[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing Boren Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":196},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,49,73,94,121,143,161,177],{"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":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100640019","early-phase-1-autologous-bcma-targeted-car-t-cell-injection-for-relapsedrefractory-light-chain-amyloidosis-100640019",false,"NCT07626476","Autologous BCMA-targeted CAR-T Cell Injection for Relapsed\u002FRefractory Light Chain Amyloidosis","An Exploratory Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Autologous BCMA-targeted CAR-T Cell Injection in Participants With Relapsed\u002FRefractory Light Chain Amyloidosis","Inclusion Criteria:\n\n* The participant must personally sign an ethics-committee-approved informed consent form before study start.\n* Age ≥18 years.\n* Pathologically confirmed light chain amyloidosis.\n* Relapsed\u002Frefractory light chain amyloidosis previously treated with 2 or more lines of therapy.\n* dFLC \\>50 mg\u002FL.\n* Expected survival ≥12 weeks.\n* ECOG score ≤2.\n* Diagnosis of AL amyloidosis must meet the following conditions: (1) clinical manifestations, physical examination, laboratory or imaging examinations confirm tissue or organ involvement; (2) tissue biopsy pathology confirms amyloid deposition, and the precursor protein of amyloid protein is immunoglobulin light chain or heavy and light chain; and the participant is relapsed\u002Frefractory.\n* Female participants of childbearing potential should agree to use effective contraception from the date of signing informed consent until 365 days after infusion. Effective contraception is defined as abstinence or contraception using methods specified in the protocol with an annual failure rate \\\u003C1%.\n* Adequate organ function before enrollment, meeting all of the following:\n\n  * Absolute neutrophil count ≥1.0×10\\^9\u002FL; granulocyte colony-stimulating factor (G-CSF) support is permitted.\n  * Platelet count ≥50×10\\^9\u002FL.\n  * Hemoglobin ≥8 g\u002FdL.\n  * Bilirubin ≤1.5×upper limit of normal (ULN), except biliary obstruction caused by tumor compression.\n  * ALT or AST ≤2.5×ULN; for participants with liver involvement, ≤5×ULN.\n  * Mayo 2004 stage I-IIIa.\n  * Stable coagulation function: INR ≤1.5 and APTT ≤1.2×ULN, except tumor-related anticoagulant therapy.\n  * Baseline oxygen saturation on room air \\>92%.\n\nExclusion Criteria:\n\n* Participants who have received the following prior treatments:\n\n  * Prior gene therapy before enrollment.\n  * Live vaccine injection within 4 weeks before enrollment.\n  * Other interventional clinical study drug treatment within 12 weeks before leukapheresis.\n* Central nervous system involvement or complete intestinal obstruction.\n* Moderate or higher pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage.\n* Active malignancy within the past 5 years, unless it is a curable tumor and has been clearly cured.\n* HBsAg positivity with abnormal peripheral blood HBV DNA testing; HCV antibody positivity with peripheral blood HCV RNA positivity; HIV antibody positivity; CMV DNA positivity; or positive syphilis RPR test.\n* Uncontrolled active infection, except CTCAE grade \\\u003C2 urogenital infection and upper respiratory tract infection.\n* Severe heart disease, including but not limited to unstable angina, myocardial infarction within 6 months before screening, congestive heart failure (New York Heart Association \\[NYHA\\] class ≥III), positive six-minute walk test, interventricular septum and left ventricular posterior wall thickness \\>1.5 cm, or ventricular arrhythmia and atrioventricular block indicated by ambulatory electrocardiography.\n* Hypertension that cannot be controlled by medication.\n* Toxicity from prior treatment not recovered to baseline or ≤grade 1 according to NCI CTCAE v5.0, except alopecia and clinically insignificant laboratory abnormalities.\n* Major surgery within 2 weeks before enrollment, or planned surgery during the waiting period before infusion or within 12 weeks after study treatment, except planned local anesthesia surgery.\n* Solid organ transplantation.\n* Pregnant or breastfeeding women.\n* History of central nervous system disease, such as cerebral aneurysm, epilepsy, stroke, senile dementia or psychiatric disease, or disturbance of consciousness.\n* Other systemic disease judged unstable by the investigator, including but not limited to severe hepatic, renal or metabolic disease requiring medication.\n* Known life-threatening allergic reaction, hypersensitivity or intolerance to the CAR-T cell product or its components.\n* Bleeding or severe thrombosis as judged by the investigator, hereditary\u002Facquired bleeding or severe thrombosis, including hemophilia, coagulopathy, thrombocytopenia and hypersplenism, or current thrombolytic or anticoagulant therapy.\n* Other conditions that the investigator considers unsuitable for enrollment.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","Systemic light chain amyloidosis (AL amyloidosis) is the most common type of systemic amyloidosis, with diverse clinical manifestations and difficulties in diagnosis and treatment. AL amyloidosis may involve multiple organs; the kidney and heart are the most commonly involved organs. The treatment goal is to reduce monoclonal immunoglobulin light-chain levels, prevent further amyloid deposition in important organs, and alleviate or reverse organ dysfunction caused by amyloid deposition. The principal approach to achieve this goal is to eliminate the plasma-cell or B-cell clones producing abnormal light chains. For patients with relapsed\u002Frefractory AL amyloidosis, the protocol states that there is currently no suitable treatment method and that participation in clinical trials is recommended.\n\nThis study evaluates targeted BCMA autologous CART cell injection in participants with relapsed\u002Frefractory light chain amyloidosis. The main purpose is to evaluate safety, preliminarily verify efficacy, and explore in vivo pharmacokinetics, pharmacodynamics, immunogenicity and related characteristics after infusion.",[26,27,28],"Relapsed\u002FRefractory Light Chain Amyloidosis","AL Amyloidosis","Systemic Light Chain Amyloidosis",[30,31,32,33,34,35],"AL amyloidosis","light chain amyloidosis","relapsed\u002Frefractory","BCMA","CAR-T","autologous CAR-T","RECRUITING","2026-05-29",{"date":39,"type":40},"2026-06-04","ACTUAL",{"date":42,"type":40},"2024-12-16",{"date":44,"type":20},"2029-12-15",{"name":46,"class":47},"Beijing Boren Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100631605","early-phase-1-a-study-of-ben301-injection-in-the-treatment-of-autoimmune-diseases-100631605","NCT07502859","A Study of BEN301 Injection in the Treatment of Autoimmune Diseases","A Phase I Exploratory Study on the Safety and Efficacy of BEN301 Injection in the Treatment of Autoimmune Diseases","Inclusion Criteria:\n\n1. General Requirements\n\n   * Voluntary participation in the study, providing written informed consent, and willingness and ability to comply with the protocol.\n   * Age 18-70 years (inclusive) at the time of signing informed consent.\n   * Expected survival ≥ 12 months.\n2. Disease-Specific Criteria 1) Systemic Sclerosis (SSc)\n\n   * Diagnosis of Systemic Sclerosis according to the 2013 ACR\u002FEULAR Classification Criteria for SSc, with a total score ≥ 9.\n   * Disease duration (defined as time from onset of first non-Raynaud's phenomenon manifestation) ≤ 6 years. If disease duration \\> 6 years at screening, the participant may be enrolled if the investigator determines potential benefit and following discussion with the medical monitor of the BEN301 manufacturing site.\n   * Evidence of active disease at screening meeting at least one of the following criteria:\n\n     * Modified Rodnan Skin Score (mRSS) ≥ 10 and ≤ 35;\n     * Increase in mRSS ≥ 3 points compared to the most recent assessment within 6 months;\n     * Increase in mRSS ≥ 2 points with involvement of a new body region compared to the most recent assessment within 6 months;\n     * Increase in mRSS ≥ 1 point with involvement of two new body regions within 6 months;\n     * Progressive Interstitial Lung Disease (ILD) meeting the following standards:\n\n   Inadequate response or intolerance to at least one prior treatment (including cyclophosphamide, methotrexate, mycophenolate\u002Fmycophenolic acid, nintedanib, rituximab, or tocilizumab); AND at least one of the following:\n\n   Evidence of progression on High-Resolution Computed Tomography (HRCT); OR Forced Vital Capacity (FVC) \\\u003C 80% predicted, Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) \\\u003C 80% predicted, evidence of FVC decrease (absolute) ≥ 10%, or FVC decrease 5%-9% with DLCO decrease ≥ 15%.\n   * Inadequate response or intolerance to conventional therapies (glucocorticoids and immunosuppressants).\n\n     2\\) Rheumatoid Arthritis (RA)\n   * Diagnosis of RA according to the 1987 ACR or 2010 ACR\u002FEULAR classification criteria.\n   * Inadequate response, intolerance, or contraindication to at least one conventional synthetic DMARD (csDMARD) and at least one targeted synthetic DMARD (tsDMARD) or biologic DMARD (bDMARD), failing to achieve remission or low disease activity.\n   * Moderate-to-severe active RA at screening, defined as ≥ 4 tender joints (of 68 assessed) and ≥ 4 swollen joints (of 66 assessed).\n   * Erythrocyte Sedimentation Rate (ESR) \\> 28 mm\u002Fhr and\u002For C-reactive protein (CRP) \\> 10 mg\u002FL.\n   * Positive Rheumatoid Factor (RF) and\u002For Anti-Citrullinated Protein Antibody (ACPA).\n   * Duration of RA diagnosis \\> 6 months. 3) Primary Sjögren's Syndrome (pSS)\n   * Meets the 2016 ACR\u002FEULAR Classification Criteria for Sjögren's Syndrome.\n   * High disease activity index: ESSDAI ≥ 6 points.\n   * Inadequate response or intolerance to conventional therapies (glucocorticoids and immunosuppressants).\n   * Positive for Anti-Sjögren's Syndrome A (SSA\u002FRo) and\u002For Anti-Sjögren's Syndrome B (SSB\u002FLa) antibodies.\n\n     4\\) Idiopathic Inflammatory Myopathies (IIM) \u002F Dermatomyositis (DM) \u002F Polymyositis (PM)\n   * Suspected or confirmed diagnosis of Polymyositis (PM) or Dermatomyositis (DM) according to the 2017 EULAR\u002FACR Classification Criteria.\n   * Moderate-to-severe PM or DM, defined as meeting both Part A and Part B below:\n\n     * Part A: Manual Muscle Testing (MMT-8) total score \\\u003C 142.\n     * Part B: At least 2 of the following 5 items:\n\n   Physician Global Assessment (PhGA, 10-cm VAS) ≥ 2 cm; Patient Global Assessment (PtGA, 10-cm VAS) ≥ 2 cm; Health Assessment Questionnaire-Disability Index (HAQ-DI) \\> 0.25; Elevation of any muscle enzyme (CK, LDH, AST, ALT) ≥ 1.3 × Upper Limit of Normal (ULN); Myositis Disease Activity Assessment Tool (MDAAT) global extramuscular activity (10-cm VAS) ≥ 2 cm.