[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen Geno-Immune Medical Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":531},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,63,0,25,[9,46,75,97,118,141,164,186,204,223,240,261,278,296,312,330,349,367,389,413,436,451,472,492,512],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100549583","phase-1-engineered-dendritic-cell-vaccines-for-multiple-myeloma-100549583",false,"NCT06435910","Engineered Dendritic Cell Vaccines for Multiple Myeloma","Engineered Dendritic Cell Vaccines for Remission Maintenance in Multiple Myeloma Patients","Inclusion Criteria:\n\n* Male and female subjects with multiple myeloma or plasmacytoma\n* Very good partial or complete remission (CR) after prior combination therapies.\n* Expected survival \\> 12 weeks\n* Adequate venous access for blood withdrawal or apheresis, and no other contraindications for blood withdrawal\n* Voluntary informed consent is given with willingness to continue follow up\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Uncontrolled active infection\n* HIV or active hepatitis B or hepatitis C infection\n* Concurrent use of systemic steroids; the use of inhaled steroids is not exclusionary","ALL","18 Years","80 Years",{"count":21,"type":22},10,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this study is to determine the feasibility, safety, and efficacy of dendritic cell (DC) vaccines in the treatment of multiple myeloma (MM) or plasmacytoma based on immune-modified DC vaccines (DCvac). This approach is aimed to achieve prolonged maintenance of remission in multiple myeloma or plasmacytoma patients.",[28],"Multiple Myeloma or Plasmacytoma",[30,31,32],"MM","CAR T","DC vaccine","RECRUITING","2026-06-18",{"date":36,"type":37},"2026-06-23","ACTUAL",{"date":39,"type":37},"2024-05-11",{"date":41,"type":22},"2027-12-31",{"name":43,"class":44},"Shenzhen Geno-Immune Medical Institute","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":74,"locationsCount":45},"100549582","phase-1-autoimmune-disease-treatment-with-mesenchymal-stem-cells-mscs-and-car-t-cells-100549582","NCT06435897","Autoimmune Disease Treatment With Mesenchymal Stem Cells (MSCs) and CAR-T Cells","Management of Autoimmune Conditions With Mesenchymal Stem Cells (MSCs) and CAR-T Cells","Inclusion Criteria:\n\n1. older than 18 years of age.\n2. established autoimmune conditions.\n3. the KPS score over 80 points, and survival time is more than 3 months.\n4. greater than Hgb 80 g\u002FL.\n5. no contraindications to blood cell collection.\n\nExclusion Criteria:\n\n1. accompanied with other active diseases and difficult to assess treatment response.\n2. bacterial, fungal, or viral infection, unable to control.\n3. living with HIV.\n4. active HBV or HCV infection.\n5. pregnant and nursing mothers.\n6. under systemic steroid treatment within a week of the treatment.\n7. prior failed CAR-T treatment.","75 Years",{"count":55,"type":22},30,[25,57],"PHASE2","The purpose of this study is to assess the feasibility, safety and efficacy of mesenchymal stem cells (MSCs) in combination with CAR-T cells in treating autoimmune disease. Another goal of the study is to learn more about the safety and function of the MSCs combined with CAR-T cells and their long term effects in autoimmune disease patients.",[60],"Autoimmune Diseases",[62,63,64,65,66,67,68,69],"CAR-T","MSC","autoimmune disease","autoantibody","B cell","plasma cell","CD19","BCMA",{"date":36,"type":37},{"date":72,"type":37},"2024-05-15",{"date":41,"type":22},{"name":43,"class":44},{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":96,"locationsCount":45},"100549064","phase-1-frontline-combination-car-t-cell-therapy-for-multiple-myeloma-or-plasmacytoma-100549064","NCT06429150","Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma","Frontline Management of High-Risk Multiple Myeloma or Plasmacytoma With BCMA and GPRC5D Combination CAR-T Cell Therapy","Inclusion Criteria:\n\n* Male and female subjects with multiple myeloma or plasmacytoma\n* Strictly complete remission (sCR) is a treatment goal\n* Expected survival \\> 12 weeks\n* After prior auto-SCT is eligible regardless of other prior therapies\n* Adequate venous access for apheresis, and no other contraindications for leukapheresis\n* Voluntary informed consent is given and commitment to continued follow-up\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Uncontrolled active infection\n* Active HIV, hepatitis B or hepatitis C infection\n* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.\n* Any medical conditions that may preclude participation",{"count":83,"type":22},20,[25,57],"The aim of this clinical trial is to assess the feasibility, safety, and efficacy of CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma or plasmacytoma as part of a frontline treatment regimen for patients. Another goal of the study is to learn more about the persistence and function of these CAR-T cells in the body.",[87,88],"Multiple Myeloma","Plasmacytoma",[90,91,69,92],"multiple myeloma","chimeric antigen receptor","GPRC5D",{"date":36,"type":37},{"date":39,"type":37},{"date":41,"type":22},{"name":43,"class":44},{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":45},"100516609","phase-1-universal-car-t-cells-targeting-multiple-myeloma-100516609","NCT06006741","Universal CAR-T Cells Targeting Multiple Myeloma","Universal CAR-T Cells for the Treatment of Multiple Myeloma","Inclusion Criteria:\n\n1. Patients with confirmed multiple myeloma failed curative treatment options (including autologous or allogeneic SCT).\n2. Complete remission (CR) cannot be achieved after at least 2 prior therapy regimens.\n3. High risk MM in CR1 or CR2 and not eligible for SCT because of age or comorbid diseases.\n4. Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \\\u003C 1 year).\n5. Relapsed after prior autologous or allogenic SCT with residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.