Safety and Efficacy Study of CD19-CAR-DNT Cells in Autoimmune Diseases

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRenJi Hospital

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

48 Participants
are divided into 1 treatment group

Sponsors and collaborators

RenJi Hospital

Lead sponsor

Guangdong Ruishun Biotech Co., Ltd

Collaborator