[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sinocelltech Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":567},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,42,69,90,113,134,154,175,198,225,245,264,285,307,330,351,373,397,419,440,461,482,503,527,547],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100644148","phase-1-sctb41-plus-sctb39g-with-or-without-standard-therapy-in-advanced-solid-tumors-100644148",false,"NCT07665970","SCTB41 Plus SCTB39G With or Without Standard Therapy in Advanced Solid Tumors","An Open Multi-center Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB41 in Combination With SCTB39G With or Without Standard Therapy in Adult Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF);\n2. Male or female, ≥ 18 years and ≤ 75 years old;\n3. Survival duration more than 3 months;\n4. ECOG score ≤ 1 point;\n5. Histologically or cytologically confirmed diagnosis of advanced malignant solid tumor；\n6. At least one measurable tumor lesion according to RECIST v1.1;\n7. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Has participated in another clinical study within 4 weeks prior to the first dose;\n2. Has previously received other immunotherapies other than PD-(L)1 inhibitors；\n3. Other malignancies diagnosed within 5 years prior to the enrollment;\n4. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;\n5. Significant bleeding risk;\n6. Presence of pleural effusion, peritoneal effusion, or ascites;\n7. Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment；\n8. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;\n9. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;\n10. History of severe allergies, severe drug allergies (including unapproved investigational drugs);\n11. History of organ transplantation or stem cell transplantation;\n12. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;\n13. Pregnant or breastfeeding female.","ALL","18 Years","75 Years",{"count":21,"type":22},112,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 in combination with SCTB39G with or without standard therapy in adult patients with advanced malignant solid tumors. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I\u002FII clinical trial.",[29],"Advanced Malignant Solid Tumors","NOT_YET_RECRUITING","2026-06-23",{"date":33,"type":34},"2026-06-26","ACTUAL",{"date":36,"type":22},"2026-06-30",{"date":38,"type":22},"2029-06-30",{"name":40,"class":41},"Sinocelltech Ltd.","INDUSTRY",{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100644419","phase-2-sctb41-combined-with-chemotherapy-in-advanced-squamous-non-small-cell-lung-cancer-100644419","NCT07662395","SCTB41 Combined With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer","A Multicenter Phase II\u002FIII Study Evaluating the Efficacy and Safety of SCTB41 Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Driver-Negative Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n1. Voluntary written informed consent (ICF) signed prior to screening.\n2. Age ≥18 years, male or female.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Expected survival ≥3 months.\n5. Histologically or cytologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and is not suitable for definitive concurrent or sequential chemoradiotherapy, according to the 9th edition of the TNM staging system by the Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC).\n6. For subjects with adenocarcinoma, non-smokers, or squamous cell carcinoma with mixed adenocarcinoma components, absence of sensitizing EGFR mutations (e.g., exon 19 deletion, exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I) or ALK gene rearrangements must be confirmed by tumor tissue, cytology, or blood samples prior to enrollment.\n7. Availability of tumor tissue samples for PD-L1 testing.\n8. No prior systemic anticancer therapy for the study disease.\n9. At least one measurable lesion (excluding brain lesions) per RECIST v1.1. 10 Adequate organ function.\n\nExclusion Criteria:\n\n1. Known ROS1 fusion-positive, BRAF V600E mutation, or other driver mutations for which guideline-recommended first-line targeted therapies are available.\n2. Prior thoracic radiotherapy.\n3. Symptomatic central nervous system metastases.\n4. Imaging evidence during screening showing tumor invasion of major blood vessels, invasion of critical surrounding organs, or risk of tracheoesophageal fistula or esophagopleural fistula as assessed by the investigator.\n5. History of hypertensive crisis or hypertensive encephalopathy, or uncontrolled hypertension despite medication.\n6. Active autoimmune disease or a history of autoimmune disease with a risk of recurrence.\n7. Bleeding tendency, high bleeding risk, or coagulation disorders.\n8. Other malignancies.\n9. Active serious infection prior to first dose, including active infection, active tuberculosis, HIV positivity, active hepatitis B or C, or known active syphilis.\n10. Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n11. History of non-infectious pneumonia requiring systemic corticosteroid therapy or current interstitial lung disease.\n12. Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n13. Known allergy to any component of the investigational drug(s), or history of severe hypersensitivity reaction to any monoclonal antibody.\n14. Participation in another clinical trial, except for follow-up in observational (non-interventional) studies or follow-up phases of interventional studies.\n15. Pregnant or breastfeeding women.\n16. Known alcohol or drug abuse, psychiatric disorders, or history of illicit drug use.\n17. Any other condition deemed unsuitable for enrollment by the investigator.",{"count":50,"type":22},410,[26,52],"PHASE3","This is a multicenter Phase II\u002FIII study evaluating the efficacy and safety of SCTB41 combined with chemotherapy versus tislelizumab combined with chemotherapy as first-line treatment in patients with driver-negative locally advanced or metastatic non-small cell lung cancer (NSCLC).\n\nThe Phase II portion is an open-label safety run-in study enrolling approximately 30-60 patients to evaluate the safety and tolerability of SCTB41 plus chemotherapy. Following confirmation of acceptable safety and preliminary efficacy, the study will proceed to the Phase III portion.\n\nThe Phase III portion is a randomized, double-blind, active-controlled study enrolling approximately 350 patients. Eligible participants will be randomized in a 1:1 ratio to receive SCTB41 plus chemotherapy or tislelizumab plus chemotherapy. The primary objective is to compare progression-free survival assessed by blinded independent central review according to RECIST version 1.1.",[55],"Double Blind",[57,58,59],"Advanced Non-Small Cell Lung Cancer","Non-Small Cell Lung Cancer","SCTB41","RECRUITING","2026-06-22",{"date":31,"type":34},{"date":64,"type":34},"2026-05-09",{"date":66,"type":22},"2030-01-24",{"name":40,"class":41},1,{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":68},"100639125","phase-2-a-clinical-study-of-sctb41-combined-with-docetaxel-in-patients-with-previously-treated-locally-advanced-or-metastatic-non-small-cell-lung-cancerphase-ii-study-ongoing-100639125","NCT07609251","A Clinical Study of SCTB41 Combined With Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer（Phase II Study Ongoing）","A Phase II\u002FIII Study of SCTB41 Plus Docetaxel vs Placebo Plus Docetaxel in Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF);\n2. ECOG 0-1;\n3. Survival duration more than 3 months;\n4. Histologically or cytologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and cannot receive curative concurrent\u002Fsequential chemoradiotherapy;\n5. Without AGA: Have experienced disease progression during or after prior treatment with PD-(L)1 inhibitors and chemotherapy.With AGA: Must have received adequate targeted therapy; EGFR-positive patients must have received prior treatment with PD-(L)1\u002FVEGF bispecific antibody and\u002For TROP-2 ADC;\n6. At least one measurable non-brain lesion according to RECIST v1.1;\n7. Adequate major organ function.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed presence of small cell carcinoma components;\n2. Prior treatment with docetaxel;\n3. Symptomatic central nervous system (CNS) metastases;\n4. Received the last dose of prior systemic anti-tumor therapy within 4 weeks before the first dose of study drug;\n5. Imaging findings at screening show tumor invasion into major blood vessels or surrounding vital organs, or the presence of a risk of esophagotracheal or esophagopleural fistula, which the investigator assesses as unsuitable for enrollment;\n6. History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension despite medical therapy;\n7. Presence of any active autoimmune disease or history of autoimmune disease with anticipated risk of relapse;\n8. Bleeding tendency, high risk of bleeding, or coagulation disorders;\n9. Diagnosis of another malignancy;\n10. Severe infection, active infection, active tuberculosis, positive HIV antibody, active hepatitis B or hepatitis C, or known active syphilis prior to the first dose;\n11. Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n12. History of non-infectious pneumonitis that required systemic corticosteroid therapy, or current presence of interstitial lung disease;\n13. Prior history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n14. Known hypersensitivity to any component of the study drug; known hypersensitivity to taxanes; or history of severe hypersensitivity reaction to any other monoclonal antibody;\n15. Pregnant or breastfeeding women;\n16. Any other condition that the investigator considers inappropriate for enrollment.",{"count":77,"type":22},90,[26],"This study aims to evaluate the safety and efficacy of SCTB41 combined with docetaxel in patients with previously treated non-small cell lung cancer. The Phase II part of this study is an open-label, multicenter clinical trial.",[81],"NSCLC (Advanced Non-small Cell Lung Cancer)","2026-05-19",{"date":84,"type":34},"2026-05-27",{"date":86,"type":22},"2026-05",{"date":88,"type":22},"2029-07",{"name":40,"class":41},{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":97,"targetDuration":4,"studyType":23,"phases":99,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"100638178","phase-1-phase-iii-study-of-sctb41-plus-sctb39-1with-or-without-standard-therapy-in-advanced-solid-tumours-100638178","NCT07594028","Phase I\u002FII Study of SCTB41 Plus SCTB39-1with or Without Standard Therapy in Advanced Solid Tumours","An Open Multi-center Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB41 in Combination With SCTB39-1With or Without Standard Therapy in Adult Patients With Advanced Malignant Solid Tumours","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF);\n2. Male or female, ≥ 18 years and ≤ 75 years old;\n3. Survival duration more than 3 months;\n4. ECOG score ≤ 1 point;\n5. histologically or cytologically confirmed diagnosis of advanced malignant solid tumour；\n6. At least one measurable tumor lession according to RECIST v1.1;\n7. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Has participated in another clinical study within 4 weeks prior to the first dose;\n2. Has previously received other immunotherapies other than PD-(L)1 inhibitors；\n3. Other malignancies diagnosed within 5 years prior to the enrollment;\n4. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;\n5. Significant bleeding risk;\n6. Presence of pleural effusion, peritoneal effusion, or ascites;\n7. Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment；\n8. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;\n9. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;\n10. History of severe allergies, severe drug allergies (including unapproved investigational drugs);\n11. History of organ transplantation or stem cell transplantation;\n12. