[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chimeric-antigen-receptor-t-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chimeric-antigen-receptor-t-cell":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100583341","phase-1-gb5005-cart-cell-injection-in-the-treatment-of-patients-with-cd19-positive-rr-b-nhl-100583341",false,"NCT06875063","GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL","The Safety, Tolerability, Efficacy, and Pharmacokinetic Characteristics of GB5005 Chimeric Antigen Receptor T-cell Injection in Treating Patients With CD19-positive Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma (B-NHL).","Inclusion Criteria:\n\n1. The candidate is able to communicate effectively with researchers and sign informed consent forms in writing;\n2. Age greater than or equal to 18 years old and less than or equal to 70 years old, regardless of gender; Sign informed consent form;\n3. Non Hodgkin lymphoma confirmed by cytology and genetics;\n4. Positive expression of CD19 in tumor cells confirmed by flow cytometry or pathological histology;\n5. When screening, it meets the definition of recurrence or refractory: having received at least second-line or above systemic anti-tumor therapy (including autologous hematopoietic stem cell transplantation) containing rituximab (or other CD20 targeted drugs) and anthracycline drugs in the past, and disease progression (PD) or recurrence after the last treatment; Or recurrent patients who do not fully meet the above conditions but refuse chemotherapy and strongly demand CAR-T treatment;\n6. There is no obvious evidence of central nervous system lymphoma on brain MRI;\n7. Blood routine: Neutrophils ≥ 1.0 × 10 \\^ 9\u002FL; Hemoglobin ≥ 70 g\u002FL; Platelets ≥ 50 × 10 \\^ 9\u002FL;\n8. Coagulation function: fibrinogen ≥ 1.0 g\u002FL; Activated partial thromboplastin time (APTT) ≤ ULN+10 s, prothrombin time (PT) ≤ ULN+3 s;\n9. Liver and kidney function indicators: total bilirubin ≤ 1.5 times the upper limit of normal range (excluding Gilbert syndrome or hemolysis), ALT and AST ≤ 3.0 times the upper limit of normal range (ULN), serum creatinine ≤ 2.0 times the upper limit of normal range. If the above abnormalities are considered to be caused by tumor infiltration, they can be excluded;\n10. Assessment of left ventricular ejection fraction (LVEF) ≥ 45% using echocardiography (ECHO) or radionuclide active vascular scanning (MUGA). (After corrective treatment and meeting the criteria, it can be included in the group);\n11. Pulmonary function: Dyspnea ≤ CTCAE level 1 and SaO2 ≥ 92% in indoor air environment; 12. The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States ranges from 0 to 2 points;\n12. Expected survival is greater than 6 months; 14. The subjects have sufficient levels of functional organs during screening;\n13. Female participants of childbearing age must undergo a serum pregnancy test during screening and before receiving pre-treatment chemotherapy, and the result must be negative. They are willing to use highly effective and reliable methods of contraception within one year after using the study treatment;\n14. Male participants who engage in active sexual activity with women with reproductive potential must be willing to use highly effective and reliable methods of contraception within one year after using the study treatment. Moreover, all males are strictly prohibited from donating sperm within one year after receiving research treatment infusion during the study period.\n\nExclusion Criteria:\n\n1. Patients with a history of allergies to serum albumin and DMSO in the past;\n2. Active hepatitis B virus (HBV) (HBV-DNA positive), hepatitis C virus antibody (HCV) (HCV-RNA positive), or human immunodeficiency virus (HIV) infection;\n3. Within the past 2 years, terminal organ damage caused by autoimmune diseases such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, or the need for systemic use of immunosuppressive or other systemic disease control drugs;\n4. History of unstable angina, myocardial infarction, coronary angioplasty, or significant heart disease within one year of enrollment;\n5. Primary central nervous system tumors or hematological tumors with central nervous system metastases;\n6. Uncontrolled mental