[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"car-t-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:car-t-cell":114},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,38,69,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100625555","long-term-follow-up-of-subjects-treated-with-seattle-childrens-therapeutics-gene-therapy-products-100625555",false,"NCT07424157","Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products","LTFU-01","Inclusion Criteria:\n\n1. Enrolled in an SCTx GTP clinical trial;\n2. Received or planned to receive an SCTx GTP;\n3. Subject and\u002For legally authorized representative have provided consent\u002Fassent for study participation.","ALL",{"count":18,"type":19},500,"ESTIMATED","OBSERVATIONAL","Subjects exposed to gene therapy products (GTPs) may be at risk for delayed or long-term adverse events. This is a long-term follow-up (LTFU) protocol designed to evaluate the long-term safety of Seattle Children's Therapeutics (SCTx) GTPs and incorporates in monitoring guidance from the U.S. Food and Drug Administration (FDA). Subjects will be followed for up to 15 years starting from the date of the most recent infusion of an SCTx GTP. Subjects planning to receive, or who have received, at least one infusion of an SCTx GTP will be offered participation in this LTFU study. Subjects enrolled in this study will have safety assessments and laboratory evaluations performed at scheduled intervals for each unique SCTx GTP received. No treatment is administered in this LTFU study.",[23,24],"CAR T Cell","CAR T Cell Therapy","RECRUITING","2026-06-23",{"date":28,"type":29},"2026-06-25","ACTUAL",{"date":31,"type":29},"2026-06-15",{"date":33,"type":19},"2041-03-31",{"name":35,"class":36},"Seattle Children's Hospital","OTHER",1,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":16,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":37},"100580644","phase-1-cd19-directed-chimeric-antigen-receptor-autologous-t-cells-cart19-for-lupus-100580644","NCT06839976","CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus","CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Adolescents and Young Adults With Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n1. Signed informed consent form must be obtained prior to any study procedure. Labs or other procedures obtained during routine clinical care may be used for eligibility if obtained within the protocol required window.\n2. Patient age must be 12-29 years, inclusive, at time of enrollment.\n3. Meeting ACR\u002FEULAR Classification Criteria for SLE\n4. ANA positive \\> 1:80 and\u002For double-stranded DNA (dsDNA) positive\n5. Active (refractory) disease, defined as follows:\n\n   a. Lupus nephritis subjects must meet both the following criteria: i. ISN\u002FRPS active nephritis Class III\u002FIV +\u002F- V lupus nephritis diagnosed by biopsy within past 12 months.\n\nii. Persistent and clinically significant: ≥2 measurements with urine protein with either of the following:\n\n1. \\> 1mg\u002Fmg creatinine\n2. \\> 0.5 mg\u002Fmg creatinine associated with renal dysfunction or low albumin.\n3. \\> 0.5 mg\u002Fmg creatinine in a patient with rising proteinuria after prior complete renal response b. Non-renal SLE subjects must meet either of the following criteria: i. SLEDAI-2K ≥ 8 and clinical SLEDAI-2K ≥ 6 ii. Inability to decrease prednisone ≤7.5mg\u002Fday or 0.15mg\u002Fkg\u002Fday, whichever is lower, due to active disease.\n\n6\\. Patients must have had at least 3 months of cumulative conventional therapy defined as:\n\n1. Conventional induction immunosuppressive agent(s) (e.g., mycophenolate mofetil, cyclophosphamide), and\n2. At least one additional therapy:\n\ni. B-cell directed biologic therapy (e.g., rituximab, belimumab, ofatumumab, obinutuzumab) ii. Calcineurin inhibitor (e.g., tacrolimus, cyclosporine, voclosporin) iii. Other immunosuppressive medication for SLE (e.g., anifrolumab, abatacept, JAK inhibitor) 7. Adequate organ function status\n\n1. Renal: eGFR must be ≥30 and subject cannot be receiving dialysis.