A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.

Inclusion criteria

• Willing and able to provide written informed consent.
• Aged ≥18 years and ≤75 years.
• Adequate organ function defined as:

• Bone marrow function: Defined as absolute neutrophil count (ANC) ≥1500/μL, absolute lymphocyte count (ALC) ≥100/μL, hemoglobin (Hb) ≥80 g/L, and platelet count (PLT) ≥50,000/μL. Transfusions and growth factors must not have been used within 7 days prior to screening to meet these criteria.
• Liver function: Defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN), and total bilirubin <1.5 × ULN (or <3.0 × ULN for subjects with Gilbert's syndrome).
• Coagulation function: Defined as international normalized ratio (INR) or partial thromboplastin time (PTT) ≤1.5 × ULN.
• Pulmonary function: Defined as dyspnea ≤ Grade 1 per CTCAE and oxygen saturation (SpO₂) ≥92% on room air (by pulse oximetry).
• Female subjects of childbearing potential must have a negative serum or urine pregnancy test. Females who are surgically sterile or postmenopausal for at least 2 years are considered not of childbearing potential.
• From the time of signing the informed consent form until 6 months after the completion of RD06-05 infusion, female subjects of childbearing potential and male subjects with partners of childbearing potential must use highly effective methods of contraception.

Inclusion criteria

for Subjects with Anti-GBM Disease:

Diagnosis of anti-GBM disease according to the 2012 Chapel Hill Consensus Conference definitions, meeting both of the following criteria:

• Positive for anti-GBM antibody (based on historical or screening test results);
• Evidence of renal involvement at screening, defined as:

• Presence of active, pathologically confirmed anti-GBM disease (renal biopsy must have been performed within 1 year prior to the screening visit or during the screening period); and
• Accompanied by proteinuria and hematuria.

Inclusion criteria

for Subjects with SLE/LN:

• Diagnosis of SLE according to the 2019 European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.
• Positive for antinuclear antibody (ANA), and/or anti-double-stranded DNA (anti-dsDNA) antibody, and/or anti-Smith (anti-Sm) antibody at screening.
• SLEDAI-2K score > 6 points at screening.

Inclusion criteria

for Subjects with AAV/AAGN:

• Diagnosis of microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA) according to the 2022 ACR/EULAR classification criteria for ANCA-associated vasculitis.
• Positive for anti-myeloperoxidase (MPO-ANCA) antibody or anti-proteinase 3 (PR3-ANCA) antibody at screening or based on historical testing.
• For AAV without renal involvement: A Birmingham Vasculitis Activity Score (BVAS) version 3 score of ≥3 at screening, indicating active vasculitis.

Inclusion criteria

for Subjects with MN:

• Diagnosis of primary (idiopathic) membranous nephropathy confirmed by renal biopsy pathology (the renal biopsy must have been performed within 2 years prior to screening or during the screening period).
• Meeting the criteria for high-risk or relapsed/refractory membranous nephropathy:

High-risk patients, defined as meeting any of the following criteria:

• Normal eGFR with urine protein >3.5g/24h, a reduction of <50% in urine protein after 6 months of ACEI/ARB treatment, and serum albumin <25 g/L or anti-PLA2R antibody >50 RU/mL;
• eGFR <60 mL/min/1.73m² and/or urine protein >8g/24h for more than 6 months.

Refractory/Relapsed patients:

Refractory patients are defined as those resistant to prior immunosuppressive therapy (persistent urine protein ≥3.5g/24h with a <50% reduction from baseline).

Relapsed patients are defined as those who achieved complete or partial remission with prior immunosuppressive therapy but subsequently developed recurrent urine protein ≥3.5g/24h.

Inclusion criteria

for Subjects with SSC:

• Diagnosis of systemic sclerosis (SSc) according to the 2013 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria.
• Diagnosis of diffuse cutaneous SSc at screening.

Inclusion criteria

for Subjects with IIM:

1.Diagnosis of idiopathic inflammatory myopathy (IIM) according to the 2017 ACR/EULAR classification criteria (including probable or definite diagnosis, corresponding to a probability score of ≥55%). The subtypes include dermatomyositis (DM), anti-synthetase syndrome (ASS), and immune-mediated necrotizing myopathy (IMNM).

Exclusion criteria

• Subjects with SLE/LN:

• Severe active central nervous system (CNS) lupus, including psychosis, seizures, lupus headache, or other signs/symptoms associated with neuropsychiatric lupus, as assessed by a qualified specialist during screening.
• Drug-induced or secondary lupus.
• Subjects with AAV/AAGN:

• Drug-induced or secondary AAV/AAGN.
• Presence of alveolar hemorrhage requiring invasive ventilatory support at screening.
• Subjects with Anti-GBM Disease:

• Anuria for more than 7 days.
• Dialysis dependence for more than 30 days.
• Ongoing moderate or severe pulmonary hemorrhage (or cessation within the past two weeks) defined as pulmonary hemorrhage requiring assisted ventilation, supplemental oxygen, or blood transfusion.
• Symptomatic congestive heart failure (NYHA Class 2-4) requiring prescription medication or clinically significant cardiogenic peripheral edema.
• Subjects with MN:

Secondary membranous nephropathy.

• Subjects with IIM:

Presence of severe rhabdomyolysis or CK level ≥120 × ULN at screening.

• Subjects with SSc:

• History of scleroderma renal crisis within 1 year prior to screening.
• History of cardiac tamponade within 6 months prior to screening.
• Active infection of digital ulcers within 3 months prior to screening.
• Presence of digital gangrene at screening.