[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-sjogren39s-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-sjogren39s-syndrome":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100607122","phase-1-clinical-study-of-bcmacd70-targeted-car-t-therapy-for-refractory-pediatric-rheumatic-diseases-100607122",false,"NCT07184450","Clinical Study of BCMA\u002FCD70-targeted CAR-T Therapy for Refractory Pediatric Rheumatic Diseases","Clinical Study of BCMA\u002FCD70 Targeting Chimeric Antigen Receptor T Lymphocytes(CAR-T) in the Treatment of Refractory Pediatric Rheumatic Diseases","Inclusion Criteria:\n\n* Age ≥5 years old.\n* To meet the diagnostic criteria of refractory B-cell-related pediatric rheumatic diseases, including but not limited to juvenile dermatomyositis, polyarticular juvenile idiopathic arthritis, systemic sclerosis, and primary Sjogren's syndrome.\n\n  1. Diagnosed as juvenile dermatomyositis(JDM) according to the criteria of Bohan and Peter, and meeting the following conditions:\n\n     1. The classification criteria of RJDM must meet (1) and any one of (2)-(5): (1) Patients who are intolerant or unresponsive to glucocorticoids and at least 2 immunosuppressants, and the duration of adequate hormone therapy should be at least 6 months; (2) The disease progresses rapidly and\u002For involves organs such as lungs, heart and gastrointestinal tract; (3) Calcification of subcutaneous or muscle and joint tissues; (4) Repeated rashes or skin ulcers; (5) Repeated or persistent myasthenia(muscle MRI indicates extensive, diffuse edema or the Childhood Myositis Assessment Scale(CMAS) should be less than 48 points, and at least two of the following five core measurement indicators should have abnormal results: Physician Global Assessment(PhGA) ≥2cm, Patient Global Assessment(PtGA) ≥2cm, Disease Activity Score(DAS) ≥2 points, Childhood Health Assessment Questionnaire(C-HAQ) ≥0.25 points, muscle enzyme level \\> 1.5×upper limit of normal);\n     2. RJDM with anti-synthetase syndrome who are positive for anti-synthetase antibody and those with immune-mediated necrotizing myopathy who are positive for SRP or HMGCR antibody can be included.\n  2. Meet the classification criteria for polyarticular juvenile idiopathic arthritis as defined by the International League of Associations for Rheumatology(ILAR) classification in 2001, and meeting the following conditions: After at least 6 months of traditional DMARDS treatment and at least one stable dose of DMARDS or biologic agent for ≥12 weeks, the disease is still active, that is, there are at least 2 active joints (defined as swollen joints; if there is no swelling, there must be limited passive range of motion, accompanied by pain during movement or joint tenderness).\n  3. Meet the classification criteria for Systemic sclerosis (SSc) as defined by the 2013ACR\u002FEULAR standards, and meeting the following conditions:\n\n     1. Meet the definition of intractable disease: Glucocorticoids (≥0.5mg\u002Fkg\u002Fd) and cyclophosphamide, as well as one or more of the following immunomodulators (including antimalarial drugs, azathioprine,mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, beliumab, and telitacicept, etc.), did not show significant remission of the disease for more than 3 months; Or meet the criteria for rapid disease progression , clinical routine treatment is ineffective, and the benefits outweigh the risks as determined by the investigator and the patient's or guardian's full and informed consent can be considered for inclusion;\n     2. Modified Rodnan Skin Score (mRSS) ≥15 points (total 51 points).\n  4. Meet the classification criteria for primary Sjogren's syndrome as defined by the 2002 ACEG classification criteria \u002F2016 EULAR\u002FACR classification criteria, and meeting the following conditions:\n\n     1. Meet (1) and any one of (2)-(6): (1) For those who are intolerant or have an insufficient response to glucocorticoid (prednisone 1-2 mg\u002Fkg\u002Fd or an equivalent dose of other hormones) and at least two immunosuppressants, the duration of hormone treatment should be at least 6 months; (2) The disease progresses rapidly and\u002For involves organs such as the kidneys, nervous system, and lungs; (3) Repeated parotid gland swelling or repeated parotitis; (4) Recurrent rashes or skin ulcers; (5) Involvement of the blood system, repeated leukopenia, anemia or thrombocytopenia; (6) cryoglobulinemia;\n     2. Positive for anti-SSA \u002FRo antibody;\n     3. ESSDAI score ≥5 points or clinESSDAI score ≥5 points.\n* Positive expression of CD19 in peripheral blood B cells determined by flow cytometry, and B cells \\> 5 per\u002FuL.\n* Previously not treated with CAR-T; or recurrence or poor efficacy after previous autologous or universal CD19-targeted CAR-T treatment (evaluated by the researcher).\n* The functions of important organs are basically normal:\n\n  1. Cardiac function: left ventricular ejection fraction (LVEF) ≥55%, no obvious abnormality in electrocardiogram;\n  2. Renal function: eGFR≥30mL\u002Fmin\u002F1.73m2;\n  3. Liver function: AST and ALT≤3.0 ULN, total bilirubin ≤2.0×ULN;\n  4. Lung function: SpO2≥92%.\n* Meet standards for leukapheresis or intravenous blood collection, and no other contraindications for leukapheresis.\n* The subject of childbearing age has a negative urine pregnancy test result and agrees to take effective contraceptive measures during the test period until 1 year after the infusion.