[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Simnova Biotechnology Co.,Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100656731","early-phase-1-snc116-therapy-for-relapsedrefractory-b-cell-acute-lymphoblastic-leukemia-100656731",false,"NCT07830238","SNC116 Therapy for Relapsed\u002FRefractory B-cell Acute Lymphoblastic Leukemia","An Exploratory Clinical Study Evaluating the Safety and Pharmacokinetic Profile of SNC116 in Adult Patients With Relapsed\u002FRefractory B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n\\- Participants must meet all of the following inclusion criteria to be enrolled in this study:\n\n1. Age ≥ 18 years and ≤ 75 years, with no gender restrictions.\n2. ECOG score 0 to 2.\n3. Diagnosed with B-ALL through MICM (cytological morphology, immunology, cytogenetics, and molecular genetics), and tested positive for CD19 by flow cytometry or immunohistochemistry.\n4. Recurrence or refractory B-ALL is defined as:\n\n   * Early recurrence: Recurrence occurring within 12 months after the first complete remission;\n   * Primary refractory: Failure to achieve complete remission after two cycles of standardized chemotherapy;\n   * ≥ 2 lines of systemic treatment for recurrence or refractory;\n   * Recurrent or refractory after allogeneic hematopoietic stem cell transplantation (Allo-HSCT) (at least 6 months from the transplantation date to the administration date of SNC116);\n   * For participants with Ph-positive disease, at least 2 different TKIs must have relapsed or been refractory, or the participant must be intolerant to TKI treatment, or have a TKI treatment contraindication, or be TKI-resistant (with T315i mutation or other resistance mechanisms).\n5. Bone marrow morphology shows \\> 5% of primitive cells.\n6. Participants who have received targeted CD19 therapy (including monoclonal antibodies, bispecific antibodies, ADCs, CAR-NK, experimental treatments, etc.) must have CD19 expression still present after the last targeted CD19 therapy (if the CD19 expression is a quantitative result, the positive CD19 in the primitive cells must be \\> 90%).\n7. Expected survival is greater than 3 months.\n8. Blood routine and lymphocyte subsets within 7 days before SNC116 administration meet the following requirements:\n\n   * Absolute neutrophil count (ANC) ≥ 0.5 × 10\\^9\u002FL;\n   * Absolute lymphocyte count (ALC) ≥ 0.5 × 10\\^9\u002FL;\n   * Hemoglobin (Hb) ≥ 80 g\u002FL;\n   * Platelet count (PLT) ≥ 50 × 10\\^9\u002FL;\n   * CD3+ T cell absolute count ≥ 0.25 × 10\\^9\u002FL.\n9. Adequate liver, kidney, lung, and heart function, defined as:\n\n   1. Serum ALT and AST ≤ 2.5 times the upper limit of normal;\n   2. Total bilirubin ≤ 1.5 times the upper limit of normal, except for Gilbert syndrome patients, whose total bilirubin must be ≤ 3.0 times the upper limit of normal;\n   3. Creatinine clearance rate (estimated by Cockcroft-Gault formula) ≥ 50 ml\u002Fmin;\n   4. Saturations of blood oxygen ≥ 92% under indoor ventilation conditions without clinical significance of pleural effusion;\n   5. Left ventricular ejection fraction ≥ 45%; Echocardiography shows no clinical significance of pericardial effusion; ECG has no clinical significance of abnormal findings.\n10. Participants receiving hematopoietic growth factor support therapy, including erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), and platelet agonists (TPO), must have a 1-week interval between the last administration of growth factor support therapy and the screening period assessment; Participants receiving blood product transfusions must have a blood platelet assessment at least 1 week apart from the last platelet transfusion, and a blood hemoglobin assessment at least 1 week apart from the last red blood cell transfusion.\n11. During the screening period, serum pregnancy test results of fertile female participants must be negative (women who have undergone surgical sterilization or have been menopausal for at least 2 years are considered to have no fertility). Fertile female participants and male participants must use highly effective contraceptive methods throughout the entire clinical study period and within one year after the last study treatment; they must also commit not to donate eggs (oocytes, oocyte cells) \u002F sperm for assisted reproduction within one year after the last study treatment.