[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Excyte Biopharma Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":142},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,40,63,83,102,122],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100610968","phase-1-a-phase-i-study-of-yk012-in-primary-membranous-nephropathy-100610968",false,"NCT07234474","A Phase I Study of YK012 in Primary Membranous Nephropathy","A Phase I Study of YK012, a Humanized CD19 × CD3 Bispecific Antibody, in Participants With Very High-Risk, Refractory Primary Membranous Nephropathy","Inclusion Criteria:\n\n* Age 18-80 (inclusive), both gender.\n* Diagnosed with primary (idiopathic) membranous nephropathy by renal biopsy within 10 years.\n* Participants who meet the criteria of very high-risk primary (idiopathic) membranous nephropathy based on 2021 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Management of Glomerular Diseases and who have failed available therapies for the treatment of pMN.\n* eGFR estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula is ≥45 mL\u002Fmin\u002F1.73 m².\n* If taking angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), or Sodium-Glucose Co-Transporter 2 (SGLT-2) inhibitor, the medication dosage must have been stable (≤50% change in dose) for at least 4 weeks prior to screening and continue being stable prior to the initiation of the investigational product.\n* Laboratory tests within 7 days prior to enrollment meet the pre-defined criteria.\n* Be able to understand and voluntarily participate in this clinical trial with written signed informed consent and available for scheduled visits, treatments, examinations, and other study procedures.\n\nExclusion Criteria:\n\n* Diagnosed with secondary membranous nephropathy.\n* Any prior receipt of protocol-specified pharmacological treatment for membranous nephropathy.\n* History of malignant tumor within 5 years prior to screening.\n* Poorly controlled hypertension.\n* Participants with severe renal insufficiency who have received or require dialysis or kidney transplantation within 6 months prior to the initiation of the investigational product.\n* History of diabetic nephropathy confirmed by renal biopsy.\n* History of severe or chronic infections within 6 months prior to screening or currently infection requiring systemic antibiotic or antiviral therapy.\n* History of cardiovascular event leading to hospitalization within 6 months prior to screening.\n* Other severe or poorly controlled diseases that may affect the protocol compliance or efficacy assessments.\n* Have active tuberculosis with clear evidence of infection.\n* History of substantial organ or bone marrow transplantation.\n* Received live vaccination, underwent major surgery, or participated in other clinical trials and applied any other study drugs within 28 days prior to the initiation of the investigational product.\n* Hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive with hepatitis B virus (HBV) DNA quantification ≥ 1×103 copies\u002FL or ≥ 50 IU\u002FL (HBcAb positive participants require regular HBV DNA testing); Hepatitis C virus (HCV) antibody positive; Human immunodeficiency virus (HIV) seropositive; Syphilis helical antibody positive.\n* Peripheral blood CD4+ T-lymphocyte count \\\u003C 200 cells\u002FμL.\n* The peripheral blood B-cell count is below the lower limit of normal.\n* Known hypersensitivity to any of the ingredients of YK012.\n* Female participants who are pregnant or breastfeeding, or women of childbearing potential (WOCBP) who have a positive pregnancy test result at screening; or those who plan to have children during the trial period and for 12 months after the end of the trial, and those who are unwilling to use one or more physical contraceptive methods during the trial period and for 12 months after the end of the trial.\n* Other conditions that the investigator considers inappropriate for participation in this trial.","ALL","18 Years","80 Years",{"count":20,"type":21},66,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics(PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YK012 in participants with primary membranous nephropathy (pMN).",[27],"Primary Membranous Nephropathy","NOT_YET_RECRUITING","2026-02-04",{"date":31,"type":32},"2026-02-05","ACTUAL",{"date":34,"type":21},"2026-10",{"date":36,"type":21},"2028-02",{"name":38,"class":39},"Excyte Biopharma Ltd","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100593776","phase-1-study-of-yk012-in-moderate-to-severe-systemic-lupus-erythematosus-100593776","NCT07010835","Study of YK012 in Moderate to Severe Systemic Lupus