This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) receive CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, and pSS-PAH. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after CD19-BCMA CAR T cell infusion.
Refractory Lupus Nephritis（LN）: Patients who meet all the following requirements can be enrolled in the group.
Male or female, aged 10-65 years;
Meeting the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for Systemic Lupus Erythematosus (Appendix 4);
The ANA result is positive which means ANA titer≥ 1:80 (based on the equivalent detection results by Hep-2 immunofluorescence assay or enzyme immune assay), and/or according to the detection results from center laboratory, during the screening visit,the anti dsDNA serum antibody test is positive (based on ELISA assay, ≥30 IU/mL);
Intracranial hypertension or disorder of consciousness;
Symptomatic heart failure or severe arrhythmia;
Symptoms of severe respiratory failure;
Complicated with other types of malignant tumors;
Single group
CD19-BCMA CAR-T cells infusion
DrugApproximately 3-5 days prior to CD19-BCMA CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.
Dose-limiting toxicity (DLT)
Incidence and type of dose-limiting toxicity(DLT) within 28 days of CD19-BCMA CAR-T infusion.
Adverse events (AEs)
Total number, incidence and severity of adverse events (AEs) within 30 days of CD19-BCMA CAR-T infusion
Overall remission rate (ORR)
The assessment of ORR by dose group at 90 and 120 Days after CD19-BCMA CAR T infusion.
Serious adverse event（SAE)
The incidence and grade of serious adverse events (SAEs) from 30 days to 2 years post-infusion
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