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;\n13. Pregnant or breastfeeding female.",{"count":98,"type":22},126,[25,26],"This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 in combination with SCTB39-1with or without standard therapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I\u002FII clinical trial.",[102],"Advanced Malignant Solid Tumor",[104],"advanced malignant solid tumor","2026-05-11",{"date":107,"type":34},"2026-05-18",{"date":109,"type":22},"2026-05-30",{"date":111,"type":22},"2029-05-30",{"name":40,"class":41},{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":131,"leadSponsor":133,"locationsCount":68},"100636833","phase-3-a-study-to-evaluate-the-safety-and-efficacy-of-sctb35-in-combination-with-gemcitabine-and-oxaliplatin-in-patients-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-100636833","NCT07570823","A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma","A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Age 18-80 years old\n* Histologically confirmed diffuse large B-cell lymphoma according to WHO 2022 criteria\n* Relapsed or refractory (R\u002FR) disease following at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy\n* Participants who have failed after one prior line of therapy are not candidates for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)\n* Presence of measurable or evaluable disease at baseline ECOG PS 0-2\n* ECOG PS 0-2\n* Adequate organ function and bone marrow function\n* Expected survival ≥ 3 months\n\nExclusion Criteria:\n\n* Prior treatment with antibodies targeting both CD20 and CD3\n* Contraindication to rituximab, gemcitabine or oxaliplatin, or prior treatment with an anti-CD20 antibody in combination with the GemOx regimen\n* Peripheral neuropathy assessed to be Grade \\>1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0 at enrollment\n* Known central nervous system (CNS) involvement by lymphoma\n* Known any major episode of active infection requiring treatment with systemic antibiotics within 2 weeks\n* Treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to first SCTB35 administration\n* Autologous HSCT within 100 days prior to first SCTB35 administration, or any prior allogeneic HSCT or solid organ transplantation\n* Major surgery within 4 weeks prior to first SCTB35 administration\n* Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to first SCTB35 administration\n* Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study","80 Years",{"count":122,"type":22},101,[52],"The purpose of this study is to evaluate the efficacy and safety of SCTB35 in Combination With Gemcitabine and Oxaliplatin vs Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma.",[126],"DLBCL - Diffuse Large B Cell Lymphoma","2026-04-29",{"date":129,"type":34},"2026-05-06",{"date":86,"type":22},{"date":132,"type":22},"2029-04",{"name":40,"class":41},{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":120,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":151,"leadSponsor":153,"locationsCount":68},"100636156","phase-3-a-study-to-evaluate-the-safety-and-efficacy-of-sctb35-in-combination-with-lenalidomide-in-patients-with-relapsed-or-refractory-follicular-lymphoma-100636156","NCT07562022","A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma","A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Lenalidomide Versus Rituximab and Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma","Inclusion Criteria:\n\n* Age 18-80 years old\n* Histologically confirmed Follicular lymphoma (FL) grade 1, 2, or 3a according to WHO 2022 criteria\n* Relapsed or refractory (R\u002FR) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy\n* Judged by the investigator, the participant must urgently need to receive systemic treatment, based on meeting at least one GELF criterion\n* A measurable or evaluable disease at the time of enrolment\n* ECOG PS 0-2\n* Adequate organ function and bone marrow function\n* Expected survival ≥ 6 months\n\nExclusion Criteria:\n\n* Documented refractoriness to lenalidomide.\n* Have lenalidomide exposure within 12 months prior to randomization",{"count":142,"type":22},93,[52],"The purpose of this study is to evaluate the efficacy and safety of SCTB35 in Combination With Lenalidomide in Patients With Relapsed or Refractory Follicular lymphoma (FL).",[146],"Follicular Lymphoma (FL)","2026-04-24",{"date":149,"type":34},"2026-05-01",{"date":86,"type":22},{"date":152,"type":22},"2029-06",{"name":40,"class":41},{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":68},"100611740","phase-2-efficacy-and-safety-of-sct650c-in-participants-with-moderate-to-severe-hidradenitis-suppurativa-100611740","NCT07244510","Efficacy and Safety of SCT650C in Participants With Moderate to Severe Hidradenitis Suppurativa","A Phase II, Multicenter, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SCT650C in Adult Participants With Moderate to Severe Hidradenitis Suppurativa","Inclusion Criteria:\n\n1. The participants must be at least 18 years of age at the time of signing the ICF.\n2. Study participants must have a diagnosis of HS based on clinical history and physical examination for at least 6 months prior to the baseline visit; diagnosis must be verifiable through medical notes and documentation.\n3. Study participants must have HS lesions in at least 2 distinct anatomic areas (eg, left and right axilla), 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits.\n4. Study participants must have moderate to severe HS defined as a total of ≥ 5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits.\n5. Study participants must have had a history of inadequate response, intolerance or contraindication to a course of systemic antibiotics for treatment of HS at the Screening Visit as assessed by the investigator.\n6. Participants agree to daily use of topical antiseptics on the areas affected by HS lesions while on study treatment. Allowable antiseptic washes are limited to one of the following: chlorhexidine gluconate, benzoyl peroxide, benzalkonium chloride, benzethonium chloride, or dilute bleach in bath water.\n7. Participants entering the study while undergoing concomitant treatment with systemic antibiotics (as specified in the protocol) must be on a stable dose. A stable dose is defined as a dosage or regimen that has remained unchanged for at least four weeks prior to baseline and is expected to remain unchanged for at least the first 16 weeks of the study.\n8. Female participants must be not of childbearing potential or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception up to 40 weeks after the last administration of the investigational medical product (IMP) and have a negative pregnancy test prior to the first dose. The following methods are considered highly effective when used consistently and correctly:\n\n   1. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);\n   2. combined (estrogen and progestogen) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal);\n   3. intrauterine device (IUD);\n   4. intrauterine hormone-releasing system (IUS);\n   5. bilateral tubal occlusion;\n   6. vasectomized partner (where postvasectomy testing had demonstrated sperm clearance);\n   7. Sexual abstinence if it is in accordance with a participant's preferred and common lifestyle.\n\n   Note: Participants who use abstinence as a form of birth control must agree to abstain from heterosexual intercourse until 40 weeks after the final dose of IMP. Study personnel must confirm the continued use of abstinence is still in accordance with the participant's lifestyle at regular intervals during the study.\n\n   Male participants with a partner of childbearing potential must be willing to use a condom when sexually active, until 40 weeks after the last administration of IMP.\n9. An Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the participant.\n\nExclusion Criteria:\n\n1. Study participant has any medical or psychiatric condition could jeopardize or would compromise the study participant's ability to participate in this study as determined by the investigator based on protocol-required assessments.\n2. Study participant has a draining fistula count of \\> 20 at the Baseline Visit.\n3. Study participant has any other active skin disease or condition (eg, bacterial cellulitis, candida intertrigo, extensive condyloma) that may, in the opinion of the investigator, interfere with the assessment of HS.\n4. Study participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease (IBD).\n5. Study participant has a primary immunosuppressive condition, including taking immunosuppressive therapy following an organ transplant or has had a splenectomy.\n6. Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 40 weeks following the final dose of IMP.\n7. Study participant has an active infection or history of infection(s) as follows:\n\n   * Any infection requiring systemic treatment within 28 days prior to Baseline;\n   * A history of opportunistic, recurrent, or chronic infections that, in the opinion of the investigator, might cause this study to be detrimental to the study participant.\n\n   Opportunistic infections are infections caused by uncommon pathogens (eg, Pneumocystis jirovicii, cryptococcosis), or unusually severe infections caused by common pathogens (eg, cytomegalovirus, herpes zoster).\n8. Study participant has any of the following (for more information, refer to Section 9.2):\n\n   * Known active tuberculosis (TB) disease;\n   * History of active TB involving any organ system unless adequately treated according to World Health Organization\u002F Centers for Disease Control and Prevention therapeutic guidance and proven to be fully recovered upon consult with a TB specialist.\n   * Latent TB infection (LTBI).\n   * High risk of acquiring TB infection.\n   * Current or history of NTMB infection.\n9. Study participant has an acute or chronic hepatitis B virus, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection or treponema pallidum antibody (TPPA) positive. Study participants who have evidence of, or tested positive for, hepatitis B or hepatitis C will be excluded.\n\n   1. A positive test for hepatitis B virus is defined as: 1) positive for hepatitis B surface antigen (HBsAg+), or 2) HBsAg is negative, HBcAb is positive and HBV-DNA test results ≥ the upper limit of the reference value of each center or need antiviral treatment.\n   2. A positive test for HCV is defined as: 1) positive for hepatitis C antibody (HCVAb+); and 2) positive via a confirmatory test for HCV (for example, HCV polymerase chain reaction).\n10. Study participants with concurrent malignancy are excluded. Study participants with a history of malignancy within the past 5 years prior to the Screening Visit are excluded, EXCEPT if the malignancy was a cutaneous squamous or basal cell carcinoma, or in situ cervical cancer that has been treated and is considered cured.\n11. Study participant has a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.\n12. Study participant has had major surgery within the 3 months prior to the Baseline Visit, or has planned major surgery after entering the study.\n13. Study participant has any systemic disease (ie, cardiovascular, neurological, renal, liver, metabolic, gastrointestinal, hematological, immunological, etc.) considered by the investigator to be uncontrolled, unstable, or likely to progress to a clinically significant degree during the course of the study.\n14. Study participant has had a myocardial infarction or stroke within the 6 months prior to the Screening Visit.\n15. Study participant has a history of chronic alcohol or drug abuse within 6 months prior to Screening as evaluated by the investigator based on medical history and interview.\n16. Study participant has a history of depression and\u002For suicidal thoughts or behaviors are considered not suitable for participation in the clinical study by the investigator.\n17. The participant has a known hypersensitivity to any excipients of SCT650C.\n18. Study participants with prior exposure to biologic agents that block IL-12\u002F23 (e.g., ustekinumab), IL-23 (e.g., risankizumab, guselkumab), or IL-17 (e.g., secukinumab) within 3 months prior to the Baseline visit.\n19. Study participants with prior exposure to anti-TNF therapy (e.g., adalimumab, infliximab) for any indication within 2 months prior to the Baseline visit.\n20. Study participants who have had prior exposure to other immunomodulatory biologic therapies, including anti-IL-1 (e.g., anakinra, canakinumab), within 3 months or 5 half-lives, whichever is longer, prior to the Baseline visit.\n21. Previous treatment with any cell-depleting therapies, including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to the Baseline visit or until B cell count returns to normal level.\n22. Use of traditional medicines or herbal remedies within 28 days prior to the Baseline visit.\n23. Study participants have received non-allowable topical therapies (including topical antibiotics) for the treatment of HS within 14 days prior to the Baseline visit.\n24. Study participants have received systemic non-biologic therapies (e.g. methotrexate (MTX), cyclosporine A, retinoids, apremilast, phototherapy) for the treatment of HS within 28 days prior to the Baseline visit.\n25. For HS and non-HS related pain, participants have received oral concomitant analgesics (including opioids) within 14 days prior to the Baseline visit.\n\n    Exception: Participants may continue on non-opioid analgesics provided that the dose and dosing regimen have been stable for at least 14 days preceding the Baseline visit and are expected to remain stable at least until Week 16 visit.\n26. Study participants have received any live vaccine within 8 weeks prior to the first dose of study drug (Baseline), or expect the need for live vaccination during study participation including within 40 weeks after the last dose of study drug administration.\n27. Study participants have been treated with any other investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study.