\n\n   • Alternatively, presence of active disease: evidence of active muscle inflammation on MRI or muscle biopsy within 12 weeks.\n3. Adequate Organ Function\n\n   Within 7 days prior to screening (without transfusion, hematopoietic growth factors within 2 weeks, or medication correction):\n   * Bone Marrow:\n\n     * Hemoglobin (Hb) ≥ 80 g\u002FL;\n     * Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL;\n     * Platelet count (PLT) ≥ 50 × 10⁹\u002FL.\n   * Renal Function: Creatinine Clearance (CrCl, calculated by Cockcroft-Gault formula, see Appendix 1) ≥ 50 mL\u002Fmin (without hydration assistance).\n   * Hepatic Function: Serum ALT and AST ≤ 2.5 × ULN (exceptions for CK-induced elevations may be determined by the investigator); Total bilirubin ≤ 1.5 × ULN.\n   * Pulmonary Function: Oxygen saturation ≥ 92% on room air without supplemental oxygen; no clinically significant pleural effusion.\n   * Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 40%; no pericardial effusion; ECG at screening showing no clinically significant abnormalities.\n   * Coagulation: Fibrinogen ≥ 1.5 g\u002FL; Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN; Prothrombin Time (PT) ≤ 1.5 × ULN.\n4. Biological Requirements\n\n   * Presence of CD19+ B cells in peripheral blood.\n   * Adequate venous access for leukapheresis, without contraindications to leukapheresis.\n5. Reproductive Criteria\n\n   * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening. (Women who are surgically sterile or postmenopausal for at least 2 years are considered non-childbearing).\n   * Sexually active WOCBP and male participants must agree to use highly effective contraception from the time of signing informed consent until 1 year after the last study treatment, and must not donate eggs\u002Fsperm for assisted reproduction during this period.\n\nExclusion Criteria:\n\n1. Severe Renal Disease\n\n   * History of severe nephritis or nephrotic syndrome.\n   * Severe is defined as:\n\n     * Prior receipt of any of the following treatments within specified timeframes:\n\n   Prior kidney transplantation; Dialysis or plasmapheresis within 3 months prior to screening; Glucocorticoid pulse therapy (defined as ≥500 mg\u002Fday prednisone or equivalent) within 1 month prior to screening.\n\n   o Requirement for any of the following treatments during the study period: Use of prohibited medications per protocol; Need for dialysis or plasmapheresis; Need or planned kidney transplantation.\n2. Severe Cardiovascular Disease\n\n   * History of severe cardiovascular disease, including but not limited to: symptomatic chronic heart failure requiring intervention, acute myocardial infarction or coronary artery bypass grafting within 6 months, unstable angina, history of severe arrhythmia, or history of stroke.\n   * New York Heart Association (NYHA) Class III-IV heart failure.\n   * QTcF interval \\> 450 ms (male) or \\> 470 ms (female) on screening ECG (Fridericia formula: QTcF = QT \u002F (RR\\^0.33)).\n3. SSc-Specific Exclusions\n\n   * Receipt of oral, intramuscular, or intravenous glucocorticoids (\\>10 mg\u002Fday prednisone or equivalent) within 1 week prior to leukapheresis. (Note: Investigators may consider dose reduction prior to leukapheresis\u002Finfusion provided the participant's disease is controlled).\n   * Receipt of immunosuppressants within 1 week prior to leukapheresis, including but not limited to methotrexate, hydroxychloroquine, cyclosporine A, azathioprine, mycophenolate, sirolimus, colchicine, or D-penicillamine.\n4. RA-Specific Exclusions\n\n   * Use of anti-TNF agents within 8 weeks prior to dosing (or 4 weeks for etanercept).\n   * Use of any JAK inhibitor within 2 weeks prior to dosing.\n   * Use of other biologics or non-B-cell depleting investigational drugs within fewer than 5 half-lives prior to dosing.\n5. pSS-Specific Exclusions\n\n   * Diagnosis of secondary Sjögren's syndrome (defined as overlap with other autoimmune or systemic inflammatory diseases, e.g., RA, SLE, scleroderma, or idiopathic inflammatory myopathy).\n   * Severe systemic involvement assessed by the investigator, including:\n\n     o Serious vasculitis involving kidneys, digestive system, heart, lungs, or CNS (excluding cutaneous vasculitis);\n\n     o Active CNS or PNS involvement requiring high-dose glucocorticoids;\n\n     o Severe renal involvement (e.g., GFR \\\u003C 60 mL\u002Fmin);\n\n     o Severe pulmonary involvement (e.g., dyspnea at rest, or FVC \\\u003C 60% or DLCO \\\u003C 40%);\n\n     o Myopathy requiring high-dose glucocorticoids;\n\n     o Lymphoma.\n   * Use of sodium hyaluronate eye drops, artificial tears, artificial saliva, or sialogogues (e.g., pilocarpine) within 7 days prior to dosing; use of immunosuppressants (e.g., cyclophosphamide, leflunomide, methotrexate, azathioprine) within 4 weeks prior to dosing; use of JAK inhibitors or other kinase inhibitors within 2 weeks prior to dosing; use of targeted biologics (e.g., Telitacicept, Belimumab, Abatacept, Adalimumab) within 6 weeks prior to dosing.\n   * Requirement for medications causing dry mouth\u002Fdry eyes during the study.\n6. IIM-Specific Exclusions\n\n   * Participants with a record of Inclusion Body Myositis (IBM), juvenile myositis, drug-induced PM\u002FDM, cancer-associated PM\u002FDM (defined as cancer diagnosed within 3 years of PM\u002FDM diagnosis), or non-inflammatory myopathies (e.g., muscular dystrophies).\n   * Patients with PM\u002FDM who have a high risk of malignancy.\n   * Permanent muscle weakness due to causes other than PM\u002FDM (e.g., stroke) as judged by the investigator.\n   * Any of the following prior treatments\u002Fprocedures:\n\n     * Topical corticosteroids or topical immunomodulators (e.g., tacrolimus) for IIM-associated rash within ≤ 1 week prior to dosing;\n     * JAK inhibitors within 2 weeks prior to dosing;\n     * Cyclophosphamide, rituximab, or other anti-CD20 antibodies within 12 weeks prior to dosing;\n     * Other investigational products within 4 weeks or 5 half-lives (whichever is longer) prior to dosing;\n     * Combination therapy with \\>1 immunosuppressant, \\>1 antimalarial, or immunosuppressants plus antimalarials within 2 weeks prior to dosing.\n7. Other Autoimmune Diseases • History of other autoimmune diseases excluding the target indications, including Eosinophilic Granulomatosis with Polyangiitis (EGPA), Henoch-Schönlein purpura, cryoglobulinemic vasculitis, anti-glomerular basement membrane disease, Behçet's disease, or Takayasu arteritis.\n8. Malignancy\n\n   • History of malignancy within 5 years prior to enrollment, including patients with tumor-associated PM\u002FDM. Exceptions include: surgically removed and cured non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, low-stage bladder cancer, ductal carcinoma in situ of the breast, or patients cured with no evidence of recurrence in the past 2 years requiring no treatment.\n9. Hypersensitivity\n\n   • Known allergy, hypersensitivity, intolerance, or contraindication to BEN301 or any component of the study medications; or history of severe allergic reactions.\n10. Prior Cell Therapy\n\n    • Prior receipt of autologous\u002Fallogeneic hematopoietic stem cell transplantation or CAR-T cell therapy.\n11. Recent Procedures\u002FVaccinations\n\n    • Major surgery, live vaccine administration, or participation in other clinical trials within 1 month prior to screening.\n12. Active Infection\n\n    • Uncontrolled active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to screening (prophylactic treatment excluded); active tuberculosis (excluded if T-SPOT positive).\n13. Viral Serology\n\n    • Positive serology for Hepatitis B (HBsAg positive regardless of HBV-DNA level), Hepatitis C (HCVAb positive), HIV (HIV antibody positive), or Syphilis (confirmed TPPA positive) at screening.\n14. Prohibited Medications\n\n    • Use of medications\u002Ftreatments prohibited by the protocol during screening.\n15. Investigator's Discretion • Any other condition deemed unsuitable for study participation by the investigator, such as certain psychiatric disorders, dementia, suicidal ideation, or poor compliance.","70 Years",{"count":58,"type":20},24,[23],"The study aims to investigate the safety, tolerability, and preliminary clinical efficacy of BEN301 Injection in patients with autoimmune diseases.\n\nIn patients with autoimmune diseases, Treg cells are typically deficient or dysfunctional. CAR-Treg cell therapy represents a promising strategy for the treatment of autoimmune diseases and may be applicable to a broad spectrum of autoimmune conditions. Preclinical studies have shown that BEN301Injection not only effectively suppresses the aberrant activation of T and B cells in SLE models, but also significantly reduces total lgG secretion and the production of SLE-specific autoantibodies, particularly anti-double-stranded DNA (dsDNA) antibodies. Moreover, no significant treatment-related toxicities were observed.\n\nTreg cell therapy has already demonstrated favorable efficacy in multiple indications, including organ transplantation and autoimmune diseases, with a well-established safety and tolerability profile. Meanwhile, CAR-Treg cell therapy has been actively explored in various autoimmune conditions; several products have shown therapeutic potential, and some patients have already benefited from treatment. These findings highlight the promising prospects of CAR-Treg cell therapy in the management of autoimmune diseases.",[62],"SSC RA SS IIM","NOT_YET_RECRUITING","2026-04-07",{"date":66,"type":40},"2026-04-13",{"date":68,"type":20},"2026-03-25",{"date":70,"type":20},"2029-02-28",{"name":46,"class":47},2,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":92,"leadSponsor":93,"locationsCount":48},"100627412","early-phase-1-a-clinical-study-of-afn50-in-the-treatment-of-autoimmune-diseases-100627412","NCT07448298","A Clinical Study of AFN50 in the Treatment of Autoimmune Diseases","Inclusion Criteria:\n\n1\\. General Inclusion Criteria 1.1 Must be capable of understanding and voluntarily providing written informed consent.\n\n1.2 Age 18 to 69 years (inclusive), any gender. 1.3 Adequate bone marrow, coagulation, cardiac, pulmonary, hepatic, and renal function at screening:\n\nBone Marrow Function:\n\n* Absolute neutrophil count (ANC) ≥1.0 × 10⁹\u002FL (no use of granulocyte colony-stimulating factor (G-CSF) within 7 days before screening; for long-acting G-CSF, a 14-day interval is required); ② Haemoglobin (Hb) ≥90 g\u002FL (no red blood cell transfusion within 14 days before screening; use of recombinant human erythropoietin is permitted); ③ Platelet count (PLT) ≥75 × 10⁹\u002FL; absolute lymphocyte count (ALC) ≥0.5 × 10⁹\u002FL.\n\nCoagulation Function: International normalised ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5 × the upper limit of normal (ULN).