[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen Genocury Biotech Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":110},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,68,89],{"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":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100630690","cluster-of-differentiation-19-cd19b-cell-maturation-antigen-bcma-chimeric-antigen-receptor-t-cell-car-t-therapy-for-refractory-autoimmune-diseases-100630690",false,"NCT07490951","Cluster of Differentiation 19 (CD19)\u002FB Cell Maturation Antigen (BCMA) Chimeric Antigen Receptor T-Cell (CAR-T) Therapy for Refractory Autoimmune Diseases","A Clinical Study on the Safety, Tolerability and Preliminary Efficacy of Targeted CD19\u002FBCMA CAR-T Therapy in the Treatment of Refractory Autoimmune Diseases (ADs)","Inclusion Criteria:\n\n1. Age: 18\\~70 years old, male or female; provided written informed consent form (ICF).\n2. Diagnosis of one of the following diseases:\n\n   1. Systemic lupus erythematosus (SLE), diagnosed according to the European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) 2019 criteria, with Antinuclear Antibody (ANA) \\> 1:80 or positive anti-dsDNA antibody;\n   2. Sjögren's syndrome (SS), diagnosed according to the 2016 ACR\u002FEULAR criteria, with at least positive anti-Sjögren's-syndrome-related antigen A antibody (SSA) antibody;\n   3. Systemic sclerosis (SSc), diagnosed according to the 2013 ACR\u002FEULAR criteria, with ANA \\> 1:80 or positive anti-Scleroderma (SCL)-70 antibody;\n   4. Dermatomyositis (DM), meeting the 1975 Bohan and Peter criteria for DM or the 2020 European Neuromuscular Centre (ENMC)-DM classification criteria;\n   5. Antisynthetase syndrome (ASS), meeting the 2010 Conners classification criteria or the 2011 Solomon classification criteria;\n   6. Immune-mediated necrotizing myopathy (IMNM), meeting the 2020 ACR\u002FEULAR classification criteria;\n   7. Rheumatoid arthritis (RA), meeting the ACR\u002FEULAR classification criteria for RA;(8) Antineutrophil Cytoplasmic Antibody (ANCA)-associated vasculitis (AAV), including granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), or eosinophilic granulomatosis with polyangiitis (EGPA), diagnosed according to the 2022 ACR\u002FEULAR criteria, with positive ANCA (any of c-ANCA, p-ANCA, anti-Proteinase 3 (PR3), or anti-Myeloperoxidase (MPO) positive).\n3. Patients who have received treatment with ≥ 2 immunosuppressants for 3 months,or require prednisone ≥ 15 mg daily to maintain stable disease,or are intolerant to standard therapy, or have relative contraindications to standard therapy,and meet the following disease activity criteria:\n\n   1. For SLE patients: SLEDAI score ≥ 8;\n   2. For SS patients: EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥ 14;\n   3. For SSc patients: modified Rodnan Skin Score (mRSS) score 10-35 (inclusive), and\u002For complicated with interstitial lung disease (ILD);\n   4. For DM patients: disease duration ≥ 1 year, and meeting all of the following:a. Skin rash Visual Analogue Scale (VAS) score (based on MDAAT) ≥ 3 cm, with at least 3 abnormal Cutaneous, Skeletal Muscle, Systemic (CSM) items;b. Active inflammation demonstrated by muscle biopsy, muscle MRI, or muscle ultrasound;c. Elevation of at least one muscle enzyme \\[creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), alanine aminotransferase (ALT), aspartate aminotransferase (AST)\\] to a minimum level of 1.3 × upper limit of normal (ULN);\n   5. For ANCA-AAV patients: Birmingham Vasculitis Activity Score (BVAS) ≥ 15, with positive ANCA.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n5. Organ function meeting the following criteria:\n\n   1. Hematology: hemoglobin ≥ 60 g\u002FL, platelet count ≥ 20 × 10⁹\u002FL;\n   2. Cardiac function: left ventricular ejection fraction (LVEF) ≥ 55%, no significant abnormality on electrocardiogram;\n   3. Renal function: estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73 m²;\n   4. Hepatic function: AST and ALT ≤ 3.0 × ULN, total bilirubin ≤ 2.0 × ULN;\n   5. Eligible for leukapheresis or venous blood collection, with no other contraindications to cell collection.