Systemic Lupus Erythematosus (SLE) Clinical Trials

• 1\. The age at the time of signing the informed consent form is ≥18 years old and ≤65 years old;

• 2\. For cohort 1: recurrent or refractory systemic lupus erythematosus (all of the following four items must be met simultaneously)

‣ Diagnosed with SLE according to the 2012 SLICC or 2019 EULAR/ACR revised criteria.

⁃ During screening, the patient exhibits positive anti-nuclear antibodies, and/or positive anti-ds-DNA antibodies, and/or positive anti-Smith antibodies.

⁃ Before screening, patients must have received treatment with glucocorticoids combined with immunosuppressants and/or biologics for at least 3 months, with a stable dose for more than 2 weeks, and the disease remains active or the patient is intolerant to the medication.

⁃ During the screening period, the SLEDAI-2K score is ≥8 points

• 3\. For cohort 2: recurrent or refractory IgG4-related disease (all three of the following criteria must be met simultaneously)

‣ Meet the American College of Rheumatology (ACR)/EULAR 2019 classification criteria for IgG4-RD.

⁃ Patients with clinical manifestations of recurrent or refractory IgG4-RD and ineffective conventional treatment

⁃ Meet the clinical phenotype of Mikulicz-system involvement

• 4\. For cohort 3: relapsed or refractory systemic sclerosis (all of the following 5 items must be met simultaneously)

‣ Meet the 2013 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) classification criteria for SSc.

⁃ Anti-Scl 70 antibody positive, or anti-centromere protein antibody positive, or anti-RNA polymerase III antibody positive

⁃ Patients with a modified Rodnan skin score (mRSS) of ≥10 at screening

⁃ Before screening, patients must have received treatment with glucocorticoids combined with immunosuppressants and/or biologics for at least 3 months, with a stable dose for more than 2 weeks, and the disease remains active or intolerable.

• 5\. For cohort 4: relapsed or refractory idiopathic inflammatory myopathies (all of the following 5 criteria must be met)

‣ Meet the 2017 EULAR/ACR classification criteria for inflammatory myopathies (including dermatomyositis DM, polymyositis PM, anti-synthetase syndrome ASS, and necrotizing myositis NM).

⁃ At least one myositis-specific antibody (MSA) or myositis-associated antibody (MAA) positive (+ or above)

⁃ During the screening period, the patient meets 2 of the following criteria: PGA(VAS)≥2cm (VAS-10cm scale); PtGA(VAS)≥2cm (VAS-10cm scale); HAQ\>0.25; one or more muscle enzymes are elevated (CK, LDH, AST, ALT) ≥1.5×ULN; overall muscle extrinsic assessment (MDAAT) ≥2.0cm (VAS-10cm scale)

⁃ After at least 3 months of treatment with glucocorticoids and immunosuppressants and/or biologics, with stable doses for more than 2 weeks, the disease remains active or the patient is intolerant to the medication.

⁃ Active myositis is present in muscle biopsy or muscle MRI during the screening period or within the first 6 months before the screening period.

• 6\. For cohort 5: relapsed or refractory AAV (all three of the following conditions must be met simultaneously)

‣ According to the 2022 ACR/EULAR criteria, the patient is diagnosed with AAV (GPA or MPA subtype). According to the KDIGO guidelines, after 3 months of treatment with glucocorticoids combined with immunosuppressants such as cyclophosphamide or biologics such as rituximab, and the dose is stable for more than 2 weeks, the disease is still active or the patient is intolerant to the drug;

⁃ The patient is currently or has been in the course of AAV related antibodies positive;

⁃ Severe disease requiring treatment (BVAS score ≥3.0).

• 7\. Possess sufficient organ function

• 8\. Men with fertility and women of childbearing age must agree to use effective contraception from the time they sign the informed consent form until 1 year after the study drug is administered. Blood pregnancy tests for women of childbearing age must be negative at screening and before infusion;

• 9\. The subject or his/her guardian agrees to participate in this clinical study and signs the informed consent form (ICF), indicating that he/she understands the purpose and procedures of this clinical study and is willing to participate in the study.