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.
malignant tumors.
subjects with current or history of CNS disorders such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
previous subjects who have undergone allogeneic hematopoietic stem cell transplantation (HSCT).
subjects who have received chemotherapy other than pretreatment chemotherapy within 2 weeks prior to infusion.
Sequential
Anti-CD19 CART cells will be given IV at split doses.
DrugSplit intravenous infusion of Anti-CD19 CART cells of (Dose escalating infusion of 1 - 6 x10\^6 CART cells/kg).
Safety Outcome
All adverse events (AEs) will be listed and summarized. Summaries of laboratory data will include, at a minimum, treatment-emergent laboratory abnormalities. Summaries of AEs and laboratory abnormalities will be based on the All Treated analysis set.
The persistence, accumulation, and migration of Anti-CD19 CART cells
Assessing the trafficking of Anti-CD19 CART cells in the peripheral blood at the time of each infusion as well as at each time of follow-up by Quantitative Real-time Polymerase Chain Reaction or flow cytometry. Peripheral blood will be collected prior to the initial infusion and will be set as baseline.
Erythrocyte Sedimentation Rate
To evaluate RA disease activity
American College of Rheumatology (ACR) criteria 20, 50, 70 response rate
To evaluate RA disease activity
Swollen and tender joint count
To evaluate RA disease activity
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