\n6. Residual disease after primary therapy and not eligible for ASCT\n7. Expected survival \\> 12 weeks• Creatinine \\\u003C 2.5 mg\u002Fdl• ALT (alanine aminotransferase)\u002FAST (aspartate aminotransferase) \\\u003C 3x normal\n8. Bilirubin \\\u003C 2.0 mg\u002Fdl\n9. Any relapse after prior SCT is eligible regardless of other prior therapy\n10. Adequate venous access for apheresis, and no other contraindications for leukapheresis\n11. Voluntary informed consent is signed\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Uncontrolled active infection\n3. Active hepatitis B or hepatitis C infection\n4. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.\n5. Previous related CAR-T cell therapy\n6. Any uncontrolled active medical disorder that would preclude participation\n7. HIV infection",{"count":83,"type":22},[25],"The aim of this study is to assess the feasibility, safety and efficacy of universal CAR T cells targeting multiple myeloma. Another goal of the study is to learn more about the persistence and function of the universal CAR T cells in the body.",[108],"Multiple Myeloma in Remission",[110,111],"Universal CART","multiple myelomachimeric antigen BCMA CD38 CD56 CD138 CD19",{"date":36,"type":37},{"date":114,"type":37},"2023-10-31",{"date":116,"type":22},"2026-12-31",{"name":43,"class":44},{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":53,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":45},"100515710","phase-1-universal-car-t-cells-targeting-aml-100515710","NCT05995041","Universal CAR-T Cells Targeting AML","Universal CAR T Cells for the Treatment of Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Age older than 6 months.\n2. Confirmed expression of CLL-1, CD123, CD38 and\u002For CD33 in AML blasts by immuno-histochemical staining or flow cytometry.\n3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \\> 3 months.\n4. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg\u002FdL.\n5. Hgb≥80g\u002FL.\n6. No cell separation contraindications.\n7. Abilities to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.\n2. Active bacterial, fungal or viral infection not controlled by adequate treatment.\n3. Known HIV or active hepatitis C virus (HCV) infection.\n4. Pregnant or nursing women may not participate.\n5. Use of glucocorticoid for systemic therapy within one week prior to entering the trial.\n6. Previous treatment with any gene therapy products.\n7. The bone marrow AML burden (MRD) is above 50%.\n8. Patients, in the opinion of investigators, may not be able to comply with the study.","6 Months",{"count":55,"type":22},[25],"The purpose of this clinical trial is to assess the feasibility, safety and efficacy of universal CAR T-cell products targeting CLL-1, CD33, CD38 and CD123 in patients with relapsed and refractory AML. The study also aims to learn more about the function of the universal CAR T cells and their persistency in AML patients.",[130],"Acute Myeloid Leukemia",[132,133,134],"AML","Universal CAR T","CD33, CD123, CD38, CLL-1",{"date":36,"type":37},{"date":137,"type":37},"2026-06-01",{"date":139,"type":22},"2030-12-31",{"name":43,"class":44},{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":53,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":150,"conditions":151,"keywords":155,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":162,"leadSponsor":163,"locationsCount":45},"100515709","phase-1-universal-4scar7u-targeting-cd7-positive-malignancies-100515709","NCT05995028","Universal 4SCAR7U Targeting CD7-positive Malignancies","Safety and Efficacy of Universal 4SCAR7U T Cell Therapy Targeting CD7-positive Hematological Malignancies","Inclusion Criteria:\n\n1. Age older than 6 months.\n2. Confirmed expression of CD7 and additional surface antigens in the cancer cells by immuno-histochemical staining or flow cytometry.\n3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \\> 3 months.\n4. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg\u002FdL.\n5. Hgb≥80g\u002FL.\n6. No cell separation contraindications.\n7. Abilities to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.\n2. Active bacterial, fungal or viral infection not controlled by adequate treatment.\n3. Known HIV or hepatitis C virus (HCV) infection.\n4. Pregnant or nursing women may not participate.\n5. Use of glucocorticoid for systemic therapy within one week prior to entering the trial.\n6. Previous treatment with any gene therapy products.\n7. Patients, in the opinion of investigators, may not be able to comply with the study.",{"count":55,"type":22},[25],"The purpose of this clinical trial is to assess the feasibility, safety and efficacy of universal CAR T cells based on 4SCAR7U design against CD7-positive hematological malignancies using CD7 specific universal CAR T cells. The study also aims to learn more about the function of CD7 targeting CAR T cells and their persistence in patients of hematological malignancies.",[152,153,130,154],"T-cell Acute Lymphoblastic Leukemia","T-cell Acute Lymphoblastic Lymphoma","NK Cell Lymphoma",[156,157,132,158,133,159],"T-ALL","TCL","NK lymphoma","CD7",{"date":36,"type":37},{"date":114,"type":37},{"date":116,"type":22},{"name":43,"class":44},{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":53,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":184,"leadSponsor":185,"locationsCount":45},"100515708","phase-1-4scar19u-t-cells-targeting-b-cell-malignancies-100515708","NCT05995015","4SCAR19U T Cells Targeting B Cell Malignancies","Universal 4SCAR19U T Cell Therapy for the Treatment of Relapsed and Refractory B Cell Malignancies","Inclusion Criteria:\n\n1. Age older than 6 months.\n2. Primary B cell surface expression of CD19.\n3. The KPS score over 80 points, and survival time is more than 1 month.\n4. Greater than Hgb 80 g\u002FL.\n5. No contraindications to blood cell collection.\n\nExclusion Criteria:\n\n1. Accompanied with other active diseases, and difficult to assess response after treatment.