\n28. Study participant has laboratory abnormalities at Screening, including any of the following:\n\n    * \\>2× the upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)\n    * Total Bilirubin \\>2×ULN\n    * White blood cell count \\\u003C3.00×103\u002FμL\n    * Absolute neutrophil count \\\u003C1.5×103\u002FμL\n    * Lymphocyte count \\\u003C500 cells\u002FμL\n    * Hemoglobin \\\u003C8.5g\u002FdL\n    * Creatinine \\>1.5 ×ULN Note: Tests that result in ALT, AST, ALP or total bilirubin up to 25% above the exclusion limit may be repeated for confirmation during the Screening Period. Upon retesting, participants whose ALT, AST, or ALP remain over the above-defined thresholds should not be randomized.\n29. Study participant has an estimated glomerular filtration rate (GFR) as measured by Chronic Kidney Disease Epidemiology Collaboration \\\u003C60mL\u002Fmin\u002F1.73m2 \\[GFR (male)=(140-age)ⅹWeight\u002Fserum creatinineⅹ1.23; GFR (female)=(140-age)ⅹWeight\u002Fserum creatinineⅹ1.04\\].\n30. Study participant has any other laboratory abnormality that, in the investigator's opinion, will prevent the study participant from completing the study or will interfere with the interpretation of the study results.\n31. The participant is a SinoCellTech (SCT) employee or is an employee of third-party organizations involved in the study.\n32. The participant and\u002For his or her immediate family member is an employee, volunteer, or other worker at the investigative site, either affiliated or not affiliated with this study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.",{"count":162,"type":22},60,[26],"The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SCT650C in patients with Moderate to Severe Hidradenitis Suppurativa",[166],"Hidradenitis Suppurativa (HS)","2026-04-22",{"date":169,"type":34},"2026-04-28",{"date":171,"type":34},"2025-12-16",{"date":173,"type":22},"2028-02-16",{"name":40,"class":41},{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":4},"100634320","phase-1-a-clinica-study-of-sctc21c-in-participants-with-systemic-lupus-erythematosus-100634320","NCT07538154","A Clinica Study of SCTC21C in Participants With Systemic Lupus Erythematosus","A Phase Ib\u002FII Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SCTC21C in Participants With Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Aged 18-75 years;\n2. Diagnosed with SLE for ≥12 weeks prior to screening, met the 2019 ACR\u002FEULAR diagnostic criteria for SLE screening period;\n3. SELENA-SLEDAI ≥8 at screening;\n4. Positive immunological markers within 12 months prior to baseline;\n5. Currently receiving ≥1 stable doses of standard treatment: oral corticosteroids, antimalarials, or conventional immunosuppressive drugs;\n6. All male participants or females of reproductive potential must agree to use reliable contraception with their partner from signing the ICF through 5 months after the last dose of the study drug\n7. Understanding of the study procedures and voluntary signing of the informed consent form\n\nExclusion Criteria:\n\n1. Severe active or unstable lupus-related neuropsychiatric disorders;\n2. Combined with active infections, malignant tumors, or other autoimmune diseases;\n3. Catastrophic antiphospholipid syndrome;\n4. severe lupus nephritis;\n5. Study participants who received a live or attenuated vaccine within 28 days prior to baseline or during the screening period;\n6. Received any investigational treatment within 30 days prior to baseline or within 5 half-lives of the investigational drug (whichever is longer);\n7. Patients at high risk of severe clinical bleeding, or those requiring plasma transfusion, intravenous immunoglobulin, or acute blood products;;\n8. Patients who experienced any of the following cardiovascular or cerebrovascular events within 24 weeks prior to baseline: myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association (NYHA) Class II or higher heart failure, stroke, etc.;\n9. In accordance with the protocol requirements, participants with abnormal laboratory test results;\n10. Participants with positive results of viral serology, including Treponema pallidum, HIV, HCV, and HBV;\n11. participants with a history of tuberculosis or latent tuberculosis infection;\n12. Diagnosed with type 1 or type 2 diabetes with poor control;\n13. Uncontrolled hypertension;\n14. Intolerance to the study drug or contraindications, including a history of severe allergic reactions to monoclonal antibodies or any component of SCTC21C injection;\n15. Required hospitalization for major surgery within 4 weeks prior to screening or within 12 weeks post-study drug administration;\n16. History of solid organ or hematopoietic stem cell\u002Fbone marrow transplant, or expected to undergo transplant surgery during the study;\n17. Pregnant or breastfeeding;\n18. Any other condition that the investigator deems unsuitable for participation in the study",{"count":183,"type":22},159,[25,26],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in participants with systemic lupus erythematosus",[187],"Systemic Lupus Erythematosus (SLE)",[189],"SLE","2026-04-12",{"date":192,"type":34},"2026-04-20",{"date":194,"type":22},"2026-04",{"date":196,"type":22},"2028-04",{"name":40,"class":41},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":205,"minAge":4,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":68},"100626574","phase-3-efficacy-and-safety-evaluation-study-of-sct800-in-previously-untreated-hemophilia-a-patients-100626574","NCT07437404","Efficacy and Safety Evaluation Study of SCT800 in Previously Untreated Hemophilia A Patients.","An Open Label, Uncontrolled Study to Evaluate the the Safety and Efficacy of SCT800 for Prophylaxis Treatment in Severe Previously Untreated Hemophilia Patients.","Inclusion Criteria:\n\n* Male subjects with severe hemophilia A (FVIII:C \\\u003C 1% in central laboratory tests)\n* previously untreated with pdFVIII\u002FrFVIII, including marketed SCT800 (those who have previously used ≤5EDs of blood products such as cryoprecipitate or fresh frozen plasma are acceptable).\n* FVIII inhibitor negative\n* informed consent.\n\nExclusion Criteria:\n\n* Known allergy to recombinant coagulation factor VIII concentrate or any excipient; known allergy to bovine, rodent or hamster bovine;\n* subjects with a history or family history of FVIII inhibitor formation;\n* Clinical liver function test (ALT、AST) ≥ 5 ULN or clinical kidney function test (BUN，Cr) ≥2 ULN;\n* Patients with other coagulation dysfunction diseases in addition to hemophilia A.\n* International Normalized Ratio (INR) \\> 1.5.","MALE","6 Years",{"count":208,"type":22},36,[52],"This is an Open Label, Uncontrolled Study to Evaluate the the Safety and Efficacy of SCT800 for Prophylaxis Treatment in Severe Previously Untreated Hemophilia Patients.",[212],"Haemophilia A",[214,215,216],"SCT800","haemophilia A","previously untreated patients","2026-02-23",{"date":219,"type":34},"2026-02-27",{"date":221,"type":34},"2024-04-26",{"date":223,"type":22},"2028-12-26",{"name":40,"class":41},{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":68},"100622821","phase-3-a-study-to-evaluate-the-safety-and-efficacy-of-sctc21c-in-combination-with-bortezomib-cyclophosphamide-and-dexamethasone-in-patients-with-newly-diagnosed-systemic-light-chain-amyloidosis-ndslca-100622821","NCT07388602","A Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Newly Diagnosed Systemic Light-Chain Amyloidosis (NDSLCA)","A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone Versus Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Newly Diagnosed Systemic Light-Chain Amyloidosis","Inclusion Criteria:\n\n* Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red stained tissue specimens or characteristic electron microscopy appearance;\n* Measurable disease of amyloid light-chain (AL) amyloidosis;\n* One or more organs impacted by AL amyloidosis according to consensus guidelines\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2\n\nExclusion Criteria:\n\n* Prior therapy for AL amyloidosis;\n* Other amyloidosis;\n* Uncontrolled infection.\n* Subjects with conditions that may affect safety or efficacy assessments include, but are not limited to, cardiovascular, respiratory, endocrine\u002Fmetabolic, immune system, hepatic, gastrointestinal (such as gastrointestinal bleeding, perforation, ulcers, etc.), and malignant neoplasms, and are deemed clinically significant by the investigator.\n* Subjects who have undergone major surgery or experienced significant trauma within 4 weeks prior to the first use of the investigational drug, or who require elective surgery during the trial period.\n* Received a live or attenuated vaccine within 30 days prior to the first dose; Female subjects who are currently breastfeeding.\n* Subjects with mental disorders or poor compliance, or other circumstances deemed unsuitable for participation in this study by other investigators.",{"count":77,"type":22},[52],"The purpose of this study is to evaluate the efficacy and safety of SCTC21C plus cyclophosphamide, bortezomib and dexamethasone (VCd) compared with VCd alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.",[236],"Amyloidosis","2026-01-28",{"date":239,"type":34},"2026-02-05",{"date":241,"type":34},"2026-01-08",{"date":243,"type":22},"2028-12",{"name":40,"class":41},{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":254,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":263,"locationsCount":68},"100615801","phase-3-a-study-to-evaluate-the-safety-and-efficacy-of-sctc21c-in-combination-with-bortezomib-lenalidomide-and-dexamethasone-in-patients-with-newly-diagnosed-multiple-myeloma-not-eligible-for-transplant-100615801","NCT07297329","A Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant","A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Lenalidomide and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant","Inclusion Criteria:\n\n* Newly diagnosed multiple myeloma (IMWG criteria) not eligible for transplant.\n* Evidence of measurable disease.\n* With adequate organ function and hematological parameters.\n* Contraception，and during the study period and for 5 months after the last dose, all subjects must not donate reproductive cells.\n\nExclusion Criteria:\n\n* Other hematologic malignancies.\n* Subjects with confirmed or suspected central nervous system infiltration or meningeal involvement.\n* Uncontrolled infection.\n* Subjects with conditions that may affect safety or efficacy assessments include, but are not limited to, cardiovascular, respiratory, endocrine\u002Fmetabolic, immune system, hepatic, gastrointestinal (such as gastrointestinal bleeding, perforation, ulcers, etc.), and malignant neoplasms, and are deemed clinically significant by the investigator.\n* Subjects who have undergone major surgery or experienced significant trauma within 4 weeks prior to the first use of the investigational drug, or who require elective surgery during the trial period.\n* Received a live or attenuated vaccine within 30 days prior to the first dose; Female subjects who are currently breastfeeding.\n* Subjects with mental disorders or poor compliance, or other circumstances deemed unsuitable for participation in this study by other investigators.",{"count":253,"type":22},292,[52],"The purpose of this study is to evaluate if the addition of SCTC21C to bortezomib, lenalidomide and dexamethasone (VRd) in patients with newly diagnosed multiple myeloma not eligible for transplant will prolong progression-free survival (PFS) and\u002For improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.",[257],"Multiple Myeloma (MM)",{"date":259,"type":34},"2026-01-29",{"date":261,"type":34},"2025-12-29",{"date":243,"type":22},{"name":40,"class":41},{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":68},"100620810","phase-3-a-study-to-evaluate-the-safety-and-tolerability-of-sctb14-as-first-line-therapy-in-non-small-cell-lung-cancer-100620810","NCT07362459","A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer.","A Phase III, Randomized, Double-blind, Multicenter Clinical Study to Evaluate the Efficacy and Safety of SCTB14 Versus Pembrolizumab as First-Line Therapy in Patients With Driver Gene-Negative, TPS ≥10% Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily sign the written informed consent form prior to screening.\n2. Age ≥ 18 years, both male and female.\n3. ECOG Performance Status score of 0 to 1.\n4. An expected survival of ≥ 3 months.\n5. Histologically or cytologically confirmed, unresectable locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) that is not amenable to curative surgery or radical concurrent\u002Fsequential chemoradiotherapy.\n6. For subjects with non-squamous cell carcinoma, as well as non-smoking subjects with squamous cell carcinoma containing mixed adenocarcinoma components, confirmation of the absence of EGFR sensitizing mutations or ALK gene rearrangements from tumor tissue is required prior to enrollment.