[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Base Therapeutics (Shanghai) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":153},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,66,86,108,133],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100641237","early-phase-1-nk521-in-the-treatment-of-advanced-solid-tumors-100641237",false,"NCT07657416","NK521 in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n* Patients with pathologically confirmed relapsed\u002Frefractory advanced solid tumors, including hepatocellular carcinoma and ovarian cancer. Patients enrolled in the intraperitoneal perfusion group (Group B) must have malignant ascites with tumor cells identified in the ascitic fluid.\n* Patients with advanced solid tumors who have received ≥ 1 line of standard therapy.\n* At least one measurable lesion on CT or MRI per RECIST v1.1.\n* ECOG performance status 0-2.\n* Life expectancy ≥3 months.\n* Women of childbearing potential must be non-lactating with a negative serum pregnancy test within 1 week before enrollment; all subjects must agree to use contraception from signing informed consent until 6 months after the last NK521 infusion.\n* Able to comply with the study protocol and follow-up procedures.\n* Voluntarily signed and provided written informed consent.\n\nExclusion Criteria:\n\n* Symptomatic central nervous system (CNS) metastasis and\u002For carcinomatous meningitis.\n* History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or organ transplantation.\n* History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac arrhythmia or conduction abnormality requiring clinical intervention (e.g., ventricular arrhythmia, third-degree atrioventricular block); QTc interval \\>480 ms on 12-lead ECG at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥3 cardiovascular\u002Fcerebrovascular events within 6 months before enrollment; NYHA Class ≥II heart failure or left ventricular ejection fraction (LVEF) \\\u003C50%; uncontrolled hypertension.\n* Received radical radiotherapy within 4 weeks before enrollment; received local palliative radiotherapy within 2 weeks before enrollment.\n* Received cellular antineoplastic therapy within 1 year before dosing; received other antineoplastic therapy outside this protocol within 4 weeks before dosing, including but not limited to chemotherapy, molecular targeted therapy, hormonal therapy, immunotherapy, biotherapy, or Chinese herbal patent medicine with antineoplastic indications.\n* Received blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor therapy within 2 weeks before enrollment.\n* Received systemic therapy with corticosteroids (prednisone \\>10 mg\u002Fday or equivalent) or other immunomodulatory agents (e.g., thymosin, interleukin-2, interferon) within 2 weeks before enrollment. Inhaled or topical corticosteroids are allowed in subjects without active autoimmune disease.\n* Positive virology test for hepatitis B or hepatitis C at screening, meeting any of the following:\n\n  a. HBsAg positive with positive HBV-DNA titer or above upper limit of normal (ULN); b. HCV antibody positive.\n* Meeting any of the following laboratory criteria:a. Hematology: Absolute neutrophil count \\\u003C1.5×10⁹\u002FL; platelet count \\\u003C75×10⁹\u002FL; hemoglobin \\\u003C90 g\u002FL.b. Hepatic function: ALT \\>3×ULN (≥5×ULN for liver metastasis); AST \\>3×ULN (≥5×ULN for liver metastasis); TBIL \\>1.5×ULN, or TBIL \\>2.5×ULN (3.0 mg\u002FdL) for subjects with Gilbert syndrome.c. Renal function: Serum creatinine \\>1.5×ULN or creatinine clearance \\\u003C50 mL\u002Fmin.\n* Any other severe or uncontrolled medical disease, active infection, abnormal physical examination, abnormal laboratory test, altered mental status, or psychiatric disease that, in the investigator's opinion, increases subject risk or affects study results.","ALL","18 Years","65 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","Eligible subjects with advanced hepatocellular carcinoma and ovarian cancer will be divided into two treatment groups based on the volume of ascites. Group A consists of patients with mild ascites, who will receive NK521 via intravenous infusion. Group B includes patients with moderate to severe ascites, who will be treated with investigator-selected systemic regimens combined with intraperitoneal perfusion of NK521.