\n2. Bacterial, fungal, or viral infection, unable to control.\n3. Living with HIV.\n4. Active HBV or HCV infection.\n5. Pregnant and nursing mothers.\n6. under systemic steroid treatment within a week of the treatment.\n7. Prior failed CAR-T treatment.",{"count":55,"type":22},[25],"The purpose of this study is to assess the feasibility, safety and efficacy of universal CAR T cell therapy against CD19-positive hematological malignancies using a novel CD19-specific CAR T cell product, 4SCAR19U T cells. The study also aims to learn more about the function of the 4SCAR19U T cells and their persistence in patients. This is a phase I trial enrolling patients from multiple clinical centers.",[175],"B Cell Malignancies",[177,178,179,180,181],"Universal CAR-T","CD19 B-ALL","PMBCL","CNS-BCL","BCL",{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":193,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":197,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":202,"leadSponsor":203,"locationsCount":45},"100474589","phase-1-car-t-cells-targeting-autoimmune-diseases-100474589","NCT05459870","CAR-T Cells Targeting Autoimmune Diseases","CAR-T Cells Targeting B Cell Related Autoimmune Diseases","Inclusion Criteria:\n\n1. age older than 18 years.\n2. expression of B cell surface molecules.\n3. the KPS score over 80 points, and survival time is more than 3 months.\n4. greater than Hgb 80 g\u002FL.\n5. no contraindications to blood cell collection.\n\nExclusion Criteria:\n\n1. accompanied with other active diseases and difficult to assess treatment response.\n2. bacterial, fungal, or viral infection, unable to control.\n3. living with HIV.\n4. active HBV or HCV infection.\n5. pregnant and nursing mothers.\n6. under systemic steroid treatment within a week of the treatment.\n7. prior failed CAR-T treatment.",{"count":55,"type":22},[25,57],"The purpose of this study is to assess the feasibility, safety and efficacy of CAR-T cell therapy in patients with autoimmune disease. Another goal of the study is to learn more about the safety and function of the CAR-T cells and their persistency in autoimmune disease patients.",[60],[62,64,65,68,69,198,199],"CD138","BAFF-R",{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":53,"enrollmentInfo":211,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":214,"conditions":215,"keywords":216,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":221,"leadSponsor":222,"locationsCount":45},"100472793","phase-1-cd1979b-bi-specific-car-t-cell-therapy-100472793","NCT05436509","CD19\u002F79b Bi-specific CAR-T Cell Therapy","CD19\u002F79b Bi-specific CAR-T Cells Targeting B Cell Malignancies","Inclusion Criteria:\n\n1. age older than 6 months.\n2. malignant B cell surface expression of CD19 or CD79b molecules.\n3. the KPS score over 80 points, and survival time is more than 1 month.\n4. greater than Hgb 80 g\u002FL.\n5. no contraindications to blood cell collection.\n\nExclusion Criteria:\n\n1. accompanied with other active diseases and difficult to assess patient response.\n2. bacterial, fungal, or viral infection, unable to control.\n3. living with HIV.\n4. active HBV or HCV infection.\n5. pregnant and nursing mothers.\n6. under systemic steroid treatment within a week of the treatment.\n7. prior failed CD19 and CD79b CAR-T treatment.",{"count":212,"type":22},60,[25,57],"The purpose of this study is to assess the feasibility, safety and efficacy of CD19\u002F79b bi-specific CAR-T cell therapy in patients with CD19 and\u002For CD79b positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19\u002F79b bi-specific CAR-T cells and their persistency in patients.",[175],[62,217,68,218],"B cell Malignancies","CD79b",{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":53,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":231,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":238,"leadSponsor":239,"locationsCount":45},"100472515","phase-1-cd1922-bi-specific-car-t-cell-therapy-100472515","NCT05432882","CD19\u002F22 Bi-specific CAR-T Cell Therapy","CD19\u002F22 Bi-specific CAR-T Cells Targeting B Cell Malignancies","Inclusion Criteria:\n\n1. age older than 6 months.\n2. malignant B cell surface expression of CD19 or CD22 molecules.\n3. the KPS score over 80 points, and survival time is more than 1 month.\n4. greater than Hgb 80 g\u002FL.5. no contraindications to blood cell collection.\n\nExclusion Criteria:\n\n1. accompanied with other active diseases and difficult to assess patient response.\n2. bacterial, fungal, or viral infection, unable to control.\n3. living with HIV.4. active HBV or HCV infection.\n\n5\\. pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. prior failed CD19 and CD22 CAR-T treatment.",{"count":212,"type":22},[25,57],"The purpose of this study is to assess the feasibility, safety and efficacy of anti-CD19\u002F22 bi-specific CAR-T cell therapy in patients with CD19 and\u002For CD22 positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19\u002F22 bi-specific CAR-T cells and their persistency in patients.",[175],[62,217,68,235],"CD22",{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":17,"minAge":247,"maxAge":53,"enrollmentInfo":248,"targetDuration":4,"studyType":23,"phases":249,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":259,"leadSponsor":260,"locationsCount":45},"100472936","phase-1-gd2cd70-bi-specific-car-t-cell-therapy-100472936","NCT05438368","GD2\u002FCD70 Bi-specific CAR-T Cell Therapy","GD2\u002FCD70 Bi-specific CAR-T Cells for Cancer Treatment","Inclusion Criteria:\n\n1. Patients with tumors received standard first-line therapy and judged to be non-resectable, metastatic, progressive or recurrent.\n2. The expression status of GD2 or CD70 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 CD70-specific CAR T cells.