[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616480":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":28,"studyPopulation":28,"armGroups":35,"interventions":41,"overallOfficials":28,"centralContacts":47,"locations":53,"responsibleParty":70,"collaborators":74,"id":78,"slug":28,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":28,"studyType":91,"phases":92,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":56,"whyStopped":28,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"The Second Hospital of Anhui Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":28},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Overall Response Rate (ORR)","The percentage of patients with complete response (CR) and partial response (PR) according to the RECIL 2017 criteria determined by the study investigators","Month 12 post CAR-T infusion",{"measure":14,"description":15,"timeFrame":12},"EBV DNA clearance rate","Defined as the proportion of patients achieving two consecutive negative tests in plasma or whole blood at least 7 days apart following treatment, relative to the total treated population",{"measure":17,"description":18,"timeFrame":19},"Treatment Emergent Adverse Event (TEAE)","TEAE is defined as an adverse event that occurs or worsens after receiving the first dose of the trial drug","Within 3 months post-infusion",[21,25],{"measure":22,"description":23,"timeFrame":24},"Progression-Free Survival (PFS)","PFS is defined as the time from the GP350 CAR-T infusion date to the date of disease progression","1 yesr post CAR-T infusion",{"measure":26,"description":27,"timeFrame":24},"Overall Survival (OS)","OS is the time from date of GP350 CAR-T infusion to the date of death due to any reason",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"NA","SINGLE_GROUP","TREATMENT",{"masking":34,"maskingDescription":28,"whoMasked":28},"NONE",[36],{"label":37,"type":38,"description":28,"interventionNames":39},"CAR-T Treatment","EXPERIMENTAL",[40],"Biological: GP350 CAR-T",[42],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":28},"BIOLOGICAL","GP350 CAR-T","Lymphodepletion chemotherapy with fludarabine (25 mg\u002Fm²\u002Fday) and cyclophosphamide (250 mg\u002Fm²\u002Fday) should be administered for 2-3 consecutive days, with the final dose completed 48 hours before infusion. Alternatively, investigators may individualize this regimen based on the subject's specific clinical circumstances.\n\nThe target dose of GP350 CAR-T cells is 1.0-5.0×10⁶ CAR-T cells per kilogram of body weight, administered via intravenous injection. (The actual infused dose is allowed to vary within ±20% from the target dose, depending on the as-released product yield)\n\nPatients with less than partial response AND without \\> Grade 2 CRS or any ICANS may receive 1 to 2 additional infusion of GP350 CAR-T cells at the same dose.",[37],[48],{"name":49,"role":50,"phone":51,"phoneExt":28,"email":52},"Zhimin Zhai, MD","CONTACT","+86-0551-63869571","zzzm889@163.com",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"The Second Affiliated Hospital of Anhui Medical University","RECRUITING","Hefei","Anhui","230031","China","CN",{"type":63,"coordinates":64},"Point",[65,66],117.28083,31.86389,{"lat":66,"lon":65},[69],{"name":49,"role":50,"phone":51,"phoneExt":28,"email":52},{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Zhimin Zhai","Chief of Hematology Department",[75],{"name":76,"class":77},"Zeno Therapeutics Pte. Ltd","UNKNOWN","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":89,"type":90},24,"ESTIMATED","INTERVENTIONAL",[93,94],"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",[97],"EBV Associated Lymphoid Neoplasms",[99,100,101,102,103],"LAHS","EBV","Lymphoma","Lymphoid neoplasms","CAR-T","2025-12-24",{"date":106,"type":107},"2025-12-29","ACTUAL",{"date":109,"type":107},"2025-11-10",{"date":111,"type":90},"2032-11-20",{"name":72,"class":6},1]