\n7. Subjects must provide a histology sample suitable for PD-L1 testing, with a Tumor Proportion Score (TPS) ≥ 10%.\n8. No prior systemic anti-tumor therapy for the studied disease.\n9. At least one measurable non-CNS lesion according to RECIST v1.1 criteria.\n10. Adequate function of major organs.\n\nExclusion Criteria:\n\n1. Known actionable driver gene mutations such as ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET exon 14 skipping mutation, and RET fusion mutation.\n2. Received non-specific immunomodulatory therapy or immunosuppressive drugs within 2 weeks before the first dose; received traditional Chinese medicine with antineoplastic indications within 1 week before the first dose.\n3. Prior thoracic radiotherapy; or local anti-tumor therapy within 2 weeks before first dosing.\n4. Prior treatment with antitumor immunotherapy, antiangiogenic therapy, or other small molecule tyrosine kinase inhibitor (TKI)-based antitumor drugs.\n5. subjects with metastasis or compression involving the brainstem, meninges, or spinal cord, or those with active CNS metastases or multiple brain metastases.\n6. Imaging demonstrates tumor invasion of major blood vessels, significant necrosis or cavitation within the primary tumor lesions, or the presence of lymphangitic carcinomatosis.\n7. Imaging demonstrates tumor invasion or compression of adjacent vital organs or carries a risk of developing an esophagotracheal fistula or esophagopleural fistula.\n8. History of hypertensive crisis or hypertensive encephalopathy, or the presence of uncontrolled hypertension despite medication, or poorly controlled diabetes despite pharmacotherapy.\n9. A history of arterial thrombosis, deep vein thrombosis, cerebral infarction, transient ischemic attack, or significant vascular disease within 6 months prior to enrollment.\n10. A history of myocardial infarction, unstable angina, cardiac insufficiency with New York Heart Association (NYHA) class ≥ III, or severe arrhythmia uncontrolled by medication within 6 months prior to enrollment.\n11. The presence of any active autoimmune disease or a history of autoimmune disease with an anticipated recurrence.\n12. A history of esophageal\u002Fgastric varices, severe ulcer, abdominal fistula, intra-abdominal abscess, gastrointestinal perforation and\u002For fistula, acute gastrointestinal bleeding, intestinal obstruction, or extensive intestinal resection within 6 months prior to the first dose.\n13. A history of bleeding tendency, high bleeding risk, or coagulation dysfunction,.\n14. The presence of other malignant tumors.\n15. Toxicities from prior neoadjuvant\u002Fadjuvant therapy, surgery, radiotherapy, or other previous antitumor treatments have not recovered to Grade 0-1.\n16. Receipt of a live or attenuated vaccine within 4 weeks prior to the first dose, or a plan to receive a live or attenuated vaccine during the study period; however, the use of inactivated vaccines is permitted.\n17. Presence of any of the following infectious conditions: a) severe infection within 4 weeks prior to the first dose; b) active infection within 2 weeks prior to enrollment; c) active tuberculosis; d) positive HIV antibody; e) active hepatitis B or C; f) known active syphilis.\n18. Major surgery planned or anticipated during the study period, or unhealed tissue present before enrollment..\n19. Presence of symptomatic or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.\n20. A history of non-infectious pneumonia requiring treatment or the presence of interstitial lung disease\n21. A history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n22. Known hypersensitivity to any component of the investigational drug or a documented history of severe hypersensitivity reactions to any other monoclonal antibody.\n23. Current participation in another clinical trial, with the exception of observational (non-interventional) studies or the follow-up phase of an interventional trial.\n24. Pregnancy or lactation in female subjects.\n25. A known history of alcohol or drug addiction, psychiatric disorders, or drug abuse in the subject.\n26. Tumor-induced conditions or symptoms associated with a high medical risk.\n27. Any other condition deemed by the investigator to be inappropriate for enrollment.",{"count":272,"type":22},246,[52],"This Phase III, randomized, double-blind study compares the efficacy and safety of SCTB14 versus pembrolizumab as first-line treatment in patients with driver gene-negative, TPS ≥10% locally advanced or metastatic non-small cell lung cancer (NSCLC). The primary objective is to assess superiority of SCTB14 over pembrolizumab in prolonging progression-free survival. Safety will be closely monitored.",[276],"Non-Small Cell Lung Carcinoma (NSCLC)","2026-01-15",{"date":279,"type":34},"2026-01-23",{"date":281,"type":34},"2025-12-30",{"date":283,"type":22},"2029-09",{"name":40,"class":41},{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":17,"minAge":292,"maxAge":120,"enrollmentInfo":293,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":68},"100567772","phase-1-multicenter-phase-iii-study-to-evaluate-the-safety-tolerability-pk-and-efficacy-of-sct520ff-in-patients-with-namd-100567772","NCT06672536","Multicenter, Phase I\u002FII Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients With nAMD","A Multicenter, Dose-escalation and Dose-expansion, Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy Characteristics of SCT520FF in Patients With Neovascular Age-related Macular Degeneration","Inclusion Criteria:\n\n1. Signed informed consent form.\n2. Age≥45 years, ≤80 years，male or femal.\n3. The study eye must meet the following criteria: Diagnosis of nAMD;Active MNV lesions secondary to nAMD; Total area of all types of lesions ≤12 optic disc areas; BCVA of the study eye 73\\~19 letters.\n\nExclusion Criteria:\n\n1. Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis, atrophy or dense subfoveal exudation involving the fovea in the study eye.\n2. Significant APD or opacity of the refractive medium and miosis in the study eye that affect visual acuity or fundus examination.\n3. Aphakia (except intraocular lens) or posterior capsular rupture of the lens in the study eye.\n4. The study eye has any eye diseases or medical history other than nAMD that may affect central vision and\u002For macular examine.\n5. MNV caused by non-nAMD exists in the study eye .\n6. Active inflammation or infection in either eye before randomization.\n7. Known allergy to any component of the study intervention or history of allergy to fluorescein or indocyanine green, any anesthetics or antimicrobial agents used during the course of the study.\n8. Abnormal liver and kidney function.\n9. Poorly-controlled blood pressure before randomization.\n10. History of a cardiovascular and cerebrovascular events, including myocardial infarction, unstable angina pectoris, cerebrovascular accidents (including TIA), other thromboembolic diseases (such as thromboembolic angiitis, etc) within 6 months before randomization.\n11. Evidence of significant uncontrolled concomitant diseases.\n12. Participated in any drug (other than vitamins and minerals) or device clinical trials within 3 months or the duration of 5 half-lives of the study drug (which is longer) before randomization and have used the test drug or received device treatment.\n13. Pregnant, lactating women who can not take contraceptive measures during the trial.","45 Years",{"count":294,"type":22},82,[25,26],"Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.",[298],"nAMD","2025-08-27",{"date":301,"type":34},"2025-09-04",{"date":303,"type":34},"2024-11-26",{"date":305,"type":22},"2027-01-11",{"name":40,"class":41},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":314,"enrollmentInfo":315,"targetDuration":4,"studyType":23,"phases":317,"briefSummary":318,"conditions":319,"keywords":320,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":68},"100598881","phase-1-phase-iii-study-of-sctb39g-in-advanced-solid-tumours-100598881","NCT07077252","Phase I\u002FII Study of SCTB39G in Advanced Solid Tumours","An Open Multi-center Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB39G in Adult Patients With Advanced Malignant Solid Tumours","Inclusion Criteria:\n\n* 1.Voluntarily sign the informed consent form (ICF);\n* 2.Male or female, ≥ 18 years and ≤ 70 years old;\n* 3.Survival duration more than 3 months;\n* 4.ECOG score ≤ 1 point;\n* 5.histologically or cytologically confirmed diagnosis of advanced malignant solid tumour；\n* 6.At least one measurable tumor lession according to RECIST v1.1;\n* 7.Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n* 1.Has participated in another clinical study within 4 weeks prior to the first dose;\n* 2.Other malignancies diagnosed within 1 years prior to the enrollment;\n* 3\\. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;\n* 4.NSCLC at high risk of bleeding; Obvious invasion of tumor into adjacent organs of esophageal lesions leads to high risk of bleeding or fistula,or participants after endotracheal stent implantation;\n* 5.Participants with portal hypertension due to portal vein tumor thrombus at risk of bleeding;\n* 6.Presence of pleural effusion, peritoneal effusion, or ascites;\n* 7.Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment\n* 8.History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;\n* 9.Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;\n* 10.History of severe allergies, severe drug allergies (including unapproved investigational drugs);\n* 11.History of organ transplantation or stem cell transplantation;\n* 12.Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;\n* 13.Pregnant or breastfeeding female.","70 Years",{"count":316,"type":22},30,[25,26],"This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39G as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I\u002FII clinical trial.",[102],[321],"Phase I\u002F II Study of SCTB39G in Advanced Solid Tumours","2025-07-11",{"date":324,"type":34},"2025-07-22",{"date":326,"type":22},"2025-07-28",{"date":328,"type":22},"2027-10-17",{"name":40,"class":41},{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":342,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":68},"100596835","phase-1-phase-iii-study-of-sctb39-1-in-advanced-solid-tumours-100596835","NCT07050641","Phase I\u002FII Study of SCTB39-1 in Advanced Solid Tumours","An Open Multi-center Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB39-1 in Adult Patients With Advanced Malignant Solid Tumours","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF);\n2. Male or female, over 18 years old;\n3. Survival duration more than 3 months;\n4. ECOG score ≤ 1 point;\n5. Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour;\n6. Participants in Phase Ib (dose-expansion phase) and Phase II are required to meet the following criteria: Histologically or cytologically confirmed specific type advanced malignant solid tumours;\n7. At least one measurable tumor lession according to RECIST v1.1;\n8. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Has participated in another clinical study within 4 weeks prior to the first dose;\n2. Other malignancies diagnosed within 5 years prior to the enrollment;\n3. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;\n4. Significant bleeding risk;\n5. Presence of pleural effusion, peritoneal effusion, or ascites;\n6. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;\n7. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;\n8. History of severe allergies, severe drug allergies (including unapproved investigational drugs);\n9. History of organ transplantation or stem cell transplantation;\n10. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;\n11. Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment;\n12. Pregnant or breastfeeding female.",{"count":338,"type":22},110,[25,26],"This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39-1 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I\u002FII clinical trial.",[102],[104],"2025-07-02",{"date":345,"type":34},"2025-07-04",{"date":347,"type":34},"2025-06-23",{"date":349,"type":22},"2028-06-30",{"name":40,"class":41},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":358,"targetDuration":4,"studyType":23,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":372},"100580726","phase-1-a-study-of-sctb35-in-patients-with-systemic-lupus-erythematosus-100580726","NCT06841042","A Study of SCTB35 in Patients with Systemic Lupus Erythematosus","A Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SCTB35 in Patients with Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Age 18-75 years；\n2. Diagnosed with SLE for ≥12 weeks prior to screening (2019-ACR\u002FEULAR criteria);\n3. SLEDAI-2K ≥ 8 at screening, or ≥6 if there is hypocomplementemia or elevated anti-dsDNA antibody levels;\n4. Positive for ANA (1:80) or positive for anti-dsDNA and\u002For anti-Sm antibodies within the last 12 months or at screening;\n5. Currently receiving ≥1 stable dose of standard treatment: oral corticosteroids, antimalarials, or conventional immunosuppressive drugs\n\n   1. Stable corticosteroid dose for ≥4 weeks prior to baseline;\n   2. Stable dose of antimalarial drugs for ≥4 weeks prior to baseline;\n   3. Stable dose of immunosuppressive agents for ≥4 weeks prior to baseline;\n6. All male participants or females of reproductive potential must agree to use reliable contraception with their partner from signing the ICF through 6 months after the last dose of the study drug;\n7. Understanding of the study procedures and voluntary signing of the informed consent form.