[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idiopathic-inflammatory-myopathy-iim\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idiopathic-inflammatory-myopathy-iim":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,45,85,108,135,158,189,210],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100610558","phase-1-om336-in-seropositive-autoimmune-diseases-100610558",false,"NCT07229144","OM336 in Seropositive Autoimmune Diseases","An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Sjogren's Disease or Idiopathic Inflammatory Myopathy","Key Inclusion Criteria:\n\n* Diagnosis of active seropositive autoimmune disease\n* Relapsed\u002Frefractory after ≥2 prior\u002Fongoing treatments\n* Body weight ≥ 50 kg\n* Willing to comply with and study requirements and procedures\n\nKey Exclusion Criteria:\n\n* Previous treatment with a BCMA-targeted therapy\n* Clinically significant infection within 3 months of screening\n* Major surgery within 3 months of screening or planned during the study\n* Pregnant or breastfeeding","ALL","18 Years","75 Years",{"count":20,"type":21},39,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of OM336 in adult participants with seropositive autoimmune diseases. OM336 is administered subcutaneously in ascending dose cohorts.",[27,28],"Sjogrens Disease","Idiopathic Inflammatory Myopathy (IIM)",[30,31],"OM336","Ouro","RECRUITING","2026-06-11",{"date":35,"type":36},"2026-06-15","ACTUAL",{"date":38,"type":36},"2025-10-01",{"date":40,"type":21},"2028-03",{"name":42,"class":43},"Ouro Medicines","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":66,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":44},"100599529","phase-1-phase-1-study-of-hbi0101-car-t-in-refractory-b-cell-autoimmune-diseases-100599529","NCT07085676","Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases","A Phase 1 Dose Escalation and Safety Study of HBI0101 CART in B-cell Mediated Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age: 18\\~80 years old; for patients aged ≥ 75 years, geriatric assessment and endorsement are required;\n2. Diagnosis of B-cell mediated ARDs listed below:\n\n   SLE patients: individuals diagnosed with SLE according to American College of Rheumatology (ACR) and\u002For Systemic lupus international collaborating clinics (SLICC) classification criteria, who have severe and progressive disease course reflected by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score of 8 or more. Eligible patients must have failed to at least one of the conventional DMARDs (azathioprine, methotrexate, mycophenolate mofetil or cyclophosphamide), one of the calcineurin inhibitors (tacrolimus or cyclosporin) and one of the biologic agents (belimumab, rituximab or aniflorumab), each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories. The failure is defined as:\n   * lack of response per SLEDAI-2k (\\\u003C4 points reduction from baseline) or no improvement in BILAG domains, or\n   * disease flare per SLEDAI-2k (≥4 points increase from baseline) or new BILAG A or ≥2 new BILAG B organ scores, or intolerance or discontinuation due to adverse effects.\n\n   SSc patients: Patients who were diagnosed with diffuse or limited cutaneous SSc according to the College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR-EULAR) classification criteria, with severe or rapidly progressive disease Eligible patients must meet any of the following criteria:\n   * Progression of skin thickening ≥ 12 over the past 6 months or Modified Rodnan skin score (mRSS) ≥15\n   * Any Medsger Disease Severity Score grade 3-4 in one major organ or grade ≥2 in two organs\n   * Progressive interstitial lung disease evidenced by HRCT or FVC \\\u003C80% or DLCO \\\u003C80%, or evidence of pulmonary function decline, defined as an absolute FVC decline of ≥ 10% , or FVC decline of 5% -9% combined with DLCO 15%.\n   * Other internal organ involvement.\n\n   Eligible patients must have failed to at least two state-of-the-art immunosuppressive therapies including MTX, MMF, cyclophosphamide, azathioprine, nintedanib, tocilizumab or rituximab; each therapy must have been administered for a minimum of 3 months, unless discontinued due to a contraindication or toxicity. The failure is defined as:\n   * lack of response in skin per mRSS (≤20% relative and ≤5 point absolute reduction from baseline) or no clinically meaningful improvement in FVC, DLCO, or other organ involved assessed by Medsger DSS, or\n   * disease flare in skin per mRSS (increase in mRSS ≥20% and ≥5 points from baseline) or decline in FVC ≥10% predicted or in DLCO ≥15% predicted from baseline, other major SSc complication, or\n   * intolerance or discontinuation due to adverse effects\n\n   IIM, including dermatomyositis, anti-synthetase syndrome, immune mediated necrotizing myopathy, and polymyositis: patients must be diagnosed with IIM according to the 2017 ACR\u002FEULAR Classification Criteria for idiopathic inflammatory myopathies.\n\n   Eligible patients must have active disease, defined by at least one of the following:\n   * CPK ≥4xULN\n   * Loss of muscle strength in the weakest muscle group for less than 80% per MMT8\n   * Evidence on MRI of active myositis within last 6 months\n   * Evidence on EMG of active myositis within last 6 months\n   * Muscle biopsy evidence of active myositis within last 6 months\n\n   Only patients with refractory disease will be recruited, defined as previous failure to (1) at least two of five non-glucocorticoids immunosuppressive therapies and (2) either rituximab or IVIG, each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories. The five non-glucocorticoids therapies considered are azathioprine, MTX, MMF, IVIG, and rituximab The failure is defined as:\n   * lack of response in muscle strength per MMT-8 or CPK (\\\u003C20% relative improvement) or per MRI or\n   * disease flare in muscle strength per MMT-8 (≥30% decline) or CPK (≥30% rise) or objective worsening of other organ involvement per Myositis Disease Activity Assessment Tool or\n   * intolerance or discontinuation due to adverse effects\n\n   RA patients: Seropositive RA patients (positive for anti-cyclic citrullinated peptide and rheumatoid factor), diagnosed according to the 2010 ACR\u002FEULAR classification criteria.\n\n   Eligible patients must exhibit high disease activity (DAS28CRP ≥5.1), and be resistant to at least four conventional synthetic and biologic disease-modifying antirheumatic drugs (DMARD) groups.\n\n   Each patient must have previously received at least one medication from each of the mentioned groups, including\n   * JAK-STAT inhibitors\n   * Anti-TNF agents\n   * Anti-IL6 drugs\n   * Anti-CTLA4-Ig treatments, each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories\n\n   Drug resistance is defined as:\n   * Inadequate clinical response measured by composite score DAS28CRP (\\> 3.6) or failure to reach ACR20 or\n   * Disease progression measured by DAS28CRP (≥20% increase) or radiographic progression or\n   * Intolerance or discontinuation due to adverse effects\n\n   NMOSD: Patients must be diagnosis of AQP4-IgG-positive NMOSD based on the 2015 International Panel for NMOSD Diagnosis (IPND) criteria (Wingerchuk et al., 2015).\n\n   Eligible patients must have experienced at least two relapses in the past 24 months, with at least one occurring in the preceding 12 months before screening Each patients must have previously received with inadequate disease control (one or more clinical attacks, with new MRI activity, despite adequate treatment dosing) at least one immunosuppressant for at least 6 months (azathioprine or mycophenolate mofetil) and\u002For Rituximab for at least 3 months and\u002For a targeted therapy (eculizumab, inebilizumab, or satralizumab) or must have a contraindication to such treatment.\n\n   MS patients: must have confirmed history of diagnosis of primary progressive or secondary progressive MS .\n\n   Eligible patients must have: Expanded Disability Status Scale (EDSS) score between 3.0 and 8.5 and evidence of disease activity, defined by either clinical progression and\u002For radiological finding on MRI, such as new, enhancing or enlarging lesions in the last 12 months.\n\n   Eligible patient must have previously received at least one high efficacy drug and have been offered standard treatments and have experienced disease progression or lack of efficacy despite at least six months of treatment. These will include clinical activity (new relapse\\[s\\]), radiological activity (new or enlarging T2 lesions and\u002For gadolinium-enhancing lesions on MRI), or confirmed disability progression (an increase in least 1 point on the EDSS sustained for ≥6 months).\n\n   Eligible patient must have history of treatment with anti-CD20 mAb with continuing evidence of worsening physical disability over a period of ≥6 months, with documented clinical disability progression within the year prior to inclusion, irrespective to concurrent MRI activity.\n\n   MG patients must meet all the following criteria:\n\n   \\- Confirmed diagnosis of generalized MG, supported by positive autoantibodies (anti-AChR, anti-MuSK).\n\n   Disease Severity:\n   * Myasthenia Gravis Activities of Daily Living (MG-ADL) score of ≥6, with ocular symptoms constituting less than 50% of the total score.\n   * Myasthenia Gravis Foundation of America (MGFA) clinical classification of II to IV.