[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anca-associated-systemic-vasculitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anca-associated-systemic-vasculitis":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,70,99],{"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":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100639684","early-phase-1-cd19bcma-ucar-t-for-b-cell-related-autoimmune-disease-100639684",false,"NCT07586267","CD19\u002FBCMA UCAR-T for B Cell-Related Autoimmune Disease","An Exploratory Clinical Study Evaluate the Safety and Efficacy of Universal Universal Allogeneic CAR-T Cells Targeting CD19 and BCMA in the Treatment of B Cell-Related Autoimmune Disease","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n* 1.Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n\n  1. Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n  2. Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n  3. Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n  4. Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n  5. Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%.\n* 2.Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n* 3.Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n* Disease-Specific Inclusion Criteria\n* SLE:\n* 1.Age ≥ 5 years.\n* 2.Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n* 3.Must meet at least one of the following adequate treatment conditions:\n\n  1. Active disease persists despite adequate treatment with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent dose of other corticosteroids) in combination with at least two immunosuppressants or biologic agents for at least 3 months, or affected organ function has failed to improve; or inability to taper glucocorticoid dosage to ≤5 mg\u002Fday after 6 months of conventional treatment;\n  2. Patients who have developed intolerable drug toxicity during conventional therapy, or have contraindications precluding standard treatment, or have experienced multiple treatment failures-may be considered for enrollment following full informed consent by the investigator and the patient or legal guardian;\n  3. SLEDAI-2K Criteria: SLEDAI-2K score ≥8; or SLEDAI-2K score ≥6 combined with at least one BILAG-2004 Category A or two Category B organ system involvements (or both)；Patients with severe refractory SLE-ITP, characterized by a platelet count of \\\u003C30×10⁹\u002FL or \\\u003C50×10⁹\u002FL accompanied by bleeding tendency, regardless of the SLEDAI-2K score.\n* 4.No occurrence of macrophage activation syndrome within 1 month prior to screening.\n* 5.Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n* MDR-SRNS\n* 1.Age ≥3 years old, gender unlimited.\n* 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n* 3\\. Must meet at least one of the following adequate treatment conditions:\n\n  1. have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Telitacicept or rituximab).\n  2. if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n  3. Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n  4. Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n* 4.Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n* IgA nephropathy\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. IgA nephropathy pathologically confirmed by renal biopsy;\n* 3\\. Angiotensin-Converting Enzyme Inhibitors (ACEI) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n\n  1. Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg;\n  2. \\>50% decline in eGFR within 3 months;\n  3. Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n* 4\\. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n* Systemic Sclerosis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Scleroderma fulfilling the 2013 ACR classification criteria\n* 3\\. Positive scleroderma-related antibodies.\n* 4\\. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n* 5\\. Must meet at least one of the following adequate treatment conditions:\n\n  1. Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n  2. Meets criteria for rapidly progressive disease and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n  3. Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* 6\\. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n* Refractory\u002FRelapsed ANCA-Associated Vasculitis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n* 3\\. Refractory AAV is defined as: a reduction in the Birmingham Vasculitis Activity Score (BVAS) of less than 50%, a persistent score of ≥ 3, or the occurrence of new organ involvement following ≥3 months of standard induction therapy (including glucocorticoids in combination with Rituximab \\[RTX\\] or Cyclophosphamide \\[CYC\\]) ;or a worsening of the disease during maintenance therapy or after treatment discontinuation following the achievement of remission (BVAS = 0), which necessitates the re-initiation of induction therapy;\n* 4\\. Or meets the criteria for severe vasculitis, with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n* 5\\. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n* 6\\. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n* 2.Subjects with grade III or IV heart failure (NYHA classification).\n* 3.Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n* 4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n* 5\\. Had active pulmonary tuberculosis at screening.\n* 6\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n* 7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n* 8\\. Patients had active central nervous system disease.\n* 9\\. Patients with malignant diseases such as tumors before screening.\n* 10\\. Secondary or congenital immunodeficiency.\n* 11\\. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n* 12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n* 13\\. Received live vaccine within 4 weeks before screening.\n* 14\\. Tested positive in Blood pregnancy test.\n* 15\\. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n* 16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n* 17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.","ALL","3 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This is an exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219CX. QT-219CX is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard \"3+3\" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219CX .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .",[26,27,28,29,30,31],"Autoimmune Diseases","Systemic Lupus Erthematosus (SLE)","Multi-Drug Resistant Nephrotic Syndrome","IgA Nephropathy (IgAN)","Systemic Sclerosis (SSc)","ANCA Associated Systemic Vasculitis",[33,28,27,29,30,34],"UCART","ANCA associated systemic vasculitis","RECRUITING","2026-05-12",{"date":38,"type":39},"2026-05-14","ACTUAL",{"date":41,"type":20},"2026-05-08",{"date":43,"type":20},"2030-12-31",{"name":45,"class":46},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":14,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":47},"100631939","early-phase-1-allogeneic-cd19bcma-car-t-for-b-cell-related-autoimmune-disease-100631939","NCT07507201","Allogeneic CD19\u002FBCMA CAR-T for B Cell-Related Autoimmune Disease","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n* 1.Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n* 1)Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n* 2)Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n* 3)Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n* 4)Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n* 5)Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%.\n* 2.Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n* 3.Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n* Disease-Specific Inclusion Criteria\n* SLE:\n* 1.Age ≥ 5 years.\n* 2.Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n* 3.Must meet at least one of the following adequate treatment conditions:\n* 1)Active disease persists despite adequate treatment with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent dose of other corticosteroids) in combination with at least two immunosuppressants or biologic agents for at least 3 months, or affected organ function has failed to improve; or inability to taper glucocorticoid dosage to ≤5 mg\u002Fday after 6 months of conventional treatment;\n* 2)Patients who have developed intolerable drug toxicity during conventional therapy, or have contraindications precluding standard treatment, or have experienced multiple treatment failures-may be considered for enrollment following full informed consent by the investigator and the patient or legal guardian;\n* 3)SLEDAI-2K Criteria: SLEDAI-2K score ≥8; or SLEDAI-2K score ≥6 combined with at least one BILAG-2004 Category A or two Category B organ system involvements (or both).\n* 4.No occurrence of macrophage activation syndrome within 1 month prior to screening.\n* 5.Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n* MDR-SRNS\n* 1.Age ≥3 years old, gender unlimited.\n* 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n* 3\\. Must meet at least one of the following adequate treatment conditions:\n* a) have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab).\n* b) if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n* c) Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n* d) Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n* 4.Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n* IgA nephropathy\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. IgA nephropathy pathologically confirmed by renal biopsy;\n* 3\\. Angiotensin-Converting Enzyme Inhibitors (ACEI) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n* a) Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg;\n* b) \\>50% decline in eGFR within 3 months;\n* c) Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n* 4\\. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n* Systemic Sclerosis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Scleroderma fulfilling the 2013 ACR classification criteria\n* 3\\. Positive scleroderma-related antibodies.