Erythematosus","A Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of YK012 in the Treatment of Moderate to Severe Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive) at screening, regardless of sex\n* Meet the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria for SLE, with a confirmed SLE diagnosis for at least 24 weeks at screening\n* Positive for anti-dsDNA antibody and\u002For antinuclear antibody (ANA) and\u002For anti-Smith antibody at screening, as determined using the local laboratory's reference ranges at the study site\n* Medium to high disease activity at screening, defined as: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥7\n* Receiving stable background therapy at screening\n* Capable of understanding and voluntarily participating in this clinical trial, having provided written informed consent, and able to comply with scheduled visits, treatments, examinations, and other study procedures.\n\nExclusion Criteria:\n\n* Known allergy to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to the investigational drug or any of its components\n* Received any anti-CD19\u002FCD20 therapy or any B-cell depleting agents within 6 months prior to enrollment, or B-cell stimulatory factor inhibitors within 3 months or 5 half-lives prior to enrollment\n* Received TNF inhibitors, interleukin receptor blockers, other small molecules or biologics within 3 months or 5 half-lives prior to enrollment\n* Received intravenous immunoglobulins or plasmapheresis within 3 months prior to enrollment\n* Used traditional Chinese medicines\u002Fherbal preparations for SLE treatment containing within 2 weeks prior to enrollment\n* Received live or attenuated vaccines within 1 month prior to enrollment\n* Has other autoimmune diseases, inflammatory joint diseases, or skin disorders (other than SLE) that may interfere with disease activity assessment\n* History of malignancy within 5 years before screening, except for cured cases with no recurrence for at least 5 years, such as basal cell or squamous cell skin cancer, cervical carcinoma in situ, ductal carcinoma in situ of breast, or papillary thyroid cancer\n* Clinically significant cardiovascular\u002Fcerebrovascular diseases within 6 months prior to screening\n* Presence of QTcF interval prolongation on electrocardiogram (ECG)\n* Presence of poorly controlled hypertension at screening\n* History of non-SLE conditions requiring oral\u002Fintravenous\u002Fintramuscular\u002Fsubcutaneous corticosteroid therapy (\\>2 weeks) within 6 months prior to enrollment\n* Active tuberculosis at screening or untreated latent tuberculosis\n* History of solid organ or bone marrow transplantation\n* Presence of active infections\n* Lupus nephritis requiring protocol-prohibited medications as assessed by the investigator\n* Uncontrolled lupus crisis within 8 weeks prior to screening\n* History of central nervous system (CNS) disorders\n* Presence of clinically unstable or uncontrolled medical conditions at screening\n* Presence of clinically significant abnormal laboratory test results\n* Presence of active viral infections (e.g., hepatitis B, hepatitis C, HIV, or active syphilis)\n* Had major surgery within 4 weeks prior to enrollment or planned during study;\n* Participation in other interventional clinical trials within 4 weeks prior to enrollment\n* Pregnant or lactating women, or individuals with pregnancy plans during the study and within a specified period after treatment who are unwilling to use effective contraception\n* Other conditions deemed by investigators to preclude study participation.","75 Years",{"count":49,"type":21},189,[24,51],"PHASE2","The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of YK012 in participants with Moderate to Severe Systemic Lupus Erythematosus (SLE).",[54],"Systemic Lupus Erythematosus (SLE)","RECRUITING",{"date":31,"type":32},{"date":58,"type":32},"2025-08-25",{"date":60,"type":21},"2028-12",{"name":38,"class":39},1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100560240","phase-1-a-study-of-ykst02-in-participants-with-relapsed-or-refractory-multiple-myeloma-100560240","NCT06574568","A Study of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma","A Multicenter, Open-label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Efficacy of YKST02 in Participants With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Participants or their legally acceptable representative must sign an ICF indicating that the participants understand the purpose of, and procedures required for the study and are willing to participate in the study.\n2. Diagnosis of multiple myeloma according to the IMWG criteria.