\n12. Participants must agree not to donate blood, organs, sperm \u002F semen, and\u002For eggs after SNC116 treatment for at least one year. Currently, there is no sufficient data to confirm when donating any tissue is safe; therefore, participants should not donate any tissue after receiving SNC116.\n13. Voluntarily participate in the clinical trial and sign the informed consent form.\n\nExclusion Criteria:\n\n\\- Participants who meet any of the following exclusion criteria will not be eligible to participate in this clinical study:\n\n1. Diagnosed with Burkitt leukemia\u002Flymphoma or chronic myeloid leukemia with acute lymphocytic transformation according to the WHO classification.\n2. Recurrence with isolated extramedullary lesions.\n3. Within the previous 2 years, had a malignant tumor that required treatment or had evidence of recurrence (excluding: fully cured non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, superficial bladder cancer, breast duct carcinoma in situ, thyroid cancer, and other localized carcinomas).\n4. Known to have any allergic, hypersensitive, intolerant or contraindicated reaction to any component of SNC116 or the drugs used in the study (such as tocilizumab), or has previously experienced a severe allergic reaction.\n5. Had received any treatment using vesicular virus G glycoprotein pseudotyped virus.\n6. Had CNS diseases:\n\n   * (1) CNS-3; or with neurological changes CNS-2 (excluding those who have improved after treatment and are assessed by the investigator as meeting the criteria);\n   * (2) Had seizures, cerebrovascular accidents (ischemia\u002Fhaemorrhage), dementia, mental disorders, cerebellar diseases, any autoimmune disease involving the CNS, post-reversible encephalopathy syndrome (PRES), or brain edema, etc. severe CNS disease conditions.\n7. Those with primary immunodeficiency or severe genetic diseases.\n8. Had clinically significant major cardiovascular diseases, including any of the following:\n\n   1. Had myocardial infarction within 6 months before screening;\n   2. Had unstable angina pectoris within 3 months before screening;\n   3. Uncontrolled, clinically significant arrhythmias (such as persistent ventricular tachycardia, ventricular fibrillation, torsades de pointes);\n   4. Mobitz II type II or III atrioventricular conduction block;\n   5. Congestive heart failure with NYHA classification ≥ 3;\n   6. Uncontrolled hypertension (systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg) or with hypertensive crisis or hypertensive encephalopathy;\n   7. Had deep vein thrombosis or pulmonary embolism within 6 months before screening;\n   8. Other cardiovascular diseases that were assessed by the investigator as significantly high-risk and not suitable for enrollment.\n9. Had ≥ 3 grade 3 gastrointestinal bleeding within the previous 1 month, a history of peptic ulcer disease, and the investigator assessed as having a risk of ≥ 3 grade 3 gastrointestinal bleeding or perforation (CTCAE 6.0).\n10. Had active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the time of screening. Allowed participants to be enrolled if they had HBsAg positive and\u002For HBcAb positive but HBV-DNA negative, and\u002For HCVAb positive but HCV-RNA negative (if the research center reported reference value ranges, the normal upper limit of HBV-DNA and HCV-RNA detection was based on the detection values of each research center, and above the detection value limit was defined as \"positive\"; if the research center reported only \"negative\u002Fpositive\", \"positive\" was based on the test report result).\n11. Known positive serum HIV virus antibody or history of active HIV infection, and active syphilis patients.\n12. Had active or latent Mycobacterium tuberculosis infection confirmed by clinical, imaging or laboratory examination during the screening period.\n13. Had an uncontrolled active infection that required intravenous use of antibiotics, antiviral or antifungal drugs, etc. within 7 days before SNC116 administration.\n14. At the time of screening, had a confirmed and requiring maintenance treatment systemic autoimmune disease or a confirmed systemic autoimmune disease in an active stage, except for: thyroid diseases assessed by the investigator as well-controlled.