\n* 4\\. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n* 5\\. Must meet at least one of the following adequate treatment conditions:\n* a) Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n* b) Meets criteria for rapidly progressive disease and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* c) Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* 6\\. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n* Refractory\u002FRelapsed ANCA-Associated Vasculitis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n* 3\\. Refractory AAV is defined as: a reduction in the Birmingham Vasculitis Activity Score (BVAS) of less than 50%, a persistent score of ≥ 3, or the occurrence of new organ involvement following ≥3 months of standard induction therapy (including glucocorticoids in combination with Rituximab \\[RTX\\] or Cyclophosphamide \\[CYC\\]) ; or a worsening of the disease during maintenance therapy or after treatment discontinuation following the achievement of remission (BVAS = 0), which necessitates the re-initiation of induction therapy;\n* 4\\. Or meets the criteria for severe vasculitis, with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n* 5\\. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n* 6\\. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n* 2.Subjects with grade III or IV heart failure (NYHA classification).\n* 3.Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n* 4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n* 5\\. Had active pulmonary tuberculosis at screening.\n* 6\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n* 7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n* 8\\. Patients had active central nervous system disease.\n* 9\\. Patients with malignant diseases such as tumors before screening.\n* 10\\. Secondary or congenital immunodeficiency.\n* 11\\. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n* 12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n* 13\\. Received live vaccine within 4 weeks before screening.\n* 14\\. Tested positive in Blood pregnancy test.\n* 15\\. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n* 16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n* 17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.",{"count":19,"type":20},[23],"This is an exploratory, open-label, single-arm Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219C. QT-219C is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard \"3+3\" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219C .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .",[26,27,28,29,30,31],[33,28,59,60,30,61],"Systemic Lupus Erthematosus","IgAN - IgA Nephropathy","ANCA-Associated Vasculitis (AAV)","2026-03-30",{"date":64,"type":39},"2026-04-02",{"date":66,"type":20},"2026-04-01",{"date":68,"type":20},"2029-12",{"name":45,"class":46},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":47},"100624723","phase-1-a-clinical-study-of-ti-0032-iii-injection-in-patients-with-relapsed-and-refractory-autoimmune-diseases-100624723","NCT07413341","A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases","A Clinical Study on the Safety and Efficacy of in Vivo CAR-T Cell Therapy (TI-0032-III Injection) for the Treatment of Relapsed and Refractory Autoimmune Diseases","in vivo CAR-T","Inclusion Criteria:\n\n* Understand trial procedures and methods, voluntarily sign the informed consent form .\n* Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n* Positive expression of CD19 on peripheral blood B cells determined by flow cytometry.\n* Bone marrow function: neutrophil count ≥ 1.5 × 10\\^9\u002FL, lymphocyte count ≥ 0.8 × 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL, platelet ≥ 100 × 10\\^9\u002FL. Blood transfusion and growth factors must not be used within 14 days prior to screening to meet the above requirements.\n* Coagulation function: international normalized ratio or activated partial thromboplastin time ≤ 1.5× upper limit of normal range (ULN).\n* Cardiopulmonary function: left ventricular ejection fraction ≥ 50% on echocardiography; for lung function, dyspnea ≤Grade 1 of the NCI-CTCAE version 5.0 standards when breathing room air, and pulse oximetry ≥ 92%.\n* Liver function: alanine aminotransferase ≤ 1.5 × ULN, aspartate aminotransferase ≤ 1.5 × ULN, total bilirubin ≤ 1.5 × ULN (total bilirubin at least ≤ 3.0 mg\u002FdL in patients with Gilbert syndrome).\n* Renal function: creatinine clearance (by Cockcroft-Gault formula) ≥ 50 mL\u002Fmin.\n* Criteria for SLE：\n\n  1. Meet the 2019 European Alliance of Associations for Rheumatology\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE;\n  2. SLEDAI-2000 score \\> 6 in the moderate to severe active phase of the disease;\n  3. And have at least one British Isles Lupus Assessment Group (BILAG-2004) grade A (severe manifestation) or two grade B (moderate manifestation) organ scores, or both.