[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Imbioray (Hangzhou) Biomedicine Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100599643","phase-2-a-study-of-ibr854-combined-with-pazopanib-versus-pazopanib-in-advanced-renal-cell-carcinoma-100599643",false,"NCT07087158","A Study of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma","A Multicenter, Randomized, Open-Label, Active-Controlled Phase II Study Evaluating the Efficacy and Safety of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Male or female, age ≥ 18 years old\n2. Advanced clear cell renal cell carcinoma confirmed by histology or cytology and not amenable to curative surgery.\n3. Has not received any previous systemic anti-tumor treatment for advanced renal cell carcinoma.\n4. Expected survival period is at least 3 months.\n5. ECOG performance status of 0 or 1, or KPS score of at least 70.\n6. Has measurable disease per RECIST 1.1.\n7. Organ function should meet the following criteria:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL; Platelet (PLT) ≥90×10\\^9\u002FL; Hemoglobin (Hb) ≥ 90 g\u002FL (no blood transfusion or hematopoietic stimulator treatment within 7 days).\n   2. Albumin ≥ 30 g\u002FL; Total bilirubin ≤1.5×ULN (for subjects with Gilbert's syndrome, it can be ≤3×ULN); ALT and AST ≤1.5×ULN (If liver metastasis is combined, ALT and AST≤3×ULN).\n   3. Creatinine (Cr) ≤1.5 × ULN; Creatinine clearance (Ccr) (to be calculated only when Cr \\> 1.5× ULN) \\> 50 ml\u002Fmin (Cockcroft-Gault formula).\n   4. Activated partial thrombin time (APTT) ≤1.5×ULN, International normalized ratio (INR) ≤1.5×ULN.\n8. Voluntarily sign the informed consent form, understand the study and be willing to follow the protocol and complete all experimental procedures.\n\nExclusion Criteria:\n\n1. Documented central nervous system metastases.\n2. Received prior antineoplastic therapy (including chemotherapy, biologic therapy, immunotherapy, or Chinese traditional medicines with antitumor indications) before the first dose of study treatment.\n3. Has received major surgery (grade 3 or 4 as defined in the Measures for the Administration of Clinical Application of Medical Technology) within 28 days before the first dose of study treatment and has not yet recovered from which; or any planned curative surgery for renal cell carcinoma during the study.\n4. History of another malignancy within 5 years before the first dose of study treatment, except for Lung carcinoma in situ, low-risk early-stage prostate cancer, or cured basal-cell carcinoma, squamous-cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid carcinoma.\n5. Clinically significant gastrointestinal abnormalities such as malabsorption syndrome, major gastric or small-bowel resection that may affect drug absorption, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other conditions increasing the risk of perforation; or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days before the first dose of study treatment.\n6. Systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive agents required within 2 weeks before the first dose or anticipated during study treatment, except for:\n\n   1. Topical, intranasal, or inhaled corticosteroids.\n   2. Corticosteroids as premedication for infusion-related or hypersensitivity reactions (e.g., premedication for CT imaging).\n   3. Replacement therapy such as levothyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency.\n   4. Low-dose corticosteroids for orthostatic hypotension.\n7. Clinically significant cardiovascular or cerebrovascular disease documented by any of the following:\n\n   1. Ischemic stroke (excluding silent lacunar infarction) or severe thromboembolic event within 6 months before the first dose of study treatment.\n   2. Myocardial infarction, unstable angina, congestive heart failure, or clinically significant arrhythmia within 6 months before the first dose of study treatment.\n   3. New York Heart Association (NYHA) class ≥ II heart failure before the first dose of study treatment.\n   4. QTcF interval \\>450 ms (men) or \\>470 ms (women) before the first dose of study treatment.\n   5. Left-ventricular ejection fraction (LVEF) ≤50 % before the first dose of study treatment.\n8. Prior organ transplant, except corneal transplant; prior allogeneic stem-cell transplant.