This study is an open label, single arm exploratory clinical trial of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus. Patients who are still in an active state after systemic treatment using the standard treatment regimen specified in the treatment guidelines were selected to receive IC19 CAR-T cell single pulse infusion therapy.
Subjects diagnosed with systemic lupus erythematosus who meet the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE;
Prior to screening, treatment with glucocorticoids (sufficient or shock therapy) combined with immunosuppressants (cyclophosphamide, mycophenolate mofetil, antimalarial drugs, azathioprine, methotrexate, leflunomide, tacrolimus, cyclosporine, etc.) and at least one biological agent (rituximab, belimumab, tacrolizumab, etc.) must have been received for at least 2 months, and the dosage must be stable for more than 2 weeks. The disease should still be active or recur after disease remission.
Prednisone (or equivalent) ≥ 7.5 mg/day and ≤ 60 mg/day;
When used in combination with immunosuppressants and/or biologics, there is no minimum daily dose requirement for glucocorticoids.
Diseases of the central nervous system that have clinical significance in the past or during screening, such as seizures, epilepsy, epileptic seizures, cerebrovascular disease (ischemia/hemorrhage), cerebral edema, reversible posterior white matter encephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, encephalitis, CNS vasculitis, or psychiatric disorders;
Screening for acute severe lupus nephritis within the first 2 months, defined as significant deterioration of kidney disease (such as the presence of urine sediment and other laboratory abnormalities) that the researcher believes may require the use of contraindicated drugs or high-dose corticosteroids (prednisone ≥ 100 mg/d or equivalent corticosteroid treatment ≥ 14 days) for treatment in the first 2 months of the study.
If there is an uncontrolled lupus crisis within the first 2 months of screening, the researcher has assessed that it is not suitable to participate in this study;
A large amount of serous fluid accumulation (such as pleural effusion and peritoneal effusion) with compression symptoms that cannot be controlled after treatment;
Sequential
Engineering of chimeric antigen receptors targeting CD19 in allogeneic T cells
Biological/VaccineAbout 6 subjects will be included in the study, and a "3+3" dose escalation method will be used. The dosage will be gradually increased in two dose groups: 1 × 10 \^ 8 CAR-T cells/dose and 2 × 10 \^ 8 CAR-T cells/dose. Three subjects are enrolled in each dose group first, and within the same dose group, the cell transfusion interval between the first two subjects should not be less than 14 days. If no dose limiting toxicity (DLT) is observed in a certain dose group, the dose will be increased to the next dose; If one case of DLT occurs, this dose group needs to be divided into three additional subjects (a total of six subjects). If no new DLT occurs, the dosage will be increased to the next dose; If more than 1/6 of the 6 subjects develop DLT, the dose escalation will be terminated, and the Safety Review Committee (SRC) will discuss whether to reduce the dose and continue the monotherapy study.
Evaluate the safety of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus
The incidence of adverse events related to IC19 CAR-T cell transfusion within 28 days after IC19 CAR-T cell transfusion, abnormal laboratory test results with clinical significance, including dose limited toxicity (DLT).
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
Changes in SLE Disease Activity Index (SLEDAI-2K) scores (0-105 points; 0-4 points: almost no activity; 5-9 points: mild activity; 10-14 points: moderate activity; ≥ 15 points: severe activity) compared to baseline at 12 and 24 weeks after IC19 CAR-T cell transfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
Changes in the British Islet Lupus Assessment Group Index (BILAG-2004) compared to baseline at 12 and 24 weeks after IC19 CAR-T cell reinfusion
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
The overall assessment (PGA) of clinical physicians at 12 and 24 weeks after IC19 CAR-T cell reinfusion compared to baseline changes
Evaluate the efficacy of IC19 CAR-T cell therapy in the treatment of refractory systemic lupus erythematosus
The proportion of subjects who reached SLE response index 4 (SRI-4) at 12 and 24 weeks after IC19 CAR-T cell reinfusion
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