\n* The patient or his\u002Fher guardian agrees to participate in this clinical trial and signs an informed consent indicating that he\u002Fshe understands the purpose and procedure of this clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n* Severe major organ involvement related to the primary disease, such as severe pulmonary hypertension (PHA) (mean arterial pressure \\> 45mmHg).\n* primary immunodeficiency or severe secondary immunodeficiency that has not been corrected.\n* accompanied by serious or active or uncontrollable infectious diseases, including but not limited to active tuberculosis, latent tuberculosis infection, active viral hepatitis,etc.\n* Evidence of active malignant disease or diagnosis of malignant tumor(including hematological malignancies and solid tumors, except resected and cured skin basal cell carcinoma).\n* Congenital heart disease or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia,etc.); Or combined with a large number of pericardial effusion, serious myocarditis, etc.;Or patients with unstable vital signs who need hypertensive drugs to maintain their blood pressure.\n* suffering from other diseases that require long-term use of glucocorticoids or immunosuppressants.\n* Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months before screening; Acute graft-versushost disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n* Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive.\n* Had received live vaccine within 4 weeks prior to screening.\n* Positive blood pregnancy test.\n* Situations in which other investigators consider it inappropriate to participate in the study.","ALL","5 Years",{"count":19,"type":20},11,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is an investigator-initiated trial to evaluate the efficacy and safety of BCMA\u002FCD70-targeted CAR-T in the treatment of refractory pediatric rheumatic diseases.",[26,27,28,29],"Juvenile Dermatomyositis (JDM)","Polyarticular Juvenile Idiopathic Arthritis","Systemic Sclerosis (SSc)","Primary Sjogren's Syndrome",[31,32],"CAR-T","BCMA\u002FCD70","RECRUITING","2025-09-15",{"date":36,"type":37},"2025-09-19","ACTUAL",{"date":39,"type":37},"2025-09-01",{"date":41,"type":20},"2028-09-30",{"name":43,"class":44},"Chongqing Precision Biotech Co., Ltd","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":45},"100605824","phase-1-a-study-of-ol-cd19-gdt-in-relapsed-refractory-autoimmune-diseases-100605824","NCT07167537","A Study of OL-CD19-GDT in Relapsed\u002F Refractory Autoimmune Diseases","An Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Allogeneic CAR-T Cell Therapy (OL-CD19-GDT) in the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* Adults aged 18-65 years old\n* ECOG 0-2\n* Adequate organ function\n* Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and must agree to use a highly effective contraceptive method starting from the time of lymphodepletion and for 2 years after dosing of the IMP\n* SSc specific:\n\n  a)Fulfilling the 2013 ACR\u002FEULAR classification criteria of SSc; b) mRSS score \\>10; c) at least one vital organ involvement besides the skin; d)relapsed or refractory to at least one immunosuppressant or biologic.\n* pSS specfic: a)Fulling the 2016 EULAR\u002FACR classification critieria for pSS; b) anti-Ro\u002Fanti-SSA antibody positive; c) ESSDAI score ≥5 ; d)relapsed or refractory to at least one immunosuppressant or biologic.\n\nExclusion Criteria:\n\n* Active uncontrolled infection\n* Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load\n* Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load\n* HIV antibody positive\n* Syphilis antibody positive\n* Active tuberculosis, untreated or inadequately treated latent tuberculosis infection (LTBI)\n* History of serious infection within 3 months prior to screening (defined as requiring hospitalization or intravenous antimicrobial therapy), or history of oral antimicrobial therapy within 1 month prior to screening (e.g., viral infections, opportunistic infections, including but not limited to severe cytomegalovirus or herpes virus infections)\n* Congenital long QT syndrome or a corrected QTcF interval of ≥480 ms at screening (unless secondary to pacemaker or bundle branch block)\n* Uncontrolled hypertension (blood pressure ≥160\u002F100 mm Hg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes or other endocrine diseases, severe chronic pulmonary disease, or other serious medical condition which is likely to significantly impair the patient's ability to tolerate the study treatment\n* history of organ transplant\n* Pregnancy or lactating women\n* Use of any other experimental medication within 4 weeks or 5 half-lives prior to start of study drug\n* Use of biologics within 10 weeks, stem cell transplant within 6 months prior to the start of study drug\n* Prior CAR-T treatment\n* Received live or attenuated vaccine within 4 weeks of Cycle 1 Day 1\n* Presence of other autoimmune or auto-inflammatory diseases that may affect study assessments, such as rheumatoid arthritis, gout, or active fibromyalgia syndrome.\n* Limited to patients diagnosed with SSc: at risk for scleroderma renal crisis; SSc-associated gastric antral vascular ectasia; Severe gastrointestinal involvement leading to malabsorption or intestinal failure\n* Limited to patients diagnosed with pSS: primary biliary cholangitis","18 Years","65 Years",{"count":56,"type":20},44,[23],"This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-CD19-GDT in relapsed\u002Frefractory autoimmune diseases.",[28,29],"2025-09-10",{"date":62,"type":37},"2025-09-11",{"date":64,"type":20},"2025-10",{"date":66,"type":20},"2028-12",{"name":68,"class":69},"Beijing GoBroad Hospital","OTHER"]