\n9. Hepatitis B surface antigen (HBsAg) positive with HBV DNA \\>500 IU\u002FmL or \\>2,500 copies\u002FmL, or hepatitis C antibody positive with detectable HCV RNA, or known HIV infection, or active tuberculosis.\n10. Interstitial lung disease or non-infectious pneumonitis that is currently symptomatic or has previously required systemic corticosteroids, in the opinion of the investigator likely to interfere with toxicity assessment or management.\n11. Any severe, progressive, or uncontrolled medical condition that, in the investigator's judgment, makes the subject unsuitable for the study, including but not limited to:\n\n    1. Infection requiring systemic therapy.\n    2. Symptomatic pleural, pericardial, or ascitic fluid requiring or having undergone drainage within 2 weeks before the first dose (minimal asymptomatic effusion, third-spacing due to hypoalbuminaemia, or cases where benefit outweighs risk may be allowed).\n    3. History of coagulopathy (e.g., deep-vein thrombosis) or severe bleeding diathesis; clinically significant bleeding event (e.g., gastrointestinal bleeding) within 1 month before the first dose.\n    4. History of severe psychiatric disorder.\n    5. Any other condition that, in the investigator's opinion, renders study participation riskier than beneficial.\n12. Prior grade 3-4 immune-related adverse events that, in the investigator's judgment, should be excluded.\n13. Severe allergic or hypersensitivity disorders, significant drug allergies (including to investigational agents), or known hypersensitivity to any component of the study drug, including severe reactions to monoclonal antibodies.\n14. Participation in another clinical trial and receipt of an investigational agent within 28 days before the first dose of study treatment.\n15. Clinically significant organ dysfunction or comorbidity likely to interfere with protocol adherence.\n16. Live vaccine received within 30 days before the first dose, or planned during the study or within 1 month after the last dose.\n17. Pregnant or breast-feeding women (women who agree to discontinue breast-feeding before signing informed consent may be enrolled).\n18. Any other condition or circumstance that, in the investigator's opinion, unsuitable for participation.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a multicenter, randomized, open-label, active-controlled Phase II clinical study evaluating the efficacy and safety of IBR854 combined with Pazopanib versus Pazopanib in Advanced Renal Cell Carcinoma.",[26],"Renal Cell Carcinoma (RCC)",[28],"IBR854","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2025-09-08",{"date":37,"type":20},"2026-12-31",{"name":39,"class":40},"Imbioray (Hangzhou) Biomedicine Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100598618","phase-1-the-safety-tolerability-and-efficacy-of-ibr900-cell-injection-in-relapsedrefractory-b-cell-non-hodgkin-lymphoma-100598618","NCT07073833","The Safety, Tolerability, and Efficacy of IBR900 Cell Injection in Relapsed\u002FRefractory B-cell Non Hodgkin Lymphoma","An Open Label, Multicenter Phase I Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of IBR900 Cell Injection in the Treatment of Relapsed\u002FRefractory CD20 Positive B-cell Non Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form, understand the study and be willing to follow the protocol and complete all experimental procedures;\n2. Male or female, age ≥ 18 years old;\n3. CD20 positive B-cell non Hodgkin's lymphoma (B-NHL), including but not limited to diffuse large B-cell lymphoma non-specific, high-grade B-cell lymphoma with MYC and BCL2 rearrangements, high-grade B-cell lymphoma with MYC\u002FBCL2\u002FBCL6 rearrangements, high-grade B-cell lymphoma non-specific, primary mediastinal B-cell lymphoma, grade 3b follicular lymphoma, indolent B-cell lymphoma (mantle cell lymphoma (MCL), marginal zone B-cell lymphoma (MZL)), slow lymphocytic transformed large B-cell lymphoma with previous treatment of anthracycline containing drugs and rituximab or other CD20 targeted therapies, that meets the criteria of the 2022 WHO classification of lymphoid tissue tumors. Adequate treatment with medication. Among them, inert B-NHL must have received at least 2 lines or more of standard treatment failure, while invasive B-NHL must have received at least 1 line or more of standard treatment failure. At