\n\n   Eligible patients must have Refractory Status and meet at least one of the following criteria:\n   * No improvement or worsening myasthenic symptoms, with failure to achieve minimal manifestation status or meaningful improvement in MGFA class or MG-ADL score, or recurrent myasthenic exacerbations despite adequate immunosuppressive or immunomodulatory therapy for at least 6 months for all therapies and 3 months for B cell depletion therapy\n   * Improvement in Post-Intervention Status (PIS), but with an MG-ADL score ≥6 persisting for at least 4 months.\n   * Remission or improvement in PIS, but with ≥1 episode of disease exacerbation (MG-ADL ≥6) per year during tapering of immunotherapy medications.\n   * After experiencing a myasthenic crisis, patients who undergo multiple immunotherapies (e.g., intravenous immunoglobulin, plasma exchange, high-dose intravenous methylprednisolone), thymectomy, and active infection control but still cannot be weaned off the ventilator due to MG-induced respiratory muscle weakness for more than 14 days.\n\n   Each patient must receive stable doses of medication prior to enrollment.\n\n   Refractory APLA patients: must have confirmed history of APLA, based on Sydney 2006 or ACR\u002FEULAR 2023 criteria\n\n   \\- Eligible patients must have medium to high-titer antiphospholipid antibodies, documented repeatedly (≥2 tests spanning 12 weeks) Eligible patients must have refractory disease: persistent or recurrent arterial thrombosis, venous thrombosis or diffuse alveolar hemorrhage despite conventional therapy with stable treatment with vitamin K antagonist anticoagulation (maintained at therapeutic stable dose keeping INR consistently within target range) and immunosuppression treatment including glucocorticoid, rituximab and Plaquenil\n3. AST\u002FALT below 5 times the upper limit of normal, blood bilirubin below 3 times the upper limit of normal ;\n4. Cardiopulmonary function is basically normal, echocardiography indicates that the ejection fraction is \\>45%, normal to mild pulmonary hypertension, and the oxygen saturation is above 93% in the resting state without oxygen;\n5. No obvious active infection;\n6. There are no contraindications for blood collection;\n7. Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study;\n8. Voluntary participation and informed consent signed by the patient or his\u002Fher legal\u002Fauthorized representative.\n9. Ability and willingness to adhere to the study visit schedule and all protocol requirements\n\nExclusion Criteria\n\n1. CNS disease- History of CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis, non-autoimmune progressive neurologic condition or PML\n2. Abnormal liver function: aspartate transaminase (AST) or alanine transaminase (ALT) or glutamyl transpeptidase (GGT) or alkaline phosphatase (ALP) detection value is greater than 5 times the upper limit of normal (ULN); or total bilirubin test value greater than 3 times the upper limit of normal (ULN); Exceptional: liver function disturbance due to myositis.\n3. Cardiovascular disease: Unstable angina or myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to leukapheresis\u002F moderate- severe pulmonary hypertension\u002F severe arrhythmia (ventricular tachycardia, ventricular fibrillation, high grade ventricular block) in the past 6 months; New York heart function class (NYHA) class III- Level IV or LVEF\\\u003C45%.\n4. Lung disease: patients with chronic lung disease with any of the following: \\* Oxygen saturation (SpO2) \\\u003C 90% on room air \\* FVC≤45% of predicted or DLCO≤40% of predicted at screening. \\* Evidence of pulmonary hypertension as defined as estimated RVSP\\> 50 mmHg.\n5. Muscle disease: evidence of any of the following: \\* Severe proximal muscle atrophy of upper or lower extremity on MRI or clinical examination. \\*Finding of muscular inflammation or myopathy other than the indication, such as inclusion body myositis (IBM), or cancer-associated myositis (myositis diagnosed within 2 years of cancer).\n6. Other uncontrolled diseases: acute diseases (such as acute pneumonia or other infection, pulmonary embolism, diabetic ketoacidosis, acute pancreatitis, etc.) that are clinically unstable or have not been effectively controlled and are not related to indicated autoimmune diseases which in the judgment of the investigator may confound study results or place subjects at undue risk.\n7. Biologics therapy: Received rituximab within 4 months of expected CAR T treatment: No plasma exchange or immunoglobulin treatment within 4 weeks prior to screening. MS patients: No high dose corticosteroid treatment in the 30 days prior to enrollment; see also section 9.1 for the list of restrictions.\n8. Participated in any clinical study within 3 months prior to enrollment, or participate in other clinical investigations during the study period.\n9. Previous or concurrent malignancy with the following exceptions: Adequately treated basal cell or squamous cell carcinoma, in situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening.\n10. Transplantation: History of vital organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002For bone marrow transplantation.\n11. Disease-specific criteria: MS\u002FNMO patients: No disease relapse in the 30 days prior to enrollment\n12. Known HIV positive status.\n13. Active hepatitis B or C infection.\n14. Active CMV infection\n15. Pregnant or lactating women.\n16. Inability to understand or follow the research protocol subject requirements.\n17. Have any other clinically significant disease history or current disease that, in the judgment of the research physician, may pose a risk to the safety of the subjects, or interfere with the completion of the research procedure and the evaluation of safety and efficacy","80 Years",{"count":54,"type":21},120,[24],"A Phase 1 study of HBI0101 BCMA-CART in B-Cell Mediated Autoimmune Rheumatic Diseases. The goal of the study is evaluation of safety and identification of the maximum HBI0101 CART dose that may be administered safely to patients with B-cell mediated autoimmune disease.",[58,28,59,60,61,62,63,64,65],"Systemic Sclerosis (SSc)","Rheumatoid Arthritis (RA)","Systemic Lupus Erythematosus (SLE)","Multiple Sclerosis (MS) Primary Progressive","Multiple Sclerosis (MS) Secondary Progressive","Neuromyelitis Optica Spectrum Disorder (NMOSD)","Myasthenia Gravis (MG)","Antiphospholipid Antibody Syndrome",[67,60,68,69,70,71,72,73,63,64,74],"B-cell mediated autoimmune rheumatic diseases","Systemic sclerosis (SSC)","Idiopathic inflammatory myopathy (IIM)","Rheumatoid arthritis (RA)","B-cell maturation antigen (BCMA)","Autologous CAR-T","Multiple sclerosis (MS) Primary and Secondary progressive","refractory antiphospholipid antibody syndrome","2026-04-29",{"date":77,"type":36},"2026-05-06",{"date":79,"type":36},"2024-09-01",{"date":81,"type":21},"2030-11-01",{"name":83,"class":84},"Polina Stepensky","OTHER",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":44},"100599585","early-phase-1-gc012f-injection-in-refractory-idiopathic-inflammatory-myopathy-100599585","NCT07086404","GC012F Injection in Refractory Idiopathic Inflammatory Myopathy","Early Exploratory Clinical Study of GC012F Injection in Refractory Idiopathic Inflammatory Myopathy","Inclusion Criteria:\n\n* 1\\) The subject or his\u002Fher legally acceptable representative voluntarily signs the written informed consent form and is willing and able to comply with the procedures of this study; 2) Aged 18 to 70 years (inclusive) at the time of signing informed consent, male or female; 3) Patients should meet the following criteria:\n\n  1. Subjects with suspected or confirmed idiopathic inflammatory myopathy (IIM) based on the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria and at least one proximal limb muscle strength of less than or equal to Grade 4; patients with immune-mediated necrotizing myopathy (IMNM) may be included if he\u002Fshe meets other inclusion criteria and does not meet all exclusion criteria and the investigator assesses that the patient has no safety instability;\n  2. Active myositis on muscle biopsy or muscle magnetic resonance imaging (MRI) within the screening period or within 6 months prior to screening;\n  3. Positive (+ or above) for at least one myositis-specific antibody (MSA) or myositis-associated antibody (MAA) (including anti-TIF-1γ, NXP-2, Mi-2α, Mi-2β, MDA-5, SAE-1\u002F2, SRP, HMGCR, Jo-1, PL-7, PL-12, HA, EJ, OJ, KS, Zo, PM-Scl100, PM-Scl75, SSA\u002FRo-52, SSB\u002FLA, Ku, RNA-PIII, cN1A, etc.);\n  4. At screening, the subject must have moderate to severe IIM, defined as manual muscle testing (MMT) \\\u003C 142 and 2 of the following criteria are met:\n\n     * PGA (VAS) ≥ 2 cm (VAS 10 cm scale);\n     * PtGA (VAS) ≥ 2 cm (VAS 10 cm scale);\n     * Health assessment questionnaire (HAQ) \\> 0.25;\n     * Increase in one or more muscle enzymes (CK, LDH, AST, ALT) is ≥ 1.5 × ULN;\n     * Extramuscular global assessment (Myositis Disease Activity Assessment Tool \\[MDAAT\\]) ≥ 2.0 cm (VAS 10 cm scale); 4) Muscle enzyme increased (CK) ≥ 2 × ULN; 5) Inadequate response or intolerance to corticosteroids and at least 2 immunosuppressants and\u002For biologic agents; 6) If the patient is taking corticosteroids, the dose of prednisone should not exceed 40 mg\u002Fday (or equivalent dose of other corticosteroids) within 3 weeks before apheresis, and the dose is not uptitrated within 3 weeks before apheresis and not changed within 4 weeks before infusion (Note: under the premise that the subject's disease under study is controlled, the investigator may consider reducing the dose of corticosteroids before apheresis, lymphodepletion, and infusion); 7) Life expectancy ≥3 months; 8) Laboratory test results must meet the following criteria at screening (except for those related to the corresponding disease under study):\n\n  \u003C!