\n15. Had received the following drugs\u002Ftreatments before SNC116 administration:\n\n    1. Received salvage treatment (including chemotherapy, TKIs for Ph-positive ALL, and blinatumomab, etc.) within 1 week or 5 half-lives (whichever is shorter);\n    2. Received CNS prophylactic treatment within 1 week;\n    3. Received treatment doses of corticosteroid drugs (prednisone \\> 20 mg\u002Fday or equivalent doses of other steroid hormones), except for local application or prevention of allergic reactions;\n    4. Received prophylactic treatment with short-acting oral antiretroviral drugs;\n    5. Received local palliative radiotherapy within 2 weeks;\n    6. Received traditional Chinese medicine with anti-tumor indications within 2 weeks;\n    7. Received large molecule drug treatment within 3 weeks;\n    8. Received experimental drugs\u002Ftreatment (except for clear placebo-controlled groups);\n    9. Experienced major surgery within 4 weeks;\n    10. Received live vaccines within 4 weeks;\n    11. Received immunosuppressants within 4 weeks;\n    12. Used any drugs for treating GVHD (such as calcineurin inhibitors, methotrexate, mycophenolate mofetil, rapamycin, thalidomide, etc.) within 4 weeks (except for calcium channel blockers, methotrexate, mycophenolate mofetil, rapamycin, thalidomide, etc.);\n    13. Received donor lymphocyte infusion (DLI) within 4 weeks;\n    14. Received lymphocytotoxic drugs such as fludarabine, chlorambucil, or cladribine within 3 months, or alemtuzumab or other lymphocytotoxic drugs within 6 months;\n    15. Received immune cell therapy such as CAR-T, CAR-NK, etc. within 3 months;\n16. At the time of screening, any adverse events related to previous anti-leukemia treatment that have not recovered to ≤ grade 1 or baseline level (CTCAE version 6.0) (except for alopecia, hematological toxicity related to the inclusion criteria 8, or other grade 2 adverse events that have been converted to chronic stable state by the investigator, such as alternative treatment for hypothyroidism);\n17. Previously received CD19 CAR-T cell therapy;\n18. Experienced grade 4 neurotoxicity or grade 4 cytokine release syndrome during T-cell redirected immunotherapy;\n19. Had any indwelling catheters or drainage tubes in the body (such as percutaneous nephrostomy tube, biliary drainage tube, or thoracic\u002Fabdominal\u002Fpericardial drainage catheter, etc.), except central venous catheterization and Ommaya reservoir;\n20. Had 2-4 grade acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks before screening; or had acute or chronic GVHD that required systemic treatment within 4 weeks before screening;\n21. Pregnant or lactating women;\n22. Other situations that the investigator considers may affect the safety or study compliance of the participants and are not suitable for participation in the study.","ALL","18 Years","75 Years",{"count":20,"type":21},28,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This study aims to evaluate the safety and pharmacokinetic profile of SNC116 in adult patients with relapsed\u002Frefractory B-cell acute lymphoblastic leukemia",[27],"B-cell Acute Lymphoblastic Leukemia",[29,30,31],"in vivo CAR-T","CD19","B-ALL","NOT_YET_RECRUITING","2026-09-16",{"date":35,"type":36},"2026-09-21","ACTUAL",{"date":38,"type":21},"2026-09",{"date":40,"type":21},"2030-03",{"name":42,"class":43},"Shanghai Simnova Biotechnology Co.,Ltd.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":44},"100552099","phase-1-f01-in-the-treatment-of-moderate-to-severe-refractory-systemic-lupus-erythematosus-100552099","NCT06468683","F01 in the Treatment of Moderate-to-severe Refractory Systemic Lupus Erythematosus","A Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of F01 in Patients With Moderate-to-severe Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n\\- Participants must meet all of the following inclusion criteria to be enrolled in the study:\n\n1. Age ≥18 and ≤65 years old, gender unlimited.