\n3. Receipt of at least two prior classes of drugs either in separate regimens or as combinations. The three classes are defined as: An immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug.\n4. Measurable disease at screening, as defined by at least 1 of the following:\n\n   1. Serum M-protein ≥0.5 g\u002FdL;\n   2. Urinary M-protein excretion ≥200 mg\u002F24 hours;\n   3. Abnormal serum free light chain (FLC) ratio ( \\\u003C0.26 or \\>1.65) and serum immunoglobulin FLC≥10 mg\u002FdL.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-1.\n6. An estimated survival time of more than 12 weeks.\n7. Recovery to Grade 0-1 (Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0) from adverse events related to prior therapy except alopecia.\n8. Adequate hematological and organ function.\n9. Female participants of childbearing potential must have a negative serum pregnancy test at screening. Female patients who are sexually active must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.\n10. Male participants must agree to use reliable methods of contraception (barrier methods or sexual abstinence) and avoid sperm donation throughout the study period and until 3 months after the last dose.\n\nExclusion Criteria:\n\n1. Plasma cell leukemia (\\>2.0×10\\^9\u002FL plasma cells by standard differential), Waldenstrom's Macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary light-chain amyloidosis.\n2. History of antitumor therapy as follows, before the first dose of study drug:\n\n   1. Targeted therapy with small molecule drug within 2 weeks or 5 half-lives, whichever is longer;\n   2. Targeted therapy with macromolecular drug or Immunomodulatory agent therapy within 2 weeks;\n   3. Chemotherapy within 2 weeks;\n   4. Treatment with an investigational drug within 2 weeks or 5 half-lives, whichever is shorter;\n   5. Radical\u002Fextensive radiotherapy within 4 weeks, or local palliative radiotherapy within 2 weeks, or acute toxicity induced by previous radiotherapy have not recovered to grade ≤1;\n   6. Autologous stem cell transplantation within 12 weeks;\n   7. History of organ transplant, or allogeneic stem cell transplantation within 6 months;\n   8. Prior treatment with any B cell maturation antigen (BCMA) targeted therapy;\n   9. Prior treatment with any BCMA targeted chimeric antigen receptor modified \\[CAR\\]-T cells therapy.\n3. Any active acute graft-versus-host disease (GvHD), grade 2-4 (according to Glucksberg criteria) or active chronic GvHD requiring systemic treatment within 2 weeks.\n4. Prior myelodysplastic syndrome or malignancy within 5 years, except for localized malignancies that have been adequately treated or free of the disease for ≥ 5 years, e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-muscle invasive bladder cancer, localized prostate cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast.\n5. Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma, or other evidence of uncontrolled metastases to the CNS or meninges, judged by the investigator.\n6. (a) History of or current relevant CNS pathology as epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis; (b) Evidence for presence of inflammatory lesions and\u002For vasculitis on cerebral MRI.\n7. History or evidence of cardiovascular disease, including:\n\n   1. Acute coronary syndromes (eg, myocardial infarction, unstable angina) within 6 months prior to enrollment;\n   2. Coronary angioplasty or stenting within 6 months prior to enrollment;\n   3. Clinically significant unstable arrhythmias (eg, atrial fibrillation), however, atrial fibrillation has been controlled for over 30 days prior to the first dose of YKST02 were allowed;\n   4. New York Heart Association (NYHA) stage III or higher congestive heart failure within 6 months prior to enrollment; Cardiac valve morphological abnormalities recorded by ECHO (≥ grade 2), note that grade 1 cardiac valve morphological abnormalities (such as mild regurgitation\u002Fstenosis) were allowed, but participants with moderate valve thickening were excluded;\n   5. Left ventricular ejection fraction (LVEF) below lower limit of the study center, or LVEF\\\u003C50% if there is no lower limit at the study center;\n   6. The Fridericia-corrected QT interval (QTcF) ≥ 470 msec (female) or ≥ 450 msec (male)；\n   7. Implantable defibrillator;\n   8. Clinically uncontrollable hypertension (i.e., SBP≥160 mm Hg and\u002For DBP≥100 mm Hg).\n8. Known allergy to monoclonal antibody drugs or exogenous immunoglobulin.\n9. Any major organ surgery or significant trauma within 4 weeks prior to the first dose of YKST02, or those requiring elective surgeries during the study, and all AEs associated with surgery or significant trauma have not recovered before the first dose of the YKST02.