\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.","1 Year",{"count":55,"type":22},[25,57],"The purpose of this study is to assess the feasibility, safety and efficacy of GD2\u002FCD70 bi-specific CAR-T cell therapy in patients with GD2 and\u002For CD70 positive tumor. Another goal of the study is to learn more about the function of the GD2\u002FCD70 bi-specific CAR-T cells and their persistency in patients.",[252],"Cancer Disease",[62,254,255,256],"cancer","GD2","CD70",{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":17,"minAge":247,"maxAge":53,"enrollmentInfo":268,"targetDuration":4,"studyType":23,"phases":269,"briefSummary":270,"conditions":271,"keywords":272,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":276,"leadSponsor":277,"locationsCount":45},"100472857","phase-1-psmacd70-bi-specific-car-t-cell-therapy-100472857","NCT05437341","PSMA\u002FCD70 Bi-specific CAR-T Cell Therapy","PSMA\u002FCD70 Bi-specific CAR-T Cells for Cancer Treatment","Inclusion Criteria:\n\n1. Patients with tumor cells have received standard first-line therapy and have been judged to be non-resectable, metastatic, progressive or recurrent.\n2. The expression status of CD70 or PSMA antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by CD70 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 enrollment 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 4 weeks following completion of therapy are eligible.\n3. Previous treatment with other genetically engineered CD70 or PSMA-specific CAR T cells.\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.",{"count":212,"type":22},[25,57],"The purpose of this study is to assess the feasibility, safety and efficacy of anti-PSMA\u002FCD70 bi-specific CAR-T cell therapy in patients with CD70 and PSMA positive malignancies. Another goal of the study is to learn more about the function of the PSMA\u002FCD70 bi-specific CAR-T cells and their persistency in patients.",[252],[62,254,256,273],"PSMA",{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":247,"maxAge":53,"enrollmentInfo":285,"targetDuration":4,"studyType":23,"phases":286,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":294,"leadSponsor":295,"locationsCount":45},"100472856","phase-1-gd2cd56-bi-specific-car-t-cell-therapy-100472856","NCT05437328","GD2\u002FCD56 Bi-specific CAR-T Cell Therapy","GD2\u002FCD56 Bi-specific CAR-T Cells for Cancer Treatment","Inclusion Criteria:\n\n1. Patients with tumors received standard first-line therapy and have been judged to be non-resectable, metastatic, progressive or recurrent.\n2. The expression status of GD2 or CD56 antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by GD2 and CD56 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 CD56-specific CAR T cells.\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.",{"count":212,"type":22},[25,57],"The purpose of this clinical trial is to assess the feasibility, safety and efficacy of anti-GD2\u002FCD56 bi-specific CAR-T cell therapy in patients with GD2 and\u002For CD56 positive cancer. Another goal of the study is to learn more about the function of the anti-GD2\u002FCD56 bi-specific CAR-T cells and their persistency in patients.",[289],"Malignant Disease",[62,254,255,291],"CD56",{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":53,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":304,"briefSummary":305,"conditions":306,"keywords":307,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":310,"leadSponsor":311,"locationsCount":45},"100472792","phase-1-cd1970-bi-specific-car-t-cell-therapy-100472792","NCT05436496","CD19\u002F70 Bi-specific CAR-T Cell Therapy","CD19\u002F70 Bi-specific CAR-T Cells Targeting B Cell Malignancies","Inclusion Criteria:\n\n1. age older than 6 months.\n2. malignant B cell surface expression of CD19 or CD70 molecules.\n3. the KPS score over 80 points, and survival time is more than 1 month.\n4. greater than Hgb 80 g\u002FL.\n5. no contraindications to blood cell collection.\n\nExclusion Criteria:\n\n1. accompanied with other active diseases and difficult to assess patient response.\n2. bacterial, fungal, or viral infection, unable to control.\n3. living with HIV.\n4. active HBV or HCV infection.\n5. pregnant and nursing mothers.\n6. under systemic steroid treatment within a week of the treatment.\n7. prior failed CD19 and CD70 CAR-T treatment.",{"count":55,"type":22},[25,57],"The purpose of this study is to assess the feasibility, safety and efficacy of CD19\u002F70 bi-specific CAR-T cell therapy in patients with CD19 and\u002For CD70 positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19\u002F70 bi-specific CAR-T cells and their persistency in patients.",[175],[62,217,68,256],{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":17,"minAge":247,"maxAge":53,"enrollmentInfo":319,"targetDuration":4,"studyType":23,"phases":320,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":328,"leadSponsor":329,"locationsCount":45},"100472855","phase-1-gd2psma-bi-specific-car-t-cell-therapy-100472855","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.",{"count":212,"type":22},[25,57],"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.",[323],"Solid Tumor",[62,325,255,273],"Solid tumor",{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":343,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":347,"leadSponsor":348,"locationsCount":45},"100460601","phase-1-ngs-mrd-assessment-of-combination-immunotherapies-targeting-t-all-100460601","NCT05277753","NGS-MRD Assessment of Combination Immunotherapies Targeting T-ALL","NGS-MRD Evaluation of Antigen-specific T Cells and DC Vaccine Combination Targeting T-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Age older than 6 months.\n2. High-burden (≥ 30% blast cells) bone marrow sample for NGS TCR clonal identification and CTL\u002FDC vac preparation is required\n3. Expression of CD7, CD5, CD317, CD47, CD99, CD38 or TRBC1\u002F2 is determined in malignant cells by flow cytometry or immuno-histochemical staining.\n4. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \\> 3 months.