\n6. Female subjects of childbearing potential must have a negative urine pregnancy test and agree to use effective contraception during the study until 1 year after infusion.\n7. The patient or legal guardian agrees to participate in this clinical study, signs the informed consent form, and demonstrates understanding of the purpose and procedures of the study.\n\nExclusion Criteria:\n\n1. Prior treatment with CAR-T cell therapy;\n2. Suffering from severe cardiac, hepatic, pulmonary, hematological, or endocrine diseases, for whom the investigator determines that the risks of participation outweigh the benefits;\n3. Active infection requiring systemic therapy or uncontrolled infection within 1 week prior to screening;\n4. Prior hematopoietic stem cell transplantation or solid organ transplantation (excluding corneal and hair transplantation), or acute graft-versus-host disease (GVHD) of Grade 2 or higher within 2 weeks prior to screening;\n5. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer above the normal reference range;or positive for hepatitis C virus (HCV) antibody with peripheral blood HCV RNA titer above the normal reference range;or positive for human immunodeficiency virus (HIV) antibody;or positive for syphilis;or positive for cytomegalovirus (CMV) DNA;\n6. Administration of live vaccines within 4 weeks prior to screening;\n7. Positive pregnancy test;\n8. Patients with malignant tumors or other malignant diseases prior to screening, excluding adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer after radical treatment, and ductal carcinoma in situ after radical surgery;\n9. Patients who participated in other clinical trials within 3 months prior to screening;\n10. Any other conditions deemed by the investigator to render the subject ineligible for this study.","ALL","18 Years","70 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of CD19\u002FBCMA CAR-T in the treatment of refractory autoimmune diseases.",[27],"Autoimmune Diseases",[29,30],"CD19\u002FBCMA","CAR-T","NOT_YET_RECRUITING","2026-03-18",{"date":34,"type":35},"2026-03-24","ACTUAL",{"date":37,"type":21},"2026-03-22",{"date":39,"type":21},"2029-12-31",{"name":41,"class":42},"Shenzhen Genocury Biotech Co., Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":43},"100618838","early-phase-1-jy232jy232-injection-in-relapsedrefractory-multiple-myeloma-100618838","NCT07336823","JY232(JY232) Injection in Relapsed\u002FRefractory Multiple Myeloma","A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of JY232 Injection in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. The subject voluntarily signs the informed consent form, is willing and able to comply with all study requirements.\n2. Age 18-75 years, male or female.\n3. Diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).\n4. Must have undergone stem cell transplantation (SCT) or be transplant-ineligible.\n5. Must have received at least 2 prior lines of anti-MM therapy (including immunomodulatory drugs, proteasome inhibitors, and anti-Cluster of Differentiation 38 (CD38) therapy, as single agents or in combination. Patients who are intolerant or have contraindications to these therapies are eligible for enrollment if they meet other inclusion\u002Fexclusion criteria). Each line of therapy must have included at least one complete cycle, and there must be documented evidence of disease progression on or relapse after the last line of therapy, or permanent discontinuation of therapy due to treatment-related toxicities (the reason for permanent discontinuation due to toxicity must be documented in the CRF). Furthermore, the patient must be refractory or intolerant to any established standard-of-care regimen that, in the investigator's assessment, is of significant clinical benefit to the patient.\n6. The subject's tumor sample (bone marrow) tests positive for B-Cell Maturation Antigen (BCMA) expression on the plasma cell membrane via immunohistochemistry (IHC) or flow cytometry.