illness;\n7. Merge other life-threatening severe organ failure;\n8. Participated in other clinical studies within 4 weeks;\n9. Received live vaccination within 4 weeks of enrollment;\n10. Using prohibited drugs: a. Hormones: Corticosteroids (defined as\\>20mg\u002Fday prednisone or equivalent) used at therapeutic doses within 7 days prior to leukocyte collection. But the use of physiological substitutes, local and inhaled steroids is allowed. b. Chemotherapy: rescue chemotherapy, including tyrosine kinase inhibitors (TKIs), received within 1 week before leukocyte collection. c. Donor lymphocyte infusion (DLI) received within 4 weeks before leukocyte collection. d. graft-versus-host disease (GvHD) treatment: systemic anti GVHD treatment received within 3 months before GB5005 cell infusion. e. Alenumab used within 6 months before leukocyte collection, or chlorofarabin or cladribin used within 3 months. f. Checkpoint inhibitors or stimulants used before enrollment (excluding those with more than 3 biological half lives);\n11. Patients with known history of lung injury or hemorrhagic cystitis associated with cyclophosphamide treatment;\n12. Women who are already pregnant, preparing for pregnancy during the trial period, or breastfeeding;\n\n13：As per the investigator's judgment, the subject is unlikely to complete all required visits or procedures stipulated in the protocol (including the follow-up period) or has insufficient compliance with the study.","ALL","18 Years","70 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed\u002Frefractory B-cell non-Hodgkin lymphoma (B-NHL).",[27,28,29],"Non-hodgkin Lymphoma","Refractory Lymphoma","Chimeric Antigen Receptor T-cell","RECRUITING","2026-03-11",{"date":33,"type":34},"2026-03-13","ACTUAL",{"date":36,"type":21},"2026-04-30",{"date":38,"type":21},"2027-05-31",{"name":40,"class":41},"The First Affiliated Hospital of Xiamen University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100626166","phase-1-clinical-study-on-the-safety-efficacy-and-pharmacokinetics-of-universal-cll1-chimeric-antigen-receptor-t-cell-in-relapsedrefractory-acute-myeloid-leukemia-100626166","NCT07432100","Clinical Study on the Safety, Efficacy and Pharmacokinetics of Universal CLL1 Chimeric Antigen Receptor T-Cell in Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* The patient meets the diagnostic criteria for AML as per the 2022 WHO Fifth Edition Classification of Tumours of Haematopoietic and Lymphoid Tissues (WHO-HAEM5) and the definitions of relapse and refractory AML in the \"Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory Acute Myeloid Leukemia (2023 Edition)\":Relapsed AML is defined as the reappearance of leukemia cells in the peripheral blood after achieving complete remission (CR), or the presence of more than 5% blasts in the bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or the presence of leukemia cell infiltration in extramedullary sites.Refractory AML is defined as cases that do not respond to two standard treatment courses as initial therapy; cases that relapse within 12 months after achieving CR and consolidation therapy; cases that relapse after 12 months and do not respond to conventional chemotherapy; cases with two or more relapses; and cases with persistent extramedullary leukemia.\n* Diagnosis based on bone marrow and\u002For peripheral blood morphology within 28 days before enrollment.\n* Leukemia cells express CLL1 at a level greater than 50%.\n* Previous use of approved targeted drugs for relevant mutations.\n* After treatment with CLL1 CAR-T, the subject must have a confirmed stem cell donor.Available for potential allo-SCT at any time.\n* ECOG performance score of 0 or 1.\n* Adequate bone marrow reserve function: a) Absolute neutrophil count (ANC) ≥ 1000\u002FμL, unless the investigator believes that the neutropenia is due to the underlying leukemia; b) Platelet count ≥ 50,000\u002FμL, unless the investigator believes that the thrombocytopenia is due to the underlying leukemia; c) Absolute lymphocyte count (ALC) ≥ 100\u002FμL.