\n\nSystemic and local medications will be administered in accordance with the treatment regimens of respective groups, and the safety of the study drug will be monitored. Preliminary anti-tumor efficacy will be assessed using the RECIST 1.1 criteria at Week 6 after the first infusion of NK521. Catheter placement and ascites drainage will be performed 3 days prior to the first intraperitoneal perfusion of NK521. After the initial intraperitoneal perfusion treatment, the therapeutic effect on ascites will be evaluated per the WHO criteria for ascites assessment.",[26,27,28],"Hepatocellular Carcinoma (HCC)","Ovarian Cancer","Malignant Ascites","NOT_YET_RECRUITING","2026-06-15",{"date":32,"type":33},"2026-06-18","ACTUAL",{"date":35,"type":20},"2026-06",{"date":37,"type":20},"2028-07",{"name":39,"class":40},"Base Therapeutics (Shanghai) Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":41},"100523612","early-phase-1-safety-and-efficacy-of-nk510-to-treat-nsclc-100523612","NCT06097962","Safety and Efficacy of NK510 to Treat NSCLC","First-in-Human Phase I Study of TIGIT-Blocked NK510 Cells in Patients With PD-1 Refractory Advanced NSCLC","Inclusion Criteria:\n\n* Age ≥ 18 years, male or female.\n* For dose expansion group (Group A\u002FB\u002FC):\n\nA. EGFR mutation-negative, ROS1-negative, and ALK-negative; unresectable and non-radiotherapeutic stage III or IV, locally advanced, recurrent or metastatic NSCLC.\n\nB. Disease progression after ≥4 courses of PD-(L)1 blockade ± chemotherapy.\n\n* For pleural perfusion group (Group D1\u002FD2): Advanced NSCLC with malignant pleural effusion ≥500ml (confirmed by B-ultrasound or CT); patients with driver gene-positive and resistant to targeted therapy are acceptable.\n* At least one CT or MRI measurable lesion according to RECIST v1.1.\n* ECOG performance status 0-2.\n* Expected survival ≥3 months.\n* All toxicities from previous anti-tumor therapy (except alopecia and fatigue) resolved to grade 1 (CTCAE v5.0) or baseline; subjects with long-term sequelae from previous therapy (e.g., neuropathy after platinum-based therapy) are acceptable.\n* Fertile females must be non-lactating and have a negative serum pregnancy test within 1 week before enrollment; all subjects (male or female) must agree to use contraception from signing informed consent until 6 months after the last NK510 infusion.\n* Able to comply with the study protocol and follow-up procedures.\n* Voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Symptomatic central nervous system (CNS) metastasis and\u002For carcinomatous meningitis.\n* Active, known or suspected autoimmune diseases (excluding type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic treatment \\[e.g., vitiligo, psoriasis, alopecia\\] or diseases not expected to recur without external triggers).\n* History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac arrhythmia or conduction abnormalities requiring clinical intervention (e.g., ventricular arrhythmia, grade III atrioventricular block); QTc interval \\>480 ms on 12-lead ECG at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade ≥3 cardiovascular and cerebrovascular events within 6 months before enrollment; NYHA cardiac function class ≥II or left ventricular ejection fraction (LVEF) \\\u003C50%; clinically uncontrolled hypertension.\n* Blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor treatment within 2 weeks before enrollment.\n* Systemic treatment with corticosteroids (prednisone \\>10 mg\u002Fday or equivalent) or other immunosuppressive\u002Fimmunomodulatory drugs (e.g., thymosin, interleukin-2, interferon) within 2 weeks before enrollment; inhalation or topical corticosteroids are allowed in subjects without active autoimmune diseases.\n* Known allergy or intolerance to PD-(L)1 blockade.\n* Meeting any of the following laboratory criteria:\n\n  1. Hematology: Neutrophils \\\u003C1.5×10⁹\u002FL; Platelets \\\u003C75×10⁹\u002FL; Hemoglobin \\\u003C90 g\u002FL.\n  2. Liver function: ALT \\>3×ULN (≥5×ULN in patients with liver metastasis); AST \\>3×ULN (≥5×ULN in patients with liver metastasis); TBIL \\>1.5×ULN or \\>2.5×ULN (3.0 mg\u002FdL) in patients with Gilbert syndrome.\n  3. Renal function: Serum creatinine \\>1.5×ULN or creatinine clearance \\\u003C50 mL\u002Fmin.