-- -->\n\n  1. Neutrophil count \\> 1.0 × 10\\^9\u002FL, Hemoglobin ≥ 80g\u002FL, platelet count ≥ 50 × 10\\^9\u002FL;\n  2. Alanine aminotransferase ≤ 3 × upper limit of normal (ULN); aspartate aminotransferase ≤ 3 × ULN (unless the increases in alanine aminotransferase and\u002For aspartate aminotransferase are assessed by the investigator as related to polymyositis \\[PM\\] or dermatomyositis \\[DM\\]); total bilirubin (TBIL) \\\u003C 2 × ULN (direct bilirubin \\[DBIL\\] ≤ 1.5 × ULN for subjects with Gilbert's syndrome);\n  3. Creatinine clearance ≥ 60 ml\u002Fmin;\n  4. Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN;\n  5. Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed by echocardiogram, with no evidence of pericardial effusion as determined; 9) Women of childbearing potential must:\n\n  \u003C!-- -->\n\n  1. Have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result at screening as confirmed by the investigator;\n  2. Agree to avoid breastfeeding during the study period and until at least 2 years after infusion of GC012F Injection, or until two consecutive flow cytometry tests indicate that CAR-T cells are no longer present (whichever occurs later); 10) Male subjects with sexual partners and female subjects of childbearing potential must agree to use highly effective contraception methods (e.g., oral contraceptives, intrauterine devices, or condoms) starting from screening and continuing for at least 2 years after GC012F Injection infusion or until two consecutive flow cytometry tests indicate that CAR-T cells are no longer present (whichever occurs later). Male subjects must agree to use condoms during any sexual contact with pregnant women or women of childbearing potential for at least 2 years after GC012F Injection infusion, even if they have undergone successful vasoligation.\n\n     11\\) The required venous access for collection can be set up, with no contraindications for leukapheresis.\n\n     Exclusion Criteria:\n* 1\\) Documented inclusion body myositis (IBM), drug-induced PM or DM, tumor-related PM or DM, amyopathic DM, non-inflammatory myopathy (e.g., muscular dystrophy); for patients with PM or DM, they were \\> 40 years of age at onset of PM or DM symptoms and the diagnosis time is less than 3 years, and the investigator considered a possible malignancy based on the patient's clinical presentation; 2) Uncontrolled extramuscular disease impairment associated with PM or DM:\n\n  1. Interstitial lung disease (ILD): Forced vital capacity (FVC) \\\u003C 55% or requiring oxygen therapy;\n  2. Severe dysphagia manifestations, that will increase the risk associated with the patient's participation in the clinical trial, as judged by the investigator;\n  3. Severe cardiac manifestations (e.g., congestive heart failure, arrhythmia, conduction abnormality requiring treatment or myocardial infarction) that, in the judgment of the investigator, will increase the risk associated with the patient's participation in the clinical trial; 3) Patients with severe muscle injury who meet one of the following criteria:\n\n  \u003C!-- -->\n\n  1. Myositis damage index (MDI) ≥ 5;\n  2. Severe proximal muscle atrophy of the upper or lower extremities as shown on MRI;\n  3. Severe proximal muscle atrophy of the upper or lower extremities as found by clinical examinations; 4) History of severe hypersensitivity or allergy; 5) Contraindications or hypersensitivity to fludarabine, cyclophosphamide, or any component of the investigational product; 6) Presence of the following cardiac disorders:\n\n  \u003C!-- -->\n\n  1. New York Heart Association (NYHA) Class III or IV congestive heart failure;\n  2. Myocardial infarction or coronary artery bypass grafting within 6 months prior to screening;\n  3. History of clinically significant ventricular arrhythmia or unexplained syncope not due to a vasovagal reaction or dehydration, or QTc interval \\> 480 milliseconds at screening;\n  4. History of severe non-ischemic cardiomyopathy; 7) Any active malignancy or history of malignancy within 5 years prior to screening. Exceptions include curatively treated early stage tumors (carcinoma in situ or stage I tumors, non-ulcerative primary melanoma with a depth of less than 1 mm and no involvement of lymph nodes), cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, in-situ carcinoma of cervix, or in-situ carcinoma of breast that has been potentially curatively treated; 8) Clinically significant hemorrhage symptoms or a definite tendency to hemorrhage within 6 months prior to screening, such as hemorrhage of digestive tract and hemorrhagic gastric ulcer; hereditary or acquired hemorrhage or thrombotic tendencies (e.g., hemophilia, coagulation disorders, and hypersplenism); arterial or venous thrombotic events within 6 months prior to screening, such as cerebrovascular diseases (including cerebral hemorrhage and cerebral infarction), deep vein thrombosis and\u002For pulmonary embolism; 9) Severe underlying medical conditions such as:\n\n  \u003C!-- -->\n\n  1. Evidence of viral, bacterial, fungal, or other infections that are uncontrolled or need systemic intravenous treatment;\n  2. Clear clinical evidence of dementia or altered mental status;\n  3. Any other central nervous system disease or history of neurodegenerative diseases, such as epilepsy, seizure, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, and psychosis; 10) Any of the following test results is positive:\n\n  \u003C!-- -->\n\n  1. Human immunodeficiency virus (HIV) antibody positive;\n  2. Hepatitis B surface antigen (HBsAg) positive; or hepatitis B core antibody (HBcAb) positive, and hepatitis B virus (HBV) -DNA above the lower limit of detection of the assay;\n  3. Hepatitis C virus (HCV) antibody positive and HCV RNA above the lower limit of detection of the assay;\n  4. Syphilis antibody positive; 11) Active tuberculosis or latent tuberculosis that has not been treated appropriately prior to screening; 12) Receipt of other investigational products within 4 weeks prior to signing the ICF, or if the time from the last dose of a previous investigational product to the ICF signing date is still within 5 half-lives of that drug (whichever is longer); 13) Thymectomy within 12 months prior to signing the ICF; 14) Receipt of drugs targeting B cells within 3 months prior to signing of the ICF; 15) Receipt of other biologic agents within 3 weeks prior to apheresis or within 8 weeks prior to infusion; 16) Major surgery within 8 weeks prior to signing the ICF, or planned surgery during the study; 17) History of organ transplantation; 18) Prior therapy targeting cluster of CD19 and\u002For BCMA-targeted therapy, or CAR-T product therapy targeting any antigen; 19) Pregnant women, breastfeeding women who do not agree to discontinue breastfeeding, or males and females who plan to conceive during the study or within 1 years after receiving study treatment; 20) Any condition, as determined by the investigator, that would interfere with the subject's full participation in the study, confound the study results, or render participation in the study not in the best interest of the subject.","70 Years",{"count":94,"type":21},12,[96],"EARLY_PHASE1","This is a single-arm, open-label, early exploratory clinical study to evaluate the safety and efficacy of GC012F Injection in subjects with refractory idiopathic inflammatory myopathy and to assess the pharmacokinetic and pharmacodynamic profiles.\n\nThis study consists of screening period, apheresis period, baseline period, lymphodepleting preconditioning period, pre-infusion evaluation period, CAR-T cell infusion period and follow-up period.\n\nEligible subjects will undergo apheresis and receive infusion following the manufacture of the CAR-T product. Subjects will receive lymphodepleting preconditioning before CAR-T cell infusion and will be assessed before infusion. If the criteria for cell infusion are met, CAR-T cell infusion will be performed and the infusion dose in the same group or subsequent treatment groups may be adjusted according to the safety and clinical response.\n\nA total of 1 dose group will be set for CAR-T cell infusion dose in this study: 3 × 10\\^5\u002Fkg. Approximately 12 subjects are planned to be enrolled. Subjects will be monitored for dose-limiting toxicity (DLT) within 28 days following the infusion of GC012F Injection. For the first 3 patients receiving infusions of GC012F, 3 additional patients will be included in this cohort if no more than 1\u002F3 of the patients experience DLTs at a given dose level. If 2\u002F3 or more DLTs occur at this dose level, a spare dose of 2.0 × 10\\^5\u002Fkg or 1.0 × 10\\^5\u002Fkg may be administered to subsequent subjects following discussion between the investigator and the partner. If no more than 1 out of the first 6 subjects experiences a DLT, 6 additional subjects will be enrolled. Once 2 subjects experience DLTs, the investigator and the partner will discuss and decide whether to use a spare dose group of 2.0×10\\^5\u002Fkg or 1.0×10\\^5\u002Fkg.