\n10. Regular dose of systemic corticosteroids during 4 weeks prior to initiation of study drug, or anticipated need of corticosteroids exceeding prednisone 20 mg\u002Fday or equivalent during the trial, or any other systemic immunosuppressive therapy within 4 weeks prior to study entry.\n11. Virological tests: Hepatitis B virus surface antigen (HBsAg) positive and\u002For hepatitis B core antibody (HBcAb) positive, and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) quantitative \\>ULN of the testing institution; Hepatitis C antibody (HCV-Ab) positive and hepatitis C virus-RNA (HCV-RNA) quantitative \\> ULN of the testing institution; Anti-human immunodeficiency virus (Anti-HIV) positive. Participants will be excluded from the study if any of the above criteria is met.\n12. Uncontrolled active infections requiring oral or intravenous systemic therapy, except for local treatment.\n13. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently).\n14. Pregnant or lactating women.\n15. Known mental disorder that may affect study compliance or poor compliance.\n16. Receipt of any live attenuated vaccines or live virus vaccine within 4 weeks prior to the first dose of study treatment.\n17. Other serious systemic diseases or laboratory abnormalities or other reasons that the investigator believes are not appropriate for participating the study.",{"count":71,"type":21},70,[24],"This study aims to provide a basis for further clinical development of YKST02. YKST02 is a study medicine that targets multiple myeloma and activates the human body to fight against this disease.",[75],"Relapsed or Refractory Multiple Myeloma",{"date":31,"type":32},{"date":78,"type":32},"2024-06-14",{"date":80,"type":21},"2027-06-30",{"name":38,"class":39},12,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":101,"locationsCount":82},"100560680","phase-1-study-of-yk012-in-b-cell-acute-lymphoblastic-leukemia-100560680","NCT06580301","Study of YK012 in B-cell Acute Lymphoblastic Leukemia","An Open-Label, Multi-Center, Phase Ib\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YK012 in Participants With B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Participants or their legally acceptable representative must sign an ICF indicating that the participants understand the purpose of, and procedures required for the study and are willing to participate in the study.\n2. Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.\n3. An estimated survival time of more than 12 weeks.\n4. A definitive diagnosis of CD19-positive B-cell acute lymphoblastic leukemia with any of the following conditions:\n\n   1. Ph-negative B-ALL with any of the following: i. Failure to achieve complete remission after initial induction therapy. ii. Failure to achieve complete remission after salvage treatment. iii. Relapse with first remission duration ≤12 months. iv. Second or later relapse. v. Relapse after hematopoietic stem cell transplantation (HSCT).\n   2. Ph-positive B-ALL: failure to 1 or more tyrosine kinase inhibitors (TKIs), or intolerance to treatment with TKIs, or with the T315I mutation.\n5. ≥ 5% blasts in the bone marrow by morphologic assessment.\n6. Recovery to Grade 0-1 (Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0) from adverse events related to prior therapy except alopecia.\n7. Adequate hematological and organ function.\n8. Female participants of childbearing potential must have a negative serum pregnancy test at screening. Female patients who are sexually active must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.\n9. Male participants must agree to use reliable methods of contraception (barrier methods or sexual abstinence) and avoid sperm donation throughout the study period and until 3 months after the last dose.\n\nExclusion Criteria:\n\n1. Burkitt´s Leukemia according to World Health Organization (WHO) classification.\n2. History of antitumor therapy as follows, before the first dose of study drug:\n\n   1. Targeted therapy with small molecule drug within 2 weeks or 5 half-lives, whichever is longer\n   2. Targeted therapy with macromolecular drug or Immunomodulatory agent therapy within 3 weeks\n   3. Radiotherapy or chemotherapy (except for intrathecal chemotherapy and dexamethasone), or treatment with Chinese traditional\u002Fpatent medicine that has definite antitumor effect within 2 weeks\n   4. Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is shorter\n   5. Receipt of any live attenuated vaccines or live virus vaccine within 4 weeks\n   6. Autologous stem cell transplantation within 6 weeks\n   7. History of organ transplant, or allogeneic stem cell transplantation within 12 weeks.