[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guangdong ProCapZoom Biosciences Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":119},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,62,82,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100611652","early-phase-1-allogeneic-cd19-car-nk-cells-in-patients-with-refractory-myasthenia-gravis-100611652",false,"NCT07243366","Allogeneic CD19-CAR-NK Cells in Patients With Refractory Myasthenia Gravis","Exploratory Clinical Trial of Allogeneic CD19-CAR-NK Cells in Patients With Refractory Myasthenia Gravis","Inclusion Criteria:\n\n* Aged 18-65 years old, including the boundary value, no gender restriction;\n* MGFA clinical class II-IV;\n* Anti-acetylcholine-receptor antibody (AChR-Ab) shows positive;\n* Willing to participate in the study, understand and sign the informed consent form (ICF).\n* Baseline characteristics - all must be fulfilled:\n\n  1. Refractory MG patients: Meet the diagnostic criteria in the Chinese Guidelines for the Diagnosis and Treatment of MG (2020 edition). On the basis of typical MG clinical features (fluctuating muscle weakness), a diagnosis can be made if any of the following three points are met, including pharmacological examination, electrophysiological characteristics, and serum anti-AChR antibody testing. Other diseases must also be excluded.\n  2. Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 6, with ocular sub-score \\\u003C 50 % of total.\n* Diagnostic Criteria: Meeting any one of the following four conditions:\n\n  1. Following an adequate dose and full course of at least two conventional immunotherapies (including both corticosteroids and non-steroidal immunosuppressants), and at least one complete treatment cycle with a biologic agent (efgartigimod, eculizumab, rituximab, or telitacicept), the post-intervention status (PIS) remains unchanged or worsens.\n  2. Following an adequate dose and full course of at least two conventional immunotherapies (including both corticosteroids and non-steroidal immunosuppressants) and at least one complete treatment cycle with a biologic agent, the PIS improves, yet the MG-ADL score is still ≥6 and persists for at least six months.\n  3. Following an adequate dose and full course of at least two conventional immunotherapies (including both corticosteroids and non-steroidal immunosuppressants) and at least one complete treatment cycle with a biologic agent, the PIS shows remission or improvement; however, during the regular tapering of immunotherapy drugs, the patient experiences ≥2 exacerbations per year with an MG-ADL score ≥6.\n  4. Despite treatment with multiple immunotherapies-including intravenous immunoglobulin (IVIG), plasma exchange, and high-dose intravenous methylprednisolone (IVMP)-as well as aggressive infection control after a myasthenic crisis, the patient remains unable to be weaned from mechanical ventilation for more than 14 days due to respiratory muscle weakness caused by MG.\n* Within 30 days before enrollment: glucocorticoids unchanged for 1 month, immunosuppressants for 3 months, pyridostigmine for 2 weeks, and stable MG-ADL score for 1 month.\n\nNote: 1. \"Two conventional immunotherapies\" consist of one corticosteroid plus one non-steroidal immunosuppressant. 2. \"Adequate dose for a full course\" is defined as follows: 1) Corticosteroid: 0.5-1.0 mg · kg-¹ · d-¹ for ≥ 8 weeks. 2) One of the following non-steroidal immunosuppressants taken for the specified minimum duration: A. Azathioprine: 1.5-2.5 mg · kg-¹ · d-¹ in 2-3 divided doses for ≥ 24 weeks. B. Methotrexate: 15 mg once weekly for ≥ 24 weeks. C. Mycophenolate mofetil: 0.75-1.00 g twice daily for ≥ 24 weeks. D. Cyclophosphamide: 400-800 mg intravenously every week OR 100 mg\u002Fday orally in two divided doses, with a cumulative dose ≥ 15 g. E. Tacrolimus: 2-3 mg\u002Fday with at least one trough level ≥ 4.8 ng\u002FmL for ≥ 12 weeks. F. Cyclosporine: 2-4 mg · kg-¹ · d-¹ in two divided doses, with at least one fasting trough level ≥ 100 ng\u002FmL for ≥ 24 weeks. 3. Failure to complete the full dose and course of any one conventional immunotherapy due to contraindications, comorbidities, or inability to tolerate drug adverse effects is considered equivalent to having an inadequate response after completing a full dose and course of that conventional immunotherapy. 4. Biologic agents include efgartigimod, eculizumab, rituximab, and telitacicept.\n\nExclusion Criteria:\n\n* Received IVMP, IVIG, or TPE within the 2 months before the current visit;\n* Unable to cooperate in completing the MG-ADL, or QMG, or Quantitative QMG questionnaire.\n* Judged by a senior clinician to have any of the following: 1)Severe or chronic urinary-tract infection; 2)History of recurrent infections; 3)Previous allergy to any human-derived biologic drug; 4)Depression, suicidal ideation, or other psychiatric disorder;\n* Patients with active infection, such as herpes zoster, HIV, active tuberculosis, or active hepatitis.\n* Rituximab within 6 months, eculizumab within 3 months, or efgartigimod within 1 month before enrollment.\n* Receipt of any live vaccine within 3 months before screening or planned vaccination during the study.\n* Subjects deemed unsuitable for participation in this trial by the investigator (e.g., severe psychiatric illness).","ALL","18 Years","65 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This study is a single-center, prospective, nonrandom, single-arm trial.",[27],"Refractory Myasthenia Gravis","NOT_YET_RECRUITING","2025-11-19",{"date":31,"type":32},"2025-11-21","ACTUAL",{"date":34,"type":21},"2025-11-25",{"date":36,"type":21},"2027-11-30",{"name":38,"class":39},"Guangdong ProCapZoom Biosciences Co., Ltd.