\n7. Presence of measurable disease at screening determined by any one of the following criteria:\n\n   * Proportion of clonal plasma cells in bone marrow cytology, bone marrow biopsy histology, or flow cytometry ≥ 5%;\n   * Serum monoclonal protein (M-protein) level: Immunoglobulin G (IgG) type M-protein ≥10 g\u002FL; or Immunoglobulin A (IgA), Immunoglobulin D (IgD), Immunoglobulin E (IgE), Immunoglobulin M (IgM) type M-protein ≥5 g\u002FL;\n   * Urine M-protein level ≥200 mg\u002F24 hours;\n   * For MM without measurable serum or urine M-protein: involved serum free light chain ≥100 mg\u002FL (10 mg\u002FdL) and abnormal serum κ\u002Fλ free light chain ratio (\\\u003C0.26 or \\>1.65);\n   * Or clinical relapse: a. New bone lesions or soft tissue plasmacytomas (excluding osteoporotic fractures); b. Confirmed increase in Sum of the Product of Diameters (SPD) of existing plasmacytomas or bone lesions (≥50% increase in SPD of measurable lesions, absolute increase ≥1 cm).\n8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 (see Appendix 1 for ECOG scale).\n9. Expected survival time ≥12 weeks.\n10. The subject must have adequate organ function, meeting all the following laboratory results prior to enrollment:\n\n    * Hematology: Absolute neutrophil count (ANC) ≥ 1×10\\^9 \u002FL (growth factor support is allowed, but must not have been administered within 7 days prior to the laboratory test); Absolute lymphocyte count (ALC) ≥0.3×10\\^9 \u002FL; Platelets ≥50×10\\^9 \u002FL (must not have received transfusion support within 7 days prior to the laboratory test); Hemoglobin ≥60 g\u002FL (no red blood cell (RBC) transfusion within 7 days prior to the laboratory test; recombinant human erythropoietin is allowed);\n    * Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN); Serum total bilirubin ≤1.5 × ULN;\n    * Renal function: If available, measured CrCl from 24-hour urine collection; otherwise, calculated creatinine clearance (CrCl) via Cockcroft-Gault formula ≥ 40 ml\u002Fmin;\n    * Coagulation: Fibrinogen ≥1.0 g\u002FL; Activated partial thromboplastin time (aPTT) ≤1.5 × ULN; Prothrombin time (PT) ≤1.5 × ULN;\n    * Oxygen saturation \\>91% (on room air);\n    * Left ventricular ejection fraction (LVEF) ≥ 50 %;\n    * No clinically significant pericardial effusion detected.\n11. The subject and their spouse agree to use effective barrier or pharmacological contraception from signing the informed consent until one year after CAR-T cell infusion (excluding the rhythm method).\n\nExclusion Criteria:\n\n1. History of graft-versus-host disease (GvHD), or presence of autoimmune disease, immunodeficiency, or any condition requiring long-term immunosuppressive therapy.\n2. Allogeneic hematopoietic stem cell transplantation within 6 months prior to infusion, or autologous hematopoietic stem cell transplantation within 3 months prior to infusion.\n3. Prior anti-tumor therapy as follows:\n\n   * Monoclonal antibody therapy for multiple myeloma (MM) within 21 days prior to dosing or within at least 5 half-lives (whichever is longer), or\n   * Cytotoxic chemotherapy within 14 days prior to dosing or within at least 5 half-lives (whichever is longer), or\n   * Proteasome inhibitor or immunomodulatory agent therapy within 14 days prior to dosing or within at least 5 half-lives (whichever is longer), or\n   * Treatment with investigational drugs within 30 days prior to screening or within 5 half-lives (whichever is longer), or still within the washout period; or treatment involving invasive investigational medical devices, or\n   * Radiotherapy within 4 weeks prior to dosing, or\n   * Other anti-tumor therapies not listed above within 14 days prior to dosing or within at least 5 half-lives (whichever is longer).\n4. Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent \\> 20mg\u002Fday) within 7 days prior to screening, except for physiological replacement, topical, and inhaled steroids.\n5. Hypertension uncontrolled by two or more antihypertensive medications to the following range (systolic BP \\\u003C160 mmHg, diastolic BP \\\u003C90 mmHg); or hypotension below normal range despite treatment (systolic BP \\\u003C90 mmHg or diastolic BP \\\u003C60 mmHg).\n6. Severe cardiac disease: including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure New York Heart Association (NYHA) class ≥III, severe arrhythmia.