[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"920th Hospital of Joint Logistics Support Force of People's Liberation Army of China\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":161},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,40,67,91,115,139],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100555644","early-phase-1-jy231-jy231-injection-for-the-treatment-of-b-cell-acute-lymphoblastic-leukemia-b-all-100555644",false,"NCT06514768","JY231 (JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL)","Early Exploratory Clinical Study on the Safety, Tolerability and Preliminary Efficacy of JY231 Injection in the Treatment of Acute B Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. up to 75 years (Child, Adult) , either sex；\n2. Bone marrow cell morphology examination showed the proportion of primitive and immature lymphocytes in the bone marrow is \\>5%, or the bone marrow MRD analysis comfirmed as B-ALL.\n3. Flow cytometry or histology confirmed positive expression of cluster of differentiation 19 (CD19);\n4. According to the researcher's assessment, the expected survival period is greater than 3 months;\n5. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 3;\n6. The patient has good liver, kidney, heart, and lung functions: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN), which can be relaxed to ≤ 5 × ULN for patients with liver invasion; Total serum bilirubin \\\u003C 34 μ Mol\u002FL; Creatinine clearance rate\\>30 mL\u002Fmin; Cardiac ejection fraction (EF) ≥ 40%, without pericardial effusion and significant arrhythmia; Indoor oxygen saturation (SpO2) ≥ 92%;\n7. Peripheral blood lymphocyte absolute count: absolute lymphocyte count (ALC) ≥ 0.5E9\u002FL, blood platelet (PLT) \\> 30E9\u002FL, Hb \\> 80g\u002FL, with a single venous access and no other contraindications for blood cell separation;\n8. MRI examination showed no active malignant cells in the cerebrospinal fluid, no brain metastases, or no central nervous system leukemia;\n9. Individuals with fertility must agree to the use of efficient contraceptive methods;\n10. The subject or their legal guardian can understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, as well as women with pregnancy plans within six months;\n2. Virological tests of hepatitis B, hepatitis C, AIDS, syphilis and cytomegalovirus were positive;\n3. Having a history of other tumors (excluding skin or cervical carcinoma in situ cured by root therapy and without evidence of disease activity);\n4. Previously received treatment targeting CD19;\n5. Received autologous hematopoietic stem cell transplantation within 6 weeks;\n6. The presence of uncontrollable active bacterial or fungal infections;\n7. Allergies to research related drugs or cellular components;\n8. Active autoimmune diseases exist;\n9. Patients with unstable or active ulcers or gastrointestinal bleeding currently present;\n10. Individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation;\n11. Received other experimental drug treatments within the past 3 months;\n12. Existence of grade II-IV acute graft versus-host disease (GVHD) or widespread chronic GVHD;\n13. Researchers believe that other reasons are not suitable for clinical trial participants.","ALL","75 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of B-cell acute lymphoblastic leukemia (B-ALL)",[26],"B-cell Acute Lymphoblastic Leukemia (B-ALL)","RECRUITING","2025-12-31",{"date":30,"type":31},"2026-01-06","ACTUAL",{"date":33,"type":31},"2024-06-20",{"date":35,"type":20},"2026-06-30",{"name":37,"class":38},"920th Hospital of Joint Logistics Support Force of People's Liberation Army of China","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":17,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":39},"100597960","jy231jy231-injection-for-the-treatment-of-rr-b-cell-malignancies-100597960","NCT07065279","JY231(JY231) Injection for the Treatment of R\u002FR B-cell Malignancies","JY231 Injection for the Treatment of B-cell Malignancies Early Exploratory Clinical Studies on Safety, Tolerability, and Initial Efficacy","Inclusion Criteria:\n\n1. up to 75 years (Child, Adult) , either sex, sign informed consent (ICE);\n2. Histologically confirmed as B-cell Malignancies ;\n3. Flow cytometry or histology confirmed positive expression of cluster of differentiation 