[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhimin Zhai\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100616480","phase-1-gp350-car-t-for-relapserefractory-and-epstein-barr-virus-infection-associated-lymphoid-neoplasms-100616480",false,"NCT07306156","GP350 CAR-T for Relapse\u002FRefractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms","GP350 CAR-T Cells for Relapse\u002FRefractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms, an Open-label, Single-arm Clinical Trial","ANXIN-02","Inclusion Criteria:\n\n1. Diagnosis: Confirmed diagnosis of lymphoid neoplasms according to WHO-HAEM5 (Alaggio R. et al. doi:10.1038\u002Fs41375-022-01620-2);\n2. Disease Assessment:\n\n   1. Criteria for Relapsed\u002FRefractory lymphoid neoplasms: Meeting any one of the following three conditions: ① Failure to achieve at least a partial response (PR) per Lugano criteria after two cycles of standard first-line therapy; ② Disease progression within six months after achieving a response to first-line therapy, or progression after six months with no response to the original first-line or second-line regimen; ③ Relapse after hematopoietic stem cell transplantation.\n   2. Criteria for EBV Infection: Meeting any one of the following three conditions: ① Peripheral blood (plasma or whole blood) EBV DNA load ≥ 10³ copies\u002Fml by quantitative PCR; ②Tumor cell GP350 positivity (≥10% of tumor cells by immunohistochemistry or flow cytometry); ③ Serological detection of EBV antibodies indicating any of the following: positive anti-VCA-IgM; positive anti-EA-IgG; or simultaneous positivity for anti-VCA-IgM, anti-VCA-IgG, and anti-EBNA-IgG.\n   3. At least one evaluable lymphoma lesion according to Lugano criteria, or confirmed active lytic EBV infection.\n3. Performance Status: ECOG score 0-2 and expected survival ≥3 months;\n4. Age: 18-70 years, regardless of sex;\n5. Hematologic Criteria:\n\n   * Absolute neutrophil count (ANC) ≥1.0×10⁹\u002FL;\n   * Hemoglobin \\>60 g\u002FL;\n   * CD3+ T-cell count \\>0.5×10⁹\u002FL;\n   * Platelet count \\>30×10⁹\u002FL;\n6. Organ Function:\n\n   * Creatinine clearance ≥60 mL\u002Fmin;\n   * ALT\u002FAST ≤2× upper limit of normal (ULN);\n   * Total bilirubin ≤2× ULN;\n   * Left ventricular ejection fraction (LVEF) ≥50%, no pericardial effusion, and no clinically significant ECG abnormalities;\n   * Minimal or no pleural\u002Fascitic fluid;\n   * Oxygen saturation ≥95%;\n7. Contraception:\n\n   * Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception until the last follow-up;\n   * Male participants with fertile partners must agree to use effective contraception until the last follow-up;\n8. Informed Consent: Psychologically stable, capable of understanding the study's purpose and procedures, willing to participate voluntarily, and able to provide signed informed consent and comply with protocol requirements.\n\nExclusion Criteria:\n\n1. Active Infections: Presence of active hepatitis A, B, or C infection, or other uncontrolled severe active infections (excluding EBV infection);\n2. Immunosuppression:\n\n   * History of acquired immunodeficiency syndrome (AIDS);\n   * Chronic use of immunosuppressants (including corticosteroids at doses equivalent to \\>15 mg\u002Fday of prednisone) for other conditions;\n3. Cardiac Dysfunction:\n\n   1. NYHA Class III or IV congestive heart failure;\n   2. Myocardial infarction or coronary artery bypass grafting within the past 6 months;\n   3. Clinically significant ventricular arrhythmia or unexplained syncope;\n   4. History of severe non-ischemic cardiomyopathy;\n   5. Cardiac insufficiency (left ventricular ejection fraction \\\u003C45%) within 8 weeks prior to apheresis;\n4. Pregnancy\u002FContraception:\n\n   * Pregnant or lactating women;\n   * Participants (male or female) unwilling to use contraception;\n5. Hepatic\u002FRenal Impairment:\n\n   * AST\u002FALT \\>3× upper limit of normal (ULN);\n   * Total bilirubin \\>3× ULN;\n   * Creatinine clearance \\\u003C60 mL\u002Fmin;\n6. Allergies: History of severe hypersensitivity to any study drugs;\n7. Prior Stem Cell Transplant: Must have discontinued immunosuppressants for \\>6 weeks post-transplant with no signs of graft-versus-host disease (GVHD);\n8. Other Exclusionary Conditions: Any other condition deemed unsuitable by the investigator (e.g., coagulation disorders, hemolytic anemia, etc.).","ALL","18 Years","70 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This is a Phase 1\u002FPhase 2 open-label, single-arm clinical study of GP350 CAR-T for Relapse\u002FRefractory and Epstein-Barr virus infection associated lymphoid neoplasms.