\n\nAfter the first 3 subjects have all completed the 28-day DLT observation period, the Safety Monitoring Committee (SMC) will conduct an assessment based on clinical safety and pharmacokinetic data (if available). Subsequently, the SMC may, depending on the safety profile and study progress, request an increased frequency of safety committee assessments and reviews. After completing the DLT observation period for all subjects in this dose group, all clinical study data collected during the DLT observation period for this dose group, especially safety data, will be assessed, and whether to add new subjects to this dose group and whether to explore a different dose group will be decided upon discussion between the investigator and the partner.\n\nFollowing CAR-T cell infusion, subjects will be followed for safety, cell proliferation and survival, and efficacy until the subject withdraws from the study and refuses subsequent follow-up, or dies, or withdraws consent, or is lost to follow-up, whichever occurs first.",[28],"2026-01-12",{"date":101,"type":36},"2026-01-14",{"date":103,"type":36},"2025-09-15",{"date":105,"type":21},"2029-09-15",{"name":107,"class":84},"Daishi Tian",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":44},"100563292","anti-cd19-il-10il15-car-nk-cells-in-refractoryrelapsed-autoimmune-diseases-100563292","NCT06614270","Anti-CD19 IL-10\u002FIL15 CAR-NK Cells in Refractory\u002FRelapsed Autoimmune Diseases","Clinical Study of Core Blood-derived Anti-CD19 IL-10\u002FIL15 CAR-NK in the Treatment of Refractory\u002FRelapsed Autoimmune Diseases","Common inlcusion Criteria:\n\n1. Age 18-65 years old, male or female;\n2. Routine blood count: hemoglobin ≥60g\u002FL, white blood cell count ≥ 2.5×109\u002FL, neutrophil count ≥1.0×109\u002FL (no colony-stimulating factor treatment within 2 weeks before examination);\n3. Liver function: ALT ≤3×ULN, AST≤3×ULN, TBIL≤1.5×ULN;\n4. Coagulation function: international normalized ratio (INR) \\< 1.5×ULN, prothrombin time (PT) \\<1.5×ULN;\n5. Cardiac function: good hemodynamic stability;\n6. Female subjects of childbearing age must have a negative pregnancy test and agree to use effective contraception during the trial;\n7. Voluntarily participate in this study and sign the informed consent form, agreeing to participate in the follow-up as required.\n\nSLE Enrollment Criteria:\n\n1. patients meet the classification criteria of SLE;\n2. Refractory or relapsed cases classified as non-response to standard therapy or disease recurrence after remission. Standard treatment is defined as therapy with at least three agents, including glucocorticoids at a dose \\>1 mg\u002Fkg\u002Fday, together with at least two of the following immunomodulatory drugs administered for more than 6 months: cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, leflunomide, tacrolimus, cyclosporine, iguratimod, antimalarials, and biologic agents, including rituximab, belimumab, or telitacicept.\n\nSystemic Sclerosis (SSc) Enrollment Criteria:\n\n1. Patients who meet the SSc classification criteria of the 2013 ACR\u002FEULAR and have a diagnosis of systemic sclerosis;\n2. the patient\\'s disease duration ≤ 60 months (defined as the onset of the first non-Raynaud\\'s symptoms);\n3. Patient-modified Rodnan skin score (mRSS) ≥10 at the baseline visit; or active interstitial lung disease (ILD): ground-glass opacity on high-resolution computed tomography (HRCT), pulmonary function suggestive of forced vital capacity (FVC) or diffusing capacity for carbon monoxide (DLCO) less than 70% predicted;\n4. A or B needs to be met:\n\nA. Refractory or relapsed cases classified as non-response to standard therapy or disease recurrence after remission. Standard treatment is defined as the use of glucocorticoids and cyclophosphamide, as well as any of the following immunomodulatory drugs, for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, tocilizumab, etc.; B. Presence of progressive disease, specifically defined as, within the past 6 months: a) Progression of cutaneous involvement: more than 25% increase in mRSS; or b) progression of lung disease: 10% reduction in FVC, or 5% reduction in FVC with 15% reduction in DLCO.\n\nIdiopathic Inflammatory myopathy enrollment criteria:\n\n1. Diagnosis according to the 2017 EULAR\u002FACR classification criteria for inflammatory myopathies, including dermatomyositis (DM), polymyositis (PM), antisynthetase antibody syndrome (ASS), and immune-mediated necrotizing myositis (IMNM);\n2. patients with muscle involvement with a manual strength test-8 (MMT-8) score less than 142 and at least 2 abnormalities in the following 5 core assessments: Physician Global Assessment (PhGA), Patient Global Assessment (PtGA), Extramuscular Disease Activity Score ≥2 points, Health Assessment Questionnaire (HAQ) total score ≥0.25, muscle enzyme level ≥1.5×ULN); or MMT-8≥142 with active interstitial lung disease (HRCT suggests ground-glass opacities);\n3. Positive myositis-specific antibodies;\n4. A or B needs to be met:\n\nA. Relapsed or refractory patients: relapsed or reactive after remission. Definition of conventional treatment: use of glucocorticoids (more than 1 mg\u002Fkg\u002Fd) and cyclophosphamide and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, tetatercept, etc.; B. Patients with progressive disease: rapid progressive interstitial pneumonia in a short period of time.\n\nANCA-associated vasculitis enrollment criteria:\n\n1. Meets the 2022 ACR\u002FEULAR ANCA-ASSOCIATED VASCULITIS CLASSIFICATION CRITERIA, INCLUDING MICROSCOPIC POLYANGIITIS (MPA), GRANULOMATOSIS WITH POLYANGIITIS (MPA);\n2. Positive PR3-ANCA or MPO-ANCA (either previous or current positive);\n3. Birmingham Vasculitis Activity Scale (BVAS) score of ≥ 15 points, and at least 1 major item caused by active vasculitis, or at least 3 non-major items, or at least renal involvement hematuria, proteinuria;\n4. estimated glomerular filtration rate (eGFR) ≥15 mL\u002Fminute\u002F1.73 m2 (MDRD method);\n5. Definition of refractory\u002Frelapsed: Conventional treatment that remains ineffective for more than 6 months, or disease recurrence after remission. Conventional treatment definition: use of glucocorticoids (more than 1 mg\u002Fkg\u002Fday) and cyclophosphamide, as well as any one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, tocilizumab, etc.\n\nSjögren\\'s syndrome enrollment criteria:\n\n1. Meet the 2002 European and American Consensus Group (AECG) standards or the 2016 ACR\u002FEULAR Primary Sjögren\\'s Syndrome (pSS) classification criteria;\n2. positive anti-SSA\u002FRo-60 antibody;\n3. Definition of disease activity: EULAR Sjögren\\'s Syndrome Disease Activity Index (ESSDAI) score ≥ 5;\n4. Definition of recurrence\u002Frefractory: Conventional treatment that remains ineffective for more than 6 months, or disease recurrence after remission. Conventional treatment is defined as the use of glucocorticoids (\\>1 mg\u002Fkg\u002Fday) and cyclophosphamide, as well as any one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab.\n\nAntiphospholipid syndrome enrollment criteria:\n\n1. Primary antiphospholipid syndrome meeting the 2006 Sydney criteria;\n2. Medium to high titer phospholipid antibody (aPL) positive: lupus anticoagulant (LA), IgG or IgM anti-β2 glycoprotein 1 antibody (anti-β2-GP1) or anticardiolipin antibody (aCL), at least 2 or more times positive, with an interval of more than 12 weeks;\n3. A or B needs to be met:\n\nA. Definition of refractory\u002Frelapsed: recurrent thrombosis with standard therapy with warfarin or other vitamin K antagonist coagulation (INR maintained within the range required for treatment), or standard therapeutic dose low molecular weight heparin (LMWH) with glucocorticoids and cyclophosphamide; B. Catastrophic antiphospholipid syndrome requires the following four criteria: (1) involvement of ≥ 3 organs, systems, and\u002For tissues (vascular embolism requires radiographic evidence, renal involvement requires a \\>50% increase in creatinine, blood pressure \\> 180\u002F100 mmHg, and\u002For urine protein \\>0.5 g\u002F24 hours); (2) all clinical manifestations appear simultaneously or sequentially within 1 week; (3) Pathological basis for the presence of small vessel occlusion in at least one organ or tissue (evidence of vascular embolism is required for pathological diagnosis, occasionally complicated by vasculitic manifestations); (4) Positive aPL antibody.