacodynamic characteristics in participants for all participants
Monitor serum cytokine levels after infusion
Time frame: From infusion to 2 months