\n* Any other severe or uncontrollable medical diseases, active infections, physical examination abnormalities, laboratory test abnormalities, mental status changes or mental illnesses that increase subject risk or affect study results (assessed by investigator).",{"count":50,"type":20},12,[23],"This study assesses the safety and efficacy of NK510 combined with PD-(L)1 inhibitors for relapsed\u002Frefractory advanced NSCLC, with two administration routes: intravenous infusion and intrapleural perfusion for malignant pleural effusion. Eligible patients need confirmed measurable lesions; intravenous cohort requires EGFR\u002FROS1\u002FALK negativity and disease progression after PD-(L)1 inhibitor treatment, while intrapleural cohort accepts targeted therapy-resistant patients with ≥500ml pleural effusion, and the treatment's safety, efficacy and immune microenvironment changes will be evaluated.",[54],"NSCLC",[56],"Malignant Pleural Effusion","RECRUITING","2026-05-18",{"date":60,"type":33},"2026-05-20",{"date":62,"type":33},"2023-07-01",{"date":64,"type":20},"2026-07-01",{"name":39,"class":40},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":41},"100636111","early-phase-1-nk521-in-the-treatment-of-malignant-ascites-associated-with-advanced-solid-tumors-100636111","NCT07561437","NK521 in the Treatment of Malignant Ascites Associated With Advanced Solid Tumors","Inclusion Criteria:\n\n* Pathologically diagnosed with relapsed\u002Frefractory advanced solid tumors, including but not limited to liver cancer, gastric cancer, colorectal cancer, ovarian cancer, etc.\n* Complicated with malignant ascites with identifiable tumor cells in ascites. Patients with advanced solid tumors who have failed at least 2 lines of standard therapy.\n* At least one measurable lesion on CT or MRI per RECIST v1.1.\n* ECOG performance status 0-2.\n* Life expectancy ≥3 months.\n* All toxicities from prior antineoplastic therapy have resolved to Grade 1 (CTCAE v5.0) or baseline except alopecia and fatigue; subjects with long-term stable sequelae from prior therapy (e.g., platinum-induced neuropathy) are allowed.\n* Women of childbearing potential must be non-lactating with a negative serum pregnancy test within 1 week before enrollment; all subjects must agree to use contraception from signing informed consent until 6 months after the last NK521 infusion.\n* Able to comply with the study protocol and follow-up procedures.\n* Voluntarily signed and provided written informed consent.\n\nExclusion Criteria:\n\n* Symptomatic central nervous system (CNS) metastasis and\u002For carcinomatous meningitis.\n* History of other malignancies within the past 3 years.\n* Active, known or suspected autoimmune disease, excluding hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia), or diseases not expected to relapse without external triggers.\n* History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or organ transplantation.\n* History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac arrhythmia or conduction abnormality requiring clinical intervention (e.g., ventricular arrhythmia, third-degree atrioventricular block); QTc interval \\>480 ms on 12-lead ECG at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥3 cardiovascular\u002Fcerebrovascular events within 6 months before enrollment; NYHA Class ≥II heart failure or left ventricular ejection fraction (LVEF) \\\u003C50%; uncontrolled hypertension.\n* Received radical radiotherapy within 4 weeks before enrollment; received local palliative radiotherapy within 2 weeks before enrollment.\n\nNot fully recovered from major surgery or trauma within 2 weeks before enrollment.\n\n-Participated in another investigational drug trial and received investigational therapy or used an investigational device within 4 weeks before enrollment.\n\nReceived cellular antineoplastic therapy within 1 year before dosing; received other antineoplastic therapy outside this protocol within 4 weeks before dosing, including but not limited to chemotherapy, molecular targeted therapy, hormonal therapy, immunotherapy, biotherapy, or Chinese herbal patent medicine with antineoplastic indications.\n\n* Received blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor therapy within 2 weeks before enrollment.\n* Received systemic therapy with corticosteroids (prednisone \\>10 mg\u002Fday or equivalent) or other immunomodulatory agents (e.g., thymosin, interleukin-2, interferon) within 2 weeks before enrollment. Inhaled or topical corticosteroids are allowed in subjects without active autoimmune disease.\n* Positive virology test for hepatitis B or hepatitis C at screening, meeting any of the following:\n\n  1. HBsAg positive with positive HBV-DNA titer or above upper limit of normal (ULN);\n  2. HCV antibody positive.\n* Known hypersensitivity or intolerance to PD-1 monoclonal antibody.\n\nMeeting any of the following laboratory criteria:\n\n1. Hematology: Absolute neutrophil count \\\u003C1.5×10⁹\u002FL; platelet count \\\u003C75×10⁹\u002FL; hemoglobin \\\u003C90 g\u002FL.