\n2. Subjects with moderate-to-severe refractory SLE must meet all of the following criteria:\n\n   * Diagnosis of SLE at least 24 weeks prior to screening in accordance with the European Federation of Rheumatological Societies (EULAR)\u002FAmerican College of Rheumatology (ACR) 2019 SLE classification criteria at screening;\n   * Applicants must meet one of the following criteria at screening: a. positive for antinuclear antibody (ANA); b. Positive anti-dsDNA antibody;c. Positive anti-Smith antibody;\n   * SLEDAI-2000 score ≥ 8 at screening\n3. Have received adequate standard doses of glucocorticoids, antimalarials, immunosuppressants\u002Fimmunomodulators, and at least one biologic agent for at least 2 months prior to screening, with a stable dose \\> disease remaining active after 2 weeks of treatment. Oral glucocorticoids must meet the following requirements: 1) Prednisone (or equivalent) ≥ 7.5 mg\u002Fday and ≤ 60 mg\u002Fday. 2) When used in combination with immunosuppressants and\u002For biologics, there is no minimum daily dose requirement for glucocorticoids. The blood routine within 7 days of clear drenching conditioning chemotherapy meets the following requirements:\n\n   * Absolute neutrophil value (ANC) ≥ 1.5×109\u002FL;\n   * Hemoglobin (Hb) ≥ 80g\u002FL;\n   * Platelet count (PLT) ≥ 50×109\u002FL.\n4. Adequate hepatic, renal, lung, and cardiac function, defined as:\n\n   1. Serum ALT and AST ≤ 2.5 times the upper limit of normal;\n   2. Total bilirubin ≤ 1.5 times the upper limit of normal, except for patients with Gilbert\\'s syndrome, where total bilirubin must be ≤ 3.0 times the upper limit of normal;\n   3. creatinine clearance (estimated by Cockcroft Gault\\'s formula) (Appendix 1) ≥ 50 ml\u002Fmin;\n   4. Oxygen saturation of ≥ 92% in non-oxygenated conditions under indoor ventilation; No clinically significant pleural effusion;\n   5. Left ventricular ejection fraction ≥ 50%; Echocardiography to confirm the absence of pericardial effusion; There were no clinically significant abnormal findings on ECG.\n5. Subjects receiving hematopoietic growth factor supportive therapy, including erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage-colony-stimulating factor (GM-CSF) and platelet agonists (TPO), etc., must have a 2-week gap between the last growth factor supportive therapy and the screening period evaluation; Patients receiving blood product transfusions should have at least 1 week between the screening platelet assessment and the last platelet transfusion, and at least 2 weeks between the screening hemoglobin assessment and the last red blood cell transfusion.\n6. During the screening period, female subjects of childbearing potential must have a negative serum pregnancy test result (women who have been surgically sterilized or postmenopausal for at least 2 years are considered not of childbearing potential). Female subjects of childbearing potential and male subjects must use a highly effective method of contraception throughout the clinical study period and for 1 year after the last dose of study treatment; At the same time, a commitment should be made not to donate eggs (oocytes, oocytes)\u002Fsperm for assisted reproduction within 1 year after the last study treatment.\n7. Voluntarily participate in clinical trials and sign informed consent.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following exclusion criteria will not be admitted to this clinical study:\n\n  1. Known allergies, hypersensitivity, intolerance, or contraindications to F01 or any ingredient of drugs that may be used in the study (including fludarabine, cyclophosphamide, tocilizumab), or subjects who have had severe allergic reactions in the past.\n  2. Severe lupus nephritis (defined as urine protein \\>6g\u002F24 hours or serum creatinine \\>2.5mg\u002FdL or 221μmol\u002FL) within 3 months prior to screening, or requiring active nephritis with drugs prohibited by the protocol, or requiring hemodialysis or treatment with prednisone ≥100mg\u002Fd or equivalent glucocorticoids ≥for 14 days.\n  3. Previous history or pathological changes of clinically significant central nervous system disease, including but not limited to lupus encephalopathy, seizures, cerebrovascular accident (ischemia\u002Fhemorrhage), dementia, cerebellar disease, organic encephalopathy syndrome, encephalitis, central nervous system vasculitis, or psychiatric disease.