\n* Adequate renal, hepatic, pulmonary and cardiac function:a) Creatinine clearance (estimated by the Cockcroft-Gault formula) ≥ 60 mL\u002Fmin; b) Serum alanine aminotransferase\u002Faspartate aminotransferase ≤ 2.5 times the upper limit of normal; c) Total bilirubin ≤ 1.5 mg\u002FdL, except for patients with Gilbert's syndrome; d) Ejection fraction ≥ 50%, with no clinical significance in pericardial effusion as determined by echocardiogram (ECHO) and no clinical significance in electrocardiogram (ECG); e) Baseline oxygen saturation \\> 92%, with no clinically significant pleural effusion as determined by chest imaging.\n* Contraception: Male and female patients of reproductive potential must agree to use effective contraceptive methods.\n* Pregnancy test: Female patients of reproductive potential must have a negative serum or urine pregnancy test.\n\nExclusion Criteria:\n\n* Patients diagnosed with acute promyelocytic leukemia.\n* Patients who underwent autologous hematopoietic stem cell transplantation (SCT) within 6 weeks before enrollment.\n* Patients who received donor lymphocyte infusion (DLI) within 28 days before enrollment.\n* Patients with grade II-IV acute graft-versus-host disease (GVHD).\n* Patients with active disease involving the central nervous system.\n* Patients with a history of other malignancies except non-melanoma skin cancer or carcinoma in situ (such as cervical cancer, bladder cancer or breast cancer), who have been disease-free for at least 3 years since the last curative treatment, can be enrolled.\n* Patients with a history of severe hypersensitivity reactions to aminoglycoside drugs.\n* Patients with genetic syndromes related to bone marrow failure.\n* Patients with hereditary syndromes increase the risk of allo-SCT, such as Down syndrome (trisomy 21), which should be excluded.\n* Those with a history of myocardial infarction, coronary angioplasty or stent placement, unstable angina, New York Heart Association class II or higher congestive heart failure, atrial fibrillation or other clinically significant heart diseases within 12 months prior to enrollment.\n* Patients with leukemia involving the atria or ventricles.\n* Those with a history of symptomatic deep vein thrombosis (DVT) or pulmonary embolism within 6 months prior to enrollment, or a history of distal upper extremity DVT within 3 months prior to conditioning.\n* Patients with primary immunodeficiency diseases.\n* Those with a history of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection.\n* Patients with mental disorders.\n* Those with existing or suspected fungal, bacterial, viral or other uncontrolled infections.\n* Those who have received live vaccines within 4 weeks prior to enrollment or are expected to receive live vaccines during the study.\n* Those who cannot tolerate prophylactic antifungal and antibacterial treatments.\n* Those with persistent grade 2 or higher toxicity from previous treatments, excluding hematological toxicity.\n* Pregnant or lactating women of childbearing age.",{"count":50,"type":21},20,[24],"Acute myeloid leukemia (AML) is a common type of acute leukemia in adults. Although the treatment of AML has improved in recent decades, the 5-year survival rate remains below 50% due to the chemoresistance or toxicity of these treatments. Most patients eventually die from relapse and\u002For progressive disease, and these patients urgently need new treatment strategies. Chimeric antigen receptor T-cell (CAR-T cell) therapy is an adoptive immunotherapy that expresses one or more specific chimeric antigen receptors (CARs) on T cells through genetic engineering, enabling them to target tumor cells. CAR-T cell immunotherapy has been a milestone in tumor immunotherapy in recent years and has achieved remarkable efficacy in the treatment of hematological malignancies. Human C-type lectin-like molecule 1 (CLL-1) is specifically expressed on the tumor cells of more than 90% of AML patients. CLL1 is selectively expressed on the surface of leukemia stem cells but not on normal hematopoietic stem cells, making it an ideal target for AML. Autologous CLL1 CAR-T cells have shown strong therapeutic effects in previous studies. However, autologous CAR-T cells have disadvantages such as long preparation time and high cost. Universal CAR-T cells have effectively solved this problem. In this study, universal CAR-T cells targeting the CLL1 target were prepared based on the non-gene editing intracellular