\n7. Unstable systemic diseases as judged by the investigator: including but not limited to severe hepatic, renal, respiratory, or metabolic diseases requiring medication.\n8. Diagnosis of malignancy other than MM within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer treated with radical surgery, ductal carcinoma in situ of the breast treated with radical surgery.\n9. History of solid organ transplantation.\n10. Presence of central nervous system (CNS) involvement, symptoms of CNS involvement (including cranial nerve lesions and extensive lesions or spinal cord compression), or CNS metastasis.\n11. MM patients with extramedullary disease (except for those with a single para-medullary lesion with a maximum transverse diameter ≤3cm).\n12. MM patients with concomitant plasma cell leukemia (peripheral blood plasma cell proportion ≥5%).\n13. Major surgery within 2 weeks prior to dosing, or planned surgery within 2 weeks after study treatment (subjects scheduled for local anesthesia surgery may participate).\n14. Treatment with other interventional investigational drugs within 1 month prior to signing the informed consent form (ICF).\n15. Uncontrolled active infection within 7 days prior to dosing, e.g., positive blood culture ≤72 hours prior to infusion (except for \\\u003CCTCAE Grade 2 genitourinary tract and upper respiratory tract infections), or infection requiring medication.\n16. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable Hepatitis B Virus (HBV) DNA ≥1×10\\^3 copies\u002FmL in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA; positive for syphilis.\n17. Pregnant or breastfeeding women.\n18. Psychiatric illness, impaired consciousness, or central nervous system disorders.\n19. Non-hematological toxicities from prior therapy have not recovered to baseline or ≤ Grade 1 (per NCI-CTCAE v5.0, except for alopecia and Grade 2 peripheral neuropathy).\n20. Any other condition considered by the investigator to be unsuitable for enrollment.","75 Years",{"count":53,"type":21},9,[55],"EARLY_PHASE1","This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed\u002Frefractory multiple myeloma. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY232 injection in the treatment of relapsed\u002Frefractory multiple myeloma.",[58],"Multiple Myeloma","RECRUITING","2026-01-04",{"date":62,"type":35},"2026-01-13",{"date":64,"type":21},"2026-01-20",{"date":66,"type":21},"2028-12-31",{"name":41,"class":42},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":43},"100584494","jy231jy231-injection-for-the-treatment-of-relapsedrefractory-b-cell-lymphoma-leukemia-100584494","NCT06890065","JY231(JY231) Injection for the Treatment of Relapsed\u002FRefractory B Cell Lymphoma\u002F Leukemia","An Early-Phase Exploratory Clinical Study of JY231 Injection in Relapsed\u002FRefractory B-Cell Lymphoma\u002FLeukemia: Safety, Tolerability, and Preliminary Efficacy","Inclusion Criteria:\n\n1. Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;\n2. Age is 18-75 years old and gender is not limited;\n3. Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis;\n4. Meet the clinical criteria for relapsed or refractory B-cell lymphoma, including: indolent lymphoma (iNHL), such as follicular lymphoma (FL) and marginal zone lymphoma (MZL); aggressive B-cell lymphoma, like diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-rich lymphocyte-bearing large B-cell lymphoma (TCRBCL), or have a diagnosis of acute B-lymphocytic leukemia (B-ALL) and meet one of the following conditions:\n\n   * Refractory B-ALL: those who did not achieve complete remission after 2 courses of standard induction regimen chemotherapy, or those who did not achieve complete remission after first-line or multi-line salvage chemotherapy;\n   * Relapsed B-ALL: relapse within 12 months after first remission, or relapse after first-line \u002F multi-line salvage chemotherapy;\n   * Relapse after autologous or allogeneic hematopoietic stem cell transplantation; In addition, patients with Philadelphia chromosome positive (Ph +) should be relapsed after at least two tyrosine kinase inhibitors (TKI) treatment, or they could not tolerate TKI therapy, or have a t315i mutation, resistant to TKI drugs.