\n2. Hepatic function: ALT \\>3×ULN (≥5×ULN for liver metastasis); AST \\>3×ULN (≥5×ULN for liver metastasis); TBIL \\>1.5×ULN, or TBIL \\>2.5×ULN (3.0 mg\u002FdL) for subjects with Gilbert syndrome.\n3. Renal function: Serum creatinine \\>1.5×ULN or creatinine clearance \\\u003C50 mL\u002Fmin.\n\n   * Any uncertain factors affecting subject safety or compliance.\n   * Any other severe or uncontrolled medical disease, active infection, abnormal physical examination, abnormal laboratory test, altered mental status, or psychiatric disease that, in the investigator's opinion, increases subject risk or affects study results.","75 Years",{"count":19,"type":20},[23],"Study Population: Adult subjects aged 18-75 years with relapsed\u002Frefractory advanced solid tumors (including liver, gastric, colorectal, ovarian cancer, etc.) and malignant ascites confirmed by cytology, who have failed at least 2 lines of standard systemic therapy.\n\nStudy Design: This is a dose-escalation, single-center, open-label, prospective Phase 1 study. A total of 18 subjects will be enrolled and assigned to 2 administration groups (9 subjects each):\n\nGroup A (Intravenous infusion): For subjects with small-volume malignant ascites.\n\nGroup B (Intraperitoneal perfusion): For subjects with large-volume symptomatic malignant ascites.\n\nEach group will follow a conventional \"3+3\" dose-escalation design with 3 dose levels (1×10⁹, 3×10⁹, 6×10⁹ NK cells per dose), administered once weekly, 3 weeks per cycle, for 2 consecutive cycles.\n\nPrimary Objectives: To evaluate the safety and tolerability, and to determine the dose-limiting toxicity (DLT) of NK521 administered intravenously and intraperitoneally.\n\nSecondary Objectives: To assess the preliminary anti-tumor efficacy including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), puncture-free survival (PuFS), and changes in tumor markers, as well as health-related quality of life (HRQoL).",[77],"Advanced Solid Tumors","2026-04-28",{"date":80,"type":33},"2026-05-01",{"date":82,"type":33},"2026-03-09",{"date":84,"type":20},"2028-10",{"name":39,"class":40},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":41},"100605726","early-phase-1-safety-and-efficacy-of-nk510-to-treat-gastric-cancer-and-colorectal-cancer-100605726","NCT07166263","Safety and Efficacy of NK510 to Treat Gastric Cancer and Colorectal Cancer","Exploratory Study of NK510 Cell Therapy in the Treatment of Recurrent and Refractory Advanced Gastric Cancer and Colorectal Cancer","Inclusion Criteria:\n\n1. Aged ≥ 18 years, regardless of gender.\n2. Gastric cancer and colorectal cancer that are inoperable and unresectable with radiotherapy: For gastric cancer, molecular diagnosis confirms that it is not AFP-producing gastric cancer.\n3. Progressive disease or recurrence after receiving ≥ 2 lines of treatment.\n4. Patients are divided into two groups (Group A and Group B) based on the presence or absence of peritoneal metastasis. The criteria for determining peritoneal metastasis are as follows:\n\n   1. Drained ascites ≥ 500ml, or B-ultrasound\u002FCT in the supine position shows ascites depth ≥ 3cm.\n   2. Peritoneal metastasis confirmed by any of the following criteria:\n\n   i. Positive for exfoliated cancer cells in ascites. ii. Diagnosed as peritoneal metastatic carcinoma by imaging and symptoms. iii. Peritoneal metastasis confirmed by abdominal exploration. iv. Ascites confirmed as exudate by routine ascites examination and ascites biochemistry.\n5. At least one measurable lesion on CT or MRI according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors).\n6. ECOG performance status of 0-2.\n7. Expected survival period ≥ 3 months.\n8. Able to comply with the study protocol and follow-up procedures, and voluntarily sign the informed consent form for participation in this study.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Subjects with central nervous system (CNS) metastases and\u002For carcinomatous meningitis with obvious symptoms.\n3. A history of other malignant tumors within the past 3 years.\n4. Subjects with active, known or suspected autoimmune diseases \\[excluding type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or diseases that are not expected to relapse without external triggers\\].