[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472855":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":11,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":11,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Shenzhen Geno-Immune Medical Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"bi-4SCAR-GD2\u002FPSMA T Cell Therapy for GD2 and PSMA positive tumor","EXPERIMENTAL",null,[13],"Biological: bi-4SCAR GD2\u002FPSMA T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","bi-4SCAR GD2\u002FPSMA T cells","Infusion of bi-4SCAR GD2\u002FPSMA T cells at 10\\^6 cells\u002Fkg body weight via IV",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Lung-Ji Chang, PhD","CONTACT","+86 0755-86573763","c@szgimi.org",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Shenzhen Geno-immune Medical Institute","RECRUITING","Shenzhen","Guangdong","518000","China","CN",{"type":36,"coordinates":37},"Point",[38,39],114.0683,22.54554,{"lat":39,"lon":38},[42],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},{"type":44,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100472855","phase-1-gd2psma-bi-specific-car-t-cell-therapy-100472855",false,"NCT05437315","GD2\u002FPSMA Bi-specific CAR-T Cell Therapy","GD2\u002FPSMA Bi-specific CAR-T Cells For the Treatment of GD2 and PSMA Positive Solid Tumors","Inclusion Criteria:\n\n1. Patients with tumors have received standard first-line therapy and have been judged to be non-resectable, metastatic, progressive or recurrent.\n2. The expression status of GD2 or PSMA antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by GD2 and PMSA antibody staining results based on immunohistochemistry or flow cytometry analyses.\n3. Body weight greater than or equal to 10 kg.\n4. Age: ≥1 year and ≤ 75 years of age at the time of enrollment.\n5. Life expectancy: at least 8 weeks.\n6. Prior Therapy:\n\n   There is no limit to the number of prior treatment regimens. Any grade 3 or 4 non-hematologic toxicity of any previous therapy must be resolved to grade 2 or less.\n7. Participant must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection.\n8. At least 7 days must have elapsed since the completion of therapy with a biologic agent, selected targeted agent or a metronomic non-myelosuppressive regimen.\n9. At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody.\n10. At least 1 week since any radiation therapy at the time of study entry.\n11. Karnofsky\u002Fjansky score of 60% or greater.\n12. Cardiac function: Left ventricular ejection fraction greater than or equal to 40\u002F55 percent.\n13. Pulse Ox greater than or equal to 90% on room air.\n14. Liver function: defined as alanine transaminase (ALT) \\\u003C3x upper limit of normal (ULN), aspartate aminotransferase (AST) \\\u003C3x ULN; serum bilirubin and alkaline phosphatase \\\u003C2x ULN.\n15. Renal function: Patients must have serum creatinine less than 3 times upper limit of normal.\n16. Marrow function: White blood cell count ≥1000\u002Ful, Absolute neutrophil count ≥500\u002Ful, Absolute lymphocyte count ≥500\u002Ful, Platelet count ≥25,000\u002Ful (not achieved by transfusion).\n17. Patients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria, and the marrow disease does not have hematologic toxicity.\n18. For all patients enrolled in this study, themselves or their parents or legal guardians must sign an informed consent and assent.\n\nExclusion Criteria:\n\n1. Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, or greater than grade 2 hematologic toxicity.\n2. Untreatable central nervous system (CNS) metastasis: Patients with previous CNS tumor involvement that has been treated and is stable for at least 6 weeks following completion of therapy are eligible.\n3. Previous treatment with other genetically engineered GD2 or PSMA-specific CAR T cells or antibody therapy.\n4. Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.\n5. Patients who require systemic corticosteroid or other immunosuppressive therapy.\n6. Evidence of tumor potentially causing airway obstruction.\n7. Inability to comply with protocol requirements.\n8. Insufficient CAR T cells availability.","ALL","1 Year","75 Years",{"count":56,"type":57},60,"ESTIMATED","INTERVENTIONAL",[60,61],"PHASE1","PHASE2","The purpose of this clinical trial is to assess the feasibility, safety and efficacy of anti-GD2\u002FPSMA bi-specific CAR-T cell therapy in patients with GD2 and PSMA positive tumor. Another goal of the study is to learn more about the function of the anti-GD2\u002FPSMA bi-specific CAR-T cells and their persistency in patients.",[64],"Solid Tumor",[66,67,68,69],"CAR-T","Solid tumor","GD2","PSMA","2026-06-18",{"date":72,"type":73},"2026-06-23","ACTUAL",{"date":75,"type":73},"2026-06-01",{"date":77,"type":57},"2030-12-31",{"name":5,"class":6},1]