\n\nEach participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy, and an intravenous infusion of CAR-T cells.\n\nEach participant will proceed through the following study procedures:\n\n* Screening\n* Enrollment\u002FLeukapheresis\n* Conditioning chemotherapy\n* CAR T treatment\n* Post-treatment assessment\n* Long-term follow-up",[29],"EBV Associated Lymphoid Neoplasms",[31,32,33,34,35],"LAHS","EBV","Lymphoma","Lymphoid neoplasms","CAR-T","RECRUITING","2025-12-24",{"date":39,"type":40},"2025-12-29","ACTUAL",{"date":42,"type":40},"2025-11-10",{"date":44,"type":22},"2032-11-20",{"name":46,"class":47},"Zhimin Zhai","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":48},"100565426","early-phase-1-ex02-car-t-cells-for-relapsed-and-refractory-acute-myeloid-leukemia-100565426","NCT06642025","EX02 CAR-T Cells for Relapsed and Refractory Acute Myeloid Leukemia","An Open-label, Single-arm Clinical Study of EX02 CAR-T Therapy for Relapsed and Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. According to the Chinese Adult Acute Myeloid Leukemia (AML) Diagnosis and Treatment Guidelines (2023 edition\u002Fprevious edition), patients diagnosed with acute myeloid leukemia (AML) and meeting the diagnostic criteria for refractory AML are eligible, including: initial treatment cases with no response after two courses of standard therapy; relapse within 12 months after achieving complete remission (CR) and failure of consolidation therapy; relapse after 12 months with no response to conventional chemotherapy; two or more relapses; and presence of extramedullary leukemia.\n2. Peripheral blood, bone marrow, or extramedullary lesion specimens showing leukemia cells with positive surface expression of EX02;\n3. ECOG performance status score of 0-2;\n4. Age ≥18 and ≤70 years, any gender;\n5. Blood cell examination meeting the following conditions: hemoglobin \\> 60g\u002FL, normal T lymphocyte count (CD3+) \\> 0.5×10\\^9\u002FL, platelet count \\> 30×10\\^9\u002FL;\n6. Negative pregnancy test for women of childbearing potential before the start of the trial, and agreement to use effective contraception measures during the trial until the final follow-up; male participants of reproductive potential agreeing to use effective contraception measures during the trial until the final follow-up;\n7. Voluntary participation in this clinical study: after fully understanding the study content, voluntary signing of the informed consent form, and commitment to complete all trial procedures and activities.\n\nExclusion Criteria:\n\n1. Active hepatitis A, B, C, HIV infection, or other severe active infections that are not yet controlled;\n2. History of acquired immune deficiency syndrome (AIDS) or long-term use of immunosuppressants due to other diseases (including steroids, equivalent to prednisone \\>15mg\u002Fday);\n3. Conditions of the heart function: a. New York Heart Association (NYHA) class III or IV heart failure; b. Myocardial infarction or coronary artery bypass surgery within the six months prior to enrollment; c. Clinically significant ventricular arrhythmia or unexplained syncope; d. History of severe non-ischemic cardiomyopathy; e. History of cardiac dysfunction (left ventricular ejection fraction \\\u003C45%) within 8 weeks before enrollment;\n4. Pregnant or lactating women; participants (both male and female) unwilling to use contraception;\n5. Severe liver or kidney dysfunction: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels exceeding 3 times the upper limit of normal, bilirubin exceeding 3 times the upper limit of normal; serum creatinine ≥ 178 μmol\u002FL (decompensated phase);\n6. History of severe allergic reactions to any drugs planned for use in this study;\n7. Recipients of hematopoietic stem cell transplantation must have discontinued immunosuppressants for at least 6 weeks before enrollment and have no signs of graft-versus-host disease;\n8. Other conditions deemed unsuitable for participation in this trial by the investigator.",{"count":57,"type":22},9,[59],"EARLY_PHASE1","This is a early Phase 1 open-label, single-arm clinical study of EX02 CAR-T therapy for relapsed and refractory acute myeloid leukemia.\n\nEach participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy of cyclophosphamide and fludarabine, and an an intravenous infusion of CAR-T cells.\n\nEach participant will proceed through the following study procedures:\n\n* Screening\n* Enrollment\u002FLeukapheresis\n* Conditioning chemotherapy\n* CAR T treatment\n* Post-treatment assessment\n* Long-term follow-up",[62,35],"Acute Myeloid Leukemia (AML)","2024-10-13",{"date":65,"type":40},"2024-10-15",{"date":67,"type":40},"2024-09-01",{"date":69,"type":22},"2029-09-01",{"name":46,"class":47},""]