Safety and Efficacy of SWK002 in Patients With D2T-Rheumatoid Arthritis
This is an open label, single-site, dose-escalation study in up to 18 participants with refractory rheumatoid arthritis. This study aims to evaluate the safety and efficacy of the treatment with Anti-CD19 CART.
• no gender restriction and age of 18 years and above at the time of signing the informed consent form.
• written informed consent approved by the Ethics Committee must be signed in person by all subjects or guardians prior to the commencement of any screening procedure.
• adult refractory patients who meet the 2010 ACR / EULAR RA diagnostic criteria, with refractory defined as (1) failure of treatment with csDMARDs (2) experiencing failure of treatment with ≥2 bDMARDs/tsDMARDs with different mechanisms of action (3) meeting one of the following criteria: 1) DAS28-ESR \>3.2 or CDAI \>10 2) inability to hormone Hormone cannot be reduced to less than 7.5mg/day (3) Number of swollen joints and/or painful joints ≥3.
• Stable treatment with 1 or 2 cs DMARD ( s ) prior to enrollment as follows: (1) at least 12 weeks of methotrexate and at least 4 weeks of administration at a dose of 7.5-25 mg/week (2) at least 4 weeks of stable hydroxychloroquine dose of ≤400 mg/d (3) at least 4 weeks of stable oral salicylsulphadiazepine 1-3 g/d (4) at least 4 weeks of stable oral leflunomide 10-20 mg/day Methylphenidate 10-20 mg/d.
• no active or latent tuberculosis.
• Adequate organ function: (1) blood creatinine ≤1.5 times the upper limit of normal, or glomerular filtration rate (eGFR) ≥60m/min/1.73m2 as estimated by the MDRD formula (2) and ALT ≤ 5 times the upper limit of normal for the corresponding age and total bilirubin ≤ 2.0 mg/dl (3) and ≤ 1 grade of dyspnea and oxygen saturation \> 91% in room air.
• hemodynamically stable with a left ventricular ejection fraction (LVEF) ≥45% as determined by echocardiography or multichannel radionuclide angiography (MUGA).
• female subjects of childbearing potential and all male subjects must agree to use a highly effective method of contraception until at least 12 months after SWK002 infusion and until two consecutive PCR assays show no more CAR-T cells in the body.