[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616480":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"The Second Hospital of Anhui Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-T Treatment","EXPERIMENTAL",null,[13],"Biological: GP350 CAR-T",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"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.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Zhimin Zhai, MD","CONTACT","+86-0551-63869571","zzzm889@163.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"The Second Affiliated Hospital of Anhui Medical University","RECRUITING","Hefei","Anhui","230031","China","CN",{"type":36,"coordinates":37},"Point",[38,39],117.28083,31.86389,{"lat":39,"lon":38},[42],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Zhimin Zhai","Chief of Hematology Department",[48],{"name":49,"class":50},"Zeno Therapeutics Pte. Ltd","UNKNOWN","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":63,"type":64},24,"ESTIMATED","INTERVENTIONAL",[67,68],"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",[71],"EBV Associated Lymphoid Neoplasms",[73,74,75,76,77],"LAHS","EBV","Lymphoma","Lymphoid neoplasms","CAR-T","2025-12-24",{"date":80,"type":81},"2025-12-29","ACTUAL",{"date":83,"type":81},"2025-11-10",{"date":85,"type":64},"2032-11-20",{"name":45,"class":6},1]