\n5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5x upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x upper limit of normal, total bilirubin ≤ 2.0 mg\u002FdL.\n6. Hgb ≥ 80g\u002FL.\n7. No cell separation contraindications.\n8. Abilities to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.\n2. Active bacterial, fungal or viral infection not controlled by adequate treatment.\n3. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n4. Pregnant or nursing women may not participate.\n5. History of glucocorticoid for systemic therapy within the week prior to entering the test.\n6. Previous treatment with any gene therapy products.\n7. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.","65 Years",{"count":21,"type":22},[25],"The purpose of this study is to determine the feasibility, safety, and efficacy of a combination therapy in the treatment of T-cell acute lymphoblastic leukemia (T-ALL): multi-antigen-targeted chimeric antigen receptor T cells (CAR-T) followed by engineered immune effector cytotoxic T cells (CTLs) and immune modified dendritic cell vaccine (DCvac). This approach is aimed to achieve NGS MRD negativity in T-ALL patients, which can identify a very low risk of relapse and define patients with possible long-term remission without further treatment.",[342],"T-Cell Acute Lymphoblastic Leukemia",[156,31,344,32],"CTL",{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":337,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":357,"briefSummary":358,"conditions":359,"keywords":361,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":365,"leadSponsor":366,"locationsCount":45},"100459442","phase-1-ngs-mrd-assessment-of-combination-immunotherapies-targeting-b-all-100459442","NCT05262673","NGS-MRD Assessment of Combination Immunotherapies Targeting B-ALL","NGS-MRD Evaluation of Antigen-specific T Cells and DC Vaccine Combination Targeting B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Age older than 6 months.\n2. High-burden (≥30% blast cells) B-ALL tumor specimen for clonal IgH identification and CTL\u002FDC vac preparation is required\n3. Expression of CD19, CD22, CD20, CD10 or CD123 is determined in malignant cells by flow cytometry or immuno-histochemical staining.\n4. Karnofsky performance status (KPS) score is higher than 60 and life expectancy \\> 3 months.\n5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5x upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x upper limit of normal, total bilirubin ≤ 2.0mg\u002FdL.\n6. No cell separation contraindications.\n7. Abilities to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.\n2. Active bacterial, fungal or viral infection not controlled by adequate treatment.\n3. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n4. Pregnant or nursing women may not participate.\n5. History of glucocorticoid for systemic therapy within the week prior to entering the test.\n6. Previously treatment with any gene therapy products.\n7. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.",{"count":21,"type":22},[25],"The purpose of this study is to determine the feasibility, safety, and efficacy of a combination therapy in the treatment of B-cell acute lymphoblastic leukemia (B-ALL) based on multi-antigen-targeted chimeric antigen receptor T cells (CAR-T) followed by engineered immune effector cytotoxic T lymphocytes (CTLs) and immune-modified dendritic cell vaccine (DCvac). This approach is aimed to achieve NGS MRD negative in B-ALL patients, which can identify a very low risk of relapse and define patients with possible long-term remission without further treatment.",[360],"B-Cell Acute Lymphoblastic Leukemia",[362,31,344,32],"B-ALL",{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":247,"maxAge":337,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":376,"briefSummary":377,"conditions":378,"keywords":380,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":387,"leadSponsor":388,"locationsCount":45},"100411436","phase-1-4scar-t-therapy-targeting-gd2-psma-and-cd276-for-treating-neuroblastoma-100411436","NCT04637503","4SCAR-T Therapy Targeting GD2, PSMA and CD276 for Treating Neuroblastoma","Multi-center Phase I\u002FII Clinical Trial of 4SCAR-T Therapy Targeting GD2, PSMA and CD276 for Treating Neuroblastoma","Inclusion Criteria:\n\n* Patients with tumors have received standard first-line therapy and been judged to be non-resectable, metastatic, progressive or recurrent.\n* The expression status of GD2, PSMA and CD276 antigens of the tumor will be determined for eligibility. Positive expression is defined by GD2, PMSA and CD276 antibody staining results based on immunohistochemistry or flow cytometry analyses.\n* Body weight greater than or equal to 10 kg.\n* Age: ≥1 year and ≤ 65 years of age at the time of enrollment.\n* Life expectancy: at least 8 weeks.\n* Prior Therapy:\n\n  1. There is no limit to the number of prior treatment regimens. Any grade 3 or 4 non-hematologic toxicity of any previous therapy must have resolved to grade 2 or less.\n  2. Participant must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection.\n  3. At least 7 days must have elapsed since the completion of therapy with a biologic agent, targeted agent, tyrosine kinase inhibitor or a metronomic non-myelosuppressive regimen.\n  4. At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody.\n  5. At least 1 week since any radiation therapy at the time of study entry.\n* Karnofsky\u002Fjansky score of 60% or greater.\n* Cardiac function: Left ventricular ejection fraction greater than or equal to 40\u002F55 percent.\n* Pulse Ox greater than or equal to 90% on room air.\n* 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.\n* Renal function: Patients must have serum creatinine less than 3 times upper limit of normal.\n* 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).\n* Patients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria, and the marrow disease not evaluable for hematologic toxicity.