[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory--relapsing--progressive-inflammatory-myopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory--relapsing--progressive-inflammatory-myopathy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100630638","phase-1-allogeneic-cd19bcma-targeted-car-t-cell-therapy-safety-and-preliminary-pharmacodynamics-in-relapsedrefractory-autoimmune-diseases-100630638",false,"NCT07490275","Allogeneic CD19\u002FBCMA-Targeted CAR-γδT Cell Therapy: Safety and Preliminary Pharmacodynamics in Relapsed\u002FRefractory Autoimmune Diseases","Safety and Preliminary Pharmacodynamics of Allogeneic CD19\u002FBCMA-Targeted CAR-γδT Cell Therapy in Patients With Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* Age ≥18 years (including 18 years), no gender restrictions.\n* Confirmed by flow cytometry to express CD19 or BCMA antigen on the surface of peripheral blood B cells.\n* Major organ function must meet the following requirements (excluding abnormalities related to active autoimmune disease):\n* Bone marrow function: Neutrophil count ≥ 1 × 10\\^9\u002FL (no colony-stimulating factor therapy within 2 weeks prior to testing); Haemoglobin ≥ 60 g\u002FL.\n* Liver function: Alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN) (excluding ALT elevation due to inflammatory myopathy) ; Aspartate Aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy); Total Bilirubin (TBIL) ≤ 2 times ULN (may be relaxed to ≤ 3.0 times ULN for subjects with Gilbert's syndrome).\n* Renal function: Creatinine clearance (CrCl) ≥ 30 ml\u002Fmin (calculated using the Cockcroft-Gault formula, excluding acute CrCl decline due to target disease; lupus nephritis (LN) patients excluded).\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n* Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstain from sexual intercourse for at least 6 months during study treatment and for at least 6 months after study treatment completion.\n* Voluntary participation in this clinical study, signing of informed consent, good compliance, and ability to complete follow-up.\n\nDisease-specific inclusion criteria:\n\n* Relapsed\u002Frefractory systemic lupus erythematosus\n* Diagnosis of systemic lupus erythematosus (SLE) meeting the 2019 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria.\n* Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2000) ≥ 8 points; or significant organ involvement, such as lupus nephritis (histologically confirmed active nephritis of type III or IV, with or without type V involvement; National Institutes of Health \\[NIH\\] activity score \\> 2 points; evidence of elevated chronicity index; urine protein\u002Fcreatinine ratio \\> 1.0 g\u002Fg, or 24-hour urine protein quantification \\> 1.0 g).\n* Refractory or recurrent disease is defined as: no response after more than 6 months of conventional therapy, or recurrence of disease activity following remission. Conventional therapy is defined as: glucocorticoids combined with one or more of the following immunomodulatory agents: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as rituximab, belimumab, or tatalimab.\n* Refractory\u002FRecurrent\u002FProgressive Systemic Sclerosis\n* Scleroderma diagnosis conforms to the 2013 ACR（American College of Rheumatology） classification criteria.\n* Positive for scleroderma-associated antibodies.\n* Presence of diffuse cutaneous sclerosis or active interstitial lung disease (high-resolution computed tomography (HRCT) showing ground-glass opacities).\n* Definition of recurrent\u002Frefractory: No response to conventional therapy for over 6 months, or recurrence following remission. Conventional therapy defined as: Glucocorticoids combined with any one or more of the following immunomodulators: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as belimumab, rituximab, or tocilizumab.\n* Progressive definition: Rapid progression of cutaneous lesions (Modified Rodnan Skin Score (mRSS) increase \\> 25%); or progression of pulmonary lesions (Forced Vital Capacity (FVC) decline ≥10%, or FVC decline ≥5% accompanied by Diffusion Capacity for Carbon Monoxide (DLCO) decline ≥15%).\n\nNote: Fulfilment of either criterion 4 or 5 is sufficient.\n\n* Refractory\u002FRecurrent\u002FProgressive Inflammatory Myopathies\n* Diagnosis of inflammatory myopathy conforms to the 2017 EULAR（European Alliance of Associations for Rheumatology）\u002FACR classification criteria (including dermatomyositis (DM), polymyositis (PM), anti-synthetase syndrome (ASS), and necrotising myopathy (NM)).\n* Muscle involvement present, Manual Muscle Test - 8 (MMT-8) score \\\u003C 142 points, and at least 2 abnormalities in the following 5 core indicators: Physician Global Assessment (PhGA), Patient Global Assessment (PtGA) or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire (HAQ) total score ≥ 0.25 points; Muscle enzyme levels ≥1.5 times the upper limit of normal.