\n\nCardiac Function: Left ventricular ejection fraction (LVEF) ≥50% as shown by echocardiography (ECHO).\n\nPulmonary Function: Dyspnea ≤ CTCAE Grade 1, and pulse oxygen saturation (SpO₂) \\>92% on room air.\n\nHepatic Function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2.5 × ULN; total bilirubin ≤1.5 × ULN.\n\nRenal Function: Creatinine clearance (Cockcroft-Gault formula) ≥50 mL\u002Fmin, without requiring fluid support.\n\n1.4 Baseline oxygen saturation \\>92% without supplemental oxygen. 1.5 Non-pregnant\u002Fnon-lactating subjects. Women of childbearing potential must have a negative serum or urine pregnancy test report (women who have undergone surgical sterilisation or are postmenopausal for at least 2 years are not considered to be of childbearing potential) and must be willing to use contraception for 12 months following drug infusion.\n\nDisease-Specific Inclusion Criteria：\n\n1. Relapsed\u002FRefractory Systemic Lupus Erythematosus (SLE) 1.1 Meet the 2019 European Alliance of Associations for Rheumatology\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE.\n\n   1.2 SLEDAI-2K score ≥6; if the score includes low complement and\u002For anti-dsDNA antibodies, the SLEDAI-2K clinical symptom score after excluding these two items must be ≥4.\n\n   1.3 History of SLE for at least 6 months, with disease remaining active or relapsing despite receiving stable standard therapy for at least 8 weeks (drug doses stable for the past 2 weeks).\n\n   1.4 Oral glucocorticoids (prednisone or equivalent) at a daily dose ≥7.5 mg and ≤30 mg; if combined with immunosuppressants, there is no minimum daily dose requirement.\n\n   1.5 At least two immunosuppressants (including hydroxychloroquine) have been used in a standardised manner.\n\n   1.6 Screening tests meet: positive serum antinuclear antibody (ANA), and\u002For positive anti-double-stranded DNA (anti-dsDNA) antibody, and\u002For hypocomplementemia (low C3 and\u002For low C4).\n\n   1.7 Definition of relapsed\u002Frefractory: Ineffective to conventional therapy or recurrence of disease activity after remission. Definition of conventional therapy: Stable use, alone or in combination, of the following drugs: non-steroidal anti-inflammatory drugs (NSAIDs), antimalarials, glucocorticoids, immunosuppressants (including but not limited to cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine), targeted drugs (including but not limited to belimumab, telitacicept, eculizumab, rituximab).\n2. Relapsed\u002FRefractory Sjögren's Syndrome (SS) 2.1Meet the 2002 AECG criteria or the 2016 ACR\u002FEULAR classification criteria for primary Sjögren's Syndrome.\n\n   2.2 Definition of relapsed\u002Frefractory: Ineffective to conventional therapy or recurrence of disease activity after remission. Definition of conventional therapy: Use of glucocorticoids (≥1 mg\u002Fkg\u002Fday) and cyclophosphamide, plus any one or more of the following immunomodulatory drugs for \\>6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, telitacicept, etc.\n3. Refractory Myasthenia Gravis (MG) 3.1 Meet the diagnostic criteria for generalized myasthenia gravis as per the Chinese guidelines for the diagnosis and treatment of MG (2025 edition).\n\n   3.2 Myasthenia Gravis Foundation of America (MGFA) clinical classification: Type II, III, or IV.\n\n   3.3 Positive serology for acetylcholine receptor antibody (AChR-Ab), or muscle-specific tyrosine kinase antibody (MuSK-Ab), or low-density lipoprotein receptor-related protein 4 antibody (LRP4-Ab) at screening, or documented history of positive AChR-Ab, MuSK-Ab, or LRP4-Ab.\n\n   3.4 Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥6, with ocular-related scores comprising less than 50% of the total score.\n\n   3.5 Myasthenia Gravis (QMG) score ≥8, with at least 4 individual item scores being ≥2 points.\n\n   3.6 Definition of refractory: Ineffective to conventional therapy or disease reactivation following remission.\n4. Relapsed\u002FRefractory or Progressive Diffuse Cutaneous Systemic Sclerosis (dcSSc) 4.1 Meet the 2013 ACR classification criteria for systemic sclerosis, with diffuse cutaneous involvement.\n\n   4.2 Presence of interstitial lung disease: evidence of interstitial changes with ground-glass opacity on chest HRCT and forced vital capacity (FVC) or diffusing capacity of the lung for carbon monoxide (DLCO) \\\u003C70% of predicted value on pulmonary function tests.\n\n   4.3 Definition of relapsed\u002Frefractory: Ineffective to conventional therapy or disease reactivation following remission.\n\n   4.4 Definition of conventional therapy: Use of glucocorticoids (≥1 mg\u002Fkg\u002Fday) and cyclophosphamide, plus any one or more of the following immunomodulatory drugs for \\>6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, telitacicept, etc.\n\n   4.5 Definition of progressive disease:\n   1. Skin progression: Increase in modified Rodnan skin score (mRSS) \\>10%.\n   2. Lung disease progression: Decrease in FVC by 10%, or decrease in FVC by 5% accompanied by a decrease in DLCO by 15% (OMERACT progression).\n5. Relapsed\u002FRefractory or Progressive Idiopathic Inflammatory Myopathy (IIM) 5.1 Meet the 2017 EULAR\u002FACR classification criteria for idiopathic inflammatory myopathies (including DM, PM, ASS, and NM).\n\n   5.2 For patients with muscle involvement: Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician Global Activity (PhGA), Patient Global Activity (PtGA) or extra-muscular disease activity score ≥2; Health Assessment Questionnaire (HAQ) total score ≥0.25; muscle enzyme levels 1.5 times the upper limit of normal).\n\n   5.3 Positive myositis antibodies. 5.4 Definition of relapsed\u002Frefractory: Ineffective to conventional therapy or recurrence of disease activity after remission. Definition of conventional therapy: Use of glucocorticoids (≥1 mg\u002Fkg\u002Fday) and cyclophosphamide, plus any one or more of the following immunomodulatory drugs for \\>6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, telitacicept, etc.\n\n   5.5 Definition of progressive disease: Rapidly progressive interstitial pneumonia occurring within a short period.\n6. Relapsed\u002FRefractory Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV) 6.1 Meet the 2022 ACR\u002FEULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n\n6.2 Positive ANCA-related antibodies (MPO-ANCA or PR3-ANCA). 6.3 Birmingham Vasculitis Activity Score (BVAS) ≥15 points (total 63 points), indicating active vasculitis.\n\n6.4 The BVAS assessment must include at least one major item, at least three minor items, or at least two renal items (hematuria and proteinuria).\n\n6.5 Definition of relapsed\u002Frefractory: Ineffective to conventional therapy or recurrence of disease activity after remission. Definition of conventional therapy: Use of glucocorticoids (≥1 mg\u002Fkg\u002Fday) and cyclophosphamide, plus any one or more of the following immunomodulatory drugs for \\>6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, telitacicept, etc.\n\nExclusion Criteria:\n\n1\\. General Exclusion Criteria 1.1 Individuals with positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA or titer above the detection threshold; positive hepatitis C virus (HCV) antibody with detectable HCV RNA or titer above the detection threshold; positive human immunodeficiency virus (HIV) antibody; detectable cytomegalovirus (CMV) DNA or level above the detection limit; positive syphilis antigen or antibody.\n\n1.2 Presence of other uncontrolled active infections. 1.3 History of major organ transplantation (e.g., heart, lung, liver, kidney) or bone marrow\u002Fhematopoietic stem cell transplantation.\n\n1.4 Received any mRNA-LNP product or other LNP-based therapy within the past 2 years and has a history of allergy to LNPs or their components.\n\n1.5 Received live vaccination within the past 30 days. 1.6 History of any severe cardiovascular disease within 6 months prior to screening, including: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant cardiac disease.\n\n1.7 Pregnant or lactating women. 1.8 Individuals with asthma or a history of severe allergies. 1.9 According to the investigator's judgment, the individual is unlikely to complete all protocol-required study visits or procedures, including follow-up or compliance with study participation requirements.\n\n1.10 Other unspecified reasons that, in the opinion of the investigator, render the patient unsuitable for enrollment.\n\nDisease-Specific Exclusion Criteria\n\n1. Relapsed\u002FRefractory Systemic Lupus Erythematosus: Concurrent neuropsychiatric lupus; thrombotic thrombocytopenic purpura (TTP)\u002Fmicroangiopathy (TMA).\n2. Relapsed\u002FRefractory Sjögren's Syndrome: Concurrent liver cirrhosis; concurrent aplastic anaemia (AA), myelodysplastic syndrome (MDS), or other myeloproliferative disorders (MPD); drug-induced thrombocytopenia; TTP\u002FTMA.\n3. Relapsed\u002FRefractory Myasthenia Gravis: Presence of an uncontrolled myasthenic crisis within 2 weeks prior to screening.\n4. Relapsed\u002FRefractory or Progressive Diffuse Cutaneous Systemic Sclerosis: NYHA Class IV cardiac function; presence of moderate to severe pulmonary hypertension (mean pulmonary artery pressure \\>40 mmHg by echocardiography); FVC \\\u003C45% of predicted value; DLCO \\\u003C40% of predicted value; significant abnormalities on HRCT not attributable to SSc; persistent unexplained hematuria (\\>5 red blood cells per high-power field) or creatinine clearance \\\u003C40 mL\u002Fmin; prior history of autologous stem cell transplantation; signs of renal crisis; active gastric antral vascular ectasia.\n5. Relapsed\u002FRefractory or Progressive Idiopathic Inflammatory Myopathy: Drug-induced myositis; inclusion body myositis; cancer-associated myositis (myositis occurring within 2 years of cancer diagnosis).\n6. Relapsed\u002FRefractory ANCA-Associated Vasculitis:\n\nEstimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m²; if the participant has alveolar haemorrhage requiring invasive mechanical ventilation expected to last beyond the screening period; requiring dialysis or plasma exchange during the screening period; or prior kidney transplantation.","69 Years",{"count":81,"type":20},18,[23],"This study is a single-arm, open-label, single-centre exploratory clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of AFN50 Injection in adult patients with B-cell-mediated refractory\u002Freplapased autoimmune diseases.",[85],"Relapsed\u002FRefractory Autoimmune Diseases",[87],"Autoimmune Diseases","2026-03-09",{"date":90,"type":40},"2026-03-11",{"date":88,"type":40},{"date":70,"type":20},{"name":46,"class":47},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":48},"100620705","phase-1-autologous-cd19bcma-dual-target-car-t-for-relapsedrefractory-autoimmune-diseases-100620705","NCT07361094","Autologous CD19\u002FBCMA Dual-Target CAR-T for Relapsed\u002FRefractory Autoimmune Diseases","An Exploratory Clinical Study to Evaluate the Safety and Efficacy of Autologous CD19-BCMA Dual-Target Chimeric Antigen Receptor T-Cell Therapy in Patients With Relapsed or Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age 18 to 70 years (inclusive), of any sex.