\n* For all patients enrolled in this study, their parents or legal guardians must sign an informed consent and assent.\n\nExclusion Criteria:\n\n* Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, with the exception of grade 3 hematologic toxicity.\n* Untreated 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.\n* Previous treatment with other genetically engineered GD2, PSMA and CD276 CART cells.\n* Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.\n* Patients who require systemic corticosteroid or other immunosuppressive therapy.\n* Evidence of tumor potentially causing airway obstruction.\n* Inability to comply with protocol requirements.\n* Insufficient CART cells availability.",{"count":375,"type":22},100,[25,57],"The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multiple 4SCAR-T cell therapy which targets GD2, PSMA and CD276 surface antigens in patients with relapsed and refractory neuroblastoma (NB). Another goal of the study is to understand the function of the multi-CAR-T cells and their persistency in the patients.",[379],"Neuroblastoma",[381,91,382,383],"CART","adoptive T cell transfer","GD2, PSMA, CD276, B7-H3",{"date":385,"type":37},"2026-06-22",{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":247,"maxAge":53,"enrollmentInfo":396,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":403,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":45},"100395755","phase-1-combination-immunotherapy-targeting-sarcomas-100395755","NCT04433221","Combination Immunotherapy Targeting Sarcomas","Safety and Efficacy Evaluation of a Combination Immunotherapy Targeting Sarcomas","Inclusion Criteria:\n\n1. Stage Ⅲ，Ⅳ sarcoma patients or recurrent sarcoma patients;\n2. Age: ≥ 6 months and ≤80 years of age at the time of enrollment;\n3. At least 2 weeks since the last standard chemotherapy or radiotherapy and immunosuppressive therapy such as steroid hormone before enrollment;\n4. Side effects of chemotherapy have been well managed;\n5. Confirmed malignant cell expression of CART target antigens by IHC or flow\n6. Karnofsky \u002Fjansky score of 50% or greater;\n7. Expected survival \\> 8 weeks;\n8. ANC≥ 1×10\\^6\u002FL，PLT ≥ 1×10\\^8\u002FL;\n9. Pulse oximetry of≥90% on room air；\n10. Adequate hepatic function, defined as aspartate aminotransferase(AST)\\\u003C 5 times upper limit of normal(ULN),serum bilirubin \\\u003C 3 times ULN;\n11. Adequate renal function, defined as serum creatinine less than 2 times ULN, if serum creatinine more than 1.5 times ULN, creatinine clearance rate test is needed;\n12. Patients must have sufficient autologous CART cells at does greater than 0.5x10\\^6 cells\u002Fkg body weight;\n13. Sign an informed consent and assent.\n\nExclusion Criteria:\n\n1. The disease is progressing rapidly;\n2. The patient is receiving therapy of other new drugs and under evaluation;\n3. Evidence of tumor potentially causing airway obstruction;\n4. Epilepsy history or other CNS diseases;\n5. Patients who need immunosuppressive drugs;\n6. History of long QT syndrome or severe heart diseases;\n7. Uncontrolled active infection;\n8. Active hepatitis B virus, hepatitis C virus or HIV infection;\n9. Receiving systemic corticosteroid 2 weeks before enrollment except for inhaled steroids;\n10. Previous treatment with any gene therapy;\n11. Creatinine\\>2.5mg\u002Fdl or ALT\u002FAST\\>3 times normal or bilirubin\\>2.0 mg\u002Fdl;\n12. Patients who have other uncontrolled diseases such as obstruction of lung function would preclude participation as outlined;\n13. Pregnant or lactating women;\n14. Patients previously experienced toxicity from cyclophosphamide and doxorubicin;\n15. Patients who have CNS sarcoma;\n16. In condition that may bring risks to subjects or interference to clinical trials.",{"count":83,"type":22},[25,57],"The aim of this clinical trial is to assess the feasibility, safety and efficacy of a combination low dose chemotherapy and immunotherapy in patients who have sarcoma that is relapsed or late staged. Another goal of the study is to assess the safety and efficacy of the therapy that combines multiple CAR T cells followed by sarcoma vaccines.",[400,401,402],"Sarcoma","Osteoid Sarcoma","Ewing Sarcoma",[400,404,405,381,406],"Chemotherapy","Doxorubicin","Vaccine",{"date":36,"type":37},{"date":409,"type":22},"2026-07-01",{"date":411,"type":22},"2029-12-31",{"name":43,"class":44},{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":53,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":421,"briefSummary":422,"conditions":423,"keywords":425,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":434,"leadSponsor":435,"locationsCount":45},"100395548","phase-1-4scar-t-therapy-post-cd19-targeted-immunotherapy-100395548","NCT04430530","4SCAR-T Therapy Post CD19-targeted Immunotherapy","4SCAR-T Therapy After Anti-CD19 Immunotherapy Targeting B Cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Age older than 6 months.\n2. B cell malignancies relapsed after anti-CD19 immunotherapy.\n3. Malignant B cells expressing one or more of the following surface molecules: CD22\u002FCD123\u002FCD38\u002FCD10\u002FCD20.\n4. The KPS score over 80 points, and survival time is more than 1 month.\n5. Greater than Hgb 80 g\u002FL.\n6. No contraindications to blood cell collection.\n\nExclusion Criteria:\n\n1. Complications with other active diseases, and difficult to assess patient response.\n2. Bacterial, fungal, or viral infection unable to control.\n3. Living with HIV.\n4. Active HBV and HCV infection.\n5. Pregnant and nursing mothers.\n6. Under systemic steroid use within a week of the treatment.