A Study of CD19 Redirected Autologous T Cells for CD19 Positive Systemic Lupus Erythematosus (SLE)
Sponsored by Shanghai GeneChem Co., Ltd.
About this trial
Last updated 8 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 7 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Clinical diagnosis of systemic lupus erythematosus (SLE) patients
- Patients with CD19+ B-cell SLE as confirmed by Flow Cytometry
- Age: 18-69 years old
- Creatinine < 1.5 mg/dl
- cardiac ejection fraction>55%
- hemoglobin>9g/dL
- Bilirubin <2.0 mg/dl
- Successful test expansion of T-cells
- Adequate venous access for apheresis, and no other contraindications for leukapheresis
- Voluntary informed consent is given
Exclusion Criteria
- Pregnant or lactating women
- Uncontrolled active infection
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
- Previously treatment with any gene therapy products
- Feasibility assessment during screening demonstrates<5% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation
- Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, serious arrhythmia)