least one regimen contains anti-CD20 monoclonal antibody monotherapy or combination therapy; Note: Relapse is defined as disease progression after sufficient treatment to achieve remission (CR or PR), with at least one regimen containing anti-CD20; Difficult to treat is defined as disease progression (PD or SD) within 6 months after full treatment with an anti-CD20 regimen without remission, or during the treatment period\u002Fafter the end of full treatment;\n4. At least one measurable tumor lesion. Measurable lesions (2014 Lugano lymphoma efficacy evaluation criteria): longest diameter of lymph nodes\\>15mm, extranodal lesions\\>10mm; lesions that have received local treatment such as radiotherapy before, if disease progression has been proven, are considered measurable lesions;\n5. The ECOG score for physical fitness status ranges from 0 to 2 points;\n6. Female or male participants of childbearing age should agree to have no fertility plans and take effective contraceptive measures within 6 months from the signing of the ICF until the last dose of the study drug is used;\n7. Expected survival period is at least 3 months.\n\nExclusion Criteria:\n\n1. Patients with current or previous primary central nervous system lymphoma (PCNSL) or secondary central nervous system involvement. Patients with central nervous system symptoms must undergo lumbar puncture and magnetic resonance imaging (MRI) examination to exclude them;\n2. Patients who have received allogeneic hematopoietic stem cell transplantation and other organ transplantation, or who have received autologous hematopoietic stem cell transplantation within 100 days before the first dose;\n3. Receive attenuated live vaccine within 4 weeks before the first administration or plan to receive it during the study period;\n4. Patients with a history of malignant tumors within the past 5 years, except for those who have been completely cured of basal cell carcinoma of the skin or squamous cell carcinoma of the skin, melanoma in situ, and cervical carcinoma in situ, and\u002For any malignant tumor patients who have been cured without disease or have had no disease for at least 5 consecutive years;\n5. Patients with active autoimmune diseases or a history of possible recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or high-risk patients. But the following patients may be considered for inclusion if the researchers assess disease stability: autoimmune hypothyroidism that only requires hormone replacement therapy; Skin diseases that do not require systemic treatment (such as eczema, rash that accounts for less than 10% of the body surface);\n6. Patients who have undergone major surgery within 28 days prior to the first administration or are expected to undergo major surgery during the study period;\n7. Subjects who require systemic corticosteroid treatment (\\>10mg\u002Fday prednisone or equivalent) or other immunosuppressive drugs within 7 days prior to the first administration or during the study period, but excluding topical corticosteroids via nasal spray, inhalation, or other routes, or systemic corticosteroids at physiological doses;\n8. Subjects with active deep vein thrombosis or pulmonary embolism within the first 6 months of screening;\n9. Patients currently suffering from interstitial lung disease or non infectious pneumonia, with active tuberculosis infection;\n10. Systemic diseases not stably controlled after treatment, such as diabetes, serious organic cardiovascular and cerebrovascular diseases;\n11. The patient's heart meets any of the following conditions: left ventricular ejection fraction (LVEF) ≤ 55%; New York Heart Association (NYHA) (see Appendix 3) Grade II or above congestive heart failure or active heart disease; Serious arrhythmias that require treatment (excluding atrial fibrillation and paroxysmal supraventricular tachycardia that have been determined by the researchers to have no impact on the trial); QTc interval ≥ 450ms for males and ≥ 470ms for females (QTc formula in Appendix 4); Within 6 months prior to administration, there has been a myocardial infarction or bypass or stent surgery; Other heart diseases deemed unsuitable for inclusion by researchers;\n12. Human immunodeficiency virus (HIV) infection, hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) are positive during screening