\n* Definition of recurrent\u002Frefractory: No response to conventional therapy for over 6 months, or relapse following remission. Conventional therapy defined as: Glucocorticoids combined with any one or more of the following immunomodulators: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as belimumab, rituximab, or tocilizumab.\n* Definition of progressive disease: Rapid progression of interstitial lung disease within a short timeframe.\n\nNote: Meeting any one criterion from either section 4 or 5 suffices.\n\n* Refractory\u002FRecurrent Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis\n* Diagnosis of ANCA-associated vasculitis conforms to the 2022 ACR\u002FEULAR criteria, encompassing microscopic polyangiitis, granulomatous polyangiitis, and eosinophilic granulomatous polyangiitis.\n* ANCA-associated antibody testing is positive (myeloperoxidase antibody \\[MPO-ANCA\\] or proteinase 3 antibody \\[PR3-ANCA\\] positive).\n* Birmingham Vasculitis Activity Score (BVAS) ≥15 points (out of 63 total points), indicating active vasculitis.\n* Refractory\u002Frecurrent definition: Failure to respond to conventional therapy for over 6 months, or recurrence following remission. Conventional therapy is defined as:Use of glucocorticoids in combination with any one or more of the following immunomodulatory agents: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as belimumab, rituximab, or tocilizumab.\n* Refractory\u002FRecurrent Connective Tissue Disease-Associated Thrombocytopenia\n* Diagnosis of connective tissue disease conforming to the latest classification criteria, including but not limited to systemic lupus erythematosus, primary Sjögren's syndrome, antiphospholipid syndrome, and undifferentiated connective tissue disease.\n* Diagnosed with connective tissue disease-associated thrombocytopenia, with platelet count \\\u003C 30 × 10⁹\u002FL, or platelet count \\\u003C 50 × 10⁹\u002FL accompanied by bleeding tendency.\n* Bone marrow morphology consistent with features of immune thrombocytopenia.\n* Previous treatment with at least one course of glucocorticoid pulse therapy, or high-dose glucocorticoids combined with one or more immunosuppressants (including biologics) for at least three months, failing to achieve partial remission or unable to maintain efficacy during glucocorticoid tapering.\n\nExclusion Criteria:\n\n* -Individuals with a history of severe drug allergies or an allergic constitution.\n* Presence or suspected presence of uncontrolled or treatable fungal, bacterial, viral, or other infections.\n* Active, severe central nervous system disorders caused by autoimmune or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis).\n* Patients with cardiac insufficiency.\n* Patients with congenital immunoglobulin deficiency.\n* History of malignant tumours within the past five years.\n* End-stage renal disease (excluding lupus nephritis (LN) patients).\n* Hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive with peripheral blood hepatitis B virus (HBV) DNA \\> upper limit of normal; hepatitis C virus (HCV) antibody positive with peripheral blood hepatitis C virus (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; positive syphilis test.\n* Individuals with psychiatric disorders or severe cognitive impairment.\n* Participants who have been enrolled in another clinical trial within the three months preceding study entry.\n* Individuals who have received immunosuppressive agents or biological agents for therapeutic indications within five half-lives prior to study entry.\n* Pregnant women or women planning pregnancy.\n* Individuals deemed by the investigator to have other conditions rendering them unsuitable for inclusion in this study.","ALL","18 Years",{"count":19,"type":20},9,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study is a single-arm, intervention, dose-escalation clinical trial to evaluate the safety of allogeneic CD19\u002FBCMA-targeted CAR-γδT cell in the treatment of relapsed\u002Frefractory autoimmune diseases",[26,27,28,29,30],"Refractory\u002FRelapsed Systemic Lupus Erythematosus","Refractory \u002F Relapsed \u002F Progressive Systemic Sclerosis","Refractory \u002F Relapsing \u002F Progressive Inflammatory Myopathy","Refractory \u002F Relapsed Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis","Refractory \u002F Relapsed Connective Tissue Disease-Associated Thrombocytopenia",[32,33,34],"CD19\u002FBCMA","CAR-γδT","cell therapy","NOT_YET_RECRUITING","2026-06-08",{"date":38,"type":39},"2026-06-09","ACTUAL",{"date":41,"type":20},"2026-07-01",{"date":43,"type":20},"2028-12-31",{"name":45,"class":46},"Institute of Hematology & Blood Diseases Hospital, China","OTHER"]