19(CD19);\n4. According to the researcher's assessment, the expected survival period is greater than 3 months;\n5. Eastern Cooperative Oncology Group(ECOG) physical condition score ≤ 3;\n6. The patient has good liver, kidney, heart, and lung functions: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN), which can be relaxed to ≤ 5 × ULN for patients with liver invasion; Total serum bilirubin # 34 μ Mol\u002FL; Creatinine clearance rate\\>30 mL\u002Fmin; Cardiac ejection fraction (EF) ≥ 40%, without pericardial effusion and significant arrhythmia; Indoor oxygen saturation(SpO2) ≥ 92%;\n7. Peripheral blood lymphocyte absolute count: absolute lymphocyte count(ALC) ≥ 0.5 × 109\u002FL, blood platelet(PLT)\\>30 × 109\u002FL, Hb\\>80 g\u002FL, with a single venous access and no other contraindications for blood cell separation;\n8. Individuals with fertility must agree to the use of efficient contraceptive methods;\n9. The subject or their legal guardian can understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, as well as women with pregnancy plans within six months;\n2. Virological tests of hepatitis B, hepatitis C, AIDS, syphilis and cytomegalovirus were positive;\n3. Having a history of other tumors (excluding skin or cervical carcinoma in situ cured by root therapy and without evidence of disease activity);\n4. Previously received treatment targeting CD19;\n5. Received autologous hematopoietic stem cell transplantation within 6 weeks;\n6. The presence of uncontrollable active bacterial or fungal infections;\n7. Allergies to research related drugs or cellular components;\n8. Active autoimmune diseases exist;\n9. Patients with unstable or active ulcers or gastrointestinal bleeding currently present;\n10. Individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation;\n11. Received other experimental drug treatments within the past 3 months;\n12. Existence of grade II-IV acute graft versus-host disease(GVHD) or widespread chronic GVHD;\n13. Researchers believe that other reasons are not suitable for clinical trial participants.","2 Years",{"count":49,"type":20},36,[51],"NA","This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B-cell Malignancies.\n\nIt is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell Malignancies.",[54],"B-cell Malignancies",[56,57,58],"B cell tumor","CAR-T","in vivo","2025-07-03",{"date":61,"type":31},"2025-07-15",{"date":63,"type":20},"2025-07",{"date":65,"type":20},"2027-12",{"name":37,"class":38},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":17,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":39},"100579140","early-phase-1-safety-and-preliminary-efficacy-of-anti-cdh17-car-t-cell-therapy-in-patients-with-cdh17-positive-advanced-solid-tumors-100579140","NCT06820424","Safety and Preliminary Efficacy of Anti-CDH17 CAR-T Cell Therapy in Patients with CDH17-positive Advanced Solid Tumors","A Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of CDH17 CAR-T in Patients with CDH17-positive Advanced Solid Tumors","Inclusion Criteria:\n\n1. The patient understands and voluntarily signs the informed consent form, and is expected to complete the follow-up examination and treatment of the study procedures;\n2. Age 18-75 years old, gender unlimited;\n3. Tumor patients who have positive expression of CDH17 target in tumor tissues measured by immunohistochemistry (IHC) in a laboratory approved by the partner, and have no standard therapy or are ineffective or not suitable for standard treatment;\n4. Have at least one extracranial measurable lesion according to RECIST 1.1 criteria;\n5. Estimated survival ≥ 12 weeks;\n6. Baseline ECOG (Eastern Cooperative Oncology Group) score ≤ 1 point;\n7. The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade \\\u003C 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy);\n8. Venous access could be established; without contraindications of apheresis.\n\nExclusion Criteria:\n\n1. Patients with prior or current other malignancies;\n2. Presence of brain metastases and clinically significant central nervous system disease;\n3. Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted therapy, epigenetic therapy, or investigational drug therapy within 14 days or at least 5 half-lives, whichever is shorter;\n4. Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; CMV DNA titer is higher than the lower limit of detection of the research institution; EBV DNA titer is higher than the lower limit of detection of the research institution\n5. Those who have a positive sputum smear and T-cell test for tuberculosis infection;\n6. Patients with objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function, both past and present;\n7. Patients have a severe allergic history;\n8. Patients with severe heart disease or uncontrollable refractory hypertension;\n9. Patients with severe liver and kidney dysfunction or consciousness disorders;\n10. Active autoimmune or inflammatory diseases of the nervous system;\n11. Uncontrolled infections that need antibiotics treatment;\n12. Live attenuated vaccine within 4 weeks before screening;\n13. Alcoholics or persons with a history of drug abuse;\n14. Pregnant or Lactating Women; Patients and his or her spouse have a fertility plan within two years after CAR-T cell infusion;\n15. Any unsuitable to participate in this trial judged by the investigator.","18 Years",{"count":76,"type":20},30,[23],"This is a single-center, open-label, single-arm study to evaluate the safety and preliminary efficacy of anti-CDH17 CAR-T cells in patients with CDH17-positive advanced solid tumors.",[80],"CDH17-positive Advanced Solid Tumors",[82],"CDH17 CAR-T","2025-02-06",{"date":85,"type":31},"2025-02-11",{"date":87,"type":20},"2025-03",{"date":89,"type":20},"2028-06",{"name":37,"class":38},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":99,"maxAge":17,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":39},"100567993","phase-1-jy231-injection-for-the-treatment-of-active-systemic-lupus-erythematosus-sle-100567993","NCT06675422","JY231 Injection for the Treatment of Active Systemic Lupus Erythematosus (SLE)","JY231 Injection for the Treatment of Active Systemic Lupus Erythematosus (SLE) - A Safety, Tolerability, and Efficacy Study","JY231","Inclusion Criteria:\n\n1. Diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus Erythematosus International Clinical Collaboration (SLICC) criteria.\n2. Must have been treated with glucocorticoids in combination with immunosuppressants and\u002For biologics for at least 2 months prior to screening and have been dose stable for \\>2 weeks, with the disease remaining active (i.e., prior glucocorticoid + immunosuppressant or glucocorticoid + immunosuppressant + biologics, any of the above medications alone do not qualify). Oral corticosteroids must meet the following requirements: 1) Prednisone (or equivalent) ≥ 7.5 mg\u002Fday; 2) When used in combination with immunosuppressants and\u002For biologics, there is no minimum daily dose requirement for corticosteroids.\n3. positive anti-nuclear antibody (ANA), and\u002For positive anti-ds-DNA antibody, and\u002For positive anti-Smith antibody at screening.\n4. Screening Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score \\>6 and 'clinical' SLEDAI-2K score ≥4.\n\n1)Note: 'Clinical' SLEDAI-2K is a SLEDAI-2K score that excludes scores attributable to any urine or laboratory findings, including immunological indicators: 2)-Includes scores for the following clinical items: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, or vasculitis; 3)-excludes scores attributable to fever, SLE headache and organic brain syndromes.\n\n5.British Isles Lupus Assessment Group 2004 (BILAG2004) score of at least one of the following:\n\n1. ≥1 organ system BILAG2004 grade A disease\n2. ≥2 organ system BILAG2004 Grade B disorders 6.Physician's General Assessment (PGA) score of ≥1.0 (0-3 visual analogue scale VAS) at screening.\n\nExclusion Criteria:\n\n1. Combination of other autoimmune diseases requiring systemic therapy.\n2. SLE patients: the presence of still uncontrolled lupus crisis within 8 weeks prior to screening, including acute progressive lupus nephritis, severe neuropsychiatric lupus, severe haemolytic anaemia, severe immune thrombocytopenia, granulocyte deficiency, severe cardiac damage, severe lupus pneumonitis, severe lupus hepatitis, severe vasculitis, etc., which were assessed as unsuitable for participation in the study by the investigator.\n3. Pre-screening comorbidity with clinically significant central nervous system disease or pathological changes not due to lupus, including but not limited to: cerebral vascular accident, aneurysm, epilepsy, convulsions\u002Fconvulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndromes, or psychosis.