period, and HBV-DNA is higher than the normal range of the laboratory in the center; Patients who are positive for HCV antibodies during the screening period and have HCV-RNA levels higher than the normal range of the laboratory in their center;\n13. Evidence of uncontrollable and severe active infections during screening (such as sepsis, bacteremia, mycosis, viremia, etc.);\n14. Known subjects who have experienced severe allergic reactions to macromolecular protein preparations\u002Fmonoclonal antibodies, as well as any components of the investigational drug in the past (CTCAE v5.0 grade ≥ 3);\n15. Participated in clinical trials of other intervention drugs or medical devices within 4 weeks prior to the first administration of this study, or is currently undergoing treatment in other clinical trials (excluding non intervention studies);\n16. Patients with a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance;\n17. Pregnant or lactating women;\n18. History of stroke or intracranial hemorrhage within 6 months;\n19. Active or documented gastrointestinal bleeding within 6 months (such as esophageal or gastric varices, ulcer bleeding);\n20. Researchers believe that patients who are not suitable to participate in the trial due to other reasons, such as rapid disease progression during the screening period.",{"count":50,"type":20},40,[52],"PHASE1","This is an open label clinical study: Phase Ia is a dose escalation phase, evaluating the safety, tolerability, RP2D, PK characteristics, and preliminary efficacy of IBR900 cell injection in the treatment of relapsed\u002Frefractory B-cell non Hodgkin lymphoma (NHL); Phase Ib is the dose expansion stage, which is divided into two parts: monotherapy expansion (queue 1) and combination expansion (queue 2). The monotherapy expansion part evaluates the safety, tolerability, and preliminary efficacy of IBR900 cell injection in the treatment of relapsed\u002Frefractory CD20 positive B-cell non Hodgkin lymphoma, while the combination expansion part evaluates the safety, tolerability, and preliminary efficacy of IBR900 cell injection combined with CD20 monoclonal antibodies in the treatment of relapsed\u002Frefractory CD20 positive B-cell non Hodgkin lymphoma.",[55],"Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma",{"date":32,"type":33},{"date":58,"type":33},"2025-07-01",{"date":60,"type":20},"2028-07-30",{"name":39,"class":40},2,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":41},"100534136","phase-1-study-of-ibr733-cell-injection-in-acute-myeloid-leukemia-100534136","NCT06234904","Study of IBR733 Cell Injection in Acute Myeloid Leukemia","An Open-label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBR733 Cell Injection in Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Subjects volunteer to participate in this clinical study, are fully aware of the study and have signed the Informed Consent Form (ICF). Subjects are willing to follow and able to complete all trial procedures.\n2. Age: 18-74 (both inclusive), female or male.\n3. Patients with AML (including secondary AML) diagnosed according to the WHO 2022 criteria.\n4. Patients with AML who meet one of the following criteria: (1) Relapsed AML: reoccurrence of leukemia cells in peripheral blood or ≥5% blasts in bone marrow after complete remission (excluding other causes such as bone marrow regrowth after consolidation chemotherapy); (2) Refractory AML: treatment-naive patients who failed to respond to 2 courses of standard treatment; The patients relapsed within 12 months after consolidated intensive treatment; Patients who relapsed after 12 months but failed to respond to conventional chemotherapy (only once); Patients who are relapsed twice; (3) Patients received up to 3 additional cycles of chemotherapy or targeted therapy after the diagnosis of relapsed\u002Frefractory AML.\n5. Eastern Cooperative Oncology Group (ECOG) score ≤2.\n6. Subjects of reproductive age and their partners should agree to have no family planning and to use effective contraceptive methods for 6 months from signing the ICF until the last dose of the study drug is administered.\n7. Expected survival time ≥3 months.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia.\n2. Chronic myeloid leukemia with myeloid blast crisis.\n3. Clinically symptomatic central nervous system involvement (no need for lumbar puncture).