\n2. Patients with failure of prior single-target CD19 or BCMA therapy, with a washout period of at least 6 months since the last treatment.\n3. Disease-specific criteria for different indications:\n\n3.1 Relapsed\u002FRefractory Moderate-to-Severe Systemic Lupus Erythematosus (SLE)\n\nParticipants must meet all of the following:\n\n1. Diagnosis of SLE according to the 2019 EULAR\u002FACR Classification Criteria for Systemic Lupus Erythematosus.\n2. At screening, positive antinuclear antibody (ANA) (titer ≥1:80), and\u002For positive anti-dsDNA antibody, and\u002For positive anti-Sm antibody.\n3. Moderate-to-severe disease activity defined as: SLEDAI-2000 score ≥8 at screening; if hypocomplementemia and\u002For anti-dsDNA antibody contribute to the score, the clinical SLEDAI-2000 score (excluding low complement and\u002For anti-dsDNA) must be ≥6.\n4. A documented history of at least 6 months of stable standard-of-care therapy for SLE prior to screening, with active disease for at least 2 months before screening. Standard therapy includes stable use (alone or in combination) of one or more of the following: glucocorticoids (≤20 mg\u002Fday prednisone or equivalent), antimalarial drugs (hydroxychloroquine ≤400 mg\u002Fday; chloroquine ≤500 mg\u002Fday), nonsteroidal anti-inflammatory drugs (NSAIDs), biologic agents (rituximab, belimumab, telitacicept), and other immunosuppressive or immunomodulatory agents including mycophenolate mofetil (≤2 g\u002Fday), azathioprine (≤2 mg\u002Fkg\u002Fday), methotrexate (≤20 mg\u002Fweek), etc.\n\n3.2 Relapsed\u002FRefractory Systemic Sclerosis (SSc)\n\nParticipants must meet all of the following:\n\n1. Diagnosis of SSc according to the 2013 EULAR\u002FACR Classification Criteria for Systemic Sclerosis.\n2. Diffuse cutaneous SSc as defined by LeRoy et al. (1988), characterized by extensive skin fibrosis involving areas proximal to the elbows and\u002For knees.\n3. Presence of interstitial lung disease (ILD) at screening, with forced vital capacity (FVC) 45-70% predicted, or diffusing capacity for carbon monoxide (DLCO) 40-70% predicted.\n4. Relapsed\u002Frefractory disease defined as inadequate response to prior standard therapy or relapse after remission. Standard therapy includes glucocorticoids, cyclophosphamide, and at least one immunosuppressive or immunomodulatory agent administered for ≥6 months (e.g., azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, rituximab, belimumab, telitacicept).\n5. Evidence of active disease, defined by at least one of the following: (a) progressive skin involvement at screening with an increase in modified Rodnan skin score (mRSS) ≥10% within the past 6 months; (b) evidence of active ILD, including newly diagnosed ILD within the past 6 months, or (in patients with pre-existing ILD) a decline in FVC ≥10%, or a decline in FVC ≥5% accompanied by a decline in DLCO ≥15% within the past 6 months.\n\n   3.3 Relapsed\u002FRefractory Idiopathic Inflammatory Myopathies (IIM)\n\n   Participants must meet all of the following:\n\n(1) Diagnosis of IIM with a probability ≥55% according to the 2017 EULAR\u002FACR Classification Criteria for IIM, and classified as dermatomyositis (DM), polymyositis (PM), or immune-mediated necrotizing myopathy (IMNM).\n\n(2) Active or severe disease defined as: (a) Manual Muscle Testing-8 (MMT-8) score ≤141 (total score 150); and (b) at least two of the following abnormal core set measures: patient global disease activity VAS ≥2 (0-10 scale); physician global disease activity VAS ≥2 (0-10 scale); physician global extramuscular disease activity VAS ≥2 (0-10 scale); Health Assessment Questionnaire Disability Index (HAQ-DI) ≥0.25 (0-3 scale); at least one muscle enzyme level \\>1.5 × upper limit of normal (ULN).\n\n3.4 Relapsed\u002FRefractory Sjögren's Syndrome (SS)\n\nParticipants must meet all of the following:\n\n1. Diagnosis of SS according to the 2016 EULAR\u002FACR Classification Criteria for Sjögren's Syndrome.\n2. Positive anti-Ro\u002FSSA antibody at screening.\n3. Salivary flow rate at screening: stimulated whole salivary flow ≥0.05 mL\u002Fmin, or unstimulated whole salivary flow ≥0.01 mL\u002Fmin.\n4. Active disease defined as ESSDAI score ≥5. 3.5 Relapsed\u002FRefractory Autoimmune Hemolytic Anemia (AIHA)\n\n   Participants must meet all of the following:\n\n(1) Diagnosis consistent with the Chinese Guidelines for the Diagnosis and Treatment of Adult Autoimmune Hemolytic Anemia (2023 Edition).\n\n(2) Evidence of hemolysis, including: anemia based on hemoglobin level; reduced haptoglobin (\\\u003C250 mg\u002FL), elevated total bilirubin (≥17.1 μmol\u002FL, predominantly indirect), elevated lactate dehydrogenase (LDH), and reticulocyte percentage \\>4% or absolute reticulocyte count \\>120 × 10\\^9\u002FL; and detection of red blood cell autoantibodies.\n\n(3) Relapsed\u002Frefractory disease defined as inadequate response, intolerance, contraindication, or relapse after ≥3 months of treatment with glucocorticoids combined with at least one immunosuppressive agent (e.g., cyclophosphamide, azathioprine, vinca alkaloids, calcineurin inhibitors, mycophenolate mofetil) and\u002For rituximab.\n\n3.6 Relapsed\u002FRefractory Multiple Sclerosis (MS)\n\nParticipants must meet all of the following:\n\n(1) Diagnosis of MS according to the Chinese Guidelines for the Diagnosis and Treatment of Multiple Sclerosis (2023 Edition).\n\n(2) Evidence of disease activity, meeting at least two of the following: (a) clinical relapse within the past 12 months confirmed by a neurologist; (b) MRI activity, including ≥1 new or enlarging T2 lesion or ≥1 new gadolinium-enhancing T1 lesion; (c) disability progression defined by an increase in EDSS score from baseline (≥1.0 point if baseline EDSS ≥1.0; ≥1.5 points if baseline EDSS = 0), sustained for ≥6 months and not attributable to a single relapse.\n\n(3) Relapsed\u002Frefractory disease despite ≥12 months of disease-modifying therapy (DMT), including inadequate response, intolerance, contraindication, or relapse during or after treatment discontinuation.\n\n4\\. Documented intolerance or inadequate response to prior therapy with glucocorticoids and at least two additional immunosuppressive or immunomodulatory agents, administered at effective doses for ≥3 months.\n\n5\\. Adequate organ function, defined as:\n\n(1) Hematologic: ANC ≥0.5 × 10\\^9\u002FL; platelets ≥20 × 10\\^9\u002FL; hemoglobin ≥60 g\u002FL. (2) Coagulation: INR ≤1.5 × ULN and APTT ≤1.5 × ULN. (3) Hepatic: AST and ALT ≤5 × ULN; total bilirubin ≤1.5 × ULN. (4) Renal: serum creatinine ≤1.5 × ULN or creatinine clearance ≥30 mL\u002Fmin (Cockcroft-Gault).\n\n(5) Cardiac: NYHA class I-II; LVEF ≥50%; no pericardial effusion; and no clinically significant ECG abnormalities.\n\n(6) Pulmonary: oxygen saturation ≥92% on room air; no clinically significant pleural effusion.\n\n6\\. Estimated life expectancy greater than 6 months. 7. Agreement to use effective contraception throughout the treatment period and for 24 months after CAR T-cell infusion; women of childbearing potential must have a negative pregnancy test at screening.\n\n8\\. Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1\\. Prior history of, or concurrent, other active malignancies, including malignancy-associated polymyositis\u002Fdermatomyositis. Exceptions include cervical carcinoma in situ, noninvasive basal cell or squamous cell skin cancer, localized prostate cancer treated with curative intent, or ductal carcinoma in situ after curative surgery, provided the participant is considered cured or has been disease-free for at least 2 years.\n\n2.Severe pulmonary disease within the past 3 months, such as moderate-to-severe pulmonary arterial hypertension (mean pulmonary artery pressure \\>60 mmHg by echocardiography), requirement for supplemental oxygen via reservoir mask at screening, or requirement for noninvasive or invasive mechanical ventilation.\n\n3.At screening, serum IgA, IgG, and IgM below the lower limit of normal (LLN). 4.Use of any of the following medications or therapies within the specified time windows:\n\n1. Use of B-cell-depleting therapy within 1 month prior to screening and assessed by the investigator as not having failed therapy, including agents targeting CD19, CD20, CD22, CD52, CD38, or BCMA (monoclonal antibodies or bispecific antibodies).\n2. High-dose intravenous human immunoglobulin (IVIG) within 1 month prior to screening.\n3. Therapeutic-dose systemic corticosteroids within 24 hours prior to lymphodepleting conditioning (prednisone \\>20 mg\u002Fday or equivalent).\n4. Corticosteroid pulse therapy within 2 weeks (defined as prednisone ≥500 mg\u002Fday or equivalent).\n5. Telitacicept within 2 weeks prior to screening, or belimumab within 3 weeks prior to screening.\n\n5\\. History of severe central nervous system (CNS) disease or related symptoms within the past 6 months (simple trigeminal neuralgia excluded), including but not limited to neuropsychiatric lupus, cerebrovascular disease, encephalitis, brain injury, aneurysm, cerebellar disease, organic brain syndrome, Parkinson's disease, as well as symptoms such as seizures\u002Fconvulsions, aphasia, or dementia.\n\n6\\. Lupus crisis within 3 months prior to screening, such as active CNS lupus, severe autoimmune hemolytic anemia, severe immune thrombocytopenic purpura, severe granulocytopenia, severe myocardial injury, severe lupus pneumonitis or pulmonary hemorrhage, severe lupus hepatitis, severe vasculitis, or other severe lupus manifestations.\n\n7\\. Severe renal disease, including severe lupus nephritis within 8 weeks prior to screening (defined as urine protein \\>4 g\u002F24 hours, or serum creatinine \\>1.5 × ULN, or creatinine clearance \\\u003C30 mL\u002Fmin by Cockcroft-Gault), active nephritis requiring use of protocol-prohibited medications, or nephritis requiring prednisone \\>500 mg\u002Fday (or equivalent systemic corticosteroids) for ≥14 days.\n\n8.Severe hypersensitivity\u002Fallergy to any lymphodepleting conditioning agent used in this study or to any component related to CAR T-cell manufacture\u002Fculture.\n\n9.Hepatitis B: positive HBsAg with detectable HBV DNA in peripheral blood;Hepatitis C: positive anti-HCV with detectable HCV RNA; Syphilis: RPR\u002FTRUST titer ≥1:8; HIV: positive HIV antibody.\n\n10.Uncontrolled fungal, bacterial, or viral infection, or any other infection that, in the investigator's judgment, makes the participant unsuitable for study participation.\n\n11\\. History of major organ transplantation (e.g., heart or lung transplantation).