\n4. History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation (e.g., kidney, lung, heart, liver) or future plans for such transplantation.\n5. Presence of clinically significant cardiovascular dysfunction in the 12 months prior to screening, including, but not limited to: class III or IV heart failure as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina pectoris, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia.\n6. Presence of significant pulmonary or cardiac manifestations such as pericarditis, pleural effusion at the time of screening, assessed by the investigator to be unsuitable for participation in this study.\n7. Patients with severe asthma or chronic obstructive pulmonary disease (COPD), mild or moderate asthma or COPD on stable therapy may be enrolled.\n8. History of malignancy within 5 years prior to signing the Informed Consent Form (ICF), except adequately treated or surgically resected, non-melanoma skin cancers or carcinoma in situ (e.g., cervical cancer, bladder cancer, breast cancer) without residual disease.\n9. Women who are pregnant or breastfeeding.\n10. History of recurrent infections requiring hospitalisation and intravenous antibiotics (e.g. 3 or more episodes of the same type of infection in the past 1 year).\n11. Active infection requiring systemic treatment, such as infectious pneumonia, tuberculosis, etc., within 2 weeks prior to clearance.\n12. Hepatitis B surface antigen (HBsAg) positive, or Hepatitis B core antibody (HBcAb) positive and peripheral blood Hepatitis B Virus (HBV) DNA test positive; Hepatitis C Virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody positive.\n13. Have received a live attenuated vaccine within 4 weeks prior to clearance or plan to receive a live attenuated vaccine during the course of the study.\n14. Have received high-dose corticosteroids (prednisone ≥ 60 mg\u002Fday or equivalent) within 4 weeks prior to clearance, or are unable to taper prednisone to ≤ 10 mg\u002Fday 5 days prior to clearance.\n15. Inability to taper or elute background therapy prior to clearing chemotherapy as described in Table 3.\n16. Receiving renal replacement therapy within 3 months prior to screening or anticipating the need for renal replacement therapy during the study.\n17. History of drug or alcohol abuse within 1 year prior to screening.\n18. History or evidence of suicidal thoughts within 6 months prior to screening or any suicidal behaviour within the previous 12 months that the investigator considers to be a significant risk of suicide.\n19. Use of another study drug within 4 weeks or 5 half-lives (whichever is longer) prior to screening.\n20. History of hypersensitivity or life-threatening reaction to the study drug or any component or preparation of the study treatment (including clear chemotherapy). See the Investigator's Brochure (IB) for more information about the components of the study drug.\n21. Any condition that, in the opinion of the investigator, may affect participation in the study, pose a safety risk to patients, or may confound the interpretation of study results.","14 Years",{"count":19,"type":20},[102,103],"PHASE1","PHASE2","Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of active systemic lupus erythematosus (SLE)",[106],"Systemic Lupus Erythematosus (SLE)","2024-11-04",{"date":109,"type":31},"2024-11-05",{"date":111,"type":31},"2024-10-09",{"date":113,"type":20},"2026-12-31",{"name":37,"class":38},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":122,"maxAge":17,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":39},"100543162","phase-1-efficacy-and-safety-of-car-t-cells-therapy-for-chronic-or-refractory-primary-immune-thrombocytopenia-itp-100543162","NCT06352281","Efficacy and Safety of CAR-T Cells Therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP)","An Investigator-initiated Trial to Evaluate the Efficacy and Safety of CAR-T Cells Therapy in the Treatment of Chronic or Refractory Primary Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n1. Willingness to complete the informed consent process and to comply with study procedures and visit schedule;\n2. Men and women aged 8-75;\n3. Participants diagnosed with chronic (\\>12 months duration) or