\n3. Any active acute graft-versus-host disease (GvHD), grade 2-4 (according to Glucksberg criteria) or active chronic GvHD requiring systemic treatment.\n4. Other malignancy within 5 years, except localized malignancies that have been adequately treated or free of the disease for ≥ 5 years, e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-muscle invasive bladder cancer, localized prostate cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast.\n5. Active central nervous system (CNS) involvement or meningeal involvement with clinical signs, or other evidence of uncontrolled metastases to the CNS or meninges, judged by the investigator.\n6. a. History of or current relevant CNS pathology as epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis. b. Evidence for presence of inflammatory lesions and\u002For vasculitis on cerebral MRI.\n7. History or evidence of cardiovascular disease, including:\n\n   1. Acute coronary syndromes (e.g., myocardial infarction, unstable angina)\n   2. Coronary angioplasty or stenting within 6 months prior to enrollment\n   3. Clinically significant unstable arrhythmias (e.g., atrial fibrillation), however, atrial fibrillation has been controlled for over 30 days prior to the first dose of YK012 were allowed\n   4. New York Heart Association (NYHA) stage III or higher congestive heart failure\n   5. Left ventricular ejection fraction (LVEF) below lower limit of the study center, or LVEF\\\u003C50% if there is no lower limit at the study center\n   6. The Fridericia-corrected QT interval (QTcF, mean of triplicate measurements) ≥ 470 msec (female) or ≥ 450 msec (male)\n   7. Implantable defibrillator\n   8. Clinically uncontrollable hypertension (i.e., SBP≥160 mm Hg and\u002For DBP≥100 mm Hg).\n8. Known allergy to monoclonal antibody drugs or exogenous immunoglobulin.\n9. History of CD19 targeted therapy and positive test result for immunogenicity of YK012 at screening.\n10. Any major organ surgery or significant trauma within 4 weeks prior to the first dose of YK012, or those requiring elective surgeries during the study, and all AEs associated with surgery or significant trauma have not recovered to Grade ≤1 or baseline graded by CTCAE v5.0 before the first dose of the YK012.\n11. Regular dose of systemic corticosteroids during 4 weeks prior to initiation of study drug, or anticipated need of corticosteroids exceeding prednisone 20 mg\u002Fday or equivalent during the trial, or any other immunosuppressive therapy within 4 weeks prior to study entry.\n12. Virological tests: Hepatitis B virus surface antigen (HBsAg) positive and\u002For hepatitis B core antibody (HBcAb) positive, and hepatitis B virus (HBV) deoxyribonucleic acid (DNA)\\>ULN of the testing agency; Hepatitis C antibody (HCV-Ab) positive and hepatitis C virus-RNA (HCV-RNA)\\>ULN of the testing agency; Anti-human immunodeficiency virus (Anti-HIV) positive. Participants will be excluded from the study if any of the above criteria is met.\n13. Uncontrolled active infections requiring oral or intravenous systemic therapy, except for local treatment.\n14. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently).\n15. Pregnant or lactating women.\n16. Known mental disorder that may affect study compliance or poor compliance.\n17. Other serious systemic diseases or laboratory abnormalities or other reasons that the investigator believes are not appropriate for participating in the study.",{"count":91,"type":21},46,[24,51],"The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YK012 administered as monotherapy in participants with B-cell acute lymphoblastic leukemia (B-ALL).",[95],"B-cell Acute Lymphoblastic Leukemia",{"date":97,"type":32},"2026-02-06",{"date":99,"type":32},"2024-09-25",{"date":80,"type":21},{"name":38,"class":39},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":62},"100559558","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-yk012-100559558","NCT06565689","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012","A Multi-center, Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Written informed consent obtained from the patient prior to performing any study-related procedures, including screening visits.\n2. Males or females aged ≥ 18 to ≤ 65 years.\n3. Participants with an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 1.\n4. Participants with an estimated survival time of more than 12 weeks.