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Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases

RecruitingEARLY Phase 1Ages 18 Years - 70 YearsAllChanghai Hospital
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In plain words

What the trial is, and whether it could suit you

A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases. 60 patients are planned to be enrolled in the dose-escalation trial.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Common inclusion criteria: 1. Age: ≥ 18 years old and ≤ 70 years old, male or female; 2. The functions of critical organs meet the following requirements: a )Neutrophil count ≥ 1 x 10\^9/L, Hemoglobin ≥60g/L; b) Liver function: ALT ≤ 3 x ULN,AST≤3 x ULN, TBIL≤1.5 x ULN; c) Coagulation function: International standardized ratio (INR) ≤1.5x ULN, prothrombin time (PT) ≤1.5 x ULN; d) Cardiac function: good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥50%; 3. Female subjects of childbearing potential and male subjects whose partner is a female of childbearing potential are required to use medically approved contraception or abstain from sex for at least 6 months during and at least 6 months after the end of the study treatment period; female subjects of childbearing potential have had a negativeserum HCG test within 7 days prior to study enrollment and are not lactating; 4. Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up. Specific inclusion criteria: Relapsed/Refractory Systemic lupus erythematosus 1. Subject have previous diagnosis of systemic lupus erythematosus (SLE) (according to the 1997 American College of Rheumatology revised SLE classification criteria, the 2012 Systemic Lupus International Collaborating Clinics classification criteria, or the 2019 European League Against Rheumatism/American College of Rheumatology joint classification criteria); 2. Subjects had a modified SLEDAI-2K score of ≥8 at screening; 3. Subject has ≥ 1 organ system with BILAG-2004 Class A mobility score or ≥ 2 organ systems with BILAG-2004 Class B mobility score at screening; 4. Based on the results of the central laboratory tests at screening, the subject meets one of the following: a. ANA by immunofluorescence ≥ 1:80 b. Anti-dsDNA antibodies above the normal level c. Anti-Smith antibodies above the normal level. Relapsed/Refractory Systemic Sclerosis 1. Meets 2013 ACR classification criteria for systemic sclerosis; 2. If combined with interstitial pneumonia, interstitial changes suggestive of ground-glass exudates on chest HRCT and FVC or DLCO \<70% predictive value on pulmonary function tests; 3. Ineffective conventional treatment or relapse of disease activity after remission. Definition of routine treatment: Use of glucocorticoids (above 1mg/Kg/d) and cyclophosphamide, as well as any of the following immunomodulatory drugs for more than 6 months: antimalarials, 4. methotrexate, leflunomide, cyclophosphamide, azathioprine, mertiomate, tacrolimus, cyclosporine, and biologics, including rituximab, belimumab and tetracycline; 5. Definition of progressiveness; 1) Definition of cutaneous progression: increase in mRSS \>10%; 2) Definition of lung disease progression: 10% decrease in FVC or 5% decrease in FVC with 15% decrease in DLCO (OMERACT progression). Relapsed/Refractory Primary Sjögren's Syndrome 1. Meets 2002 AECG criteria or 2016 ACR/EULAR classification criteria for primary dry syndrome (pSS); 2. Definition of disease activity: investigator-assessed disease ESSDAI score of 5 or higher; 3. Ineffective conventional treatment or relapse of disease activity after remission. Definition of routine treatment: Use of glucocorticoids (above 1mg/Kg/d) and cyclophosphamide, as well as any of the following immunomodulatory drugs for more than 6 months: antimalarials, methotrexate, leflunomide, cyclophosphamide, azathioprine, mertiomate, tacrolimus, cyclosporine, and biologics, including rituximab, belimumab and tetracycline. Relapsed/Refractory rheumatoid arthritis 1. Meets the diagnostic criteria of the 2010 ACR/EULAR classification. Diagnosis of moderately or severely active rheumatoid arthritis with a previous diagnosis of rheumatoid arthritis ≥ 6 months; 2. A swollen joint count of ≥ 6 (based on 66 joint counts) and a tender joint count of ≥ 6 (based on 68 joint counts) during the Screening Period; 3. C-reactive protein (CRP) ≥ 10 mg/L or erythrocyte sedimentation rate (ESR) ≥ 28 mm/h during the Screening Period; 4. EULAR definition of refractory rheumatoid arthritis: 1) Failure of treatment according to EULAR recommended guidelines and failure of treatment with ≥2 b/tsDMARDs despite failure of treatment with csDMARDs. (i) unless treatment with bDMARDs/tsDMARDs is limited due to socioeconomic factors; and (ii) if treatment with csDMARDs is contraindicated, then failure of treatment with ≥2 b/tsDMARDs of different mechanisms also fulfills the condition); 2) Symptom management of RA is considered problematic by both the patient and the physician; 3) Signs suggestive of active or progressive disease if at least 1 of the following 5 items is met (Meeting all three of the below criteria can be diagnosed as rheumatoid arthritis): i. At least moderate disease activity (DAS28-ESR \>3.2 or CDAI\>10); ii. Signs and/or symptoms suggestive of active disease; iii. Inability to reduce glucocorticoids to less than 7.5 mg/dayprednisone or equivalent; iv. Rapid imaging progression (1-year increase of ≥5 points in vander Heijde modified Sharp score); v. Decreased quality of life due to RA, although RA is well controlled. Relapsed/refractory anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis 1. Meets 2022 ACR/EULAR diagnostic criteria for ANCA vasculitis, including microscopic polyangiitis, granulomatous polyangiitis, eosinophilic granulomatous polyangiitis; 2. Positive ANCA related antibodies (MPO-ANCA or PR3-ANCA positive); 3. The Birmingham Vasculitis Activity Scale (BVAS) is ≥ 15 points (a total score of 63 points), indicating the activity of the vasculitis condition; 4. Glomerular filtration rate (eGFR, CKD-EPI formula) ≥15 ml/min/1.73 m2 during the screening period. Exclusion Criteria: Subjects who meet any of the following common exclusion criteria or disease-specific exclusion criteria will not be eligible for this study. Common exclusion Criteria: 1. Subjects with known severe allergic r
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What it tests

  • anti-CD19/BCMA U CAR T cells
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Where

1 site
Changhai Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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