\n\n12\\. Active tuberculosis or latent tuberculosis at screening (defined as a positive tuberculin skin test or positive interferon-gamma release assay), regardless of the absence of clinical symptoms or imaging evidence.\n\n13\\. Any of the following cardiovascular diseases within 6 months prior to screening, including but not limited to:\n\n1. Congestive heart failure, myocardial infarction, unstable angina, coronary angioplasty, stent implantation, or coronary\u002Fperipheral artery bypass surgery.\n2. Severe arrhythmias requiring treatment (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes); congenital long QT syndrome; left anterior fascicular block (bifascicular block). Asymptomatic right bundle branch block is permitted.\n3. Uncontrolled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy.\n\n14\\. History of other autoimmune diseases (other than the target indication) requiring systemic therapy, including but not limited to eosinophilic granulomatosis with polyangiitis, cryoglobulinemic vasculitis, inclusion body myositis, anti-glomerular basement membrane disease, Behçet's disease, or Takayasu arteritis.\n\n15\\. Non-IIM myopathy, such as drug-induced myopathy, or a family history of human immunodeficiency virus (HIV)-associated myopathy.\n\n16\\. Pregnancy or breastfeeding. 17. Receipt of a live vaccine within 6 weeks prior to lymphodepleting conditioning.\n\n18\\. Participation in another interventional clinical study within 3 months prior to signing informed consent, receipt of an active investigational drug, or intention to participate in another clinical trial during this study period, or receipt of autoimmune disease treatment not specified in the protocol during the study period.\n\n19\\. Psychiatric disorders such as depression with suicidal ideation or suicidal tendency.\n\n20\\. Any other condition or factor that, in the investigator's judgment, makes the participant unsuitable for enrollment or may affect participation in or completion of the study.",{"count":102,"type":20},12,[104],"PHASE1","Autoimmune diseases occur when the immune system mistakenly attacks the body's own tissues, leading to chronic inflammation and damage to organs such as the kidneys, lungs, muscles, nerves, or blood cells. Although many treatments are available, some patients do not respond adequately or experience repeated disease flares despite long-term therapy. New treatment approaches are therefore needed for patients with relapsed or refractory autoimmune diseases. This study is an exploratory clinical trial designed to evaluate the safety and potential benefits of a novel cell-based therapy called autologous CD19-BCMA dual-target CAR T-cell therapy. This treatment uses a patient's own immune cells, which are collected from the blood, modified in the laboratory to recognize specific immune cells involved in autoimmune disease, and then infused back into the patient. The study includes adult patients with certain relapsed or refractory autoimmune diseases, such as systemic lupus erythematosus, systemic sclerosis, inflammatory muscle diseases, Sjögren's syndrome, autoimmune hemolytic anemia, and multiple sclerosis. After cell collection and preparative treatment, participants will receive a single infusion of the investigational CAR T-cell therapy and will be closely monitored for safety. The main purpose of this study is to better understand the safety of this treatment, including possible side effects. The study will also explore how the disease responds to treatment over time. Participants will be followed for up to two years after treatment to assess safety and clinical outcomes. The results of this study may help researchers better understand whether this type of cell therapy could be a feasible treatment option for patients with difficult-to-treat autoimmune diseases in the future.",[107,108,109,110,111,112],"Relapsed\u002FRefractory Systemic Lupus Erythematosus","Relapsed\u002FRefractory Systemic Sclerosis","Relapsed\u002FRefractory Idiopathic Inflammatory Myopathies","Relapsed\u002FRefractory sjögren's Syndrome","Relapsed\u002FRefractory Autoimmune Hemolytic Anemia","Relapsed\u002FRefractory Multiple Sclerosis","2026-01-14",{"date":115,"type":40},"2026-01-22",{"date":117,"type":40},"2025-11-06",{"date":119,"type":20},"2028-06",{"name":46,"class":47},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":130,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":48},"100592443","autologous-cd19car-t-therapy-for-recurrentrefractory-autoimmune-diseases-100592443","NCT06993493","Autologous CD19CAR-T Therapy for Recurrent\u002FRefractory Autoimmune Diseases","An Exploratory Clinical Study to Evaluate the Safety and Efficacy of Autologous CD19 CAR - T in the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* Age range of 18 to 65 years old (including 18 and 65 years old), gender is not limited;\n* Special criteria for different indications:\n* Subjects with relapsed\u002Frefractory moderate to severe SLE must meet the following criteria:\n* According to the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) SLE classification criteria, the diagnosis is SLE;\n* Positive for anti nuclear antibody (ANA) (titer ≥ 1:80), and\u002For positive for anti dsDNA antibody, and\u002For positive for anti Sm antibody during screening;\n* The definition of moderate to severe activity is: SLEDAI-2000 score ≥ 8 during screening; If there is a low complement and\u002For anti dsDNA antibody score, the clinical symptom score for SLEDAI-2000 (excluding low complement and\u002For anti dsDNA antibodies) must be ≥ 6 points;\n* At least 6 months of stable standard treatment have been used in the SLE history prior to screening, and the condition remains active for at least 2 months prior to screening. The standard treatment plan refers to the stable use of any of the following drugs (used alone or in combination): glucocorticoids (≤ 20mg\u002Fday prednisone or equivalent), antimalarials (hydroxychloroquine ≤ 400mg\u002Fday, chloroquine ≤ 500mg\u002Fday), nonsteroidal anti-inflammatory drugs (NSAIDs), biologics (rituximab, belimumab, tacept), and other immunosuppressants or immunomodulators, including mycophenolate mofetil (≤ 2g\u002Fday), azathioprine (≤ 2mg\u002Fkg\u002Fday), methotrexate (≤ 20mg\u002Fweek), etc;\n* Recurrent\u002Frefractory dcSSc subjects must meet the following criteria:\n* According to the 2013 EULAR\u002FACR classification criteria for systemic sclerosis (SSc), the diagnosis is SSc;\n* According to the definition criteria of LeRoy et al. in 1988, it meets the diffuse skin type presentation, which refers to extensive skin fibrosis and involvement of the skin near the elbow and\u002For knee;\n* When screening, interstitial lung disease (ILD) should be included, and 45% of the predicted values should be ≤ forced vital capacity (FVC) ≤ 70% of the predicted values, or 40% of the predicted values should be ≤ diffusion capacity of carbon monoxide (DLCO) ≤ 70% of the predicted values;\n* Relapse\u002Frefractory is defined as: recurrence after previous ineffective conventional treatment or disease remission. Conventional treatment refers to the use of glucocorticoids, cyclophosphamide, and at least one immunosuppressive\u002Fregulatory drug for at least 6 months. Immunosuppressive\u002Fregulatory drugs include azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, rituximab, belimumab, tacrolizumab, etc;\n* Activity is defined as having at least one of the following:\n\nThere is evidence of skin progression during screening, that is, an increase of ≥ 10% in mRSS scores within the past 6 months;\n\nDuring screening, there is evidence of any of the following ILD activities:\n\nNewly diagnosed ILD within the past 6 months; Previous ILD subjects had a 10% decrease in FVC or a 5% decrease in FVC accompanied by a 15% decrease in DLCO within the past 6 months.\n\n* Recurrent\u002Frefractory AAV subjects must meet the following criteria:\n* According to the definition of the 2012 Chapel Hill Consensus Conference (CHCC), clinical diagnosis is granulomatous vasculitis (GPA) and microscopic polyangitis (MPA);\n* In Birmingham Vasculitis Activity Score (BVAS) version 3, at least one primary item or at least three other items;\n* During screening, antibodies against PR3-ANCA or MPO-ANCA were positive;\n* The definition of recurrence\u002Frefractory is:\n\nRecurrent AAV subjects: those who have received initial efficacy (BVAS score 0 and glucocorticoid dose ≤ 7.5mg\u002Fd prednisone or other equivalent glucocorticoid drugs) after at least 3 months of combined glucocorticoid and immunosuppressive therapy (cyclophosphamide, rituximab, azathioprine, methotrexate, mycophenolate mofetil, etc.), and have experienced at least 1 disease recurrence (recurrence defined as the appearance of at least one important item in BVAS assessment, or at least 3 other items, or 1-2 new items in two consecutive assessments), and have experienced disease recurrence within 12 weeks before screening; Difficult to treat AAV subjects: Despite at least 3 months of previous treatment with corticosteroids combined with immunosuppressants (cyclophosphamide, rituximab, azathioprine, methotrexate, mycophenolate mofetil, etc.), no therapeutic effect has been achieved (BVAS score 0 and glucocorticoid dose ≤ 7.5mg\u002Fd prednisone or other equivalent glucocorticoid drugs);\n\n* Recurrent\u002Frefractory IIM subjects must meet the following criteria:\n* According to the 2017 EULAR\u002FACR IIM classification criteria, the probability of being diagnosed with IIM is ≥ 55%, and based on factors such as age of first onset, skin and muscle strength, laboratory tests, and muscle biopsy characteristics, it is classified as dermatomyositis (DM), polymyositis (PM), or immune-mediated necrotizing myopathy (IMNM):\n* Disease activity\u002Fseverity meets the following criteria:\n\nManual muscle strength check-8 (MMT-8) score ≤ 141 (total score of 150):\n\nMeet at least 2 of the anomalies in other CSMs:\n\nThe overall disease activity evaluated by the patient \\[based on Visual Analog Scale (VAS)\\] score is ≥ 2 points (range 0-10 points); The overall disease activity VAS score evaluated by physicians is ≥ 2 points (range 0-10 points); The overall extramuscular disease activity VAS score evaluated by the physician is ≥ 2 points (range 0-10 points); The Health Assessment Questionnaire Disability Index (HAQ-DI) score evaluated by physicians is ≥ 0.25 (range 0-3 points).\n\nAt least one muscle enzyme level is greater than 1.5 times the upper limit of normal (ULN).