\n\nCommon Exclusion Criteria:\n\n1. Combined with other connective tissue diseases;\n2. Involvement of important organs: heart (individuals with more severe heart disease, such as angina, myocardial infarction, heart failure, and arrhythmias), kidney (eGFR \\< 15 ml\u002Fmin\u002F1.73m2), liver (ALT\\>3×ULN, AST\\>3×ULN, TBIL \\>1.5×ULN), lung (FVC\\<50% predicted or hemoglobin-corrected DLCO\\<40% predicted), hematologic (leukocyte \\< 2.5×109\u002FL, neutrophil count \\<1.0×109\u002FL, HGB\\<60g\u002FL), etc.;\n3. Abnormal hepatitis B or hepatitis C test indicating active infection or chronic infection, including positive HBsAg or HBcAb test and positive hepatitis C antibody;\n4. Have active tuberculosis or latent tuberculosis;\n5. Human immunodeficiency virus (HIV) serology positivity or known history of HIV infection;\n6. Presence of any known serious active infection (including bacterial, viral, fungal, etc.), including those requiring hospitalization or intravenous antibiotic therapy within 4 weeks prior to screening and oral antibiotic therapy within 2 weeks prior to screening; Those who have various chronic infections and are currently receiving corresponding treatment, such as pneumocystosis, cytomegalovirus, herpes zoster, atypical mycobacteria, etc.;\n7. Patients with primary or secondary immunodeficiency;\n8. IgA deficiency (\\<10 mg\u002FdL) or IgG deficiency (\\<400 mg\u002FdL);\n9. Receiving other investigational drug treatment or participating in any other drug trial within 3 months before screening;\n10. History of documented and confirmed malignancy within 5 years prior to screening, with the exception of basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been appropriately treated or resected;\n11. Patients who are pregnant, breastfeeding, or planning a recent pregnancy, or who are unwilling to use a reliable contraceptive method of contraception for the duration of the study;\n12. Those who have been allergic to human or murine proteins and monoclonal antibodies in the past;\n13. Received live vaccine or live attenuated vaccine within 4 weeks prior to randomization;\n14. Patients who are not expected to comply with the requirements of the protocol or are not expected to complete the trial as planned (such as those with psychiatric disorders, history of alcoholism, drug or other substance abuse);\n15. Other conditions that the investigator considers the patient not suitable to enter the trial.\n\nSystemic Sclerosis Exclusion Criteria:\n\n1. Localized cutaneous SSc;\n2. the duration of the disease is greater than 5 years (defined as the onset of the first non-RP symptom);\n3. SSc-like syndrome related to environmental factors, such as vinyl chloride, bleomycin, etc.;\n4. Any history of scleroderma renal crisis;\n5. intermediate- and high-risk pulmonary hypertension;\n6. Active antral vasodilation.\n\nIdiopathic Inflammatory myopathy exclusion criteria:\n\n1. drug-induced myopathy;\n2. inclusion body myositis;\n3. Tumor-associated myositis (myositis occurring within 2 years of diagnosis of tumor).\n\nANCA-associated vasculitis exclusion criteria:\n\n1. alveolar hemorrhage, requiring invasive lung ventilation, which is expected to last longer than the screening time;\n2. Need for dialysis or plasmapheresis during screening;\n3. Have undergone a kidney transplant.\n\nSjögren\\'s syndrome exclusion criteria:\n\n1. Combined with liver cirrhosis;\n2. Combined with aplastic anemia (AA), myelodysplastic syndrome (MDS) or other myeloproliferative disorders (MPD);\n3. drug-induced thrombocytopenia;\n4. Thrombotic thrombocytopenic purpura (TTP)\u002Fmicrothrombotic vascular disease (TMA).\n\nAntiphospholipid syndrome exclusion criteria:\n\n1. Obstetric APS;\n2. APS incorporates other CTDs;\n3. APS involves the nervous system.","65 Years",{"count":117,"type":21},15,[119],"NA","This study is a single-center, open-label, single-arm, dose-escalation trial. The aim of this study is to investigate the safety and efficacy of Anti-CD19 IL-10\u002FIL15 CAR-NK cells in patients with refractory\u002Frelapsed autoimmune diseases, including systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myositis, ANCA associated vasculitis, sjogren syndrome, and antiphospholipid syndrome.",[58,122,28,123,124,125],"ANCA Associated Vasculitis (AAV)","Sjogren's Syndrome","Antiphospholipid Syndrome","Systemic Lupus Erythematosus","2025-12-21",{"date":128,"type":36},"2025-12-29",{"date":130,"type":36},"2025-01-06",{"date":132,"type":21},"2027-01-06",{"name":134,"class":84},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":44},"100584409","early-phase-1-safety-study-of-cc312-in-autoimmune-disease-patients-100584409","NCT06888960","Safety Study of CC312 in Autoimmune Disease Patients","An Exploratory Clinical Study on the Safety of CC312 in Treating Patients With Refractory Autoimmune Diseases","Inclusion Criteria:\n\n* Subjects who fully understand the objectives, nature, methods of the study, and possible adverse reactions, voluntarily participate as subjects, and sign the informed consent form (ICF).\n* Age ≥18 years (inclusive, based on the time of signing ICF), male or female.\n* For SLE:\n\n  1. Subjects who are diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)\u002F1997 American College of Rheumatology (ACR) diagnostic classification criteria;\n  2. SLEDAI-2000 score of ≥ 8 points and at least one BILAG grade A or two BILAG grade B under standard treatment conditions;\n  3. Meet one of the following conditions: antinuclear antibody (ANA) determined to be positive during the screening period, or anti-dsDNA antibodies higher than normal levels at screening, or anti-Sm antibodies higher than normal levels at screening;\n  4. Before the first dose of the investigational drug, subjects must have received at least one of the following standard treatments for 12 weeks, and the dose must have been stable for at least 30 days (dose reduction is allowed and dose increase is not allowed ). Standard treatment regimen refers to the stable use of any of the following (alone or in combination): a. Antimalarial (hydroxychloroquine) monotherapy; b. Antimalarials in combination with oral corticosteroids (OCS, e.g., prednisone or other hormones at equivalent doses) and\u002For immunosuppressants (including mycophenolate mofetil, cyclophosphamide, leflunomide, methotrexate, tacrolimus, ciclosporin, azathioprine, Tripterygium wilfordii); c. OCS and\u002For immunosuppressant combination therapy. If the subject is receiving OCS (e.g., prednisone or other hormones at equivalent doses), the following criteria must be met: at screening and during the screening period, the maximum dose of OCS is 30 mg\u002Fday of prednisone (or other hormones at equivalent doses); other drugs and traditional Chinese medicines that affect immunity may be continued at the discretion of the investigator.\n* For IIM:\n\n  1. According to the 2017 EULAR\u002FACR Classification Criteria, diagnosed as possible or definite IIM-possible IIM: with a score of 5.5 points without biopsy; definite IIM: with a score of 6.7 points with biopsy;\n  2. Meeting one of the following criteria: During or before the screening period, confirmed to have at least one positive myositis-specific autoantibody (MSA), myositis-associated autoantibody (MAA), or ANA;\n  3. Conventional treatment is ineffective or the disease relapses after remission. Conventional treatment is defined as: the use of glucocorticoids (prednisone \\>1 mg\u002Fkg\u002Fd or equivalent dose) and\u002For at least one immunomodulatory drug: such as antimalarial drugs, azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, tacrolimus, ciclosporin, and\u002For biological drug products: such as rituximab and belimumab.\n* For IIM:\n\n  1. Subjects who are diagnosed with SSc according to the 2013 EULAR\u002FACR diagnostic classification criteria;\n  2. Meets one of the following criteria: positive ANA confirmed during or before the screening period, or at least one positive SSc-related antibody profile (such as Scl70, Th\u002FTo, RP11\u002F12, U3RNP autoantibodies);\n  3. Conventional treatment is ineffective or the disease relapses after remission. Conventional treatment is defined as: using glucocorticoids (prednisone \\> 0.5 mg\u002Fkg\u002Fd or equivalent dose) and cyclophosphamide, and any of the following immunomodulatory drugs: such as antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, ciclosporin, and\u002For biological agents: such as rituximab and belimumab, with a cumulative treatment duration \\> 6 months.\n* For RA:\n\n  1. Diagnosed with RA according to the 2010 EULAR\u002FACR diagnostic classification criteria;\n  2. Disease Activity Score DAS28-ESR \\>3.2 (i.e., moderate activity or higher) during the screening period;\n  3. Failure after treatment with at least one conventional disease-modifying antirheumatic drug (DMARD) and\u002For at least one targeted synthetic DMARD (tsDMARD)\u002Fbiologic DMARD (bDMARD) (defined as no remission after at least 3 months of treatment);\n  4. At screening, if the subject is taking prednisone or an equivalent dose of a glucocorticoid, the dose must be ≤10 mg\u002Fday and stable for at least 4 weeks before the first dose;\n  5. The subject must have discontinued traditional Chinese medicine for the treatment of RA for ≥4 weeks before the first dose;\n  6. Other DMARDs, except for methotrexate (MTX) (subjects who have been on routine MTX treatment for 12 weeks before enrollment, with a stable MTX dose for 4 weeks before enrollment), must meet the washout period requirements: discontinuation of conventional synthetic DMARDs (csDMARDs) (including but not limited to sulfasalazine, leflunomide, penicillamine, azathioprine, ciclosporin A, cyclophosphamide, hydroxychloroquine, etc.) and herbal agents (including Tripterygium wilfordii, total glucosides of paeony, sinomenine, etc.) for 4 weeks before the first dose; discontinuation of intra-articular, intramuscular, or intravenous corticosteroids for 4 weeks before the first dose; discontinuation of anakinra and etanercept for 4 weeks before the first dose; discontinuation of adalimumab and infliximab for 8 weeks before the first dose; discontinuation of golimumab, certolizumab pegol, and tocilizumab for 10 weeks before the first dose; discontinuation of abatacept for 12 weeks before the first dose; in addition, stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs) are permitted to be continued.