[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630638":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":11,"studyPopulation":11,"armGroups":33,"interventions":42,"overallOfficials":11,"centralContacts":57,"locations":11,"responsibleParty":63,"collaborators":11,"id":65,"slug":11,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":11,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":11,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":86,"overallStatus":90,"whyStopped":11,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":11},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Adverse Event",null,"6 months",{"measure":14,"description":11,"timeFrame":15},"Incidence of Dose-Limiting Toxicities (DLTs)","First infusion date of allogeneic CD19\u002FBCMA-targeted CAR-γδT cell to 28 days end cell infusion",[17,21,24],{"measure":18,"description":19,"timeFrame":20},"PK(Pharmacokinetics):Number and Copy Number of CD19\u002FBCMA-targeted CAR-γδT cells","Number and copy number of CD19\u002FBCMA-targeted CAR-γδT cells were assessed by number in peripheral blood. Blood samples were collected before and one year after cell infusion (until CD19\u002FBCMA-targeted CAR-γδT cells were not detected for two consecutive times) to detect the number and copy number of CD19\u002FBCMA-targeted CAR-γδT cells, and to evaluate the pharmacokinetics of CD19\u002FBCMA-targeted CAR-γδT cells.","12 months",{"measure":22,"description":23,"timeFrame":20},"PK(Pharmacokinetics): Persistence of CD19\u002FBCMA-targeted CAR-γδT cells","Persistence of CD19\u002FBCMA -targeted CAR-γδT cells assessed by number in peripheral blood.",{"measure":25,"description":26,"timeFrame":20},"PD(Pharmacodynamics)：Peak Level of Cytokines in Serum","The cytokines mainly include interleukin-2 (IL-2 ), IL-6, IL-8, IL-10, interferon-γ（IFN-γ). Peak was defined as the maximum post-baseline level of the cytokine.",{"allocation":28,"interventionModel":29,"interventionModelDescription":11,"primaryPurpose":30,"observationalModel":11,"timePerspective":11,"maskingInfo":31},"NA","SINGLE_GROUP","TREATMENT",{"masking":32,"maskingDescription":11,"whoMasked":11},"NONE",[34],{"label":35,"type":36,"description":37,"interventionNames":38},"Patients with relapsed\u002Frefractory autoimmune diseases","EXPERIMENTAL","A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered, followed by the investigational therapy: allogeneic CD19\u002FBCMA-targeted CAR-γδT cells.\n\nInterventions:\n\nBiological: Allogeneic CD19\u002FBCMA-targeted CAR-γδT cell injection Drug: Fludarabine Drug: Cyclophosphamide",[39,40,41],"Biological: Allogeneic CD19\u002FBCMA-targeted CAR-γδT cell injection","Drug: Cyclophosphamide","Drug: Fludarabine",[43,48,53],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":11},"BIOLOGICAL","Allogeneic CD19\u002FBCMA-targeted CAR-γδT cell injection","Biological: Allogeneic CD19\u002FBCMA-targeted CAR-γδT cell. Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine), patients will be treated with dose-escalation phase (3+3 design): Dose A (5 × 10\\^6 CAR+cells) ,Dose B(1 × 10\\^7 CAR+cells), Dose C (1.5 × 10\\^7 CAR+cells).",[35],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":11},"DRUG","Cyclophosphamide","Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises cyclophosphamide (300 mg\u002Fm² administered 3 days).",[35],{"type":49,"name":54,"description":55,"armGroupLabels":56,"otherNames":11},"Fludarabine","Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30 mg\u002Fm² administered 3 days).",[35],[58],{"name":59,"role":60,"phone":61,"phoneExt":11,"email":62},"Ying Wang","CONTACT","+86 15900225626","wangying1@ihcams.ac.cn",{"type":64,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":74,"type":75},9,"ESTIMATED","INTERVENTIONAL",[78],"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",[81,82,83,84,85],"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",[87,88,89],"CD19\u002FBCMA","CAR-γδT","cell therapy","NOT_YET_RECRUITING","2026-06-08",{"date":93,"type":94},"2026-06-09","ACTUAL",{"date":96,"type":75},"2026-07-01",{"date":98,"type":75},"2028-12-31",{"name":5,"class":6}]