\n\nExclusion Criteria:\n\n1. Severe active or unstable lupus-related neuropsychiatric disorders;\n2. Other autoimmune diseases that may interfere with efficacy evaluation;\n3. Catastrophic antiphospholipid syndrome;\n4. Received treatments that may affect the drug's effect:\n5. Received live vaccines or attenuated vaccines within 28 days prior to baseline or screening;\n6. Clinically significant bleeding risk;\n7. Abnormal laboratory results:\n\n   1. AST or ALT \\>2.5 x ULN;\n   2. Total bilirubin \\>1.5 x ULN;\n   3. ANC \\\u003C1.5x10⁹\u002FL;\n   4. Platelets \\\u003C75x10⁹\u002FL;\n   5. Hemoglobin \\\u003C100g\u002FL;\n8. eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²;\n9. Positive serum HCG;\n10. Received any investigational treatment within 30 days prior to baseline or within 5 half-lives of the investigational drug (whichever is longer);\n11. Participants with recurrent, chronic, or other active infections as assessed by the investigator;\n12. Severe or uncontrolled disease, which would prevent participation in the study;\n13. Positive viral serology tests, including HIV, HCV, and HBV;\n14. Tuberculosis screening: Known active tuberculosis or latent tuberculosis infection (LTBI);\n15. Any type of active infection except nail bed fungal infections;\n16. Severe infections;\n17. History of progressive multifocal leukoencephalopathy (PML);\n18. Diagnosed with type 1 or type 2 diabetes with poor control;\n19. Uncontrolled hypertension (systolic \\>140 mmHg or diastolic \\>90 mmHg);\n20. History of malignancy within 5 years prior to baseline;\n21. Alcohol abuse or drug misuse within 12 months prior to screening;\n22. Intolerance to the study drug or contraindications, including a history of severe allergic reactions to monoclonal antibodies or any component of SCTB35 injection;\n23. Required hospitalization for major surgery within 4 weeks prior to screening or within 12 weeks post-study drug administration;\n24. Participants with mental disorders or poor compliance;\n25. Severe lupus nephritis;\n26. History of solid organ or hematopoietic stem cell\u002Fbone marrow transplant, or expected to undergo transplant surgery during the study;\n27. Pregnant or breastfeeding;\n28. Any other condition that the investigator deems unsuitable for participation in the study.",{"count":359,"type":22},168,[25,26],"This study is a multicenter Phase Ib\u002FII clinical trial aimed at evaluating the safety, tolerability and efficacy of SCTB35 in patients with systemic lupus erythematosus (SLE).",[363],"System Lupus Erythematosus","2025-02-18",{"date":366,"type":34},"2025-02-21",{"date":368,"type":22},"2025-02",{"date":370,"type":22},"2028-10",{"name":40,"class":41},14,{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":380,"sex":17,"minAge":18,"maxAge":381,"enrollmentInfo":382,"targetDuration":4,"studyType":23,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":396},"100574078","phase-1-a-study-to-evaluate-the-safety-tolerability-and-immunogenicity-of-a-recombinant-respiratory-syncytial-virus-vaccine-100574078","NCT06754605","A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine","A Randomized, Double-blind, Placebo-controlled Phase 1\u002F2 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (SCTV02) in Healthy Adults ≥18 Years of Age","Inclusion Criteria:\n\n* Phase I: male and female participants ≥18 years old at the time of signing the ICF; Phase II: male and female participants ≥50 years of age at the time of signing the ICF.\n* Be able to sign a written Informed consent form (ICF) and participate in the trial voluntarily, and can fully understand the trial procedures and risks of participating in the trial.\n* Be able to complete the diary card, contact card and diary\u002Fcontact card by own or with the assistance of others.\n* Phase I: healthy subjects or healthy subjects judged by the investigator according to the clinical data of the subjects; Stage II: Subjects who are healthy or have a stable underlying disease.\n* Fertile men and women of childbearing age voluntarily agree to use effective contraception from the time they sign the ICF until 6 months after immunization; Pregnancy test results for women of childbearing age during the screening period were negative.\n\nExclusion Criteria:\n\n* Acute illness and\u002For fever (axillary temperature ≥37.3 ° C) occurred within 3 days prior to vaccination with the study vaccine, or antipyretic, analgesic, or antiallergic drugs.\n* Use any investigational or unregistered product within 30 days prior to immunization, or plan to use any such product during the study period.\n* Concurrent participation in another clinical study where the subject has been or will be exposed to an investigational or non-investigational vaccine\u002Fproduct at any time during the study.\n* Long-term or high-dose glucocorticoid therapy (duration ≥15 days, or dose ≥1 mg\u002Fkg\u002F day of prednisone or equivalent doses of other glucocorticoids), or other immunosuppressive and cytotoxic therapy within 90 days prior to vaccination.\n* The study received a non-attenuated vaccine within 14 days prior to vaccination, or a live attenuated vaccine within 28 days; Have previously received the experimental respiratory syncytial virus (RSV) vaccine or been infected with RSV within 1 year prior to receiving the investigational vaccine.\n* History or family history of epilepsy and mental illness.\n* A family history of congenital or hereditary immunodeficiency, or a history and physical examination confirmed or suspected immunosuppression or immunodeficiency, or human immunodeficiency virus (HIV) infection, asplenia or functional asplenia.\n* Have the following organ-specific or systemic autoimmune diseases: Guillain-Barre syndrome, myasthenia gravis, autoimmune hepatitis, ulcerative colitis, systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, and systemic sclerosis.\n* Allergic to any component of the study vaccine, or any previous history of severe allergy to vaccine vaccination, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction, angioneurotic edema, etc.\n* Severe chronic disease or active chronic disease, as assessed by the investigator, including but not limited to myocardial infarction, severe arrhythmia, unstable angina, uncontrolled blood pressure after medication (systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg in subjects \\\u003C 60 years of age; Hypertensive disease with systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg in subjects ≥60 years of age, diabetes mellitus with serious complications, cancer or precancerous lesions, and other serious cerebrovascular diseases, heart diseases, respiratory diseases, liver and kidney diseases, and thyroid diseases.\n* Pregnant women (positive pregnancy test) or breastfeeding women, or those with pregnancy plans during the study period, or less than 6 weeks after the end of pregnancy (including ectopic pregnancy).\n\nPlan to donate eggs or sperm during the study.\n\n* Unable to follow the trial procedures, or plan to relocate or stay away for a long period of time during the study and cannot complete the trial follow-up.\n* Any medical condition that makes intramuscular injection unsafe due to other abnormalities, conditions that may obfuscate the results of the study, or conditions that are not in the best interest of the subject, is determined by the investigator to be unsuitable for clinical study.",true,"120 Years",{"count":383,"type":22},480,[25,26],"This is a randomised, double-blind, placebo-controlled Phase 1\u002F2 clinical trial to evaluate the safety, tolerability and immunogenicity of recombinant respiratory syncytial virus in participants aged 18 years and older.",[387],"Respiratory Syncytial Virus","2025-02-11",{"date":390,"type":34},"2025-02-13",{"date":392,"type":34},"2025-02-06",{"date":394,"type":22},"2027-07-30",{"name":40,"class":41},2,{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":380,"sex":17,"minAge":404,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":407,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":68},"100577685","phase-1-a-study-to-evaluate-the-safety-tolerability-and-immunogenicity-of-a-recombinant-herpes-zoster-vaccine-100577685","NCT06801509","A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Herpes Zoster Vaccine","A Randomized, Double-blind, Controlled Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Recombinant Herpes Zoster Vaccine in Healthy Adults","Inclusion Criteria:\n\n1. Male or female subjects ≥ 40 years of age;\n2. The subject can and fully understand the trial procedures and voluntarily sign the ICF;\n3. The subject is in a healthy state or has stable underlying diseases according to investigator's assessment based on medical history and related physical examination results;\n4. The subject can comply with the requirements of the protocol;\n5. The axillary temperature of the subject is \\\u003C 37.0℃ on the day of enrollment;\n6. Fertile men and women with childbearing potential voluntarily agree to take effective contraceptive measures from the first vaccination to at least 90 days after the last dose of study vaccines.\n\nExclusion Criteria:\n\n1. History of herpes zoster before enrollment, or close contact with a varicella\u002Fherpes zoster patient within 30 days prior to enrollment;\n2. Previous vaccination against herpes zoster and varicella (including vaccines that have been registered or under clinical research);\n3. Allergic to any component of the study vaccine, or history of severe allergy to any vaccination, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction, angioneurotic edema, etc.\n4. History or family history of convulsions, epilepsy, and psychiatric disorders;\n5. Suffering from serious chronic diseases or in the active stage of chronic diseases, which are evaluated by the investigator to affect the trial observation, including but not limited to myocardial infarction, severe arrhythmia, unstable angina, hypertension that cannot be controlled after drug treatment (subjects 40-59 years of age have systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg, and subjects ≥60 years of age have systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg), diabetes with severe complications, cancer or precancerous lesions, and other serious cerebrovascular diseases, heart disease, respiratory diseases, liver and kidney diseases, and thyroid diseases;\n6. Primary or secondary immunosuppressive condition, or diagnosed with primary or acquired immunodeficiency disease, human immunodeficiency virus (HIV) infection, etc.\n7. History of thrombocytopenia or other coagulation disorders, which may cause contraindications for intramuscular injection and venous blood collection;\n8. Fever (axillary temperature ≥37.3℃) within 3 days before enrollment or systemic antibiotic or antiviral treatment within 7 days;\n9. Use of antipyretic analgesics or other drugs with antipyretic and analgesic effects, such as acetaminophen and ibuprofen, within 72 h before vaccination.