\n* For ITP:\n\n  1. Diagnosed with ITP according to the diagnostic criteria of the Chinese Guideline on the Diagnosis and Management of Adult Primary Immune Thrombocytopenia (2020 Edition);\n  2. Ineffective response or relapse after at least one prior treatment regimen (including but not limited to TPO mimetics\u002Fagonists, corticosteroids, immunoglobulins, azathioprine, cyclophosphamide, and\u002For rituximab);\n  3. At least 2 platelet count measurements (with an interval of more than 24 hours) from the screening period to before the first dose, with an average platelet count \\\u003C30×109\u002FLand no single platelet count\\>35×109\u002FL;\n  4. If receiving standard background therapy for ITP, the dose and frequency of this therapy should be stable for at least 4 weeks (dose change ≤10%) before the first dose.\n* For AIHA:\n\n  1. Diagnosed with AIHA according to the diagnostic criteria of the Chinese Guideline on the Diagnosis and Management of Autoimmune Haemolytic Anaemia (2022 Edition);\n  2. Poor response after at least first-line treatment (corticosteroids);\n  3. Presence of anaemia-related symptoms during the screening period;\n  4. The dose of supportive care must be stable for at least 4 weeks before the first dose.\n* Laboratory test results:\n\nComplete blood count:\n\n1. SLE, SSc, and IIM: Absolute neutrophil count ≥1.0 x109\u002FL, haemoglobin ≥60 g\u002FL, platelets ≥50 x109\u002FL;\n2. RA: Neutrophil count ≥1.5 x109\u002FL, haemoglobin ≥90 g\u002FL, platelets ≥100 x109\u002FL;\n3. ITP: Absolute neutrophil count ≥1.0 x109\u002FL, haemoglobin ≥70 g\u002FL, platelets ≥10 x109\u002FL;\n4. AIHA: Absolute neutrophil count ≥1.0 x109\u002FL, platelets ≥50 x109\u002FL (≥10 x109\u002FL for patients with Evans syndrome and transfusion is permitted).\n\nLiver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 times the upper limit of normal (ULN), and total serum bilirubin ≤1.5×ULN (≤3.0×ULN for Gilbert's syndrome) or if bilirubin abnormality is caused by the study disease, participation is allowed upon investigator's judgment.\n\nRenal function: For RA, ITP, and AIHA: Serum creatinine ≤1.5 times ULN, or calculated creatinine clearance \\>50 mL\u002Fmin (Cockcroft-Gault formula).\n\n* Left ventricular ejection fraction (LVEF) ≥50%.\n* Female subjects of childbearing potential must agree to use effective contraception from the screening period until 6 months after the last dose. Additionally, they must agree to refrain from collecting or donating eggs during this period; any male partners of reproductive potential must also agree to use effective contraceptive measures during this period.\n* Male subjects with reproductive potential must agree to use effective contraception from the screening period to 6 months after the last dose, and have no plans for reproduction or sperm donation. During this period, their female partners of childbearing potential must also agree to use effective contraception.\n\nExclusion Criteria:\n\n* Subjects who have severe lupus nephritis (defined as urinary protein \\>6 g\u002F24 h or serum creatinine \\>2.5 mg\u002FdL or 221 μmol\u002FL), or required treatment of active nephritis with protocol-prohibited drugs, or required hemodialysis or received prednisone ≥100 mg\u002Fd or equivalent glucocorticoid therapy for ≥14 days within 8 weeks before screening.\n* Subjects who have central nervous system diseases caused by SLE or not caused by SLE within 8 weeks before screening (including but not limited to epilepsy, psychosis, posterior reversible encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, etc.).\n* Other types of IIM: inclusion body myositis, diabetic amyotrophy, juvenile myositis; severe muscle injury or myositis causing permanent weakness or cardiac involvement due to non-IIM causes (e.g., stroke).\n* Pulmonary arterial hypertension associated with SSc requiring treatment; or rapidly progressive SSc-related lower gastrointestinal tract (small and large intestine) involvement (requiring parenteral nutrition), active antral vascular ectasia; previous renal crisis caused by SSc.\n* Significant organ transplantation (e.g., heart, lung, kidney, liver) or history of hematopoietic stem cell\u002Fbone marrow transplantation.\n* Concomitant presence of two or more immune diseases requiring systemic treatment, if the investigator deems the subject unsuitable for enrollment.\n* IgA deficiency (serum IgA level \\\u003C10 mg\u002FdL).\n* Have participated in any other clinical trials (including cell or gene therapy) within 4 weeks before screening or within 5 half-lives of the investigational product (whichever is longer).\n* Have received CAR-T therapy within 6 months before screening.\n* Have received B-cell depleting drug rituximab or equivalent treatments (targeting CD19, CD20, BAFF, etc.) within 1 month before screening, unless it can be demonstrated that B cells have returned to pre-treatment levels or within the normal range.\n* Have received anti-SLE treatments (e.g., Saphnelo) other than standard therapy within 3 months before screening or within 5 half-lives of the investigational product (whichever is longer).\n* Have received a live\u002Fattenuated vaccine within 4 weeks before screening or plans to receive a live\u002Fattenuated vaccine during the study.\n* Active infection.\n* History of Grade 3-4 (CTCAE v5.0) allergic reaction to another monoclonal antibody treatment, or known allergy to any component or excipient of the CC312 drug product (including recombinant proteins, polysorbate 80, etc.); patients with a ≤Grade 3 allergy lasting \\\u003C24h may participate in this study after discussion with the investigator.\n* Acknowledgement of or evidence of illicit drug use, drug abuse, or alcoholism.\n* Subjects who have received major surgery within 4 weeks before screening or minor surgery within 2 weeks; wounds must be completely healed (surgical procedures such as catheter placement are not exclusion criteria).\n* History of any of the following cardiovascular diseases within 6 months before screening: NYHA Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant heart disease.\n* Any other serious underlying diseases (e.g., active gastric ulcer, uncontrolled seizures, cerebrovascular events, gastrointestinal bleeding, severe signs and symptoms of coagulation dysfunction, heart diseases), mental illnesses, psychological, familial, or endemic diseases that, in the investigator's judgment, may interfere with the planned staging, treatment, and follow-up; affect subjects; compliance; or expose the subjects to a higher risk of complications.\n* Evidence of concurrent malignant tumors within less than 5 years before screening, excluding adequately treated cervical carcinoma in situ, localized cutaneous squamous cell carcinoma, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or urothelial carcinoma of stage ≤T1. Subjects with prostate cancer undergoing active surveillance are eligible for this study.\n* Pregnant or breastfeeding women.\n* Subjects with positive results for viral serological tests during the screening period: positive for human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody (TP-Ab).\n* Subjects with active or latent tuberculosis (positive T-SPOT) identified during the screening period.\n* History of splenectomy treatment within 6 months prior to screening.\n* ITP subjects: 1) Secondary immune thrombocytopenia secondary to SLE, chronic lymphocytic leukemia (CLL), immunodeficiency common variable (CVID), or antiphospholipid syndrome (APS); 2) Drug-induced thrombocytopenia; 3) Any bleeding event requiring treatment within 4 weeks prior to screening; 4) Within 2 weeks prior to screening, the subject has continuously used drug therapy that affects platelet function (including but not limited to aspirin, aspirin-containing compounds, clopidogrel, salicylates, and\u002For NSAIDs) for \\>3 days; 5) History of any arterial or venous thrombosis (stroke, transient ischaemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism), or clinical symptoms and medical history suggestive of thrombophilia; or any of the following: known arrhythmia that increases the risk of thrombotic events (e.g., atrial fibrillation), or corrected QT interval (QTc) \\>450 msec; or a history of other coagulation abnormalities.\n* ITP and AIHA subjects: Abnormal prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (aPTT) that are considered clinically significant by the investigator.\n* Other subjects whom the investigator judges to be unsuitable for this study.",{"count":143,"type":21},18,[96],"This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune diseases. The trial also assesses pharmacokinetics (PK) and preliminary efficacy.\n\nCC312 is a trispecific T cell engager (TriTE) that targets the B cell surface antigen CD19, the T cell antigen CD3, and the T cell co-stimulatory molecule CD28. Given its mechanism of action, which is similar to the \"biopharmaceutical version\" of CAR-T, there is a higher risk of cytokine release syndrome (CRS) at the onset of infusion administration. Therefore, a lower priming dose will be administered before the therapeutic dosing phase to mitigate this risk and ensure safety, followed by a therapeutic dose to achieve and maintain efficacy.