\n  4. Ineffective conventional treatment or relapse of disease activity after remission. Definition of routine treatment: Use of glucocorticoids (Above 1 mg\u002Fkg\u002Fd) and cyclophosphamide, and any of the following immunomodulatory drugs for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as rituximab, belimumab, and telitacicept.\n* Criteria for Sjögren's syndrome:\n\n  1. Meet the 2002 AECG criteria for primary Sjögren's syndrome or the 2016 ACR\u002FEULAR classification criteria;\n  2. Disease activity ESSDAI ≥ 6;\n  3. Anti-SSA\u002FRo antibody positive;\n  4. Definition of relapse\u002Frefractory: disease activity that is ineffective to conventional treatment for more than 6 months or recurs after response. Definition of conventional treatment is use of glucocorticoids and cyclophosphamide, and any of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, and telitacicept.\n* Criteria for systemic sclerosis:\n\n  1. Meet the 2013 ACR classification criteria for systemic sclerosis and meet diffuse manifestations;\n  2. Combined interstitial pneumonia: interstitial changes with ground-glass exudate detected by chest high-resolution computed tomography (HRCT);\n\n     Needs to be met c. or d.:\n  3. Ineffective conventional treatment or relapse of disease activity after remission. Definition of routine treatment: Use of glucocorticoids (Above 0.5 mg\u002Fkg\u002Fd) and cyclophosphamide, and any of the following immunomodulatory drugs for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as rituximab and belimumab.\n  4. Meet the definition of progression: 1) Definition of skin progression: mRSS increases b \\> 25%; 2) Definition of lung disease progression: FVC decreased by 10%, or FVC decreased by 5% and DLCO decreased by 15%.\n* Criteria for inflammatory myopathy:\n\n  1. The classification criteria for inflammatory myopathy comply with the 2017 EULAR\u002FACR (including DM, PM, ASS and NM);\n  2. For patients with muscle involvement, the MMT-8 score is less than 142 and abnormalities are found in at least two of the following five core measures (PhGA, PtGA, or extramuscular disease activity score ≥ 2 points; total HAQ score ≥ 0.25; muscle enzyme level is 1.5 times upper limit of normal);\n  3. Myositis antibody positive;\n\n     Needs to be met d. or e.:\n  4. Definition of relapse\u002Frefractory: Failure of conventional treatment or relapse of disease activity after response. Definition of conventional treatment: Use of glucocorticoids (greater than 1 mg\u002Fkg\u002Fd) and cyclophosphamide, and any of the following immunomodulatory drugs for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as rituximab and belimumab.\n  5. Meet the definition of progression: Interstitial pneumonia progresses rapidly over a short period of time.\n* Criteria for ANCA-associated vasculitis:\n\n  1. Meet the diagnostic criteria for ANCA-associated vasculitis in the 2022 ACR\u002FEULAR, including microscopic polyangiitis, granulomatous polyangiitis, eosinophilic granulomatosis with polyangiitis;\n  2. ANCA-related antibody positive (MPO-ANCA or PR3-ANCA positive);\n  3. Birmingham Vasculitis Activity Scale (BVAS) ≥ 15 points (out of a total of 63 points), indicating activity of vasculitis;\n  4. Must have at least one major item, at least three minor items, or at least two renal items, hematuria and proteinuria, in the BVAS assessment;\n  5. Definition of relapse\u002Frefractory: Failure of conventional treatment or relapse of disease activity after response. Definition of conventional treatment: Use of glucocorticoids (greater than 1 mg\u002Fkg\u002Fd) and cyclophosphamide, and any of the following immunomodulatory drugs for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as rituximab and belimumab.\n\nExclusion Criteria:\n\n* Prohibited medications and treatments:\n\n  * Any RNA-LNP products or other LNP drugs received within the past two years.\n  * Received intravenous gamma immunoglobulin within 24 weeks prior to screening.\n  * Received plasmapheresis therapy within 12 weeks prior to screening.\n  * Subjects who have not fully recovered from surgery within 4 weeks prior to screening.\n  * Epilepsy or use of psychotropic or sedative drugs during the screening period (except medications for sleeping).\n  * Received any live or live attenuated vaccine within 12 weeks prior to screening, or requiring vaccination at any time during clinical trial treatment.\n  * Participated in clinical trial of other drugs or medical devices within 12 weeks prior to screening (except for those whose screening failed).\n* Concomitant diseases or clinical condition:\n\n  * History of lupus nephropathy requiring hemodialysis or treatment with high-dose corticosteroids (\\> 100 mg\u002Fd prednisone or equivalent) within 90 days prior to baseline.\n  * Epilepsy or use of psychotropic or sedative drugs during the screening period (except medications for sleeping).