\n10. Abnormal laboratory test (blood routine, blood biochemistry, urine routine) results that are outside the reference range and clinically significant (only apply to Phase I);\n11. Those who are pregnant (positive urine pregnancy test) or breast-feeding, or those who plan to become pregnant during the study period;\n12. Long-term or high-dose corticosteroid therapy (duration ≥15 days, or dose ≥1 mg\u002Fkg\u002F day of prednisone or equivalent doses of other corticosteroids), or other immunosuppressive and cytotoxic therapy within 90 days prior to vaccination. Short-term or topical use (such as ointments, eye drops, inhalants, intra-articular medications or nasal sprays) of glucocorticoids is permitted;\n13. Vaccination with non-attenuated vaccines within 14 days before the first dose of study vaccines, or with live-attenuated vaccines within 28 days before the first dose of study vaccines;\n14. Participation in other clinical trials (drug or vaccine) within 30 days preceding the first dose of study vaccines or planning to participate in other clinical trials before this clinical study is completed;\n15. Asplenia or functional asplenia;\n16. Those who are known to have been diagnosed or currently have an infectious disease, including hepatitis B, hepatitis C, syphilis or AIDS;\n17. Those who have any acute illness or acute onset of chronic illness within 72 hours before the first dose of vaccination;\n18. Those who have received blood or blood-related products, including immunoglobulins, within 3 months before the first dose of vaccination, or have planned to use them during the study period;\n19. Subjects deemed by the investigator to have other conditions that render them ineligible to participate in this study, which include but are not limited to those who are incapable of participating in follow-up visits based on the protocol.","40 Years",{"count":406,"type":22},540,[25,26],"The purposes of the study are to evaluate the Safety, Tolerability, and Immunogenicity of different dose levels of recombinant herpes zoster vaccine with 2 doses 60 days apart in healthy subjects aged 40 years and older.",[410],"Herpes Zoster","2025-01-24",{"date":413,"type":34},"2025-01-30",{"date":415,"type":22},"2025-02-15",{"date":417,"type":22},"2027-10-10",{"name":40,"class":41},{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":23,"phases":428,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":68},"100562196","phase-1-aims-to-explore-the-safety-tolerability-and-preliminary-efficacy-of-sctb41-in-adult-patients-with-advanced-malignant-solid-tumours-100562196","NCT06600022","Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB41 in Adult Patients with Advanced Malignant Solid Tumours.","A Phase I\u002FII, Open-label, Multicentre, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SCTB41 in Patients with Advanced Malignant Solid Tumours","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF);\n2. Male or female, ≥18 years old;\n3. Survival duration more than 3 months;\n4. ECOG score ≤ 1 point;\n5. Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour;\n6. Participants in Phase Ib (dose-expansion phase) and Phase II are required to meet the following criteria: Histologically or cytologically confirmed specific type advanced malignant solid tumours;\n7. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Participants with brainstem, meningeal, spinal metastases, orcompression; active central nervous system metastases;\n2. Other malignancies diagnosed;\n3. History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep veinthrombosis within 6 months prior to enrollment;\n4. Presence of any active autoimmune disease or a history of autoimmunedisease with an expected recurrence;\n5. Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment;\n6. Need for immunosuppressive drugs within 2 weeks prior to enrollment oranticipated during the study;\n7. Significant coagulopathy or other evident risk of bleeding;\n8. uncontrolled effusions in the serous cavities within 4 weeks before enrollment；\n9. Major surgery or significant trauma within 4 weeks prior to enrollment;presence of unhealed skin wounds, surgical sites, trauma sites, severe- Page 3 of 4 \\[DRAFT\\] -mucosal ulcers, or fractures, or if the Investigator deems the participantunsuitable for the study;\n10. History of permanent discontinuation of immunotherapy due to immunerelated toxicity or occurrence of ≥ Grade 3 irAEs;\n11. Known severe allergy to similar antibody drugs;\n12. Presence of active infection；\n13. History of organ transplantation or stem cell transplantation;\n14. Pregnant or breastfeeding female; women of childbearing potential withpositive pregnancy test within 7 days before the enrollment; participants(including males of childbearing potential and their female partners, and females of childbearing potential and their male partners) unwilling to use medically recognized effective contraception during the study and for 6 months after treatment ends.",{"count":427,"type":22},441,[25,26],"This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I\u002FII clinical trial.",[431],"Advanced Malignant Solid Tumours","2025-01-14",{"date":434,"type":34},"2025-01-16",{"date":436,"type":34},"2024-10-10",{"date":438,"type":22},"2028-04-30",{"name":40,"class":41},{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":460},"100575621","phase-1-a-clinical-study-of-sctc21c-in-participants-with-plasma-cell-driven-autoimmune-diseases-100575621","NCT06774664","A Clinical Study of SCTC21C in Participants With Plasma Cell-driven Autoimmune Diseases","A Randomized, Double-blind, Placebo-controlled Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTC21C in Subjects With Plasma Cell-driven Autoimmune Diseases","Inclusion Criteria:\n\n1. Age ≥18 years at the time of signing the ICF;\n2. The subject has been diagnosed with IgA nephropathy through kidney tissue biopsy;\n3. The subject has been on a stable and maximally tolerated dose of ACEI or ARB (or the maximum allowable dose according to the prescribing information) for at least 12 weeks prior to the first dose. Subjects using both ACEI and ARB simultaneously will not be accepted;\n4. The estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula must be ≥30 mL\u002Fmin\u002F1.73 m²;\n5. During the screening period, the subject must have 24-hour proteinuria ≥1.0 g or a urine protein-to-creatinine ratio (UPCR) ≥0.75 g\u002Fg based on 24-hour urine protein;\n6. All male subjects or women of childbearing potential (with a negative blood pregnancy test within 7 days prior to the first dose of investigational drug) must agree to use reliable contraception together with their partner from the time of signing the ICF until 5 months after the last dose of the study drug;\n7. Understand the study procedures and voluntarily sign the informed consent form in writing.\n\nExclusion Criteria:\n\n1. IgA nephropathy secondary to other diseases;\n2. Any kidney disease with special pathological or clinical types, such as nephrotic syndrome, crescentic glomerulonephritis, etc.;\n3. Use of systemic corticosteroids within the 3 months prior to baseline or expected use during the study period;\n4. Use of systemic immunosuppressive drugs within the 3 months prior to baseline or expected use during the study period;\n5. Use of other B-cell-targeting biologics or unapproved investigational biologics within the 6 months prior to baseline;\n6. Patients who have experienced any of the following cardiovascular events within 24 weeks prior to baseline: myocardial infarction, unstable angina, ventricular arrhythmias, heart failure with NYHA class II or higher, stroke, etc.;\n7. A history of solid organ or hematopoietic stem cell or bone marrow transplantation, or expected to undergo a transplant procedure during the treatment period with the investigational drug；\n8. Currently undergoing hemodialysis or peritoneal dialysis, or expected to require hemodialysis or peritoneal dialysis during the treatment period with the investigational drug;\n9. Any symptoms or signs within 30 days prior to baseline indicating an active infection (excluding the common cold), or requiring systemic anti-infective treatment, or being at high risk for infection;\n10. Positive viral serology, including HIV, HCV, and HBV, etc.; Hepatitis B patients: active hepatitis or severe liver disease;\n11. Currently or within the past 5 years has had malignant tumors, except for fully treated skin basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, or cervical intraepithelial neoplasia;\n12. Known allergy to the active ingredient or excipients of the investigational drug.",{"count":448,"type":22},99,[25,26],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in subjects with plasma cell-driven autoimmune diseases",[452],"IgA Nephropathy","2025-01-08",{"date":432,"type":34},{"date":456,"type":22},"2025-01",{"date":458,"type":22},"2029-03",{"name":40,"class":41},20,{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":380,"sex":17,"minAge":18,"maxAge":314,"enrollmentInfo":468,"targetDuration":4,"studyType":23,"phases":470,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":4},"100575261","phase-1-a-study-of-sctt11-in-healthy-participants-and-participants-with-thyroid-eye-disease-100575261","NCT06769984","A Study of SCTT11 in Healthy Participants and Participants with Thyroid Eye Disease.","A Multicentre, Randomized, Double-blinded, Placebo-controlled Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTT11 in Healthy Participants and Participants with Moderate-to-severe Thyroid Eye Disease","Inclusion Criteria for Healthy Participants:\n\n1. Healthy male or female participants aged between18 and 45 inclusive\n2. All participants must agree to not fall pregnant and voluntarily use highly effective double method contraception during the study for at least 180 days after the last dose; female participants must have a negative pregnancy test prior to dosing and must not be breastfeeding\n\nExclusion Criteriafor Healthy Participants:\n\n1.With any other disease or medical condition of clinical significance (e.g., past medical history of chronic hepatic, renal, cardiovascular, neurological\u002Fpsychiatric, gastrointestinal, respiratory, urological, endocrinological, or other systemic diseases, etc.) as assessed by the investigator.\n\nInclusion Criteria for TED Participants:\n\n1. Male or female participants aged between 18 and 70 inclusive\n2. Participants with moderate-to-severe (has an appreciable impact on daily life and requires intervention, but is not sight-threatening) TED\n3. Normal thyroid function, or only mild hyperthyroidism or hypothyroidism (defined as screening free triiodothyronine \\[FT3\\] and free thyroxine \\[FT4\\] levels \\\u003C 50% above or below the normal limits).\n\nExclusion Criteria for TED Participants:\n\n1. Decreased best corrected visual acuity of the study eye due to optic neuropathy within 6 months prior to the first dose\n2. Corneal abnormalities in study eye with no relief from treatment, as evaluated by the investigator\n3. A reduction of ≥2 points in the CAS value or a reduction of ≥2 mm in proptosis in the study eye from the screening assessment period to study baseline period\n4. Presence of other ocular conditions that, in the judgement of the investigator, may affect the evaluation of the study results\n5. Presence of poorly controlled diabetes mellitus\n6. The current presence of other uncontrolled clinical diseases or conditions\n7. Abnormalities in any of the following laboratory examinations during the screening phase\n8. Poorly controlled hypertension\n9. With past medical histories of major surgery and\u002For trauma within 1 month prior to the first dose\n10. With past medical histories of severe allergies, histories of severe drug allergies, known or suspected allergy to any component of this investigational product\n11. Vaccination with live or live attenuated vaccine within 1 month prior to the first dose or expected during the study\n12. Participation in a clinical study of any drug or device within 3 months prior to the first dose and have used the investigational product or have been treated with the device\n13. Pregnant, lactating females; or participants of childbearing potential who are unwilling to use effective contraception during the study and within 180 days after the last dose\n14. Other conditions evaluated by the investigator to be unsuitable for enrolment",{"count":469,"type":22},100,[25,26],"Multicentre, Randomized, Double-blinded, Phase I\u002FII Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTT11 in Healthy Participants and Participants with Thyroid Eye Disease",[473],"TED","2025-01-06",{"date":476,"type":34},"2025-01-10",{"date":478,"type":22},"2025-02-19",{"date":480,"type":22},"2028-09-19",{"name":40,"class":41},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":23,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":68},"100535474","phase-1-a-clinical-study-of-sctc21c-in-participants-with-cd38-hematologic-malignancies-100535474","NCT06252298","A Clinical Study of SCTC21C in Participants With CD38+ Hematologic Malignancies","A Phase I Clinical Study Evaluating the Safety and Efficacy of SCTC21C in Participants With CD38+ Hematologic Malignancies","Inclusion Criteria:\n\n1. Male or female aged ≥ 18 years old when signing ICF, weight ≥ 40 kg, ≤ 90 kg\n2. Relapsed or refractory CD38+（confirmed by immunohistochemistry or flow cytometry） hematologic malignancies\n3. Standard therapies failed or are unavailable or intolerant\n4. Participants have at least one of the measurable lesions\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n6. Life expectancy ≥3 months\n7. Participants with basically normal liver, kidney and heart functions\n8. Hematology requirements: platelet≥75x10\\^9 \u002FL,absolute neutrophil counts ≥ 1.0x10\\^9 \u002FL, hemoglobin ≥ 8.0 g\u002FdL\n9. Women of childbearing potential (must have a negative blood pregnancy test within 7 days before the first dose) or male participants must use a highly effective method of contraception from signed ICF to 5 months after the last dose.All participants are prohibited from donating sperms or ova during the study period and 5 months after the last dose\n\nExclusion Criteria:\n\n1. A history of allergic reactions to any SCTC21C injection or any excipients, or