[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"OriCell Therapeutics Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":101},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,56,79],{"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":41,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100536932","phase-1-a-study-to-evaluate-the-safety-pkpd-of-oricar-017-in-subjects-with-rrmm---rigel-study-100536932",false,"NCT06271252","A Study to Evaluate the Safety, PK\u002FPD of (OriCAR-017) in Subjects With RR\u002FMM - RIGEL Study","A Phase I\u002FII, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Anti-GPRC5D CAR-T Cell Product (OriCAR-017) in Subjects With Relapsed\u002FRefractory Multiple Myeloma.","Inclusion Criteria:\n\nCapable of giving signed informed consent\n\nSubjects aged 18 to 75 years (inclusive) at Screening (signing the ICF).\n\nExpected survival period is \\>12 weeks.\n\nDiagnosis of MM according to the IMWG criteria (2016 version).\n\nOne of the following criteria must be met:\n\nIf immunoglobulin (Ig)G type MM, then serum M protein \\>10 g\u002FL; if IgA, IgD, IgE or IgM type MM, then serum M protein \\>5 g\u002FL\n\nUrine M protein level \\>200 mg\u002F24 hour\n\nIf light chain type MM, then serum free light chain (sFLC) \\>100 mg\u002FL and K\u002Fλ FLC ratio is abnormal.\n\nExtramedullary lesions (\\>1 cm for diameter of the short axis).\n\nFor Phase I (dose-escalation) - Subjects who had received at least 3 prior lines of therapy, had previous exposure to BCMA-Ag+ therapies, and were refractory to the last line of therapy.\n\nFor Phase I (dose-expansion) and Phase II: Subjects with previous exposure to BCMA directed therapies including BCMA bispecific antibody (e.g., teclistamab), BCMA antibody directed conjugate (such as BLENREP), and BCMA-CAR-T (such as CARVYKT1TM)\n\nSubjects with adequate hematologic, renal, hepatic, pulmonary and cardiac function.\n\nSubject and partners willing to take and or use effective contraceptive measures until 2 years post IMP infusion.\n\nExclusion Criteria:\n\nPregnant or breastfeeding.\n\nSeropositive for history of human immunodeficiency virus Active Hepatitis B infection and or Hepatitis C infection\n\nKnown active or prior history of CNS involvement\n\nHistory of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) caused damage to terminal organs or required systemic application of immunosuppressive or other drugs in the past 2 years\n\nPresence of uncontrolled active infection\n\nSubjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study.\n\nSubjects who received allogeneic stem cell therapy.\n\nAny condition that in the opinion of the Investigator, would interfere with evaluation of the IMP.\n\nReceived Bendamustine treatment 1 year prior to Screening Visit.","ALL","18 Years","75 Years",{"count":20,"type":21},81,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed\u002Frefractory multiple myeloma.\n\nRIGEL Study",[27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Neoplasms, Plasma Cell","Neoplasms by Histologic Type","Neoplasms","Hemostatic Disorders","Vascular Diseases","Cardiovascular Diseases","Paraproteinemias","Blood Protein Disorders","Hematologic Diseases","Hemorrhagic Disorders","Lymphoproliferative Disorders","Immunoproliferative Disorders","Immune System Diseases","Multiple Myeloma",[42],"R\u002FR MM, CAR-T","RECRUITING","2024-08-01",{"date":46,"type":47},"2024-08-02","ACTUAL",{"date":49,"type":47},"2024-04-03",{"date":51,"type":21},"2028-04-12",{"name":53,"class":54},"OriCell Therapeutics Co., Ltd.","INDUSTRY",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100530124","phase-1-oricar-017-chimeric-antigen-receptor-car-modified-t-cells-for-the-treatment-of-rrmm-100530124","NCT06182696","OriCAR-017 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of R\u002FRMM","An Open Label,Multi-center Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Autologous T Cell Injection Targeting GPRC5D OriCAR-017 in Patients With Relapsed and\u002For Refractory Multiplemyeloma","Main Inclusion Criteria:\n\n* Diagnosis of R\u002FRMM according to the IMWG criteria;\n* Expected survival period is \\>12 weeks;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2 at the time of ICF signature;\n* The expression of GPRC5D in bone marrow plasma cells membrane is more than 20% by flow cytometry and\u002For immunohistochemistry, multiple myeloma with measurable lesions, and at least one of the following criteria must be met:\n\n  1. Serum M protein \\>5 g\u002FL;\n  2. Urine M protein level \\>200 mg\u002F24 hour;\n  3. Serum free light chain (sFLC) \\>100 mg\u002FL and K\u002Fλ FLC ratio is abnormal;\n  4. Primitive immature or monoclonal plasma cells \\>5% by bone marrow cytology or flow cytometry.