\n2. Hepatic: Transaminases \\\u003C 5x upper limit of normal and serum conjugated (Direct) bilirubin \\\u003C1.5x upper limit of normal unless attributable to SLE. If attributable to autoimmune disease, Child-Pugh score must be class A or class B. Child-Pugh score cannot be class C.\n3. Cardiac: Shortening fraction \\> 28%, left ventricular ejection fraction \\>45%, and no evidence of severe pulmonary hypertension\n4. Pulmonary: Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and \\\u003CGrade 3 hypoxia; DLCO ≥40% (corrected for anemia and\u002For VA volume if necessary) if PFTs are clinically appropriate as determined by the treating investigator.\n\n   8\\. Subjects of reproductive potential must agree to use acceptable birth control methods.\n\nExclusion Criteria:\n\n1. Active, untreated infections\n2. HIV infection\n3. Active Hepatitis B\n\n   a. Patients must have a negative hepatitis B surface antigen to be enrolled on this study.\n4. Active Hepatitis C\n5. Patients with severe neuropsychiatric lupus or neurologic manifestations of SLE (e.g. stroke, seizure, psychosis, demyelinating syndromes, organic brain syndrome, or lupus related headaches)\n6. Monogenic lupus (known)\n7. Previous autologous or allogenic stem cell transplant\n8. Previous kidney transplant\n9. History of seizure disorder\n10. Patients who are on anti-epileptic therapy\n11. Participation in a clinical trial in which the patient receives an investigational drug within a time period equal or less than 5.5 half-lives of the investigational agent prior to study enrollment.\n12. Subjects who are unwilling or unable to discontinue immunosuppressive medications at the times of CART19 infusion will be excluded from the trial\n13. Any comorbidity that in the opinion of the investigators would jeopardize the ability of the subject to tolerate therapy.\n14. Pregnant patients. All participants of childbearing potential must have negative pregnancy test.\n15. Lactating participants who want to continue breastfeeding.\n16. Patients who are unwilling to consent to LTFU","12 Years","29 Years",{"count":48,"type":19},24,"INTERVENTIONAL",[51,52],"PHASE1","PHASE2","This is a single-center, single-arm, open-label phase 1\u002F2 study of CART19 in children and young adults with refractory Systemic lupus erythematosus (SLE), including both patients diagnosed with lupus nephritis (LN) and patients with non-renal Systemic lupus erythematosus (SLE).\n\nPhase 1 will evaluate the safety of CART19 in 6-12 patients with Systemic lupus erythematosus (SLE). There is no planned dose escalation, but a dose de-escalation will be made based on the incidence of Dose Limiting Toxicities. Phase 2 will evaluate the efficacy and further evaluate the safety of CART19 in this population.",[55,56,23,57,58,59,60],"SLE","Systemic Lupus Erythematosus (SLE)","CART19","Cell Therapy","Lupus","Lupus Nephritis (LN)","2026-06-11",{"date":31,"type":29},{"date":64,"type":29},"2025-05-06",{"date":66,"type":19},"2030-02-28",{"name":68,"class":36},"Children's Hospital of Philadelphia",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100592027","impact-of-lymphodepletion-regimen-on-the-response-to-car-t-cells-in-patients-with-with-relapsedrefractory-large-b-cell-lymphoma-100592027","NCT06988085","Impact of Lymphodepletion Regimen on the Response to CAR T-cells in Patients With With Relapsed\u002FRefractory Large B-cell Lymphoma","Impact de la lymphodéplétion Dans la réponse Aux CAR T-cells Dans Les Lymphomes B Agressifs réfractaires ou en Rechute","CARLYM","Inclusion Criteria:\n\n* Adult patient aged 18 years and older\n* Treated with commercial CAR T-cells (Lisocabtagene maraleucel, Tisagenlecleucel, or Axicabtagene ciloleucel), with standard lymphodepletion consisting of Fludarabine and Cyclophosphamide\n* Presenting with aggressive large B-cell lymphoma that is refractory or has relapsed after at least one line of treatment\n* Creatinine clearance \\> 50 ml\u002Fmin (Cockcroft CKD-EPI)\n\nExclusion Criteria:\n\n* Weight ≤ 50 kg\n* Out-of-specification reinfusion product\n* Individual participating in another study with an ongoing exclusion period at the time of inclusion\n* Person under guardianship or curatorship, or deprived of liberty by judicial or administrative decision\n* Patient's opposition to the study","18 Years",{"count":79,"type":19},42,"CAR T cells therapy has transformed the prognostic of relapsed\u002Frefractory large B cells lymphomas. Relapse however is still high and multiple causes have been studied. CAR expansion seems to be necessary to for response and lymphodepletion type and exposure, notably to fludarabine, associated with expansion and response.