\n5. Participants with relapsed or refractory B-NHL. These patients' disease history must meet the following World Health Organization (WHO) diagnostic subtypes of B-NHL : follicular lymphoma (FL), MALT lymphoma, lymphoplasmacytic lymphoma (LPL), mantle cell lymphoma (MCL), small lymphocytic lymphoma (SLL), diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), grey zone lymphoma, Burkitt lymphoma.\n6. Participants have previously received rituximab Treatment (unless rituximab is intolerant) and at least second-line therapy.\n7. Participants with at least one evaluable tumor lesion per the Lugano 2014 criteria, i.e., a lymph node lesion \\> 15 mm in long diameter or an extranodal lesion \\> 10 mm in long diameter according to computed tomography (CT) cross-sectional imaging.\n8. Adverse reactions caused by previous treatment have recovered to below level 1 assessed by NCI CTCAE v5.0 before screening (except hair loss).\n9. Participants with essentially normal function of hematology, liver, and kidney function.\n10. Female participants of childbearing potential must have a negative blood pregnancy test and agree to use reliable methods of contraception (hormonal or barrier methods or sexual abstinence) with their partner throughout the study period and until 3 months after the last dose.\n11. Male participants must agree to use reliable methods of contraception (barrier methods or sexual abstinence) and avoid sperm donation throughout the study period and until 90 days after the last dose.\n\nExclusion Criteria:\n\n1. Participants who meet any of the following exclusion criteria will not be included in this study:\n\n   Treatment with biologic targeted therapy or anti-tumor immunotherapy within 4 weeks prior to the first dose of YK012; Participants who have received chemotherapy within 4 weeks prior to the first dose of YK012; Participants who have received small molecule targeted agents within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of YK012; Participants who have received other investigational agents within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of YK012; Participants who have received radical\u002Fextensive radiotherapy within 4 weeks prior to the first dose of YK012, or local palliative radiotherapy within 2 weeks prior to the first dose of YK012, or acute toxicity induced by previous radiotherapy have not recovered to grade ≤1; Participants who have received autologous HSCT within 12 weeks prior to the first dose of YK012; Participants who have received allogeneic HSCT or organ transplant; Participants who have received chimeric antigen receptor T cell (CAR-T) immunotherapy.\n2. History of malignancy other than B-cell NHL within 5 years prior to study entry, except for local cancers that have been clearly cured or have been free of disease for at least 5 consecutive years.\n3. Participants with clinically symptomatic metastases to the central nervous system or meninges, or other evidence of uncontrolled metastases to the CNS or meninges, judged by the Investigator.\n4. a) History of or current relevant CNS pathology as epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis; b) Evidence for presence of inflammatory lesions and\u002For vasculitis on cerebral MRI.\n5. Participants with a history or evidence of serious cardiovascular disease, including but not limited to:\n\n   Acute coronary; Coronary angioplasty or stent implantation within 6 months prior to first dose of YK012; Clinically significant unstable arrhythmias (e.g., atrial fibrillation) , however, whose atrial fibrillation have been controlled for over 30 days prior to the first dose of YK012 were allowed to be enrolled; Severe cardiac rhythm abnormalities; Grade III or higher congestive heart failure as defined by the New York Heart Association (NYHA) standards; Cardiac valve morphological abnormalities recorded by ECHO (≥ grade 2), those participants with grade 1 cardiac valve morphological abnormalities (such as mild regurgitation\u002Fstenosis) were allowed to be enrolled, but participants with moderate valve thickening were excluded; Left ventricular ejection fraction (LVEF) below lower limit of the study center, or LVEF\\\u003C50% if there is no lower limit at the research center; QTcF ≥ 470 msec (female) or ≥ 450 msec (male)； Implantable defibrillator; Participants with clinically uncontrollable hypertension (i.e., SBP≥160 mm Hg and\u002For DBP≥100 mm Hg).\n6. Known allergy to monoclonal antibody drugs or immunoglobulin.\n7. Participants who have undergone any major organ surgery or significant trauma within 4 weeks prior to the first dose of YK012, or those requiring elective surgeries during the study, and all AEs associated with surgery or significant trauma have not recovered before the first dose of the YK012.