\n5. Morphological examination of bone marrow cells showed the proportion of primitive and naive lymphocytes was\\> 5%;\n6. No Hematopoietic Stem Cell Transplantation(HSCT) within 6 months before enrollment;\n7. At least one measurable lesion was imaging for relapsed or refractory B cell lymphoma, long diameter of\\> 15mm, or extranodal lesion of\\> 10mm, along with a positive Positron Emission Tomography - Computed Tomography(PET-CT) examination.\n8. More than 12 weeks of expected survival period\n9. Baseline Eastern Cooperative Oncology Group(ECOG) score was 0-1;\n10. Adequate organ function (criteria regarding liver and kidney function can be moderately relaxed):\n\n    * Glutamic aminotransferase (ALT) ≤3 times upper limit of normal (ULN);\n    * Grass aminotransferase (AST) ≤3 times ULN;\n    * Total bilirubin ≤1.5 times ULN;\n    * Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL\u002Fmin;\n    * Indoor oxygen saturation ≥ 92%;\n    * Left ventricular ejection fraction (LVEF)≥55%, echocardiography confirmed no pericardial effusion and no clinically significant ECG findings;\n    * There is no clinically significant pleural effusion;\n11. Adequate bone marrow reserve without transfusion, defined as:\n\n    * Absolute neutrophil count (ANC)\\>1.000 \u002F mm3;\n    * Absolute lymphocyte count (ALC)≥ 300 \u002F mm3;\n    * Platelet≥50.000\u002Fmm3;\n    * Hemoglobin\\>8.0 g\u002Fdl;\n12. Subjects using the following drugs need to meet the following conditions:\n\n    * Steroids: The therapeutic dose of steroids must be stopped 72 hours before JY231 infusion. However, physiological alternative doses of steroids are allowed;\n    * Immunosuppression: Any immunosuppressive drug must be stopped at ≥4 weeks prior to enrollment;\n    * Antiproliferative therapy other than lymphodepletion chemotherapy within two weeks of infusion;\n    * Cluster of Differentiation 20(CD20) antibody-related therapy must be stopped within 4 weeks before infusion or 5 half-lives after the CD20 antibody;\n    * CNS disease prophylaxis must be stopped 1 week before JY231 infusion (e. g. intrathecal methotrexate).\n13. Reproductive men, sexual partners ensure effective contraception; fertile women, adopted effective contraception and agreed to use contraception throughout the study period.\n\nExclusion Criteria:\n\n1. Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma, or CNS leukaemia;\n2. Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia \u002F hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with CNS involvement;\n3. Subjects who have received other study drugs within 30 days before screening, or are still in the washout period;\n4. Patients who have previously received any anti-CD19 \u002F anti-Cluster of Differentiation 3(CD3) therapy or any other anti-CD19 therapy (except for those with normal T cell numbers and function and with CD19-positive tumors);\n5. Patients who have been previously treated with any gene therapy product, including Chimeric Antigen Receptor T(CAR-T) therapy (except patients who do not have CAR-T cells in vivo and have normal T cell number and function and are with CD19 positive tumors);\n6. Subjects with radiation therapy within 2 weeks prior to the infusion;\n7. Subjects with active hepatitis B (defined as Hepatitis B Virus(HBV) DNA test value\\> 500 IU \u002F mL) or hepatitis C (HCV RNA positive); subjects with HIV positive or treponema pallidum positive;\n8. Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infection (e. g. positive blood culture 72 hours before infusion);\n9. Subjects with unstable angina pectoris and \u002F or myocardial infarction within the 6 months prior to screening;\n10. Subjects with concurrent or previously diagnosed with other malignancies, except for the patients under following conditions:\n\n    * Well treated basal cells, papillary thyroid carcinoma, squamous cell carcinoma (adequate wound healing is required before enrollment into this study);\n    * Carcinoma in situ of cervical cancer or breast cancer, after curative treatment, showed no signs of recurrence for at least 3 years before the study;\n    * The primary malignancy has been completely removed and is in complete remission for 5 years.