\n\nThe study is divided into three dose groups, with 3-6 subjects enrolled in each group, resulting in a total of 9-18 subjects in the study. A \"3+3\" dose escalation design is employed to systematically evaluate the safety and determine the optimal dose of CC312.",[60,28,58,59,147,148],"Primary Immune Thrombocytopenia (ITP)","Autoimmune Hemolytic Anemia","2025-09-11",{"date":151,"type":36},"2025-09-17",{"date":153,"type":36},"2024-11-08",{"date":155,"type":21},"2026-11-08",{"name":157,"class":43},"CytoCares Inc",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":166,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":168,"phases":4,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":44},"100604475","clinical-assessment-for-rheumatologic-disease---research-and-advancement-in-safety-and-efficacy-100604475","NCT07150000","Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy","CARe RAiSE Study - Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy","CARe RAiSE","Inclusion Criteria:\n\n* Participants aged ≥ 18 years\n* Signed written informed consent to participate voluntarily in the study.\n* Confirmed diagnosis (by the treating physician) of one of the following autoimmune or autoinflammatory rheumatic diseases:\n* Rheumatoid arthritis (RA)\n* Psoriatic arthritis (PsA)\n* Axial spondyloarthritis (axSpA)\n* Giant cell arteritis (GCA)\n* Connective tissue diseases, including:\n\n  1. Systemic lupus erythematosus (SLE)\n  2. Systemic sclerosis (SSc)\n  3. Mixed connective tissue disease (MCTD)\n  4. Idiopathic inflammatory myopathies (IIM)\n* ANCA-associated vasculitides (AAV), including:\n\n  1. Microscopic polyangiitis (MPA)\n  2. Granulomatosis with polyangiitis (GPA)\n  3. Eosinophilic granulomatosis with polyangiitis (EGPA)\n* Autoinflammatory diseases, including\n\n  1. Familial Mediterranean fever (FMF)\n  2. Cryopyrin-associated periodic syndromes (CAPS)\n  3. TNF receptor-associated periodic syndrome (TRAPS)\n  4. Adult-onset Still's disease (AOSD)\n\n     Exclusion Criteria:\n* Refusal to participate in the study or inability to provide informed consent.\n\nInclusion Criteria - Healthy Control Group:\n\n* Participants aged ≥ 18 years (capable of providing informed consent).\n* Signed written informed consent to participate voluntarily in the study.\n\nExclusion Criteria - Healthy Control Group:\n\n\\- Presence of a known or active rheumatologic disease.",true,{"count":54,"type":21},"OBSERVATIONAL","The CARe RAiSE project represents a pioneering translational initiative aimed at advancing precision medicine in the treatment of autoimmune rheumatic diseases. The primary objective is the development and implementation of an innovative cell-based ex vivo assay that enables individualized prediction of therapeutic response to disease-modifying antirheumatic drugs (DMARDs). By identifying the most effective treatment option for each patient, this approach seeks to enhance therapeutic efficacy, reduce time to clinical response, and minimize healthcare costs.\n\nDespite the availability of numerous DMARDs, clinical decision-making remains largely empirical due to considerable interindividual variability in treatment response. This frequently results in a prolonged trial-and-error process, placing a significant burden on patients and the healthcare system. CARe RAiSE aims to overcome this limitation by providing a functional diagnostic tool that can predict a patient's immunological response to specific DMARDs prior to treatment initiation.\n\nThe assay is based on peripheral blood mononuclear cells (PBMCs) obtained from individual patients, enabling a physiologically relevant assessment of immune responsiveness to targeted therapies. Combining high-content imaging with homogeneous well-based cytokine and inflammasome activity assays, the platform allows for a detailed single-cell analysis of inflammatory pathways. These data are used to generate predictive signatures of treatment response, thereby facilitating a mechanistically informed and personalized therapeutic strategy.\n\nThrough this approach, CARe RAiSE introduces a scientifically grounded, efficient, and patient-specific method for DMARD selection, with the potential to substantially improve patient outcomes and reduce the socioeconomic impact of autoimmune rheumatic diseases.",[171,59,172,173,174,175,122,176,58,177,28,178,179],"Rheumatic Diseases","Giant Cell Arteritis (GCA)","Psoriatic Arthritis (PsA)","Axial Spondylarthritis (axSpA)","Polymyalgia Rheumatica (PMR)","Connective Tissue Disease (CTD)","Systemic Lupus Erthematosus (SLE)","Autoinflammatory Disease","Gout Arthritis","2025-08-24",{"date":182,"type":36},"2025-09-02",{"date":184,"type":36},"2025-04-01",{"date":186,"type":21},"2028-12",{"name":188,"class":84},"University of Bonn",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":4},"100598545","early-phase-1-gc012f-in-patients-with-autoimmune-diseases-100598545","NCT07072884","GC012F in Patients With Autoimmune Diseases","An Open-Label Study to Assess the Safety and Efficacy of GC012F in Patients With Autoimmune Diseases","Inclusion Criteria:\n\nOnly subjects who meet all of the following inclusion criteria prior to enrollment are eligible for this study. In addition, subjects should meet the relevant inclusion criteria for each indication as specified in the corresponding section of each sub-study protocol.\n\n1. The subject or legal representative voluntarily signs the written informed consent form (ICF) personally, and is willing and able to comply with study procedures;\n2. Aged 18 to 70 years (inclusive) at the time of signing the informed consent form, male or female;\n3. Willing to adhere to study-specific contraception requirements until 2 years after infusion or until two consecutive flow cytometry tests indicate that CAR-T cells are no longer present in females of childbearing potential and male subjects (whichever occurs later);\n4. Screening laboratory test results must meet the following criteria (except for indicators related to the diseases under study):\n\n   1. Neutrophil count ≥ 1.0 × 10\\^9\u002FL; hemoglobin ≥ 80 g\u002FL; platelet count ≥ 50 × 10\\^9\u002FL;\n   2. Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); aspartate aminotransferase (AST) ≤ 3 × ULN (unless ALT and\u002For AST increase is assessed by the investigator as related to IIM); total bilirubin \\\u003C 2 × ULN (for subjects with Gilbert's syndrome, direct bilirubin ≤ 1.5 × ULN);\n   3. Creatinine clearance ≥ 60 mL\u002Fmin, or estimated glomerular filtration rate (eGFR) ≥ 45 mL\u002Fmin\u002F1.73 m\\^2;\n   4. Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, and prothrombin time (PT) ≤ 1.5 × ULN;\n   5. Left ventricular ejection fraction (LVEF) ≥ 50% as determined by echocardiogram, with no evidence of pericardial effusion.\n5. Women of childbearing potential must:\n\n   1. Have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result at screening as confirmed by the investigator;\n   2. Agree to avoid breastfeeding during the study period and until at least 2 years after infusion of GC012F Injection, or until two consecutive flow cytometry tests indicate that CAR-T cells are no longer present (whichever occurs later).\n6. Male subjects with sexual partners and female subjects of childbearing potential must agree to use highly effective contraception methods (e.g., oral contraceptives, intrauterine devices, or condoms) starting from screening and continuing for at least 2 years after GC012F Injection infusion or until two consecutive flow cytometry tests indicate that CAR-T cells are no longer present (whichever occurs later). Male subjects must agree to use condoms during any sexual contact with pregnant women or women of childbearing potential for at least 2 years after GC012F Injection infusion, even if they have undergone successful vasoligation.\n7. The required venous access for collection can be set up, with no contraindications for leukapheresis.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria are not eligible for the study. In addition, subjects who meet the relevant exclusion criteria for each indication as specified in the corresponding section of each sub-study protocol must not be enrolled.\n\n1. History of severe hypersensitivity or allergy;\n2. Contraindications or hypersensitivity to fludarabine, cyclophosphamide, or any component of the investigational product;\n3. Presence of the following cardiac disorders:\n\n   1. New York Heart Association (NYHA) Class III or IV congestive heart failure;\n   2. Myocardial infarction or coronary artery bypass grafting within 6 months prior to screening;\n   3. History of clinically significant ventricular arrhythmia or unexplained syncope not caused by vasovagal reactions or dehydration, or corrected QT interval \\> 480 ms at screening;\n   4. History of severe non-ischemic cardiomyopathy.