\n\nThe aim of the study is to analyse prospectivaly Fludarabine and cyclophosphamide exposure and correlate exposure to expansion, therapeutic response and survival.",[82,23],"Large B Cell Lymphoma",[84,85,86,87],"Large B cell lymphoma","CAR T cell","Lymphodepletion","Fludarabine exposure","NOT_YET_RECRUITING","2025-05-16",{"date":91,"type":29},"2025-05-23",{"date":93,"type":19},"2025-05-30",{"date":95,"type":19},"2027-05-30",{"name":97,"class":36},"Assistance Publique - Hôpitaux de Paris",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":49,"phases":108,"briefSummary":109,"conditions":110,"keywords":115,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100300975","phase-1-gpc3mesothelinclaudin182gucy2cb7-h3pscapsmamuc1tgfher2lewis-yaxlegfr-car-t-cells-against-cancers-100300975","NCT03198052","GPC3\u002FMesothelin\u002FClaudin18.2\u002FGUCY2C\u002FB7-H3\u002FPSCA\u002FPSMA\u002FMUC1\u002FTGFβ\u002FHER2\u002FLewis-Y\u002FAXL\u002FEGFR-CAR-T Cells Against Cancers","CAR-T Targeting GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR for Immunotherapy of Lung Cancer: Phase I Clinical Trial","Inclusion Criteria:\n\n1\\. Patients with advanced cancer that expresses GPC3\u002FMesothelin\u002FClaudin18.2\u002FGUCY2C\u002FB7-H3\u002FPSCA\u002FPSMA\u002FMUC1\u002FTGFβ\u002FHER2\u002FLewis-Y\u002FAXL\u002FEGFR protein; 2. Life expectancy \\>12 weeks; 3. Adequate heart,lung,liver,kidney function; 4. Available autologous transduced T cells with greater than or equal to 20% expression ofGPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR-CAR determined by flow-cytometry and killing of GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR-positive targets greater than or equal to 20% in cytotoxicity assay; 5. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n\n\\-\n\nExclusion Criteria:\n\n1. Had accepted gene therapy before;\n2. Severe virus infection such as HBV,HCV,HIV,et al;\n3. Known HIV positivity;\n4. Active infectious disease related to bacteria, virus,fungi,et al;\n5. Other severe diseases that the investigators consider not appropriate;\n6. Pregnant or lactating women;\n7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent\u002Fkg\u002Fday);\n8. Other conditions that the investigators consider not appropriate. -","75 Years",{"count":107,"type":19},30,[51],"The third generation of CAR-T cells that target GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR have been constructed respectively and their anti-cancer function has been verified by multiple in vitro and in vivo studies.Clinical studies will be performed to test the anti-cancer function of the these individual or combination of the CAR-T cells for immunotherapy of human cancer patients with GPC3, Mesothelin, Claudin18.2, GUCY2C, B7-H3, PSCA, PSMA, MUC1, TGFβ, HER2, Lewis-Y, AXL, or EGFR expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3\u002FMesothelin\u002FClaudin18.2\u002FGUCY2C\u002FB7-H3\u002FPSCA\u002FPSMA\u002FMUC1\u002FTGFβ\u002FHER2\u002FLewis-Y\u002FAXL\u002FEGFR\n\n-CAR-T cell immunotherapy on human cancers will firstly be tested.",[111,112,113,114],"Lung Cancer","Cancer","Immunotherapy","CAR-T Cell",[111,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134],"CAR-T Cell Therapy","PSCA","MUC1","HER2","Mesothelin","Lewis-Y","GPC3","AXL","EGFR","B7-H3","Claudin18.2","TGFβ","DAP10","HPK1","PD1","CTLA4","Tigit","Knockdown","SCFV","2024-06-22",{"date":137,"type":29},"2024-06-25",{"date":139,"type":29},"2017-07-01",{"date":141,"type":19},"2036-08-01",{"name":143,"class":36},"Second Affiliated Hospital of Guangzhou Medical University",2]