\n7. Judged difficult to cooporate for continued evaluation.",{"count":375,"type":22},[25,57],"This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells (4SCAR-T) targeting CD19-negative B-ALL that express alternative surface antigens such as CD22, CD10, CD20, CD38, and CD123, as many patients relapse after anti-CD19 immunotherapy. Clinical response and optiminzation of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I\u002FII trial enrolling patients from multiple clinical centers.",[424],"CD19 Negative B-cell Malignancies",[426,427,428,429,430,431],"4S CAR-T CD22","4S CAR-T CD123","4S CAR-T CD38","4S CAR-T CD10","4S CAR-T CD20","CD19 Negative B cell leukemiaB-ALL",{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":247,"maxAge":53,"enrollmentInfo":443,"targetDuration":4,"studyType":23,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":447,"startDateStruct":448,"completionDateStruct":449,"leadSponsor":450,"locationsCount":45},"100395711","phase-1-targeting-cd276-b7-h3-positive-solid-tumors-by-4scar-276-100395711","NCT04432649","Targeting CD276 (B7-H3) Positive Solid Tumors by 4SCAR-276","Multicenter Trial of Phase I\u002FII Studies on CD276 (B7-H3) Positive Solid Tumors Treated With 4SCAR-276","Inclusion Criteria:\n\n* Patients with tumors have received standard first-line therapy and have been judged to be non-resectable, metastatic, progressive or recurrent.\n* The CD276 antigen status of the tumor is determined for eligibility. Positive expression is defined by antibody staining results based on immunohistochemistry or flow cytometry analysis.\n* Body weight greater than or equal to 10 kg.\n* Age: ≥1 year and ≤ 75 years of age at the time of enrollment.\n* Life expectancy: at least 8 weeks.\n* Prior Therapy: 1) There is no limit to the number of prior treatment regimens. Any grade 3 or 4 non-hematologic toxicity of any previous therapy must have resolved to grade 2 or less. 2) Must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection. 3) At least 7 days must have elapsed since the completion of therapy with a biologic agent, targeted agent, tyrosine kinase inhibitor or a metronomic nonmyelosuppressive regimen. 4) At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody. 5) At least 1 week since any radiation therapy at the time of study entry.\n* Karnofsky\u002Fjansky score of 60% or greater.\n* Cardiac function: Left ventricular ejection fraction greater than or equal to 40\u002F55 percent .\n* Pulse Ox greater than or equal to 90% on room air.\n* 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.\n* Renal function: Patients must have serum creatinine less than 3 times upper limit of normal.\n* 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).\n* Patients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria, and the marrow disease not evaluable to have hematologic toxicity.\n* 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\nExisting severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, or grade 3 hematologic toxicity.\n\n* Untreated central nervous system (CNS) metastasis: Patients with CNS tumor involvement that has been treated and\u002For is stable for at least 6 weeks following completion of therapy are eligible.\n* Previous treatment with other genetically engineered CD276-CAR T cells or CD276 antibody therapy.\n* Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.\n* Patients who require systemic corticosteroid or other immunosuppressive therapy.\n* Evidence of tumor potentially causing airway obstruction.\n* Inability to comply with protocol requirements.\n* Insufficient CAR T cells availability.",{"count":375,"type":22},[25,57],"Patients with refractory and\u002For recurrent solid tumor have poor prognosis despite complex multimodel therapy and therefore, novel approaches are urgently needed. This study attempts to treat these diseases using T cells genetically modified with a 4th generation lentiviral chimeric antigen receptor (4SCAR fused with an inducible apoptotic caspase 9 domain) targeting CD276 (B7-H3). The 4SCAR-CD276-modified T cells (4SCAR-276) can recognize and kill tumor cells through the recognition of CD276, a surface protein expressed at high levels on many types of tumors but at low levels on normal tissues. This study will evaluate the side effects and effective doses of 4SCAR-276 in treating refractory and\u002For recurrent tumors.",[323],{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":53,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":460,"conditions":461,"keywords":463,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":470,"leadSponsor":471,"locationsCount":45},"100395313","phase-1-4scar-cd44v6-t-cell-therapy-targeting-cancer-100395313","NCT04427449","4SCAR-CD44v6 T Cell Therapy Targeting Cancer","Multi-center Phase I\u002FII Clinical Trial of 4SCAR-CD44v6 T Cells for Treating Cancer","Inclusion Criteria:\n\n1. Age older than 6 months.\n2. Confirmed expression of CD44v6 in tumor specimens by immuno-histochemical staining or flow cytometry.\n3. Karnofsky performance status (KPS) score is higher than 70 and life expectancy \\> 3 months.\n4. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg\u002FdL.\n5. Hgb≥80g\u002FL.\n6. No cell separation contraindications.\n7. Abilities to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.\n2. Active bacterial, fungal or viral infection not controlled by adequate treatment.\n3. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n4. Pregnant or nursing women may not participate.\n5. Use of glucocorticoid for systemic therapy within one week prior to entering the trial.\n6. Receive treatment related to CD44v6 targeted therapy.