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 umbilical cord blood CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of umbilical cord blood CD19BCMA CAR T cell therapy in patients with refractory lupus nephritis (SLE-LN), systemic sclerosis (SSc), and primaryjogren syndrome combined with pulmonary artery hypertension. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after theusion of umbilical cord blood CD19-BCMA CAR T cells. It is anticipated that 45-54 participants will be recruited.
Male or female patients aged 3-65 years old;
Systemic lupus erythematosus that meets the 2019 American College of Rheumatology (ACR)/European Union of Rheumatology Associations (EULAR) classification criteria (see Annex 5);
The result of the anti nuclear antibody (ANA) test is clearly positive, that is, the ANA titer is ≥ 1:80 (equivalent test result based on Hep-2 immunofluorescence detection method or enzyme immunoassay method), and/or at the screening visit, the anti dsDNA serum antibody test is positive (≥ 30 IU/mL based on ELISA detection method) according to the test results of the research center laboratory.
B cell CD19+expression and discontinuation of immunosuppressive agents for more than 1 week;
None
Single group
umbilical cord blood CD19-BCMA CAR-T cells infusion
DrugApproximately 3-5 days prior to umbilical cord blood 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 umbilical cord blood CD19-BCMA CAR-T infusion.
Adverse events (AEs）
Total number, incidence and severity of adverse events (AEs) within 30 days of umbilical cord blood CD19-BCMA CAR-T infusion
Overall remission rate (ORR)
The assessment of ORR by dose group at 90 and 120 Days after umbilical cord blood 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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