\n5. Subjects with a history of immunodeficiency, including positive HIV test results, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n6. A history of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities such as ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.; QTc interval \\> 480 ms on 12-lead electrocardiogram at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events within 6 months before enrollment; New York Heart Association (NYHA) cardiac function classification ≥ class II or left ventricular ejection fraction (LVEF) \\\u003C 50%; clinically uncontrolled hypertension.",{"count":94,"type":20},15,[23],"This study will evaluate the safety and efficacy of NK510 in the treatment of relapsed and refractory advanced gastric cancer and colorectal cancer.NK510 will be administered by intravenous infusion for systemic therapy and intraperitoneal perfusion therapy. The safety and efficacy of this treatment will be evaluated.",[98,99],"Gastric Cancer (GC)","Colorectal Cancer","2025-09-03",{"date":102,"type":33},"2025-09-10",{"date":104,"type":20},"2025-11",{"date":106,"type":20},"2027-12",{"name":39,"class":40},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":4},"100599350","nk510-cell-therapy-for-refractory-systemic-lupus-erythematosus-100599350","NCT07083349","NK510 Cell Therapy for Refractory Systemic Lupus Erythematosus","An Open, Single-Center Exploratory Clinical Study of NK510 Cell Therapy for Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* 18 to 70 years old, male or female.\n* A diagnosis of SLE according to the 2019 EULAR (European League Against Rheumatism)\u002FACR (American College of Rheumatology).\n* The subject voluntarily participates in this clinical study and signs the Informed Consent Form (ICF).\n* Before screening, the subject must have received glucocorticoid combined with immunosuppressants and\u002For biological agents for at least 2 months, with a stable dose for more than 2 weeks, but the disease remains active; within 7 days before lymphodepleting conditioning, the blood routine test must meet the following requirements: absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; hemoglobin (Hb) ≥ 80g\u002FL; platelet count (PLT) ≥ 50×10⁹\u002FL.\n* SLEDAI-2K score \\> 8 points at screening.\n* Antinuclear antibody (ANA) ≥ 1:80 at screening.\n* Having appropriate organ functions:\n\n  1. Liver function: aspartate transaminase (AST) ≤ 3 times the upper limit of normal (ULN); alanine transaminase (ALT) ≤ 3 times ULN; total bilirubin ≤ 1.5 times ULN, unless the subject has a record of Gilbert syndrome; subjects with Gilbert-Meulengracht syndrome with total bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN can be included;\n  2. Renal function: serum creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 60 mL\u002Fmin;\n  3. Blood routine: absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; absolute lymphocyte count (ALC) ≥ 0.1×10⁹\u002FL; hemoglobin (Hb) ≥ 80 g\u002FL; platelet count (PLT) ≥ 50×10⁹\u002FL.\n* Women of childbearing age must be non-lactating and have a negative serum pregnancy test within 1 week before administration. In addition, all subjects (whether male or female) must agree to use contraception during the period of NK510 treatment starting from enrollment and within 3 months after the end of treatment.\n* Able to comply with the study protocol and follow-up procedures.\n\nExclusion Criteria:\n\n* Patients with active lupus nephritis.\n* Those with allergies to the study drug or other medications used in the study protocol.\n* Those with any of the following conditions: ① Having received autologous\u002Fallogeneic hematopoietic stem cell transplantation within 3 months; ② Having received ultraviolet irradiation therapy within 6 weeks; ③ Having received biologic agent therapy (excluding other medications used in the study protocol) within 4 weeks or 3 half-lives (whichever is longer); ④ Having undergone major surgery or received live vaccines within 4 weeks; ⑤ Having received experimental treatment (except for definite placebo control groups) within 4 weeks.\n* Those with other active, known, or suspected autoimmune diseases.\n* Presence of uncontrolled active bacterial, viral, fungal, mycobacterial, or other infections requiring treatment with intravenous antibiotics, antiviral drugs, or antifungal drugs within 14 days before lymphodepleting conditioning; however, prophylactic use of these drugs (including intravenous administration) is allowed.\n* History of immunodeficiency, including positive HIV test results, or other acquired\u002Fcongenital immunodeficiency diseases, or history of organ transplantation.