Participants with a history of severe drug allergy\n2. Participants who have other antineoplastic drug (except hormones) or radiotherapy within four weeks prior to the first dose of study drug, or the participants who have received immunotherapy or anti-CD38 monoclonal antibody within 6 months\n3. Adverse events from the previous treatment have not resolved to ≤ Grade 1\n4. Participants with prior immunotherapy and Grade ≥ 3 cytokine release syndrome(CRS)\n5. Central nervous system involvement\n6. Participants with positive Human immunodeficiency virus (HIV) antibody\n7. HBsAg positive with HBV-DNA titer higher than the lower limit of the test value of the research center, or HCV antibody positive with HCV-RNA titer higher than the lower limit of the test value of the research center\n8. Active infections that require systemic treatment within 1 week prior to the first dose\n9. History of additional malignant tumor or active autoimmune diseases,or participants with other serious medical conditions\n10. Participants underwent major surgery within 4 weeks prior to the first dose, or had a surgical schedule during the study period\n11. History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation,or history of autologous hematopoietic stem cell transplantation within 6 months prior to screening\n12. Participants with significant digestive system dysfunction that may affect drug intake, transport and absorption\n13. Participants who have received live vaccines within 30 days prior to the first dose of study drug\n14. Participants with mental disorders or poor compliance\n15. Female participants who are breastfeeding\n16. The Investigator determined that the participant is ineligible for the study for other reasons",{"count":490,"type":22},74,[25],"The purpose of this study is to evaluate the safety and efficacy of SCTC21C in patients with CD38+ hematologic malignancies",[494],"Relapsed or Refractory Hematologic Malignancies","2024-04-19",{"date":497,"type":34},"2024-04-22",{"date":499,"type":34},"2024-02-28",{"date":501,"type":22},"2027-02-28",{"name":40,"class":41},{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":23,"phases":512,"briefSummary":513,"conditions":514,"keywords":516,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":526},"100540595","phase-1-a-first-in-human-study-of-sctb35-in-patients-with-relapserefractory-b-cell-non-hodgkin-lymphoma-100540595","NCT06318884","A First-in-human Study of SCTB35 in Patients With Relapse\u002FRefractory B-cell Non-Hodgkin Lymphoma","A Phase Ia\u002FIb Dose-escalation and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SCTB35 in Patients With CD20+ Relapse\u002FRefractory B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\nPatients are eligible to be included in the study only if all the following conditions are met:\n\n1. Age ≥ 18 years\n2. Histologically or cytologically confirmed CD20+ mature B-cell neoplasm\n\n   For dose-escalation phase:\n   1. De novo or transformed diffuse large B-cell lymphoma (DLBCL)\n   2. High-grade B-cell lymphoma (HGBCL)\n   3. Primary mediastinal large B-cell lymphoma (PMBCL)\n   4. Follicular lymphoma (FL)\n   5. Mantle cell lymphoma\n   6. Small lymphocytic lymphoma (SLL)\n   7. Marginal zone lymphoma (MZL) (nodal, extranodal or mucosa associated)\n\n   For dose expansion phase:\n   1. FL cohort: histologic confirmed FL grade 1, 2, or 3a at initial diagnosis without clinical or pathological evidence of transformation\n   2. LBCL cohort: including histologic confirmed DLBCL, not otherwise specified (NOS), Epstein-Barr virus+ DLBCL, transformed DLBCL from indolent subtypes, HGBCL, NOS, double\u002Ftriple-hit HGBCL, FL grade 3b, and PMBCL\n3. For dose-escalation phase:\n\n   Relapsed, progressive and\u002For refractory disease after adequate systemic therapy containing at least an anti-CD20 monoclonal antibody (e.g. rituximab)\n   1. Patients must have exhausted or are ineligible for all standard therapeutic options\n   2. Patients with indolent lymphoma (FL, MZL or SLL) must have a need for treatment initiation based on symptoms and\u002For disease burden\n\n   For dose-expansion phase:\n\n   Relapsed, progressive and\u002For refractory disease following ≥ 2 prior lines of adequate systemic therapy containing at least an anti-CD20 monoclonal antibody (e.g. rituximab)\n4. At least 1 measurable site of disease based on computed tomography (CT) or magnetic resonance imaging (MRI) (defined as a clearly nodal lesion with the long axis \\> 1.5 cm or extranodal lesion with the long axis \\> 1.0 cm). Lesions that have previously received radiotherapy can be considered measurable only after confirming the presence of progression or residual lesions. (for the dose-escalation phase: a evaluable site of disease is allowed).\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n6. Adequate hepatic\u002Fhematologic\u002Frenal\u002Fcardiac functions indicated by laboratory values\n\n   1. Absolute neutrophil count (ANC) ≥ 1.0 x 10\\^9\u002FL within 7 days before first dose of study drug (without growth factor support). There is an exception for patients with bone marrow involvement in which case ANC must be ≥ 0.75 x 10\\^9\u002FL\n   2. Platelets \\> 75 x 10\\^9\u002FL within 7 days before first dose of study drug (without growth factor support or transfusion). There is an exception for patients with bone marrow involvement in which case platelets must be ≥ 50 x 10\\^9\u002FL\n   3. Hemoglobin \\> 90 g\u002FL within 7 days before first dose of study drug (independent of growth factor support or transfusion).\n   4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance ≥ 45 mL\u002Fmin as estimated by Cockcroft-Gault equation\n   5. Adequate liver function indicated by: i) Aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase ≤ 3 x ULN; ii) Alanine aminotransferase (ALT)\u002Fserum glutamic-pyruvic transaminase ≤ 3 x ULN; iii) Total bilirubin level ≤ 1.5 x ULN (unless documented Gilbert's syndrome).\n   6. Left ventricular ejection fraction ≥ 50%;\n7. Expected survival time is more than 3 months\n\nExclusion Criteria:\n\nA patient who conforms to any of the following criteria should be excluded from the study:\n\n1. Any prior therapy with an bispecific antibody of the same class\n2. Eligible for high dose chemotherapy with hematopoietic stem cell transplantation (HSCT)\n3. Known central nervous system (CNS) involvement by lymphoma\n4. Known past or current malignancy other than inclusion diagnosis, with the following exceptions:\n\n   1. Cervical carcinoma of Stage Ib or less\n   2. Non-invasive basal cell or squamous cell skin carcinoma\n   3. Non-invasive, superficial bladder cancer\n   4. Prostate cancer with a current prostate-specific antigen (PSA) level \\\u003C0.1 ng\u002FmL\n   5. Any curable cancer with a complete response (CR) of \\>2 years duration\n5. Known clinically significant cardiac disease, including:\n\n   1. Onset of unstable angina pectoris or acute myocardial infarction within 6 months prior to signing Informed Consent Form (ICF)\n   2. Congestive heart failure prior to signing ICF (meets the criteria of New York Heart Association Classification III or IV)\n   3. Clinically significant arrhythmia prior to signing ICF\n6. History of interstitial lung disease or uncontrolled lung diseases, or evidence of dyspnea at rest or pulse oximetry \\\u003C 93% while breathing room air.\n7. Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy (including \\>20mg\u002Fday prednisolone \\[or equivalent\\], but low-dose prednisolone is allowed). The well controlled autoimmune disease can be enrolled at investigator's discretion, including:\n\n   1. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone\n   2. Patients with a history of type 1 diabetes mellitus who were well controlled (defined as a screening hemoglobin A1c \\\u003C 8% and no urinary ketoacidosis)\n   3. Patients with skin disease who were not treated with systemic corticosteroid\n8. History of seizure disorder or confirmed progressive multifocal leukoencephalopathy (PML)\n9. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)\n10. Known any major episode of active infection requiring treatment with systemic antibiotics within 2 weeks prior to signing ICF\n11. Positive for human immunodeficiency virus (HIV) antibody. Positive for hepatitis B antibody (except for only the positive HBsAb) with detectable hepatitis B virus (HBV) DNA. Positive for hepatitis C antibody with detectable hepatitis C virus (HCV) RNA\n12. Chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to first SCTB35 administration (only applicable for dose-expansion phase)\n13. Autologous HSCT within 100 days prior to first SCTB35 administration, or any prior allogeneic HSCT or solid organ transplantation\n14. Received major surgery within 4 weeks prior to first SCTB35 administration, or planned to receive major surgery during the study\n15. Received any chemotherapeutic agent, other anti-cancer agent, or investigational drug (monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate or otherwise) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to first SCTB35 administration\n16. Exposed to live or live attenuated vaccine within 4 weeks prior to first SCTB35 administration, or planned to receive these vaccines during the study\n17. Pregnancy or breast feeding. During the study and for 6 months after last administration of SCTB35, a woman of childbearing potential or a man who is sexually active with a woman of childbearing potential disagrees to practice a highly effective method of birth control.\n18. Patient has any condition for that, in the opinion of the investigator, participation could prevent, limit, or confound the protocol-specified assessments",{"count":511,"type":22},76,[25],"This is a Phase I clinical study designed to evaluate the safety, tolerability, and pharmacokinetics, and preliminary efficacy of SCTB35 monotherapy, an bispecific antibody, in patients with relapsed and\u002For refractory B-cell non-Hodgkin lymphoma.",[515],"Non-Hodgkin Lymphoma, B-cell",[517],"Non-Hodgkin Lymphoma","2024-03-20",{"date":520,"type":34},"2024-03-22",{"date":522,"type":22},"2024-04",{"date":524,"type":22},"2027-12",{"name":40,"class":41},3,{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":534,"targetDuration":4,"studyType":23,"phases":536,"briefSummary":537,"conditions":538,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":4},"100539513","phase-1-aims-to-explore-the-safety-tolerability-and-preliminary-efficacy-of-sctb14-in-adult-patients-with-advanced-malignant-solid-tumours-100539513","NCT06304818","Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB14 in Adult Patients With Advanced Malignant Solid Tumours.","A Phase I\u002FII, Open-label, Multicentre, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SCTB14 in Patients With Advanced Malignant Solid Tumours","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF);\n2. Male or female, 18 years old ≤ age ≤ 75 years old;\n3. Survival duration more than 3 months;\n4. ECOG score ≤ 1 point;\n5. Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour;\n6. Participants in Phase Ib (dose-expansion phase) and Phase II are required to meet the following criteria: Histologically or cytologically confirmed specific type advanced malignant solid tumours;\n7. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;\n2. Other malignancies diagnosed within 5 years prior to the enrollment, except effectively treated malignant solid tumour (such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical cancer in situ, breast cancer in situ, etc.);\n3. History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollmen;\n4. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;\n5. Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment;\n6. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;\n7. Significant coagulopathy or other evident risk of bleeding;\n8. Major surgery or significant trauma within 4 weeks prior to enrollment; presence of unhealed skin wounds, surgical sites, trauma sites, severe mucosal ulcers, or fractures, or if the Investigator deems the participant unsuitable for the study;\n9. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;\n10. History of severe allergies, severe drug allergies (including unapproved investigational drugs), or known allergy to any component of the IMP;\n11. History of organ transplantation or stem cell transplantation;\n12. Pregnant or breastfeeding female; women of childbearing potential with positive pregnancy test within 7 days before the enrollment; participants (including males of childbearing potential and their female partners, and females of childbearing potential and their male partners) unwilling to use medically recognized effective contraception during the study and for 6 months after treatment ends.",{"count":535,"type":22},515,[25,26],"This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB14 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I\u002FII clinical trial.",[431],"2024-03-13",{"date":541,"type":34},"2024-03-15",{"date":543,"type":22},"2024-04-30",{"date":545,"type":22},"2028-12-30",{"name":40,"class":41},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":554,"targetDuration":4,"studyType":23,"phases":555,"briefSummary":556,"conditions":557,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":68},"100531224","phase-2-efficacy-and-safety-of-sct650c-in-participants-with-axial-spondyloarthritis-100531224","NCT06197009","Efficacy and Safety of SCT650C in Participants With Axial Spondyloarthritis","A Randomized, Double-blinded, Phase II, Placebo-controlled Study to Evaluate the Safety and Efficacy of SCT650C in Participants With Axial Spondyloarthritis","Inclusion Criteria:\n\n1. An Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the participant.\n2. Participant is considered reliable and capable of adhering to the protocol (e.g., able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator.\n3. Participant is male or female and at least 18 years of age.\n4. Participant has a documented diagnosis of adult-onset AS as defined by documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984) of at least 3 months' symptom duration and age of onset \\\u003C45 years.\n5. Participant has moderate to severe active disease at the Screening Visit as defined by each of the following:\n\n   1. BASDAI score ≥4\n   2. Spinal pain score ≥4 on a 0 to 10 numeric rating scale (NRS) (from BASDAI Item 2)\n6. Participants must have at least 1 of the following:\n\n   1. inadequate response to NSAID therapy\n   2. intolerance to administration of at least 1 NSAID\n   3. contraindication(s) to NSAID therapy An inadequate response to NSAID is defined as not improving after 4 weeks of using NSAID therapy at the recommended dose or failing to respond to at least 2 NSAIDs at the recommended dose for 2 weeks each.\n7. Participants who are regularly taking NSAIDs\u002FCOX-2 inhibitors as part of their SPA therapy are required to be on a stable dose for at least 14 days before Baseline and should remain on a stable dose up to week 16.\n8. Participants taking corticosteroids must be on an average daily dose of ≤10mg\u002Fday prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose up to week 16.\n9. Participants taking Methotrexate (MTX, ≤25mg\u002Fweek), sulfasalazine (up to 3g\u002Fday) or hydroxychloroquine (up to 400mg per day total) are allowed to continue their medication if the dose has been stable dose for at least 4 weeks before randomization. Dose, dosing schedule, and route of administration (oral or subcutaneous) should remain stable up to week 16.\n10. Subject may have prior treatment TNF inhibitor (TNFi), which must have used no more than 2 TNFi and must have been discontinued.\n11. Female participants must be postmenopausal (at least 1 year; to be confirmed hormonally as part of the screening process, if less than 2 years since last menstrual period), permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception up to 40 weeks after the last administration of IMP, and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to the first dose. The following methods are considered highly effective when used consistently and correctly.\n\n    1. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n    2. combined (estrogen and progestogen) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal)\n    3. intrauterine device (IUD)\n    4. intrauterine hormone-releasing system (IUS)\n    5. bilateral tubal occlusion\n    6. vasectomized partner (where postvasectomy testing had demonstrated sperm clearance)\n    7. Sexual abstinence if it is in accordance with a participant's preferred and common lifestyle.\n\nParticipants who use abstinence as a form of birth control must agree to abstain from heterosexual intercourse until 40 weeks after the final dose of IMP. Study personnel must confirm the continued use of abstinence is still in accordance with the participant's lifestyle at regular intervals during the study.\n\nMale participants with a partner of childbearing potential must be willing to use a condom when sexually active, until 40 weeks after the last administration of IMP.\n\nExclusion Criteria:\n\n1. Female participant who is breastfeeding, pregnant, or planning to become pregnant during the study or within 40 weeks following the final dose of IMP. Male participant planning a partner pregnancy during the study or within 40 weeks following the final dose.\n2. Participant has participated in another study of a medication under investigation within the last 3 months or at least 5 half-lives of the IMP, whichever is greater, or is currently participating in another study of a medication under investigation. Participants who participated in any clinical trial but were enrolled in placebo group and did not receive any IMP in the prior study are eligible for this study.\n3. Participant has received any IL-17 response modifier.\n4. Participant has received more than 3 bDMARDs to treat axSpA.\n5. Participant has a known hypersensitivity to any excipients of SCT650C.\n6. Participant has total ankylosis of the spine or a diagnosis of any other inflammatory arthritis e.g., RA, systemic lupus erythematosus, sarcoidosis, psoriatic arthritis, or reactive arthritis. Participants with a diagnosis of Crohn's disease or ulcerative colitis are allowed if they have no active symptomatic disease at Screening or Baseline.\n7. Participant has a secondary noninflammatory condition (e.g., osteoarthritis, fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with the evaluation of the effect of study drug on the participant's primary diagnosis of active SpA.\n8. Participant has:\n\n   1. A history of chronic or recurrent infections (e.g., more than 3 episodes requiring systemic antibiotics or antivirals during the preceding year). Minor illnesses like common cold or transient, localized infections that may have been treated with a short course of antibiotic therapy (up to 7 days) need not be counted in this assessment.\n   2. A serious or life-threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster) or hospitalization for any infection in the last 6 months.\n   3. Any current sign or symptom that may indicate an active infection (except for common cold) or has had an infection requiring systemic antibiotics within 2 weeks prior to Baseline.\n   4. A high risk of infection in the Investigator's opinion (e.g., participants with leg ulcers, indwelling urinary catheter, prior prosthetic joint infection at any time, participants who are permanently bedridden or wheelchair assisted).\n9. Participant has a history of or current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, nontuberculous mycobacteria (NTMB), Blastomyces, or Aspergillus or current active Candidiasis (local or systemic)\n10. Participant has acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection. Participants who have evidence of, or test positive for, hepatitis B or hepatitis C are excluded as follows:\n\n    1. A positive test for the hepatitis B virus (HBV) is defined as: 1) positive for hepatitis B surface antigen (HBsAg+), or 2) HBsAg is negative, HBcAb is positive and HBV-DNA test results ≥ the upper limit of the reference value of each center or need antiviral treatment.\n    2. A positive test for the hepatitis C virus (HCV) is defined as: 1) positive for hepatitis C antibody (anti-HCV Ab), and 2) positive via a confirmatory test for HCV (for example, HCV polymerase chain reaction).\n11. Participants with known TB infection, at high risk of acquiring TB infection, with latent TB infection (LTBI), or current or history of NTMB infection.\n12. Participant has a primary immunosuppressive condition, including taking immunosuppressive therapy following an organ transplant or has had a splenectomy.\n13. Participants with concurrent malignancy or a history of malignancy (including surgically resected uterine\u002Fcervical carcinoma-in-situ) during the past 5 years will be excluded with the following exceptions that may be included:\n\n    1. One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised or ablated only (other treatments, i.e., chemotherapy, do not apply) with no signs of recurrence or metastases for more than 2 years prior to Screening.\n    2. ≤3 excised or ablated basal cell carcinomas of the skin.\n    3. Actinic keratosis(-es).\n    4. Squamous cell carcinoma-in-situ of the skin successfully excised or ablated more than 6 months prior to the Screening.\n14. Participant has a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.\n15. Participant has a history of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.\n16. Participant has a current or recent history, as determined by the Investigator, of severe, progressive, and\u002For uncontrolled renal, hepatic hematological, endocrine, pulmonary, cardiac (e.g., congestive heart failure New York Heart Association \\[NYHA\\] Grade 3 and 4), gastrointestinal (GI) (note: participants with active peptic ulcer disease are excluded; participants with a history of peptic ulcer disease are allowed), or neurological disease.\n17. Participants have a history of uncompensated heart failure, fluid overload, or myocardial infarction, or evidence of new-onset ischemic heart disease or in the opinion of the Investigator other serious cardiac disease, within 12 weeks prior to Baseline.\n18. Participant has \\>2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \\>ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If participant has elevations only in total bilirubin that is\\>ULN and \\\u003C1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (i.e., direct bilirubin \\\u003C35%).\n\n    An isolated elevation between 2xULN and \\\u003C3xULN of ALP is acceptable in the absence of an identified exclusionary medical condition.\n\n    Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated for confirmation during the Screening Period. Upon retesting, participants whose ALT, AST, or ALP remain above the thresholds defined above, should not be randomized.\n\n    For randomized participants with a Baseline result \\>ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and\u002For the cause of any clinically meaningful elevation must be understood and recorded in the electronic Case Report form (eCRF).\n\n    If a participant has \\>ULN ALT, AST, or ALP that does not meet the exclusion limit at Screening, repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the participant must be discussed with the Medical Monitor.\n19. Participants with clinically significant laboratory abnormalities (e.g., creatinine \\>1.5xULN, neutropenia \\\u003C1.5x109\u002FL, hemoglobin \\\u003C8.5g\u002FdL, lymphocytes \\\u003C1.0 x109\u002FL, white blood cell (WBC) count \\\u003C3.0x109, platelets \\\u003C100 x109\u002FL). Individual screening tests for which the results are in error, borderline, or indeterminate for inclusion in the study, can be repeated once for confirmation during the Screening Period if they are within 25% of the exclusion limit. Upon retesting, participants whose results remain outside this threshold should not be randomized.\n20. Participant has an estimated glomerular filtration rate (GFR) as measured by Chronic Kidney Disease Epidemiology Collaboration \\\u003C60mL\u002Fmin\u002F1.73m2 \\[GFR (male)=(140-age)ⅹWeight\u002Fserum creatinineⅹ1.23; GFR (female)=(140-age)ⅹWeight\u002Fserum creatinineⅹ1.04\\].\n21. Participant has a 12-lead ECG with changes considered to be clinically significant upon medical review (e.g., QT corrected for heart rate \\[QTc\\] using Fridericia's correction \\[QTcF\\] \\>450ms, bundle branch block, evidence of myocardial ischemia).\n22. Participant has received any live (includes attenuated) vaccination within the 8 weeks prior to Baseline (12 months prior to Baseline for the TB Bacille Calmette-Guérin \\[BCG\\] vaccine) (e.g., inactivated influenza and pneumococcal vaccines are allowed but nasal influenza vaccination is not permitted). Live vaccines are not allowed during the study or for 40 weeks after the final dose of IMP.\n\n    Live vaccines include, but are not limited to the following:\n    1. Anthrax vaccine\n    2. Intranasal influenza vaccine\n    3. Measles-mumps-rubella (MMR) vaccine\n    4. Polio live oral vaccine (OPV)\n    5. Smallpox vaccine\n    6. Tuberculosis BCG vaccine (within 12 months prior to Baseline)\n    7. Typhoid live oral vaccine\n    8. Varicella vaccine\n    9. Yellow fever vaccine\n23. Participant has any other condition which, in the Investigator's judgment, would make the participant unsuitable for inclusion in the study.",{"count":359,"type":22},[26],"The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SCT650C in patients with Axial Spondyloarthritis",[558],"Axial Spondyloarthritis","2023-12-25",{"date":561,"type":34},"2024-01-09",{"date":563,"type":22},"2024-07-01",{"date":565,"type":22},"2026-08-01",{"name":40,"class":41},""]