\n  4. Combined with severe pulmonary diseases, such as pulmonary hypertension with World Health Organization functional classification ≥ level 3, requiring oxygen therapy with an oxygen storage mask or non-invasive or invasive ventilator to assist breathing at screening;\n  5. Unstable cardiovascular function:\n\n     1. Myocardial infarction within 6 months prior to screening;\n     2. Unstable angina within 3 months prior to screening;\n     3. Uncontrolled, clinically significant cardiac arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes);\n     4. Mobitz type II. second-degree or third-degree atrioventricular block;\n     5. New York Cardiac Function Association Class ≥ 3 congestive heart failure;\n     6. Poorly controlled hypertension (systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg) or concomitant hypertensive crisis or hypertensive encephalopathy;\n  6. Patients with a history of concomitant malignancy, including tumor-associated polymyositis\u002Fdermatomyositis. Patients with non-melanoma skin cancer, carcinoma in situ of the cervix, local prostate cancer, low-stage bladder cancer, ductal carcinoma in situ, or patients who have no evidence of recurrence in the past 2 years and do not need treatment are excluded.\n  7. Uncontrolled active bacterial, viral, fungal, mycobacterial infection or other infections requiring treatment with intravenous antibiotics, antiviral or antifungal drugs within 14 days prior to drenching conditioning chemotherapy; However, these drugs can be used for prophylactic treatment (including intravenous use).\n  8. Risk of active tuberculosis at screening, regardless of completion of adequate treatment, including the presence of signs or symptoms of active tuberculosis (such as fever, cough, night sweats, and weight loss) as judged by the investigator at screening; Chest imaging (e.g., chest x-ray, chest CT scan) documented at screening or at any time within 6 months prior to screening showing active tuberculosis; Evidence of latent tuberculosis infection, such as a positive γ-interferon release test, at screening.\n  9. Active hepatitis B virus (HBV), hepatitis C virus (HCV) infection at screening. Subjects who are HBsAg positive and\u002For HBcAb positive but HBV-DNA negative, and\u002For HCVAb positive but HCV-RNA negative are allowed to be enrolled (if the site report includes a range of reference values, the upper limit of normal for HBV-DNA and HCV-RNA tests is based on the test values of each site, and higher than the upper limit of test values is defined as \\"positive\\"; If the site report only shows \\"negative\u002Fpositive\\", the positive is based on the test report result).\n  10. Known serum HIV virus antibody positivity or history of active HIV infection, as well as syphilis antibody positive.\n  11. Received the following treatments within the prescribed time frame prior to drenching conditioning chemotherapy:\n\n      1. Received autologous\u002Fallogeneic hematopoietic stem cell transplantation within 3 months;\n      2. Received ultraviolet radiation therapy within 6 weeks;\n      3. Received macromolecule therapy (excluding anti-CD20 monoclonal antibodies) within 4 weeks or 3 half-lives (whichever is longer); Received anti-CD20 monoclonal antibody therapy within 4 weeks;\n      4. Received small molecule targeted therapy within 2 weeks or 3 half-lives (whichever is longer);\n      5. Major surgery or live vaccination within 4 weeks;\n      6. Received a trial treatment within 4 weeks (except in the definitive placebo control group);\n  12. Pregnant or lactating women.\n  13. Use of concomitant medications\u002Fconcomitant treatments expressly prohibited by the protocol during the screening period.\n  14. Presence of any life-threatening disease, medical condition, or organ system dysfunction that, in the opinion of the investigator, may affect the subject\\'s safety or study compliance.","65 Years",{"count":54,"type":21},50,[56],"PHASE1","This is a phase I clinical study to evaluate the safety , pharmacokinetic profile, and preliminary efficacy of F01 in patients with moderate-to-severe refractory systemic lupus erythematosus.",[59],"Lupus Erythematosis",[61],"Moderate-to-severe refractory systemic lupus erythematosus","2024-06-16",{"date":64,"type":36},"2024-06-21",{"date":66,"type":21},"2024-06-15",{"date":68,"type":21},"2027-12-31",{"name":42,"class":43},""]