About this trial
To evaluate the safety and efficacy of CD19-CAR-DNT cells in subjects with relapsed/refractory autoimmune diseases
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- CD19-CAR-DNT cells
Treatment groups
Sponsors and collaborators
RenJi Hospital
Lead sponsor
Guangdong Ruishun Biotech Co., Ltd
Collaborator