\n\n* Recurrent\u002Frefractory SS subjects must meet the following criteria:\n* According to the 2016 EULAR\u002FACR SS classification criteria, the diagnosis is SS;\n* Positive for anti Ro\u002FSSA antibodies during screening;\n* Dynamic saliva total flow rate ≥ 0.05 mL\u002Fmin or static saliva total flow rate ≥ 0.01 mL\u002Fmin during screening;\n* Activity is defined as a Dry Syndrome Disease Activity Index (ESSDAI) score of ≥ 5 across 8 sub items;\n* For autoimmune diseases that are intolerant to or have insufficient efficacy in the treatment of glucocorticoids and at least one other immunosuppressant or modulator in the past, it is required to be treated with glucocorticoids and at least two immunosuppressants (azathioprine, methotrexate, mycophenolate mofetil, etc.) at known effective doses for at least 3 months;\n* Having good organ function:\n* Blood routine: Absolute neutrophil count (ANC) ≥ 0.5 × 109\u002FL, platelet count (PLT) ≥ 20 × 109\u002FL, hemoglobin ≥ 60 g\u002FL;\n* Coagulation function: International normalized ratio (INR) ≤ 1.5 times ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;\n* Liver function: serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN), total bilirubin ≤ 1.5 times ULN;\n* Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (Cockcroft Gault formula) ≥ 30 mL\u002Fmin;\n* Cardiac function: NYHA grade I or II, with an echocardiogram (ECHO) left ventricular ejection fraction (LVEF) ≥ 50% and no pericardial effusion; There were no clinically significant abnormal findings in the 12 lead electrocardiogram (ECG);\n* Pulmonary function: Under indoor ventilation conditions, the oxygen saturation in non oxygenated state is ≥ 92%; No clinically significant pleural effusion;\n* Expected survival period greater than 6 months;\n* Subjects with reproductive partners agree to use effective contraceptive measures throughout the entire treatment period and for 24 months after treatment, and are not allowed to donate eggs\u002Fsperm for assisted reproduction during this period; Female subjects of childbearing age (those who have undergone sterilization surgery or have been menopausal for ≥ 12 months are not considered fertile) with negative urine pregnancy or blood pregnancy tests during the screening period; Voluntarily participate in this experiment and sign the informed consent form.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following criteria are not eligible for inclusion in this study:\n* Patients with previous or concurrent active malignant tumors, including tumor associated polymyositis\u002Fdermatomyositis. Cervical carcinoma in situ that has been cured or has not recurred for at least 2 years, non-invasive basal cell or squamous cell skin cancer, locally treated prostate cancer, and ductal carcinoma in situ after radical surgery are excluded;\n* Within the past 3 months, severe pulmonary diseases such as moderate to severe pulmonary arterial hypertension (average pulmonary arterial pressure detected by echocardiography\\>60 mmHg) require oxygen mask therapy or non-invasive or invasive ventilator assisted breathing during screening; During screening, IgA, IgG, and IgM levels were below the lower limit of normal (LLN);\n* Patients who have used any of the following medications or treatments within the specified time:\n* Individuals who have used B-cell depletion therapy within the previous month and have not failed treatment as assessed by clinical physicians, including those targeting CD20, CD22, CD52, CD38, BCMA monoclonal antibodies, or bispecific antibodies;\n* Screening for excessive use of human intravenous immunoglobulin within the previous month;\n* Use therapeutic doses of corticosteroids (prednisone ≥ 20mg\u002Fday or equivalent doses of other corticosteroids) within 24 hours prior to Qinglin pretreatment;\n* Received corticosteroid shock therapy within 2 weeks (defined as a dose ≥ 500mg\u002Fd of prednisone or equivalent dose of other corticosteroids);\n* Received tacrolizumab within 2 weeks prior to screening, or received belimumab within 3 weeks;\n* Patients with a history of severe central nervous system diseases or related symptoms (excluding simple trigeminal nerve disease) within the past 6 months, including but not limited to: lupus encephalopathy, cerebrovascular disease, encephalitis, brain injury, aneurysm, cerebellar disease, organic brain syndrome, Parkinson's disease and other central nervous system diseases, as well as epilepsy, seizures, aphasia, dementia and other symptoms;\n* Individuals who have experienced lupus crisis within the previous 3 months, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe neutropenia, severe myocardial injury, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, severe vasculitis, etc;\n* Concurrent severe kidney disease: severe lupus nephritis (defined as urinary protein\\>4g\u002F24 hours or serum creatinine\\>1.5 × ULN or creatinine clearance rate (Cockcroft Gault formula)\\\u003C30 mL\u002Fmin) within the first 8 weeks of screening, Or active nephritis that requires treatment with drugs prohibited by the protocol, or requires treatment with prednisone greater than 500mg\u002Fday or equivalent corticosteroids for ≥ 14 days;\n* Those who have severe allergies to the Qinglin pre-treatment drugs and any components of autologous CD19 CAR-T used in this study;\n* hepatitis B surface antigen (HBsAg) positive and peripheral blood HBV DNA positive; Individuals with positive hepatitis C virus (HCV) antibodies and positive HCV RNA; Positive for Treponema pallidum antibody; HIV antibody positive individuals;\n* There are uncontrolled fungi, bacteria, viruses, or other infections that researchers have assessed as unsuitable for participation in the study;\n* History of major organ transplantation (such as heart and lung); During screening, there is active tuberculosis or latent tuberculosis (referring to whether the tuberculin skin test or interferon test is positive, and there are no clinical symptoms or imaging evidence);\n* If any of the following cardiovascular diseases (including but not limited to) have occurred within the 6 months prior to screening:\n* Congestive heart failure, myocardial infarction, unstable angina, coronary angioplasty, stent implantation, coronary artery\u002Fperipheral artery bypass grafting;\n* Serious arrhythmias that require treatment (such as persistent ventricular tachycardia, ventricular fibrillation, apical torsion ventricular tachycardia, etc.); Congenital long QT syndrome, left anterior half block (double bundle block), allowing asymptomatic right bundle branch block to be included in the study;\n* Uncontrolled hypertension (systolic blood pressure greater than 160 mmHg and\u002For diastolic blood pressure greater than 100 mmHg), history of hypertensive crisis or hypertensive encephalopathy;\n* In addition to the target indication, patients with a history of other autoimmune diseases (including but not limited to eosinophilic granulomatous polyangitis, cryoglobulinemia vasculitis, inclusion body myositis, anti glomerular basement membrane disease, Behcet's disease or Takayasu arteritis, etc.) who require systematic treatment;\n* Individuals with a family history of non IIM such as drug-induced myopathy or human immunodeficiency virus related myopathy;\n* Pregnant or lactating women;\n* Those who have received a live vaccine within 6 weeks before the pre-treatment of Qinglin;\n* Participants who have participated in other interventional clinical studies, received active investigational drug treatment, or intended to participate in another clinical trial or receive treatment for autoimmune diseases outside of the protocol within 3 months prior to signing the informed consent form during the entire study period;\n* Mental illness patients with depression or suicidal tendencies; The researchers believe that there are other factors that are not suitable for inclusion or affect the participation or completion of the study by the subjects.","65 Years",{"count":102,"type":20},[131],"NA","This study is a single center, open label exploratory clinical trial aimed at evaluating the safety and efficacy of autologous CD19 CAR-T therapy in subjects with autoimmune diseases.\n\nThe study will adopt the traditional dose escalation model \"3+3\" design, with three dose groups set up, starting at a dose of 0.5 × 106 CAR+T cells\u002Fkg, to observe DLT, and conduct a 24 month safety and efficacy follow-up after cell infusion to observe the safety of autologous CD19 CAR-T and conduct preliminary efficacy evaluation.\n\nThree dose groups were set up, with dose group 1 as the starting dose, following the traditional 3+3 design rule for a single intravenous infusion:\n\nDose group dosage unit (CAR+T cells\u002Fkg) Acceptable dose range Expected sample size (± 30%, CAR+T cells\u002Fkg)\n\n1. 0.5 × 106 0.4 × 106\\~0.6 × 106 3-6 cases\n2. 1.0 × 106 0.7 × 106\\~1.3 × 106 3-6 cases\n3. 2.0 × 106 1.4 × 106\\~2.6 × 106 3-6 cases Dose escalation rule The enrollment starts from dose group 1, and if no DLT occurs in the 3 subjects included, they will be transferred to the next dose group. If one of the three subjects in a certain dose group develops DLT, three additional subjects will be added to the group for cell infusion at the same dose. If there is ≥ 1 case of DLT in the 3 additional cases, it will be reduced to the previous dose group. If there are only 3 subjects in the previous dose group at this time, an additional 3 subjects need to be added for the trial; If there are already 6 subjects in the previous dose group, the trial ends and this dose is the maximum tolerated dose (MTD).\n\nDose escalation is not allowed for the same subject. For safety reasons, the last subject in the previous dose group was observed for at least 28 days after autologous CD19 CAR-T infusion without DLT. The Safety Review Committee (SRC) held a meeting to decide whether to increase to the next dose group.