\n8. Regular dose of systemic corticosteroids during the 4 weeks prior to initiation of study drug or anticipated need of corticosteroids exceeding prednisone 20 mg\u002Fday or equivalent during the trial, or any other systemic immunosuppressive therapy within 4 weeks prior to study entry.\n9. The results of serological testing for the virus are clinically significant as judged by the investigator.\n10. Participants with uncontrolled active infections currently require systemic anti-infective therapy, except for local treatment.\n11. Participants with uncontrollable space effusion (e.g. pleural effusion, abdominal effusion, pericardial effusion, etc.), as judged by the Investigator.\n12. Pregnant or lactating women.\n13. Participants with mental disorders or poor protocol compliance.\n14. Participants who have used live attenuated vaccines within 4 weeks prior to the first dose of YK012.\n15. Participants with any other condition or circumstance that would, in the discretion of the Investigator, make the subject unsuitable for participation in this clinical study.","65 Years",{"count":111,"type":21},48,[24],"This study aims to provide a basis for further clinical development of YK012.",[115],"Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma",{"date":31,"type":32},{"date":118,"type":32},"2023-05-09",{"date":120,"type":21},"2026-12-31",{"name":38,"class":39},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":62},"100591615","phase-1-study-of-yk012-in-primary-membranous-nephropathy-100591615","NCT06982729","Study of YK012 in Primary Membranous Nephropathy","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of YK012 in the Treatment of Primary Membranous Nephropathy","Inclusion Criteria:\n\n* Aged 18 to 80 years (inclusive), regardless of gender.\n* Kidney biopsy-confirmed diagnosis of primary (idiopathic) membranous nephropathy within the past 10 years.\n* Elevated 24-hour urine protein, meeting the pre-defined criteria.\n* Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73m² as calculated by the CKD-EPI equation.\n* If currently taking an angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blocker (ARB), or sodium-glucose cotransporter-2 (SGLT-2) inhibitor, the dose must have been stable for at least 4 weeks prior to enrollment or since initiation of therapy.\n* Laboratory test results must meet the predefined criteria within 7 days prior to enrollment.\n* Capable of understanding and voluntarily participating in this clinical trial, having provided written informed consent, and able to comply with scheduled visits, treatments, examinations, and other study procedures as required.\n\nExclusion Criteria:\n\n* Diagnosis of secondary membranous nephropathy.\n* Any prior receipt of protocol-specified pharmacological treatment for membranous nephropathy.\n* History of malignancy within 5 years prior to enrollment.\n* Poorly controlled hypertension at enrollment.\n* Severe renal dysfunction with prior dialysis or kidney transplantation within 6 months prior to enrollment.\n* Prior kidney biopsy-confirmed diagnosis of diabetic nephropathy.\n* History of severe or chronic infections within the 6 months before enrollment or current need for systemic antibiotic or antiviral therapy.\n* Cardiovascular or cerebrovascular events requiring hospitalization within 6 months prior to enrollment.\n* Severe or poorly controlled comorbidities that may affect protocol compliance or efficacy evaluation.\n* Active Tuberculosis (TB) with documented evidence of infection.\n* History of solid organ or bone marrow transplantation.\n* Live vaccination, major surgery, or participated in other clinical trials with investigational drug use within 28 days prior to enrollment.\n* HBsAg-positive, or HBcAb-positive with detectable HBV DNA above the normal range; HCV antibody-positive; HIV seropositive; Treponema pallidum antibody-positive.\n* CD4+ T lymphocyte count \\\u003C200 cells\u002FμL\n* Known hypersensitivity to any component of YK012.\n* Pregnancy, breastfeeding, or positive pregnancy test at screening; or plans to become pregnant during the trial or within 12 months after study completion, or unwillingness to use physical contraceptive methods during the study and for 12 months thereafter.\n* Other conditions deemed by the investigator to make the subject unsuitable for participation in this study.",{"count":130,"type":21},72,[24],"The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YK012 in participants with primary membranous nephropathy (PMN).",[27],"2025-11-14",{"date":136,"type":32},"2025-11-17",{"date":138,"type":32},"2025-03-08",{"date":140,"type":21},"2027-12",{"name":38,"class":39},""]