\n11. Arrhythmic subjects without medical management control;\n12. Subjects receiving oral anticoagulation within 1 week before JY231 injection infusion;\n13. Having active neurological autoimmune or inflammatory conditions (such as Guillain-Barre syndrome, amyotrophic lateral sclerosis);\n14. Female subjects in pregnant or lactating, or women with planned pregnancy within 2 years after JY231 infusion or male partner with planned pregnancy within 2 years after JY231 infusion;\n15. Subjects with taboo study procedures or other medical conditions that may put them at unacceptable risk according to the investigator's judgment and \u002F or clinical criteria.\n\n16）Other conditions that the investigator believes that the subjects should not be enrolled in this clinical trial, such as poor compliance.",{"count":20,"type":21},[24],"This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma \u002Fleukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B cell lymphoma \u002F leukemia.",[79,80],"B Acute Lymphoblastic Leukemia","B-Non Hodgkin Lymphoma","2025-05-12",{"date":83,"type":35},"2025-05-15",{"date":85,"type":35},"2025-03-01",{"date":87,"type":21},"2027-12",{"name":41,"class":42},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":43},"100568212","jy231jy231-injection-for-the-treatment-of-relapsed-or-refractory-b-cell-lymphoma-leukemia-100568212","NCT06678282","JY231(JY231) Injection for the Treatment of Relapsed or Refractory B Cell Lymphoma\u002F Leukemia","JY231 Injection for the Treatment of Relapsed or Refractory B Cell Lymphoma\u002F Leukemia - A Safety, Tolerability, and Efficacy Study","Inclusion Criteria：\n\n1. Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;\n2. Age is 18-75 years old and gender is not limited;\n3. Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis;\n4. Meet the clinical criteria for relapsed or refractory B-cell lymphoma, including: indolent lymphoma (iNHL), such as follicular lymphoma (FL) and marginal zone lymphoma (MZL); aggressive B-cell lymphoma, like diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-rich lymphocyte-bearing large B-cell lymphoma (TCRBCL), or have a diagnosis of acute B-lymphocytic leukemia (B-ALL) and meet one of the following conditions:\n\n   * Refractory B-ALL: those who did not achieve complete remission after 2 courses of standard induction regimen chemotherapy, or those who did not achieve complete remission after first-line or multi-line salvage chemotherapy;\n   * Relapsed B-ALL: relapse within 12 months after first remission, or relapse after first-line \u002F multi-line salvage chemotherapy;\n   * Relapse after autologous or allogeneic hematopoietic stem cell transplantation; In addition, patients with Philadelphia chromosome positive (Ph +) should be relapsed after at least two tyrosine kinase inhibitors (TKI) treatment, or they could not tolerate TKI therapy, or have a t315i mutation, resistant to TKI drugs.\n5. Morphological examination of bone marrow cells showed the proportion of primitive and naive lymphocytes was\\> 5%;\n6. No Hematopoietic Stem Cell Transplantation(HSCT) within 6 months before enrollment;\n7. At least one measurable lesion was imaging for relapsed or refractory B cell lymphoma, long diameter of\\> 15mm, or extranodal lesion of\\> 10mm, along with a positive Positron Emission Tomography - Computed Tomography(PET-CT) examination.\n8. More than 12 weeks of expected survival period\n9. Baseline Eastern Cooperative Oncology Group(ECOG) score was 0-1;\n10. Adequate organ function (criteria regarding liver and kidney function can be moderately relaxed):\n\n    * Glutamic aminotransferase (ALT) ≤3 times upper limit of normal (ULN);\n    * Grass aminotransferase (AST) ≤3 times ULN;\n    * Total bilirubin ≤1.5 times ULN;\n    * Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL\u002Fmin;\n    * Indoor oxygen saturation ≥ 92%;\n    * Left ventricular ejection fraction (LVEF)≥55%, echocardiography confirmed no pericardial effusion and no clinically significant ECG findings;\n    * There is no clinically significant pleural effusion;\n11. Adequate bone marrow reserve