\n\nDuring the dose escalation phase, SRC determines whether to continue increasing the dose or explore more subjects in a previously explored dose group based on the safety, efficacy, and pharmacokinetic (PK) results obtained for each dose group, and determines the recommended dose (RD) for subsequent studies.",[134],"Autoimmune Disease","2025-05-20",{"date":137,"type":40},"2025-05-28",{"date":139,"type":40},"2025-02-20",{"date":141,"type":20},"2027-08-31",{"name":46,"class":47},{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":150,"targetDuration":4,"studyType":21,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":158,"leadSponsor":160,"locationsCount":48},"100591710","safety-and-efficacy-of-cd19-car-t-therapy-for-recurrentrefractory-autoimmune-diseases-100591710","NCT06983964","Safety and Efficacy of CD19 CAR-T Therapy for Recurrent\u002FRefractory Autoimmune Diseases","Exploratory Clinical Study Evaluating the Safety and Efficacy of Universal CD19 CAR-T Therapy for Recurrent\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* Participants must meet all of the following inclusion criteria in order to be included in this study;\n* Age range of 18 to 65 years old (including 18 and 65 years old), gender is not limited;\n* Special criteria for different indications:\n* Subjects with relapsed\u002Frefractory moderate to severe SLE must meet the following criteria:\n* According to the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) SLE classification criteria, the diagnosis is SLE;\n* Positive for anti nuclear antibody (ANA) (titer ≥ 1:80), and\u002For positive for anti dsDNA antibody, and\u002For positive for anti Sm antibody during screening;\n* The definition of moderate to severe activity is: SLEDAI-2000 score ≥ 8 during screening; If there is a low complement and\u002For anti dsDNA antibody score, the clinical symptom score for SLEDAI-2000 (excluding low complement and\u002For anti dsDNA antibodies) must be ≥ 6 points;\n* At least 6 months of stable standard treatment have been used in the SLE history prior to screening, and the condition remains active for at least 2 months prior to screening. The standard treatment plan refers to the stable use of any of the following drugs (used alone or in combination): glucocorticoids (≤ 20mg\u002Fday prednisone or equivalent), antimalarials (hydroxychloroquine ≤ 400mg\u002Fday, chloroquine ≤ 500mg\u002Fday), nonsteroidal anti-inflammatory drugs (NSAIDs), biologics (rituximab, belimumab, tacept), and other immunosuppressants or immunomodulators, including mycophenolate mofetil (≤ 2g\u002Fday), azathioprine (≤ 2mg\u002Fkg\u002Fday), methotrexate (≤ 20mg\u002Fweek), etc;\n* Recurrent\u002Frefractory dcSSc subjects must meet the following criteria:\n* According to the 2013 EULAR\u002FACR classification criteria for systemic sclerosis (SSc), the diagnosis is SSc; 2) According to the definition criteria of LeRoy et al. in 1988, it meets the diffuse skin type presentation, which refers to extensive skin fibrosis and involvement of the skin near the elbow and\u002For knee;\n* When screening, interstitial lung disease (ILD) should be included, and 45% of the predicted values should be ≤ forced vital capacity (FVC) ≤ 70% of the predicted values, or 40% of the predicted values should be ≤ diffusion capacity of carbon monoxide (DLCO) ≤ 70% of the predicted values;\n* Relapse\u002Frefractory is defined as: recurrence after previous ineffective conventional treatment or disease remission. Conventional treatment refers to the use of glucocorticoids, cyclophosphamide, and at least one immunosuppressive\u002Fregulatory drug for at least 6 months. Immunosuppressive\u002Fregulatory drugs include azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, rituximab, belimumab, tacrolizumab, etc;\n* Activity is defined as having at least one of the following:\n\nThere is evidence of skin progression during screening, that is, an increase of ≥ 10% in mRSS scores within the past 6 months;\n\nDuring screening, there is evidence of any of the following ILD activities:\n\nNewly diagnosed ILD within the past 6 months; Previous ILD subjects had a 10% decrease in FVC or a 5% decrease in FVC accompanied by a 15% decrease in DLCO within the past 6 months.\n\n* Recurrent\u002Frefractory AAV subjects must meet the following criteria:\n* According to the definition of the 2012 Chapel Hill Consensus Conference (CHCC), clinical diagnosis is granulomatous vasculitis (GPA) and microscopic polyangitis (MPA);\n* In Birmingham Vasculitis Activity Score (BVAS) version 3, at least one primary item or at least three other items;\n* During screening, antibodies against PR3-ANCA or MPO-ANCA were positive;\n* The definition of recurrence\u002Frefractory is:\n\nRecurrent AAV subjects: those who have received initial efficacy (BVAS score 0 and glucocorticoid dose ≤ 7.5mg\u002Fd prednisone or other equivalent glucocorticoid drugs) after at least 3 months of combined glucocorticoid and immunosuppressive therapy (cyclophosphamide, rituximab, azathioprine, methotrexate, mycophenolate mofetil, etc.), and have experienced at least 1 disease recurrence (recurrence defined as the appearance of at least one important item in BVAS assessment, or at least 3 other items, or 1-2 new items in two consecutive assessments), and have experienced disease recurrence within 12 weeks before screening; Difficult to treat AAV subjects: Despite at least 3 months of previous treatment with corticosteroids combined with immunosuppressants (cyclophosphamide, rituximab, azathioprine, methotrexate, mycophenolate mofetil, etc.), no therapeutic effect has been achieved (BVAS score 0 and glucocorticoid dose ≤ 7.5mg\u002Fd prednisone or other equivalent glucocorticoid drugs);\n\n* Recurrent\u002Frefractory IIM subjects must meet the following criteria:\n* According to the 2017 EULAR\u002FACR IIM classification criteria, the probability of being diagnosed with IIM is ≥ 55%, and based on factors such as age of first onset, skin and muscle strength, laboratory tests, and muscle biopsy characteristics, it is classified as dermatomyositis (DM), polymyositis (PM), or immune-mediated necrotizing myopathy (IMNM):\n* Disease activity\u002Fseverity meets the following criteria:\n\nManual muscle strength check-8 (MMT-8) score ≤ 141 (total score of 150):\n\nMeet at least 2 of the anomalies in other CSMs:\n\nThe overall disease activity evaluated by the patient \\[based on Visual Analog Scale (VAS)\\] score is ≥ 2 points (range 0-10 points); The overall disease activity VAS score evaluated by physicians is ≥ 2 points (range 0-10 points); The overall extramuscular disease activity VAS score evaluated by the physician is ≥ 2 points (range 0-10 points); The Health Assessment Questionnaire Disability Index (HAQ-DI) score evaluated by physicians is ≥ 0.25 (range 0-3 points).\n\nAt least one muscle enzyme level is greater than 1.5 times the upper limit of normal (ULN).\n\n* Recurrent\u002Frefractory SS subjects must meet the following criteria:\n* According to the 2016 EULAR\u002FACR SS classification criteria, the diagnosis is SS;\n* Positive for anti Ro\u002FSSA antibodies during screening;\n* Dynamic saliva total flow rate ≥ 0.05 mL\u002Fmin or static saliva total flow rate ≥ 0.01 mL\u002Fmin during screening;\n* Activity is defined as a Dry Syndrome Disease Activity Index (ESSDAI) score of ≥ 5 across 8 sub items;\n* For autoimmune diseases that are intolerant to or have insufficient efficacy in the treatment of glucocorticoids and at least one other immunosuppressant or modulator in the past, it is required to be treated with glucocorticoids and at least two immunosuppressants (azathioprine, methotrexate, mycophenolate mofetil, etc.) at known effective doses for at least 3 months;\n* Having good organ function:\n* Blood routine: Absolute neutrophil count (ANC) ≥ 0.5 × 109\u002FL, platelet count (PLT) ≥ 20 × 109\u002FL, hemoglobin ≥ 60 g\u002FL;\n* Coagulation function: International normalized ratio (INR) ≤ 1.5 times ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;\n* Liver function: serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN), total bilirubin ≤ 1.5 times ULN;\n* Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (Cockcroft Gault formula) ≥ 30 mL\u002Fmin;\n* Cardiac function: NYHA grade I or II, with an echocardiogram (ECHO) left ventricular ejection fraction (LVEF) ≥ 50% and no pericardial effusion; There were no clinically significant abnormal findings in the 12 lead electrocardiogram (ECG);\n* Pulmonary function: Under indoor ventilation conditions, the oxygen saturation in non oxygenated state is ≥ 92%; No clinically significant pleural effusion;\n* Expected survival period greater than 6 months;\n* Subjects with reproductive partners agree to use effective contraceptive measures throughout the entire treatment period and for 24 months after treatment, and are not allowed to donate eggs\u002Fsperm for assisted reproduction during this period; Female subjects of childbearing age (those who have undergone sterilization surgery or have been menopausal for ≥ 12 months are not considered fertile) with negative urine pregnancy or blood pregnancy tests during the screening period; Voluntarily participate in this experiment and sign the informed consent form.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following criteria are not eligible for inclusion in this study:\n* Patients with previous or concurrent active malignant tumors, including tumor associated polymyositis\u002Fdermatomyositis. Cervical carcinoma in situ that has been cured or has not recurred for at least 2 years, non-invasive basal cell or squamous cell skin cancer, locally treated prostate cancer, and ductal carcinoma in situ after radical surgery are excluded;\n* Within the past 3 months, severe pulmonary diseases such as moderate to severe pulmonary arterial hypertension (average pulmonary arterial pressure detected by echocardiography\\>60 mmHg) require oxygen mask therapy or non-invasive or invasive ventilator assisted breathing during screening; During screening, IgA, IgG, and IgM levels were below the lower limit of normal (LLN);\n* Patients who have used any of the following medications or treatments within the specified time:\n* Individuals who have used B-cell depletion therapy within the previous month and have not failed treatment as assessed by clinical physicians, including those targeting CD20, CD22, CD52, CD38, BCMA monoclonal antibodies, or bispecific antibodies;\n* Screening for excessive use of human intravenous immunoglobulin within the previous month;\n* Use therapeutic doses of corticosteroids (prednisone ≥ 20mg\u002Fday or equivalent doses of other corticosteroids) within 24 hours prior to Qinglin pretreatment;\n* Received corticosteroid shock therapy within 2 weeks (defined as a dose ≥ 500mg\u002Fd of prednisone or equivalent dose of other corticosteroids);\n* Received tacrolizumab within 2 weeks prior to screening, or received belimumab within 3 weeks;\n* Patients with a history of severe central nervous system diseases or related symptoms (excluding simple trigeminal nerve disease) within the past 6 months, including but not limited to: lupus encephalopathy, cerebrovascular disease, encephalitis, brain injury, aneurysm, cerebellar disease, organic brain syndrome, Parkinson's disease and other central nervous system diseases, as well as epilepsy, seizures, aphasia, dementia and other symptoms;\n* Individuals who have experienced lupus crisis within the previous 3 months, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe neutropenia, severe myocardial injury, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, severe vasculitis, etc;\n* Concurrent severe kidney disease: severe lupus nephritis (defined as urinary protein\\>4g\u002F24 hours or serum creatinine\\>1.5 × ULN or creatinine clearance rate (Cockcroft Gault formula)\\\u003C30 mL\u002Fmin) within the first 8 weeks of screening, Or active nephritis that requires treatment with drugs prohibited by the protocol, or requires treatment with prednisone greater than 500mg\u002Fday or equivalent corticosteroids for ≥ 14 days;\n* Individuals who have severe allergies