refractory (a documented intolerance or insufficient response to the first and second line standard treatment of ITP) ITP;\n4. The results of physical, instrumental, and laboratory examination of patients not suggest any disease which may cause thrombocytopenia other than ITP;\n5. Platelet count \\\u003C30 x 109 \u002F L;\n6. If the patient is taking corticosteroids, the treatment regimen\u002Fdose should be stable (at least 2 weeks prior to screening);\n7. The results of physical, instrumental, and laboratory examination of patients should be within the normal range or deviations should be regarded by the researcher as clinically insignificant;\n8. Willingness to use effective and reliable methods of contraception throughout the entire study period;\n\nExclusion Criteria:\n\n1. All subjects with diseases which may cause secondary immune thrombocytopenia\n2. Patients with preventive splenectomy;\n3. Hemostatic disorders other than chronic thrombocytopenia;\n4. Subject treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and\u002For NSAIDs) or anti-coagulants for \\> 3 consecutive days within 2 weeks of the study start and until the end of the study;\n5. History of platelet agglutination abnormality that prevents reliable measurement of platelet counts;\n6. Concurrent malignant disease and\u002For history of cancer treatment with cytotoxic chemotherapy and\u002For radiotherapy;\n7. Grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically prominent heart disease within one year prior to enrollment;\n8. History of thrombosis or presence of significant risk factors for thrombosis;\n9. Persons with acute or exacerbation of chronic diseases of the gastrointestinal tract associated with the risk of bleeding, acute infectious diseases, pathologies of the respiratory system;\n10. Any clinically significant hepatic impairment (increase of serum transaminase levels by more than 3 times the upper limit of normal);\n11. Serum creatinine levels are more than two times higher than the upper limit of normal for a given age and sex;\n12. Any other concomitant decompensated diseases or acute conditions, the presence of which, according to the researcher, may significantly affect the results of the study;\n13. Human immunodeficiency virus (HIV) seropositivity, Hepatitis B surface antigen positive or hepatitis B core antibody positive and HBV-DNA positive, Patients with hepatitis C (HCV-RNA quantitative test results positive), Or the presence of other serious active viral or bacterial infections or uncontrolled systemic fungal infections;\n14. Patients with severe history of allergy or allergic constitution;\n15. Pregnancy and lactation;\n16. History of mental illness and known alcohol\u002Fdrug addiction;\n17. Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan;\n18. Had undergone other clinical trials in the 4 weeks prior to participating in this trial;","8 Years",{"count":124,"type":20},10,[102,103],"It is a single-center, single-arm, open-labeled clinical trial to evaluate the efficacy and safety of CAR-T cells therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP).",[128],"ITP - Immune Thrombocytopenia",[57,130],"Immune Thrombocytopenia (ITP)","2024-07-18",{"date":133,"type":31},"2024-07-22",{"date":135,"type":31},"2024-02-01",{"date":137,"type":20},"2027-12-31",{"name":37,"class":38},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":17,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":39},"100555682","safety-and-efficacy-of-anti-bcma-gprc5d-car-t-cells-therapy-in-the-treatment-of-rr-mm-100555682","NCT06515262","Safety and Efficacy of Anti-BCMA-GPRC5D CAR-T Cells Therapy in the Treatment of r\u002Fr MM","A Clinical Study to Evaluate the Safety and Efficacy of BCMA-GPRC5D CAR-T in Patients With Relapsed\u002FRefractory Multiple Myeloma Who Received Three or More Lines of Therapy","Inclusion Criteria:\n\n1. The patient or his\u002Fher guardian understands and voluntarily signs the informed consent, and is expected to complete the follow-up examination and treatment of the study procedure;\n2. Age 18-75 years old, gender unlimited;\n3. Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG);\n4. The presence of measurable disease at screening meets one of the following criteria:Serum M-protein ≥ 1.0 g\u002FdL or Urine M-protein ≥ 200 mg\u002F24h or diagnosed as Light-chain MM without measurable disease in serum and urine; Serum free light chain ≥ 10 mg\u002FdL with an abnormal κ\u002Fλ ratio;\n5. Patients must relapse or be refractory after three or more lines of therapy, which at least include: one Proteasome Inhibitor (PI), one Immunomodulatory Drug (IMiD), and one anti-CD38 monoclonal antibody;\n6. diagnosed as relapsed\u002Frefractory disease or primary refractory disease;\n7. The last treatment is ineffective, or the disease progresses within 60 days after the end of the last therapy;\n8. The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade \\\u003C 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy);\n9. ECOG score 1-2 points and the expected survival period ≥ 3 months;\n10. Liver, kidney and cardiopulmonary functions meet the following requirements:\n\n    1. Total bilirubin ≤ 1.5×ULN, alanine aminotransferase (ALT) ≤ 3 × ULN and aspartate aminotransferase (AST) ≤ 3 × ULN;\n    2. Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 60 mL\u002Fmin;\n    3. Hemoglobin (Hb) ≥ 50 g\u002FL without prior blood transfusion within 7 days;\n    4. Baseline peripheral oxygen saturation \\> 92%;\n    5. Corrected serum calcium ≤ 12.5 mg\u002FdL (≤ 3.1 mmol\u002FL) or free (ionized, ionic) calcium ≤ 6.5 mg\u002FdL (≤ 1.6 mmol\u002FL);\n    6. Left ventricular ejection fraction (LVEF) \\> 45%, without confirmed pericardiac effusion and abnormal electrocardiography with clinical significance;\n    7. Without clinically significant pleural effusion;\n11. Venous access could be established; without contraindications of apheresis.\n\nExclusion Criteria:\n\n1. Have been diagnosed with or treated for aggressive malignancies other than multiple myeloma;\n2. Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted therapy, epigenetic therapy, or investigational drug therapy within 14 days or at least 5 half-lives, whichever is shorter;\n3. It is suspected that MM has involved the central nervous system or meninges and has been confirmed by MRI or CT, or there are other active central nervous system diseases;\n4. Patients with Fahrenheit macroglobulinemia, POEMS syndrome, or primary AL, amyloidosis;\n5. Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; CMV DNA titer is higher than the lower limit of detection of the research institution; EBV DNA titer is higher than the lower limit of detection of the research institution;\n6. Patients have a severe allergic history;\n7. Any unstable systemic disease: including but not limited to unstable angina, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure \\[New York Heart Association (NYHA) classification ≥ grade III\\];\n8. Systemic diseases judged by researchers to be unstable: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;\n9. Patients with acute\u002Fchronic graft-versus-host disease (GVHD) or requiring immunosuppressive therapy for GVHD within 6 months prior to screening;\n10. Active autoimmune or inflammatory diseases of the nervous system;\n11. Patients develop oncology emergencies and need to be treated before screening or infusion;\n12. Uncontrolled infections that need antibiotics treatment;\n13. Exposure to hematopoietic growth factor of cells within 1-2 weeks before apheresis;\n14. Exposure to Corticosteriods or immunosuppressive agents within 2 weeks before apheresis;\n15. Patients receive a major surgical operation within 4 weeks before lymphodepletion or do not recover completely before the enrollment; or plan to receive a major surgical operation during the study period;\n16. Live attenuated vaccine within 4 weeks before screening;\n17. Persons with serious mental illness;\n18. Alcoholics or persons with a history of drug abuse;\n19. Pregnant or Lactating Women; Patients and his or her spouse have a fertility plan within two years after CAR-T cell infusion;\n20. Any unsuitable to participate in this trial judged by the investigator.",{"count":124,"type":20},[51],"This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D CAR-T cells in patients with relapsed or refractory multiple myeloma who received three or more lines of therapy.",[150],"Relapsed\u002FRefractory Multiple Myeloma",[152],"BCMA-GPRC5D CAR-T","2024-07-17",{"date":155,"type":31},"2024-07-23",{"date":157,"type":31},"2024-07-01",{"date":159,"type":20},"2026-12",{"name":37,"class":38},""]