Patients with autoimmune diseases mediated by autoantibodies, such as recurrent or refractory systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), ANCA-associated vasculitis (AAV), Sjögren’s syndrome (SS), multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), and myasthenia gravis (MG).
Conditions
Interventions
Group 1:The drug was given by multiple infusions on D0, D3, D17 and D31. Dose group -1: 0.5 mg.
Group 2:The drug was given by multiple infusions on D0, D3, D17 and D31. Dose group 1: 1 mg.
Group 3:The drug was given by multiple infusions on D0, D3, D17 and D31. Dose group 2: 3 mg.
Sponsors
Dongguan Taixin Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: General Inclusion Criteria for All Patients: 1. The subject voluntarily agrees to participate in this trial and signs the informed consent form. 2. Age >= 18 years and = 40 ml/min. c) Complete blood count: Neutrophil count >= 1 × 10^9/L, hemoglobin >= 60 g/L, platelet count >= 20 × 10^9/L, lymphocyte count > 0.3 × 10^9/L. d) Coagulation function: International normalized ratio (INR) = 92%. f) Echocardiogram showing left ventricular ejection fraction (LVEF) >= 50%. Female subjects of childbearing potential must have a negative serum or urine pregnancy test at screening. Females of childbearing potential must agree to use effective contraception from at least 28 days prior to the start of lymphodepletion until 12 months after RC-01 infusion. Males of childbearing potential must agree to use effective barrier contraception from the start of lymphodepletion until 12 months after RC-01 infusion and should not donate semen or sperm during the entire trial period. Inclusion Criteria for SLE Patients: 1. A confirmed diagnosis of systemic lupus erythematosus (SLE) based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria. 2. Patients must have received treatment with corticosteroids in combination with immunosuppressants and/or biologics for at least 2 months prior to screening, with a stable dose for more than 2 weeks, and the disease must still be active (i.e., prior treatment with corticosteroids + immunosuppressants or corticosteroids + immunosuppressants + biologics; any single agent use of the above medications does not qualify). Oral corticosteroids must meet the following criteria: 1) Prednisone (or equivalent) = 7.5 mg/day; 2) There is no minimum daily dose requirement for corticosteroids when used in combination with immunosuppressants and/or biologics. 3. Positive antinuclear antibody (ANA) test at screening, and/or positive anti-double-stranded DNA (anti-ds-DNA) antibody, and/or positive anti-Smith antibody. 4. A SLE Disease Activity Index 2000 (SLEDAI-2K) score > 6 at screening, with a "clinical" SLEDAI-2K score >= 4. Note: The "clinical" SLEDAI-2K score excludes points attributable to any urine or laboratory test results (including immunological markers): Includes clinical items such as: arthritis, myositis, rash, alopecia, mucosal ulcers, pleuritis, pericarditis, or vasculitis; Excludes points attributable to fever, SLE headache, and organic brain syndrome. For patients with lupus nephritis, if there is proteinuria > 0.5 g/24 hours or UPCR > 500 mg/g; or active urinary sediment (excluding infection, defined as > 5 red blood cells/high power field or > 5 white blood cells/high power field, or red blood cell casts, or white blood cell casts), the requirement for a "clinical" SLEDAI-2K score >= 4 may be waived. 5.Physician’s Global Assessment (PGA) score >= 1.0 (0-3 visual analog scale). Inclusion Criteria for SSc Patients: 1. A diagnosis of systemi
Exclusion criteria
Exclusion criteria: Patients will be excluded from participating in this study if they meet any of the following criteria: 1. A primary diagnosis of an autoimmune disease that is complementary to the disease under study, which, in the investigator's opinion, could confound the efficacy evaluation of the disease under study. 2. For SLE patients: Uncontrolled lupus crisis within 8 weeks prior to screening, including but not limited to rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulocytosis, severe cardiac damage, severe lupus pneumonitis, severe lupus hepatitis, or severe vasculitis, etc., and deemed unsuitable for participation by the investigator. 3. Presence of clinically significant central nervous system diseases or pathological changes not attributable to lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/seizures, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric illness. 4. History of allogeneic bone marrow or stem cell transplantation, or solid organ transplantation (e.g., kidney, lung, heart, liver), or planned such transplantation in the future. 5. For IIM patients: Presence of severe rhabdomyolysis or CK level >=120 × ULN at screening. 6. For MG patients: Presence of uncontrolled myasthenic crisis within 2 weeks prior to screening. 7. History of clinically significant cardiovascular dysfunction within 12 months prior to screening, including but not limited to: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia. 8. Presence of significant pulmonary or cardiac manifestations at screening, such as pericarditis, pleural effusion, deemed unsuitable for participation by the investigator. 9. Patients with severe asthma or chronic obstructive pulmonary disease (COPD). Patients with mild or moderate asthma or COPD receiving stable treatment may be enrolled. 10. History of malignancy within 5 years prior to signing the ICF, except for adequately treated or surgically resected non-melanoma skin cancer or carcinoma in situ (e.g., cervical, bladder, breast) with no evidence of residual disease. 11. Pregnant or lactating women. 12. History of recurrent infections requiring hospitalization and intravenous antibiotic therapy (e.g., three or more episodes of the same type of infection within the past year). 13. Active infection requiring systemic treatment within 2 weeks prior to lymphodepletion, such as infectious pneumonia, tuberculosis, etc. 14. Positive Hepatitis B surface antigen (HBsAg), or positive Hepatitis B core antibody (HBcAb) with positive peripheral blood Hepatitis B virus (HBV) DNA test; positive Hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA; positive Human Immunodeficiency Virus (HIV) antibody; positive syphilis antibody. 15. Administration of a live attenuated vaccine within 4 weeks prior to treatment, or planned administration during the study. 16. Use of high-dose corticosteroids (prednisone >=60 mg/day or equivalent) within 4 weeks prior to treatment, or inability to taper prednisone to <=10 mg/day by 3 days prior to lymphodepletion. 17. Inability to taper or wash out background therapies as specified in Table 3 prior to treatment. 18. Currently receiving renal replaceme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability;Vital signs and physical examination;Complete blood count (CBC);Coagulation function;Cytokines;immunoglobulin;urinalysis;pharmacokinetics(PK); | — |
Countries
China
Contacts
Public ContactYuelin He/ Lan He/ Yuanying Zeng
Dongguan Taixin Hospital
Outcome results
None listed