\n4. Any active malignancy or history of malignancy within 5 years prior to screening. The following are exceptions: early-stage tumors that have received curative treatment (carcinoma in situ or stage I tumors, non-ulcerative primary melanoma with a depth \\\u003C 1 mm and no lymph node involvement), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, thyroid carcinoma in situ or early-stage thyroid cancer that has received curative treatment, cervical carcinoma in situ, or breast cancer in situ that has received potentially curative treatment;\n5. Clinically significant hemorrhage symptoms or a definite tendency to hemorrhage within 6 months prior to screening, such as hemorrhage of digestive tract and hemorrhagic gastric ulcer; hereditary or acquired hemorrhage or thrombotic tendencies (e.g., hemophilia, coagulation disorders, and hypersplenism); arterial or venous thrombotic events within 6 months prior to screening, such as cerebrovascular diseases (including cerebral hemorrhage and cerebral infarction), deep vein thrombosis and\u002For pulmonary embolism;\n6. Any of the following test results is positive:\n\n   1. Human immunodeficiency virus (HIV) antibody positive;\n   2. Hepatitis B surface antigen (HBsAg) positive; or hepatitis B core antibody (HBcAb) positive with hepatitis B virus deoxyribonucleic acid (DNA) above the lower limit of detection of the assay;\n   3. Hepatitis C virus (HCV) antibody positive with HCV ribonucleic acid (RNA) above the lower limit of detection of the assay;\n   4. Syphilis antibody positive (confirmation by a confirmatory test for syphilis is required if necessary, such as fluorescent treponemal antibody-absorption test and Treponema pallidum particle agglutination assay).\n7. Active tuberculosis or latent tuberculosis that has not received appropriate treatment prior to screening;\n8. Severe underlying medical conditions, such as:\n\n   1. Evidence of viral, bacterial, fungal, or other infections that are uncontrolled or need systemic intravenous treatment;\n   2. Clear clinical evidence of dementia or altered mental status;\n   3. Any other central nervous system disease or history of neurodegenerative diseases, such as epilepsy, seizure, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, and psychosis.\n9. Prior therapy targeting cluster of differentiation (CD)19 and\u002For B-cell maturation antigen, or CAR-T product therapy targeting any antigen;\n10. Thymectomy within 12 months prior to signing the ICF;\n11. Treatment with CD20-targeted agents within 6 months prior to signing the ICF;\n12. Receipt of other investigational products within 4 weeks prior to signing the ICF, or if the time from the last dose of a previous investigational product to the ICF signing date is still within 5 half-lives of that drug (whichever is longer);\n13. Receipt of other monoclonal antibody drugs (e.g., infliximab, certolizumab pegol, golimumab, etanercept, abatacept, adalimumab, or tocilizumab) within 4 weeks prior to apheresis;\n14. Receipt of cyclophosphamide within 4 weeks prior to apheresis;\n15. Major surgery within 8 weeks prior to signing the ICF, or planned surgery during the study;\n16. History of organ transplantation;\n17. Pregnant women, breastfeeding women who do not agree to discontinue breastfeeding, or males and females who plan to conceive during the study or within 2 years after receiving study treatment;\n18. Any condition, as determined by the investigator, that would interfere with the subject's full participation in the study, confound the study results, or render participation in the study not in the best interest of the subject.",{"count":117,"type":21},[96],"This is an open-label, early exploratory main clinical study to evaluate the safety and efficacy of GC012F Injection in subjects with autoimmune diseases (AID), as well as to assess its pharmacokinetic (PK) and pharmacodynamic (PD) profiles.",[58,28],"NOT_YET_RECRUITING","2025-07-09",{"date":203,"type":36},"2025-07-18",{"date":205,"type":21},"2025-08-18",{"date":207,"type":21},"2029-03-31",{"name":209,"class":84},"Qiong Fu",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":115,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":228,"locationsCount":230},"100591451","phase-1-a-study-of-ol-108-in-relapsedrefractory-autoimmune-diseases-100591451","NCT06980597","A Study of OL-108 in Relapsed\u002FRefractory Autoimmune Diseases","An Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Allogeneic CAR-T Cell Therapy (OL-108) in the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* General:\n* Adults aged 18-65 years old\n* ECOG 0-2\n* Adequate organ function\n* Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and must agree to use a highly effective contraceptive method starting from the time of lymphodepletion and for 2 years after dosing of the IMP\n* SLE specific:\n\n  a) Fulfilling the 1997 ACE SLE criteria\u002F 2012 SLICC criteria\u002F 2019 ACR\u002FEULAR classification criteria of SLE; b) A positive ANA titer (≥ 1:80) and\u002For presence of anti-dsDNA, or anti-Sm antibodies; c) Active disease at screening, defined as SLEDAI-2K≥8 AND clinical SLEDAI-2K≥6, AND ≥1 organ system with a British Isles Lupus Assessment (BILAG) A score (severe disease activity) or ≥2 organ systems with a BILAG B score (moderate disease activity), AND PGA≥ 1; OR biopsy proven 2003 ISN\u002FRPS class III\u002FIV +\u002F- class V lupus nephritis; d) relapsed or refractory to at least one immunosuppressant or biologic.\n* IIM specific:\n\n  a) Fulfilling the 2017 ACR\u002FEULAR classification criteria for DM, PM, ADM, ASS and IMNM; b) Active disease as defined by at least one of the following criteria: at least one muscle enzyme \\> ULN in the past 4 weeks, active disease by EMG\u002Fmuscle biopsy\u002FMRI in the past 3 months, active DM rash; c)MMT \\\u003C 142 and 2 of the following criteria: VAS patients Global ≥ 2 cm, VAS physician Global ≥ 2 cm, HAQ \\> 0.25, at least one muscle enzyme \\> 1.5x ULN, MDAAT ≥ 2 ; d) CDASI ≥14 if with skin involvement; e) At least one myositis-specific or associated antibody positive; f)relapsed or refractory to at least one immunosuppressant or biologic.\n* SSc specific:\n\n  a)Fulfilling the 2013 ACR\u002FEULAR classification criteria of SSc; b) Active disease as defined by one of following: new or progressing skin manifestation\u002Fvital organ involvement within 6 months prior to screening, CRP≥6 mg\u002FL, ESR≥28 mm\u002Fh, platelet ≥330 × 10⁹\u002FL; c) mRSS score \\>10; d)relapsed or refractory to at least one immunosuppressant or biologic.\n* AAV specific:\n\n  1. Fulfilling the 2022 ACR\u002FEULAR classification criteria for MPA\u002FGPA; b) Presence of ANCA to either proteinase 3 or myeloperoxidase; c)At least one major or three non-major items or at least two renal items of hematuria and proteinuria on the BVAS; d)relapsed or refractory to at least one immunosuppressant or biologic.\n\nExclusion Criteria:\n\n* Active uncontrolled infection\n* Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load\n* Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load\n* HIV antibody positive\n* Syphilis antibody positive\n* Active tuberculosis, untreated or inadequately treated latent tuberculosis infection (LTBI)\n* History of serious infection within 3 months prior to screening (defined as requiring hospitalization or intravenous antimicrobial therapy), or history of oral antimicrobial therapy within 1 month prior to screening (e.g., viral infections, opportunistic infections, including but not limited to severe cytomegalovirus or herpes virus infections)\n* Congenital long QT syndrome or a corrected QTcF interval of ≥480 ms at screening (unless secondary to pacemaker or bundle branch block)\n* Uncontrolled hypertension (blood pressure ≥160\u002F100 mm Hg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes or other endocrine diseases, severe chronic pulmonary disease, or other serious medical condition which is likely to significantly impair the patient's ability to tolerate the study treatment\n* history of organ transplant\n* Pregnancy or lactating women\n* Use of any other experimental medication within 4 weeks or 5 half-lives prior to start of study drug\n* Use of biologics within 3 months, stem cell transplant or CAR-T within 6 months prior to the start of study drug\n* Received live or attenuated vaccine within 4 weeks of Cycle 1 Day 1\n* Presence of other autoimmune or auto-inflammatory diseases that may affect study assessments, such as rheumatoid arthritis, gout, or active fibromyalgia syndrome.\n* Limited to patients diagnosed with SLE: patients with active neuropsychatric SLE\n* Limited to patients diagnosed with IIM: Severe involvement of respiratory muscles affecting ventilatory function; permanent muscle weakness related to IIM; other inflammatory or non-inflammatory myopathy: inclusion body myositis, infectious myopathy, metabolic myopathy, muscular dystrophy or a family history of muscular dystrophy, drug-induced or endocrine-induced myositis, and juvenile myositis\n* Limited to patients diagnosed with SSc: at risk for scleroderma renal crisis; SSc-associated gastric antral vascular ectasia; Severe gastrointestinal involvement leading to malabsorption or intestinal failure\n* Limited to patients diagnosed with AAV: Central nervous system vasculitis; Alveolar hemorrhage requiring invasive pulmonary ventilation",{"count":218,"type":21},44,[24],"This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-108 in relapsed\u002Frefractory autoimmune diseases.",[60,28,58,122],"2025-05-12",{"date":224,"type":36},"2025-05-20",{"date":226,"type":21},"2025-06",{"date":186,"type":21},{"name":229,"class":84},"Beijing GoBroad Hospital",2]