to any components of the Qinglin pre-treatment drug and the universal CD19 CAR-T used in this study;\n* hepatitis B surface antigen (HBsAg) positive and peripheral blood HBV DNA positive; Individuals with positive hepatitis C virus (HCV) antibodies and positive HCV RNA; Positive for Treponema pallidum antibody; HIV antibody positive individuals;\n* There are uncontrolled fungi, bacteria, viruses, or other infections that researchers have assessed as unsuitable for participation in the study;\n* History of major organ transplantation (such as heart and lung);\n* During screening, there is active tuberculosis or latent tuberculosis (referring to whether the tuberculin skin test or interferon test is positive, and there are no clinical symptoms or imaging evidence);\n* If any of the following cardiovascular diseases (including but not limited to) have occurred within the 6 months prior to screening:\n* Congestive heart failure, myocardial infarction, unstable angina, coronary angioplasty, stent implantation, coronary artery\u002Fperipheral artery bypass grafting;\n* Serious arrhythmias that require treatment (such as persistent ventricular tachycardia, ventricular fibrillation, apical torsion ventricular tachycardia, etc.); Congenital long QT syndrome, left anterior half block (double bundle block), allowing asymptomatic right bundle branch block to be included in the study;\n* Uncontrolled hypertension (systolic blood pressure greater than 160 mmHg and\u002For diastolic blood pressure greater than 100 mmHg), history of hypertensive crisis or hypertensive encephalopathy;\n* In addition to the target indication, patients with a history of other autoimmune diseases (including but not limited to eosinophilic granulomatous polyangitis, cryoglobulinemia vasculitis, inclusion body myositis, anti glomerular basement membrane disease, Behcet's disease or Takayasu arteritis, etc.) who require systematic treatment;\n* Individuals with a family history of non IIM such as drug-induced myopathy or human immunodeficiency virus related myopathy;\n* Pregnant or lactating women;\n* Those who have received a live vaccine within 6 weeks before the pre-treatment of Qinglin;\n* Participants who have participated in other interventional clinical studies, received active investigational drug treatment, or intended to participate in another clinical trial or receive treatment for autoimmune diseases outside of the protocol within 3 months prior to signing the informed consent form during the entire study period;\n* Mental illness patients with depression or suicidal tendencies; The researchers believe that there are other factors that are not suitable for inclusion or affect the participation or completion of the study by the subjects.",{"count":102,"type":20},[131],"This study is a single center, open label exploratory clinical trial aimed at evaluating the safety and efficacy of universal CD19 CAR-T therapy in subjects with autoimmune diseases.\n\nThe study will adopt the traditional dose escalation model \"3+3\" design, setting up three dose groups with a starting dose of 0.5 × 106 CAR+T cells\u002Fkg for incremental DLT observation. Safety and efficacy follow-up will be conducted for 24 months after cell infusion to observe the safety of the universal CD19 CAR-T and conduct preliminary efficacy evaluation.",[134],"2025-05-14",{"date":156,"type":40},"2025-05-21",{"date":139,"type":40},{"date":159,"type":20},"2027-09-30",{"name":46,"class":47},{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":175,"leadSponsor":176,"locationsCount":48},"100591709","exploratory-clinical-study-on-the-safety-and-efficacy-of-targeted-bcma-autologous-cart-cell-injection-in-subjects-with-recurrentrefractory-light-chain-amyloidosis-100591709","NCT06983951","Exploratory Clinical Study on the Safety and Efficacy of Targeted BCMA Autologous CART Cell Injection in Subjects With Recurrent\u002FRefractory Light Chain Amyloidosis","Exploratory Clinical Study Evaluating the Safety and Efficacy of Targeted BCMA Autologous CART Cell Injection in Subjects With Recurrent\u002FRefractory Light Chain Amyloidosis","Inclusion Criteria:\n\n\\- Participants must meet all inclusion criteria, and only those who do not meet any exclusion criteria can be enrolled\n\n1. Participants must personally sign the informed consent form approved by the ethics committee in writing before the start of the study;\n2. The age of the subject is ≥ 18 years old;\n3. Diagnosed with light chain amyloidosis through pathological examination;\n4. Subjects with recurrent\u002Frefractory light chain amyloidosis who have previously received second-line or higher treatment;\n5. dFLC \\> 50mg\u002FL\n6. Expected survival period ≥ 12 weeks;\n7. ECOG score ≤ 2 points;\n8. Female subjects with fertility should agree to take effective contraceptive measures from the date of signing the informed consent form until 365 days after reinfusion. Effective contraceptive measures are defined as abstinence or using contraceptive methods with an annual failure rate of less than 1% as specified in the plan;\n9. Prior to enrollment, participants must have appropriate organ function and meet all of the following test results:\n\n9.1 Absolute neutrophil count ≥ 1.0 × 109\u002FL \\[allowed to use granulocyte colony-stimulating factor (G-CSF) support\\]; 9.2 Platelet count ≥ 50 × 109\u002FL; 9.3 Hemoglobin ≥ 8 g\u002Fdl; 9.4 Bilirubin value ≤ 1.5 x upper limit of normal (ULN); 9.5 ALT or AST ≤ 2.5 times the upper limit of normal (ULN) (with liver involvement ≤ 5 times the upper limit of normal); 9.6 Mayo 2004 Stage I-IIIa participants; 9.7 Stable coagulation function: INR ≤ 1.5, APTT ≤ 1.2 x upper limit of normal (ULN); Basic blood oxygen saturation is greater than 92% in indoor natural air environment.\n\nExclusion Criteria:\n\n\\-\n\nSubjects who meet any of the following criteria will be excluded:\n\n1. Subjects who have received the following previous treatments:\n\n   1.1 Individuals who have received gene therapy prior to enrollment; 1.2 Subjects who received live vaccines within 4 weeks prior to enrollment; 1.3 Received other intervention clinical drug treatments within 12 weeks prior to single collection;\n2. Patients with central involvement or complete intestinal obstruction;\n3. Patients with moderate to severe pleural and peritoneal effusion who are difficult to control with conventional treatment and require continuous catheterization and drainage;\n4. Active malignant tumors within the past 5 years, unless they are curable tumors that have been significantly cured, such as basal or squamous cell carcinoma, cervical or breast carcinoma in situ, etc;\n5. Subjects with positive hepatitis B B surface antigen (HBsAg) and abnormal detection of HBV DNA in peripheral blood (abnormal detection of HBV DNA is defined as: quantitative detection of HBV DNA is higher than the detection limit of the testing center or higher than the normal reference value range of the testing center or positive qualitative detection of HBV DNA); Individuals with positive hepatitis C virus (HCV) antibodies and positive hepatitis C virus (HCV) RNA in peripheral blood; Individuals who are HIV antibody positive; Individuals who test positive for Cytomegalovirus (CMV) DNA; Positive RPR results in syphilis testing;\n6. There are uncontrollable active infections (excluding CTCAE grade 2 urinary and reproductive system infections and upper respiratory tract infections);\n7. Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), 24-hour dynamic electrocardiogram showing ventricular arrhythmia and atrioventricular block, positive six minute walk test, interventricular septum and left ventricular posterior wall thickness\\>1.5cm;\n8. Hypertensive subjects who cannot be controlled by drug treatment;\n9. Previous treatment toxicity reactions have not improved to baseline or ≤ grade 1 (NCI-CTCAE v5.0 version, except for hair loss and clinically insignificant laboratory test abnormalities);\n10. Have undergone major surgery within 2 weeks prior to enrollment, or plan to undergo surgery during the waiting period for reinfusion or within 12 weeks after receiving study treatment (excluding planned local anesthesia surgery);\n11. Solid organ transplant recipients;\n12. Pregnant or lactating women;\n13. Subjects with previous central nervous system disorders (such as cerebral aneurysms, epilepsy, stroke, senile dementia, mental illness, etc.) or consciousness disorders;\n14. Other researchers have identified unstable systemic diseases, including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;\n15. Known to have life-threatening allergic reactions, hypersensitivity reactions, or intolerance to cellular preparations or their components;\n16. Patients diagnosed by researchers as having bleeding, severe thrombosis, or genetic\u002Facquired bleeding and severe thrombosis (including hemophilia, coagulation dysfunction, thrombocytopenia, splenomegaly, etc.), or patients undergoing thrombolytic or anticoagulant therapy; Researchers believe that there are other situations that are not suitable for inclusion.",{"count":19,"type":20},[131],"This study is a multicenter, open label, fixed dose exploratory clinical trial with an expected enrollment of 30 subjects. The main objective is to evaluate the safety of targeted BCMA autologous CART cell injection in the treatment of recurrent or refractory light chain amyloidosis in subjects, preliminarily verify the effectiveness of targeted BCMA autologous CART cell injection in the treatment of recurrent or refractory light chain amyloidosis in subjects, and explore the pharmacokinetic, pharmacodynamic, and immunogenic characteristics of targeted BCMA autologous CART cell injection after reinfusion.",[172],"Light Chain Amyloidosis",{"date":156,"type":40},{"date":139,"type":40},{"date":159,"type":20},{"name":46,"class":47},{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":48},"100566948","a-study-of-car-t-cells-targeting-autoimmune-diseases-100566948","NCT06661811","A Study of CAR-T Cells Targeting Autoimmune Diseases","A Study of CAR-T Cells Targeting B Cell Related Autoimmune Diseases","Inclusion Criteria:\n\n1. Male or female, between 18 and 56 years old;\n2. Diagnosed with Autoimmune Diseases；\n3. Good organ functions;\n4. Voluntary participates this trial and can comprehend and sign ICF.\n\nExclusion Criteria:\n\n1. Had or has active malignancy;\n2. Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;\n3. Combined with other autoimmune disease that needs treatment;\n4. Pregnant or lactating women;\n5. Has other factors that deemed not suitable by investigator.",{"count":102,"type":20},[131],"The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in patients with autoimmune disease.",[87],"2024-10-25",{"date":190,"type":40},"2024-10-28",{"date":192,"type":20},"2024-11-15",{"date":194,"type":20},"2028-06-20",{"name":46,"class":47},""]