without transfusion, defined as:\n\n    * Absolute neutrophil count (ANC)\\>1.000 \u002F mm3;\n    * Absolute lymphocyte count (ALC)≥ 300 \u002F mm3;\n    * Platelet≥50.000\u002Fmm3;\n    * Hemoglobin\\>8.0 g\u002Fdl;\n12. Subjects using the following drugs need to meet the following conditions:\n\n    * Steroids: The therapeutic dose of steroids must be stopped 72 hours before JY231 infusion. However, physiological alternative doses of steroids are allowed;\n    * Immunosuppression: Any immunosuppressive drug must be stopped at ≥4 weeks prior to enrollment;\n    * Antiproliferative therapy other than lymphodepletion chemotherapy within two weeks of infusion;\n    * Cluster of Differentiation 20(CD20) antibody-related therapy must be stopped within 4 weeks before infusion or 5 half-lives after the CD20 antibody;\n    * CNS disease prophylaxis must be stopped 1 week before JY231 infusion (e. g. intrathecal methotrexate).\n\nReproductive men, sexual partners ensure effective contraception; fertile women, adopted effective contraception and agreed to use contraception throughout the study period.\n\nExclusion Criteria：\n\n1. Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma, or CNS leukaemia;\n2. Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia \u002F hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with CNS involvement;\n3. Subjects who have received other study drugs within 30 days before screening, or are still in the washout period;\n4. Patients who have previously received any anti-CD19 \u002F anti-Cluster of Differentiation 3(CD3) therapy or any other anti-CD19 therapy (except for those with normal T cell numbers and function and with CD19-positive tumors);\n5. Patients who have been previously treated with any gene therapy product, including Chimeric Antigen Receptor T(CAR-T) therapy (except patients who do not have CAR-T cells in vivo and have normal T cell number and function and are with CD19 positive tumors);\n6. Subjects with radiation therapy within 2 weeks prior to the infusion;\n7. Subjects with active hepatitis B (defined as Hepatitis B Virus(HBV) DNA test value\\> 500 IU \u002F mL) or hepatitis C (HCV RNA positive); subjects with HIV positive or treponema pallidum positive;\n8. Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infection (e. g. positive blood culture 72 hours before infusion);\n9. Subjects with unstable angina pectoris and \u002F or myocardial infarction within the 6 months prior to screening;\n10. Subjects with concurrent or previously diagnosed with other malignancies, except for the patients under following conditions:\n\n    * Well treated basal cells, papillary thyroid carcinoma, squamous cell carcinoma (adequate wound healing is required before enrollment into this study);\n    * Carcinoma in situ of cervical cancer or breast cancer, after curative treatment, showed no signs of recurrence for at least 3 years before the study;\n    * The primary malignancy has been completely removed and is in complete remission for 5 years.\n11. Arrhythmic subjects without medical management control;\n12. Subjects receiving oral anticoagulation within 1 week before JY231 injection infusion;\n13. Having active neurological autoimmune or inflammatory conditions (such as Guillain-Barre syndrome, amyotrophic lateral sclerosis);\n14. Female subjects in pregnant or lactating, or women with planned pregnancy within 2 years after JY231 infusion or male partner with planned pregnancy within 2 years after JY231 infusion;\n15. Subjects with taboo study procedures or other medical conditions that may put them at unacceptable risk according to the investigator's judgment and \u002F or clinical criteria.\n\nOther conditions that the investigator believes that the subjects should not be enrolled in this clinical trial, such as poor compliance.",{"count":20,"type":21},[24],"This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma \u002F leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B cell lymphoma \u002F leukemia.",[100,101],"B-NHL","B-ALL","2024-11-06",{"date":104,"type":35},"2024-11-07",{"date":106,"type":35},"2023-09-07",{"date":108,"type":21},"2026-12-31",{"name":41,"class":42},""]