systemic lupus erythematosus
Conditions
Interventions
experimental group:CD19.CAR T immune cells
Sponsors
The General Hospital of Western Theater Command
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. All cases were classified as SLE according to the classification criteria of SLE established by EULAR/ACR in 2019 (total score >=10) or the 2012 International Clinical Collaboration for Lupus Research (SLICC) (meeting more than 4 criteria). All patients gave informed consent. 2. Patients with recurrent/refractory systemic lupus erythematosus were diagnosed. 3. Recurrent/refractory cases of systemic lupus erythematosus: refers to patients who have failed to respond to formal induction therapy with two or more traditional immunosuppressants (CTX, MMF, cyclosporine, or tacrolimus) for 9 to 12 months, or relapse after remission. 4. The patient's peripheral blood contained CD19+B cells. 5. Prednisone less than or equal to a total of 10mg/ day. 6. Aged 18-70 years (inclusive). 7. No obvious active infection. 8. Adequate kidney, liver, lung, and heart function, defined as creatinine clearance (as estimated by Cockcroft Gault's formula) > 30mL/min; Serum ALT/AST = 50% showed no clinically significant abnormalities in the ECG. 9. The serum pregnancy test results of fertile women must be negative (women who have been surgically sterilized or who have been postmenopausal for at least 2 years are considered infertile).
Exclusion criteria
Exclusion criteria: 1. Known human immunodeficiency virus (HIV) infection. 2. A known history of hepatitis B (HBsAg positive) or hepatitis C (HCV antibody positive). Subjects with latent or prehepatitis B infection (defined as HBcAb positive and HBsAg negative) can be enrolled if PCR tests for HBV DNA are negative. Moreover, these subjects were required to undergo monthly PCR tests for HBV DNA. Subjects who are serologically positive for HCV antibodies, such as negative PCR results for HCV RNA, can also be enrolled. 3. Existing or prior CNS disease, such as seizures, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any CNS related autoimmune disease. 4. A history of myocardial infarction, angioplasty or stent implantation, unstable angina, or other clinically significant heart disease in the 12 months prior to enrollment. 5. Any medical condition that may affect the assessment of safety or efficacy. 6. Had severe rapid-onset hypersensitivity to any of the drugs to be used in this study. 7. Live vaccine should be administered within 6 weeks or less before starting the preconditioning regimen. 8. Pregnant or lactating subjects. 9. Subjects who did not consent to effective contraception from the time they signed informed consent to 6 months after completion of immunocell therapy. 10. Subjects judged by the investigator had difficulty in completing all visits or operations (including follow-up visits) required by the study protocol, or were not compliant enough to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Effecacy; | — |
Countries
China
Contacts
Public ContactYi Hai
The General Hospital of Western Theater Command
Outcome results
None listed