membrane protein retention technology, further expanding the application of CAR-T in the treatment of acute myeloid leukemia.",[54,29,55],"Acute Myeloid Leukemia","Universal CLL1 CAR-T","NOT_YET_RECRUITING","2026-02-24",{"date":59,"type":34},"2026-02-25",{"date":61,"type":21},"2026-02",{"date":63,"type":21},"2028-12-12",{"name":65,"class":41},"Mingfeng Zhao",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":42},"100595615","phase-ii-clinical-study-on-the-safety-and-efficacy-of-combined-car-t-therapy-following-autologous-stem-cell-transplantation-in-multiple-myeloma-100595615","NCT07034755","Phase II Clinical Study on the Safety and Efficacy of Combined CAR-T Therapy Following Autologous Stem Cell Transplantation in Multiple Myeloma","Inclusion Criteria:\n\n* Age: 18-70 years old\n* Expected survival: \\>12 weeks\n* Diagnosis: Multiple myeloma confirmed by physical examination, pathological examination, laboratory tests, and imaging studies\n* Post-chemotherapy status:\n* Patients who achieved partial response (PR) or better but failed to reach complete response (CR) after four cycles of first-line chemotherapy Patients who achieved CR after four cycles of first-line chemotherapy but have high-risk factors\n* Liver function:\n\n  * ALT and AST \\\u003C 3 times the upper limit of normal\n  * Bilirubin \\\u003C 2.0 mg\u002Fdl\n* Performance status: Karnofsky Performance Status (KPS) \\>50%\n* Organ function: No severe liver, kidney, or heart diseases\n* Stem cell transplantation: Eligible for stem cell transplantation\n* Venous access: Able to undergo venous blood sampling without contraindications to leukapheresis\n* Informed consent: Capable of understanding and voluntarily signing a written informed consent form\n\nExclusion Criteria:\n\n* Pregnancy or lactation, or women planning pregnancy within the next 6 months\n* Infectious diseases(e.g., HIV, active tuberculosis)\n* Active hepatitis B or C infection\n* Feasibility assessment showing lymphocyte-targeted transfection rate \\\u003C10% or insufficient expansion (\\\u003C5-fold) under CD3\u002FCD28 co-stimulation\n* Abnormal vital signs or inability to cooperate with examinations\n* Psychiatric\u002Fpsychological disorders precluding treatment compliance or efficacy evaluation\n* Severe allergic constitution or history of severe allergies, especially to IL-2\n* Systemic or localized severe infection requiring anti-infective therapy\n* Severe autoimmune diseases\n* Other conditions deemed unsuitable for inclusion by the investigator",{"count":50,"type":21},[74],"NA","Chimeric Antigen Receptor T-Cell (CAR-T) immunotherapy is a rapidly developing novel approach in adoptive immunotherapy for tumors in recent years. Its main characteristic lies in genetically engineering T cells to express tumor antigen-specific receptors, thereby endowing them with targeting capability, cytotoxicity, and persistence. This approach has demonstrated remarkable efficacy in relapsed\u002Frefractory hematologic malignancies. Research on multiple myeloma (MM)-specific CAR-T cells has also been progressively conducted with promising outcomes, establishing CAR-T cell therapy as an effective new treatment strategy for MM. Notably, targets such as B-cell maturation antigen (BCMA) and GPRC5D have emerged as prominent therapeutic targets for CAR-T cell therapy.\n\nTherefore, we propose to evaluate the efficacy and safety of sequential CAR-T therapy following autologous hematopoietic stem cell transplantation (ASCT) in newly diagnosed MM patients who achieve partial response (PR) or better after four cycles of first-line chemotherapy but fail to attain complete response (CR), or those who achieve CR but present with high-risk factors. The clinical data from this study will provide evidence-based support for novel treatment strategies in this subset of MM patients.",[77,78,29],"Multiple Myeloma (MM)","Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)",[80,81,82],"Chimeric Antigen Receptor T-Cell","allogeneic Hematopoietic Stem Cell Transplantation (HSCT)","multiple myeloma (MM)","2025-06-29",{"date":85,"type":34},"2025-07-02",{"date":87,"type":21},"2025-07-01",{"date":89,"type":21},"2028-04-01",{"name":91,"class":41},"The Affiliated Hospital of Xuzhou Medical University"]