\n* History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.); QTc interval \\> 480 ms on 12-lead electrocardiogram at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events within 6 months before administration; New York Heart Association (NYHA) cardiac function class ≥ II or left ventricular ejection fraction (LVEF) \\\u003C 50%.\n* Failure to fully recover from major surgery or trauma within 2 weeks before administration.\n* History of malignant tumors.\n* Screening results of hepatitis B or C virological tests meeting any of the following:\n\n  1. HBsAg positive, and peripheral blood HBV-DNA titer ≥ 1×10³ copies\u002FmL or upper limit of normal;\n  2. Anti-HCV positive.\n* Those deemed unsuitable for participation in the study by the investigator.","70 Years",{"count":117,"type":20},9,[119],"NA","This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK510 for the treatment of patients with refractory systemic lupus erythematosus (SLE) in China.",[122],"Refractory Systemic Lupus Erythematosus",[124],"SLE","2025-07-23",{"date":127,"type":33},"2025-07-28",{"date":129,"type":20},"2025-08-01",{"date":131,"type":20},"2027-09-01",{"name":39,"class":40},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":72,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":41},"100557694","early-phase-1-safety-and-efficacy-of-nk520-to-treat-relapsedrefractory-acute-myeloid-leukemia-100557694","NCT06541444","Safety and Efficacy of NK520 to Treat Relapsed\u002FRefractory Acute Myeloid Leukemia","An Open, Single Center Exploratory Study to Evaluate Safety and Efficacy of NK520 for Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Participants must be between 18 and 75 years;\n2. Diagnostic Criteria:\n\n   Meet the 2016 World Health Organization (WHO) diagnostic criteria for AML, unsuitable for current treatments or patients with relapsed\u002Frefractory AML after ≥2 lines of therapy. The definition of relapsed\u002Frefractory acute myeloid leukemia is based on the 2017 Chinese Guidelines for Diagnosis and Treatment:\n   1. Relapsed AML: Diagnosis is confirmed when leukemia cells reappear in the peripheral blood or bone marrow blast cells exceed 5% after complete remission (CR) (excluding reasons such as bone marrow regeneration post-consolidation chemotherapy) or there is extramedullary infiltration by leukemia cells;\n   2. Refractory AML: Initial cases unresponsive after two cycles of standard regimen treatment; recurrence within 12 months after CR and consolidation therapy; recurrence beyond 12 months with ineffectiveness of conventional chemotherapy; those who have relapsed twice or more; or persistent extramedullary leukemia;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;\n4. Expected survival of at least 12 weeks;\n5. Normal Organ Function.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia;\n2. Severe bleeding tendency or coagulation disorders, or currently receiving thrombolytic therapy;\n3. Active tuberculosis (TB), currently undergoing anti-TB treatment, or treated for TB within 1 year prior to the study;\n4. HIV-infected individuals, or known active syphilis infection;\n5. Use of immunosuppressive drugs within 1 week before the first dose, excluding topical, inhaled, or other locally administered glucocorticoids, or physiologic doses of systemic glucocorticoids (not exceeding 10 mg\u002Fday prednisone equivalent) for allergic reactions or for managing respiratory distress from asthma, COPD, etc;\n6. Receipt of live attenuated vaccines within 2 weeks before the first dose or planned during the study;\n7. Participation in another clinical trial and receipt of investigational drug within 4 weeks prior to the first dose;\n8. Receipt of immune-modulating drugs (including thymosin, interferons, except for local use to control pleural or ascitic fluid) within 2 weeks prior to the first dose;\n9. At screening, hepatitis B or C viral tests positive according to either:\n\n   * HBsAg positive with serum HBV-DNA titer ≥1×10\\^3 copies\u002FmL or above normal limits;\n   * HCV antibody positive;\n10. Any other condition or situation in which the investigator deems the patient unsuitable for participation in this study.",{"count":117,"type":20},[23],"This study will evaluate the safety and efficacy of NK520 in the treatment of relapsed\u002Frefractory acute myeloid leukemia. NK520 will be administered by intravenous injection. The safety and efficacy of this treatment will be evaluated.",[144],"Relapsed\u002FRefractory Acute Myeloid Leukemia","2024-08-05",{"date":147,"type":33},"2024-08-07",{"date":149,"type":33},"2024-07-01",{"date":151,"type":20},"2026-06-01",{"name":39,"class":40},""]