To evaluate the safety and efficacy of CD19-CAR-DNT cells in subjects with relapsed/refractory autoimmune diseases
Voluntarily sign an ICF and expect to complete the study procedures for follow-up examinations and treatment;
Aged 18 to 75 years (including cut-offs), regardless of gender;
Have undergone a hysterectomy or bilateral oophorectomy;
Medically recognized as ovarian failure;
Individuals with a history of severe drug allergies or allergic constitution;
Active infectious diseases: such as tuberculosis, central nervous system infection, hepatitis, enteritis, etc.;
The following serious diseases: malignant tumor, end-stage renal failure, alveolar hemorrhage requiring mechanical ventilation, acute mononeuritis multiplex, or CNS involvement;
Renal disease: creatinine clearance rate < 60mL/min and serum creatinine > 1.5 times ULN within 1 week before lymphodepleting chemotherapy; Patients required hemodialysis or high-dose glucocorticoid therapy (e.g., prednisone (or equivalent) ≥100mg per day) within 6 months before screening;
Single group
CD19-CAR-DNT cells
Biological/VaccineLentiviral vector-transduced DNT cells to express anti-CD19 CAR. Prior to cellular infusion, each patient received cyclophosphamide and fludarabine lymphodepleting chemotherapy.
DLT
To evaluate the safety, tolerability, and determine the recommended dosage of CD19-CAR-DNT Cell Therapy for Relapsed/Refractory autoimmune disease.
MTD
MTD was the highest dose for DLT in ≤1/6 subjects.
Incidence of abnormalities
Incidence of abnormalities in AE/SAE/AESI/laboratory tests/electrocardiograms/vital signs.
Pharmacokinetics (PK) indicator (Cmax)
The peak concentration of CD19-CAR-DNT cells amplified in the peripheral blood (Cmax, detected by qPCR).
Pharmacokinetics (PK) indicator (AUC)
CD19-CAR-DNT cells blood concentrations will be measured at different time points to evaluate the area under the curve (AUC). (AUC, detected by qPCR)
Pharmacokinetics (PK) indicator (Tmax)
CD19-CAR-DNT cells blood concentrations will be measured at different time points to evaluate the peak plasma time (Tmax). Tmax is defined as the time to reach the highest concentration (Tmax, detected by qPCR).
Pharmacokinetics (PK) indicator (T1/2)
CD19-CAR-DNT cells blood concentrations will be measured at different time points to evaluate the elimination half-life in hours (T1/2). T1/2 is defined as the time point when the concentration of CD19-CAR-DNT reaches half of maximum in a patient's peripheral blood (T1/2, detected by qPCR).
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RenJi Hospital
Lead sponsor
Guangdong Ruishun Biotech Co., Ltd
Collaborator