\n* Subjects who had received at least 3 prior lines of therapy including (but not limited to) immunomodulatory drugs (IMiDs), proteasome inhibitors, anti-CD38 monoclonal antibodies, etc., but have failed treatment, including those who have experienced relapse (within 12 months), refractory or intolerant to the last line treatment regimen.\n\nMain Exclusion Criteria:\n\n* Smoldering myeloma (asymptomatic)\n* Multiple myeloma with only extramedullary lesions;\n* Plasma cell leukemia;\n* Concurrent amyloidosis;\n* Central nervous system metastasis, leptomeningeal disease or metastatic central compression;\n* HBsAg or HbcAb is positive, and the quantitative detection of hepatitis B virus (HBV) DNA in peripheral blood is more than 100 copies\u002FL; hepatitis C virus (HCV) antibody and HCV RNA in peripheral blood is positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody is positive at Screening; Cytomegalovirus DNA test is positive;\n* Had hypersensitivity or intolerance to any drug\u002Fexcipient (including conditioning chemotherapy) used in this study;\n* Previously received treatment targeting GPRC5D, including but not limited to antibodies, ADC, or CAR-T;\n* Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study;\n* Any uncontrolled active infection within 4 weeks prior to ICF signing or leukapheresis requires parenteral antibiotic, antiviral, or antifungal treatment\n* Major surgery within 28 days prior to Screening Visit with the exception of a biopsy and an insertion of a central venous catheter or during the study;\n* Subjects who received allogeneic stem cell therapy;\n* Subjects complications or other conditions evaluated by investigators may affect compliance with the protocol or make them unsuitable to participate in this study;\n* Pregnant or breastfeeding.",{"count":64,"type":21},83,[24,66],"PHASE2","An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R\u002FRMM",[69],"Relapsed and\u002For Refractory Multiple Myeloma","2024-05-30",{"date":72,"type":47},"2024-05-31",{"date":74,"type":47},"2023-10-26",{"date":76,"type":21},"2028-08-31",{"name":53,"class":54},5,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100489423","phase-1-ori-c101chimeric-antigen-receptor-car-modified-t-cells-for-the-treatment-of-hcc-100489423","NCT05652920","Ori-C101Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of HCC","A Phase Ib\u002FII, Open-Label, Multi-Center Study to Investigate the Safety, PK, and Efficacy of Ori-C101 in Advanced Hepatocellular Carcinoma (HCC) Patients (BEACON)","Inclusion Criteria:\n\n1. Confirmed pathologic or radiologic diagnosis of HCC ;\n2. Tumor tissue GPC3 expression positive by immunohistochemistry(IHC) at the local laboratory (Tumor samples ≤1 years prior to ICF signature are acceptable), if no archived tumor tissue samples, tumor biopsy is required for GPC3 expression test;\n3. Unresectable stage B (intermediate) or C (advanced) HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging. If stage B, must have progressed after, or not be eligible for, surgical or locoregional therapy;\n4. Received at least two prior line of systemic therapy (included but not limited to target therapy, immunotherapy or chemotherapy) with radiologic disease progression during or following systemic therapy;\n5. Child-Pugh A or B7, no history of hepatic encephalopathy;\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the time of ICF signature;\n7. Estimated life expectancy of minimum of 12 weeks;\n8. Must have at least 1 target lesion\n\nExclusion Criteria:\n\n1. Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression;\n2. Prior bone marrow or organ transplantation;\n3. Have a history of another primary malignancy within 5 years prior to starting study treatment. Exceptions here are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ;\n4. Active hepatitis B infection (If Hepatitis B surface antigen \\[HBsAg\\] or Hepatitis B core antibody \\[HBcAb\\] positive, then HBV-DNA must be \\\u003C 20 IU\u002FmL, and HBsAg-positive patients should have been treated with antiviral therapies as per the local guidelines);\n5. Positive hepatitis C (HCV) RNA, Human Immunodeficiency Virus (HIV) antibody, Cytomegalovirus(CMV) DNA or syphilis serology;\n6. Have received prior cell-based therapies such as targeted GPC3 therapy, TCR-T therapy, CAR-T therapy;\n7. Inadequate bone marrow reserve or organ function;\n8. History or current evidence of any condition or disease that could confound the results of the study or, in the opinion of Investigator, is not in the best interest of the patient to participate.\n9. Pregnant or Breast-feeding women.","70 Years",{"count":88,"type":21},105,[24,66],"This is a Phase I, open-label, multi-center study to assess the safety, pharmacokinetics, and preliminary efficacy of GPC3-directed chimeric antigen receptor modified T cells injection (Ori-C101) in Advanced Hepatocellular Carcinoma(HCC).",[92],"Hepatocellular Carcinoma","2024-04-02",{"date":49,"type":47},{"date":96,"type":47},"2022-12-15",{"date":98,"type":21},"2026-12",{"name":53,"class":54},7,""]