\n4. Subjects who have undergone an allogeneic hematopoietic stem cell transplantation or other organ transplantation.\n5. Subjects who have undergone autologous hematopoietic stem cell transplantation less than 3 months before the first dose of treatment.\n6. Subjects who have received cell immunotherapy such as chimeric antigen receptor-modified T cells (CAR-T), chimeric antigen receptor-natural killer cells (CAR-NK), and T cell receptor gene-modified T cells (TCR-T).\n7. Subjects who have received systemic antitumor therapy (except hydroxyurea) within 2 weeks before the first dose of study drug, including chemotherapy, immunotherapy, etc..\n8. Subjects who have had other malignant tumors within 3 years before inclusion, except for any type of carcinoma in situ that has been cured in the past and cured skin basal cell carcinoma or skin squamous cell carcinoma.\n9. The absolute peripheral blood blast count (ABC) \\> 40.0×10\\^9\u002FL (ABC= total white blood cell count × blast %). The total white blood cell count can be controlled with hydroxyurea, but it must be stopped three days before the first dose of study drug or lymphodepletion.\n10. Organ function: (1) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\\>3 times upper limit of normal (ULN); If AST was elevated due to leukemia but liver function was normal (e.g., normal ALT, alkaline phosphatase, and direct\u002Findirect bilirubin measurements), participants could be enrolled after investigator consent was obtained; (2) Serum total bilirubin \\>2.5×ULN (not applicable to patients with Gilbert's syndrome); (3) Creatinine clearance \\\u003C45mL\u002Fmin (estimated by Cockcroft-Gault formula) or creatinine \\>2×ULN; (4) Activated partial thromboplastin time \\>1.5×ULN or international normalized ratio \\>1.5×ULN.\n11. Subjects whose cardiac function and disease meet one of the following conditions within 6 months before the first administration: (1) Any risk factors that increase QTcF (Fridericia formula) interval prolongation, such as uncorrectable hypokalemia, hereditary long QT syndrome, and use of drugs that prolong the QTcF interval; (2) New York Heart Association (NYHA) classification ≥Grade 3; (3) Unstable angina pectoris, and myocardial infarction; (4) Left ventricular ejection fraction \\\u003C50% in resting state; (5) Clinically significant pericardial effusion determined by echocardiography.\n12. Subjects who have a history of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) that require systemic immunosuppressive\u002Fsystemic disease modulating drugs within 2 years before the first administration.\n13. Active hepatitis B (e.g., DNA copy number \\> 1000 cps\u002FmL if only hepatitis B surface antigen is positive), active hepatitis C virus infection (anti-hepatitis C antibody positive and HCV RNA positive), or human immunodeficiency virus antibody positive.\n14. Women who are pregnant or lactating.\n15. Subjects who have received major surgery (for the definition of major surgery, refer to the Level 3 and 4 surgeries specified in the Administrative Measures for the Clinical Application of Medical Technology) within 28 days before the first administration.\n16. Subjects who have a history of alcohol, drug use or drug abuse in the past year;\n17. Subjects who have participated in other clinical trials and received any unmarketed investigational drug or treatment within 4 weeks prior to first use of the study drug.\n18. Subjects who are known to be allergic to the main components of the study drug.\n19. Subjects who have other severe, acute, or chronic diseases or laboratory abnormalities that may increase the risk of participating in the study and receiving the study drug, or may interfere with the interpretation of study results.","74 Years",{"count":72,"type":20},18,[52],"This is an open-label clinical study: phase Ia is the dose-escalation part, and phase Ib is the dose-expansion part. The phase Ia study is to evaluate the safety, tolerability, recommended phase II dose, pharmacokinetics, immunogenicity and preliminary efficacy of IBR733 cell injection in relapsed\u002Frefractory acute myeloid leukemia (AML).",[76],"Acute Myeloid Leukemia",[78,79],"AML","R\u002FR AML",{"date":32,"type":33},{"date":82,"type":33},"2024-03-26",{"date":84,"type":20},"2027-07-01",{"name":39,"class":40},""]