\n  * Received any live or live attenuated vaccine within 12 weeks prior to screening, or requiring vaccination at any time during clinical trial treatment.\n  * Participated in clinical trial of other drugs or medical devices within 12 weeks prior to screening (except for screen failures).\n  * Have active central nervous system lupus, including meningitis aseptic, cerebral vasculitis, demyelinating syndrome, myelopathy, acute demented, psychosis, acute inflammatory demyelinating polyradiculoneuropathy, mononeuropathy (single\u002Fmultiple), cranial neuropathy, plexopathy, status epilepticus or cerebellar ataxia.\n  * Presence of other systemic inflammations such as, but not limited to, rheumatoid arthritis, juvenile chronic arthritis, spondyloarthritis, Crohn's disease, ulcerative colitis, or psoriatic arthritis within 12 weeks prior to screening (except for those with secondary Sjögren's syndrome, who should not be excluded).\n  * Subjects who have Grade III or above congestive heart failure (NYHA grade), unstable angina or myocardial infarction, poorly controlled hypertension (hypertension is diagnosed as Grade 2 or above, risk factor stratified as high-risk, systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg when taking one or two antihypertensive drugs, cerebrovascular accidents, or arrhythmias requiring treatment within 6 months prior to screening.\n  * Presence of active or uncontrolled infection requiring treatment; or have known or suspected ongoing, chronic, or recurrent infectious diseases (including but not limited to opportunistic infections such as pulmonary tuberculosis, atypical mycobacterosis, listeriosis or aspergillosis, HIV, hepatitis B or hepatitis C, etc.).\n  * Subjects with suspected allergy to TI-0032-III or similar drugs or a history of severe allergy or hypersensitivity reactions.\n  * History of thyrotoxicosis, including but not limited to diffuse toxic goitre, multinodular toxic goiter, thyroid autonomic high-function adenoma, and subacute thyroiditis, or thyroid color ultrasound suggests thyroid nodules TI-RADS classification as category 4 or 5.\n  * Previous history of splenectomy or loss of spleen function after splenic infarction or splenic vein thrombosis leading to direct vascular injury; or major surgery within 2 months prior to screening; or have planned surgery before the end of the trial.\n  * Have other serious\u002Fsevere acute or chronic mental illness, including recent (within the past 1 year) or current suicidal ideation or behavior; or a history of alcohol, drug, or chemical abuse within 1 year prior to screening.\n  * History of major organ transplant (e.g., heart, lung, liver, kidney) or bone marrow\u002Fhematopoietic stem cell transplantation.\n  * History of malignancy, regardless of evidence of local recurrence or metastasis and regardless of treatment; or accompanied by a history of other major diseases, such as liver disease under treatment, including but not limited to acute or chronic hepatitis, liver cirrhosis or liver failure, etc.\n  * HIV positive, or active hepatitis B virus test positive (HBsAg positive, HBV-DNA ≥ 200 copies\u002FmL is required (conversion is required if HBV-DNA is in IU\u002FmL)), or anti-HCV antibody positive and HCV-RNA positive.\n  * Women who plan to become pregnant or are pregnant or breastfeeding; or blood pregnancy test positive during screening; or unable to take effective contraceptive measures within 12 months after the last infusion of investigational drug; or planned sperm\u002Fegg donation within 12 months after the last dose of the investigational drug.\n  * Other clinically significant abnormal laboratory tests or imaging tests judged by the investigator or considered unsuitable for clinical the trial for other reasons.","18 Years","65 Years",{"count":81,"type":20},12,[83],"PHASE1","This is an open-label, dose escalation study in patients with relapsed and refractory autoimmune diseases. Study drug, TI-0032-III injection, is composed of lipid nanoparticles (LNPs) targeting T cells that encapsulate circular RNA encoding the CD19 chimeric antigen receptor (CAR), which is a therapeutic biological product. It is clinically intended for the treatment of various relapsed and refractory B cell-related autoimmune diseases, such as systemic lupus erythematosus, sjögren's syndrome, systemic sclerosis, idiopathic inflammatory myositis, and antiphospholipid syndrome.",[86,87,30,88,31],"Systemic Lupus Erythematosus (SLE)","Sjogren's Syndrome (SS)","Inflammatory Myopathy","2026-02-09",{"date":91,"type":39},"2026-02-17",{"date":93,"type":39},"2026-01-22",{"date":95,"type":20},"2027-01-30",{"name":97,"class":98},"Therorna","INDUSTRY",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":118,"locationsCount":47},"100616400","phase-1-car-t-cell-therapy-targeting-cd19-and-bcma-in-patients-with-b-cell-mediated-autoimmune-disease-100616400","NCT07305116","CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease","Inclusion Criteria:\n\n\\- Common Inclusion Criteria:\n\n1\\. Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n\n1. Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n2. Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n3. Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n4. Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n5. Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%. 2. Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n\n3\\. Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n\nDisease-Specific Inclusion Criteria\n\nSLE:\n\n1. Age ≥ 5 years.\n2. Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n3. Must meet at least one of the following adequate treatment conditions:\n\n   a) Treated with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent) plus one or more immunomodulatory agents (including cyclophosphamide, MMF, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, thalidomide, belimumab, or rituximab) for at least 3 months.\n\n   b) Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n\n   c) Patients who cannot taper glucocorticoids to ≤5 mg\u002Fday after 6 months of conventional therapy.\n4. SLE disease activity: SLEDAI-2K score ≥ 8; or SLEDAI ≥ 6 plus at least one BILAG-2004 category A or two category B scores, or both.\n5. No occurrence of macrophage activation syndrome within 1 month prior to screening.\n6. Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n\nMDR-SRNS\n\n1. Age ≥3 years old, gender unlimited.\n2. Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n3. Must meet at least one of the following adequate treatment conditions:\n\n   a) have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab).\n\n   b) if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n\n   c) Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n\n   d) Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n4. Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n\nIgA nephropathy\n\n1. Age: ≥ 5 years old, gender unlimited;\n2. IgA nephropathy pathologically confirmed by renal biopsy;\n3. Angiotensin-Converting Enzyme Inhibitors (ACE) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n\n   a) Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg; b) \\>50% decline in eGFR within 3 months; c) Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n4. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n\nRefractory\u002FRelapsed\u002FProgressive Systemic Sclerosis:\n\n1. Age: ≥ 5 years old, gender unlimited;\n2. Scleroderma fulfilling the 2013 ACR classification criteria\n3. Positive scleroderma-related antibodies.\n4. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n5. Must meet at least one of the following adequate treatment conditions:\n\n   1. Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n   2. Meets criteria for rapidly progressive disease (see Appendix 1) and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n   3. Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n6. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n\nRefractory\u002FRelapsed ANCA-Associated Vasculitis:\n\n1. Age: ≥ 5 years old, gender unlimited;\n2. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n3. Has received glucocorticoids (≥1 mg\u002Fkg\u002Fday) in combination with at least one immunosuppressant or biologic agent (including cyclophosphamide, rituximab, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, belimumab, telitacicept, etc.) for at least 3 months without achieving sustained remission, or has experienced relapse after remission;or meets the criteria for severe vasculitis (Appendix 1), with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n4. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n5. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n\n  2\\. Subjects with grade III or IV heart failure (NYHA classification). 3. Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n\n  4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n\n  5\\. Had active pulmonary tuberculosis at screening. 6. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n\n  7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n\n  8\\. Patients had active central nervous system disease. 9. Patients with malignant diseases such as tumors before screening. 10. Secondary or congenital immunodeficiency. 11. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n\n  12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n\n  13\\. Received live vaccine within 4 weeks before screening. 14. Tested positive in Blood pregnancy test. 15. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n\n  16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n\n  17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome",{"count":19,"type":20},[83],"CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B cell mediated autoimmune disease.",[26,27,28,29,30,31],[111,28,59,60,30,61],"CAR-T","2026-01-31",{"date":114,"type":39},"2026-02-03",{"date":116,"type":39},"2025-12-01",{"date":68,"type":20},{"name":45,"class":46}]