\n7. Patients, in the opinion of investigators, may not be able to comply with the study.",{"count":375,"type":22},[25,57],"The purpose of this clinical trial is to assess the feasibility, safety and efficacy of 4SCAR-CD44v6 T-cell therapy targeting multiple cancers. The study also aims to learn more about the function of the CD44v6 CAR-T cells and their persistency in the patients.",[462],"Cancers Which Are CD44v6 Positive",[62,464,465,466,467],"CD44v6","Breast cancer","Gastric cancer","Lymphoma",{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":17,"minAge":247,"maxAge":53,"enrollmentInfo":479,"targetDuration":4,"studyType":23,"phases":480,"briefSummary":481,"conditions":482,"keywords":484,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":490,"leadSponsor":491,"locationsCount":45},"100395465","phase-1-psma-specific-car-t-cell-therapy-100395465","NCT04429451","PSMA-specific CAR-T Cell Therapy","Phase I\u002FII Clinical Trial of 4SCAR-PSMA T Cell Therapy Targeting PSMA Positive Malignancies","Inclusion Criteria:\n\n1. Patients with tumors have received standard first-line therapy and have been judged to be non-respectable, metastatic, progressive or recurrent.\n2. The expression status of PSMA antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by 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 have 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, targeted agent, tyrosine kinase inhibitor 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 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.",{"count":375,"type":22},[25,57],"The purpose of this clinical trial is to assess the feasibility, safety and efficacy of PSMA-specific CAR-T cell therapy in patients with PSMA positive tumor. Another goal of the study is to learn more about the function of the PSMA CAR-T cells and their persistency in the patients.",[483],"PSMA Positive Tumors or Tumor Tissues",[91,382,273,485,486,487],"Prostate cancer","Tumor microenvironment","CAR",{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":53,"enrollmentInfo":499,"targetDuration":4,"studyType":23,"phases":501,"briefSummary":502,"conditions":503,"keywords":505,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":510,"leadSponsor":511,"locationsCount":45},"100395464","phase-1-multi-car-t-cells-targeting-b-cell-lymphomas-100395464","NCT04429438","Multi-CAR-T Cells Targeting B Cell Lymphomas","Primary, Booster and Consolidation Multi-CAR-T Cell Therapy for the Treatment of Refractory B Cell Lymphomas","Inclusion Criteria:\n\n1. Age older than 6 months.\n2. Primary B cell lymphoma surface expression of CD19 and\u002For CD22\u002FCD70\u002FPSMA\u002F CD13\u002FCD79b\u002FGD2 molecules.\n3. The KPS score over 80 points, and survival time is more than 1 month.\n4. Greater than Hgb 80 g\u002FL.\n5. No contraindications to blood cell collection.\n\nExclusion Criteria:\n\n1. Accompanied with other active diseases, and difficult to assess response after treatment.\n2. Bacterial, fungal, or viral infection, unable to control.\n3. Living with HIV.\n4. Active HBV and HCV infection.\n5. Pregnant and nursing mothers.6. under systemic steroid treatment within a week of the treatment.\n\n7\\. Prior failed CAR-T treatment.",{"count":500,"type":22},11,[25,57],"This study aims to evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting B cell surface molecules including CD19 and alternative CARTs as booster and consolidation treatment for patients with highly resistant B cell lymphomas, including primary mediastinal B cell lymphoma (PMBCL) and BCL involving central nervous system (CNS-BCL). Clinical response and development of a simplified and standardized lentiviral vector and cell production protocol will be investigated. This is a phase I\u002FII trial enrolling patients from multiple clinical centers.",[504],"B Cell Lymphoma (BCL)",[62,68,506,235,256,273,507,218,255,179,180],"CD20","CD13",{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":519,"targetDuration":4,"studyType":23,"phases":520,"briefSummary":521,"conditions":522,"keywords":524,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":527,"startDateStruct":528,"completionDateStruct":529,"leadSponsor":530,"locationsCount":45},"100395553","phase-1-multi-4scar-t-therapy-targeting-breast-cancer-100395553","NCT04430595","Multi-4SCAR-T Therapy Targeting Breast Cancer","Multiple 4SCAR-T Cell Therapy Targeting Breast Cancer","Inclusion Criteria:\n\n1. Patients with stage III, IV or relapsed breast cancer confirmed by histology and biopsy.\n2. Age: ≥ 18 years and ≤ 75 years.\n3. 2 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.\n4. Side effects of chemotherapy have subsided.\n5. The target antigens GD2, CD44v6, or Her2 is expressed in malignancy tissues by immuno-histochemical or flow cytometry.\n6. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.\n7. Expected survival ≥ 12 weeks.\n8. Initial hematopoietic reconstitution with neutrophils (ANC) ≥ 1×10\\^6\u002FL; platelet (PLT) ≥ 1×10\\^8\u002FL.\n9. Proper renal and hepatic functions (ULN denotes \"upper limit of normal range\") with serum creatinine ≤ 2×ULN; serum bilirubin ≤ 3×ULN; AST\u002FALT ≤ 2.5×ULN.\n10. Oxygen saturation ≥ 90%.\n11. Written, informed consent obtained prior to any study-specific procedures.\n\nExclusion Criteria:\n\n1. Airway obstruction caused by tumor.\n2. History of epilepsy or other central nervous system diseases.\n3. Patients who require systemic corticosteroid or other immunosuppressive therapy.\n4. History of prolonged or serious heart disease during QT.\n5. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.\n6. Inadequate liver and renal function with serum creatinine \\> 1.5 mg\u002Fdl; serum (total) bilirubin \\> 2.0 mg\u002Fdl; AST \\& ALT \\> 3 x ULN.\n7. Pregnant or lactating females.\n8. Serious active infection during screening.\n9. Active HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) infection or uncontrolled infection.\n10. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.",{"count":375,"type":22},[25,57],"The purpose of this study is to assess the feasibility, safety and efficacy of multiple 4th generation CAR-T cells targeting Her2, GD2, and CD44v6 surface antigen in breast cancer. Another goal of the study is to learn more about the activities of the multi-CAR T cells and their persistency in the patients.",[523],"Breast Cancer",[381,382,525,255,526],"Her2","CD44V6",{"date":36,"type":37},{"date":137,"type":37},{"date":139,"type":22},{"name":43,"class":44},""]