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100608400","early-phase-1-a-study-of-sz1003-injection-in-patients-with-advanced-hepatocellular-carcinoma-100608400","NCT07201064","A Study of SZ1003 Injection in Patients With Advanced Hepatocellular Carcinoma","An Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of SZ1003 Injection in Patients With Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Aged 18-75 years old, including the boundary value, no gender restriction;\n* Meet the diagnostic criteria for advanced hepatocellular carcinoma established by histopathology and\u002For cytology, and have experienced failure of second-line therapy for advanced HCC (per 2024 CSCO Guidelines for Primary Liver Cancer). Patients must have progressed during or after at least two prior lines of standard systemic therapy (intolerant or refractory), with radiologically documented disease progression. Eligible stages are Barcelona Clinic Liver Cancer stage B or C, or stage IIb\u002FIIIa\u002FIIIb as defined in the 2024 Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (stage-IIb patients must be deemed unsuitable for surgery or TACE);\n* Have at least one measurable or evaluable lesion per RECIST 1.1;\n* GPC3 positivity confirmed by immunohistochemistry on a clinical pathology section;\n* Child-Pugh classification: class A or class B (≤ 7 points) (See Appendix 1 for the Child-Pugh classification table).;\n* ECOG performance status: the score is 0 or 1 (See Appendix 2 for the ECOG-PS scoring table);\n* Renal function: serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 50 mL\u002Fmin by Cockcroft-Gault;\n* Coagulation: INR, APTT, and PT ≤ 1.5 × ULN without anticoagulant therapy.\n* Able to undergo routine peripheral venous blood collection, establish adequate venous access, and have no contraindications to peripheral blood procurement.\n* Women of child-bearing potential must have a negative serum or urine pregnancy test within 14 days before enrollment and agree to use effective non-hormonal contraception (e.g., condoms, non-medicated IUD) throughout the trial to minimize the risk of pregnancy. Men with partners of child-bearing potential and women of child-bearing potential must maintain effective contraception from screening until 12 months after the last cell infusion.\n* Willing to participate in the study, fully informed of the study and sign the informed consent form; willing to comply with all trial procedures.\n\nExclusion Criteria:\n\n* Patients who have previously undergone liver transplantation, organ allotransplantation, allogeneic stem-cell transplantation, and renal-replacement therapy.\n* Clinically detectable hepatic encephalopathy or those requiring pharmacological treatment for hepatic encephalopathy.\n* Moderate-to-severe ascites attributable to portal hypertension or cirrhosis.\n* History of leptomeningeal or central-nervous-system metastases.\n* Neurologic disorder ≥ Grade 2 (CTCAE).\n* Having experienced esophageal or gastric variceal bleeding due to portal hypertension within the past 3 months. Patients with evidence of portal hypertension and a high bleeding risk as assessed by the investigator.\n* Having experienced any life-threatening bleeding events within the past 3 months, including those requiring transfusion, surgery, local treatment, or continuous pharmacological therapy.\n* History of stroke or central nervous system hemorrhage; Prior stroke, CNS hemorrhage, TIA, or RIND within 6 months.\n* Uncontrolled hypertension (SBP \\> 140 mmHg or DBP \\> 90 mmHg despite optimal therapy), hypertensive crisis, or hypertensive encephalopathy.\n* Symptomatic CHF (NYHA ClassII-IV), Symptomatic or poorly controlled arrhythmias. Electrocardiogram (ECG) showing clinically significant abnormalities, or QTc interval ≥ 450 milliseconds in men, ≥ 470 milliseconds in women (≥ 480 milliseconds for subjects with bundle branch block on consecutive ECGs) (calculated using Fridericia's formula).\n* Severe bleeding diathesis, coagulopathy, or ongoing thrombolytic therapy.\n* A history of or current pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, drug-related pneumonitis, or severely impaired pulmonary function.\n* HBsAg-positive subjects with HBV-DNA above the lower limit of detection at the study site must receive at least 7 days of antiviral therapy before the first dose and are willing to continue antiviral treatment for hepatitis B as required during the study to be eligible for enrollment. HBsAg-negative but HBcAb-positive subjects with HBV-DNA below the lower limit of detection at the study site will be closely monitored for HBV-DNA and liver transaminase levels during the dosing period. If HBV reactivation occurs during the treatment period, these subjects must agree to immediately initiate antiviral therapy for hepatitis B to remain eligible. All such subjects must be willing to continue antiviral treatment for hepatitis B for at least 6 months after the last dose, and the investigator may follow up on hepatitis B markers based on individual patient circumstances. Active hepatitis C: HCV antibody-positive with HCV-RNA levels above the lower limit of detection at the study site; co-infection with hepatitis B and hepatitis C.\n* Active tuberculosis (TB), subjects currently receiving anti-TB treatment or those who have received anti-TB treatment within 1 year before the first dose.\n* HIV-positive or active syphilis.\n* Subjects with active or poorly controlled serious infections; those who have had severe infections within 4 weeks before peripheral blood collection, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications.\n* Active autoimmune disease requiring systemic therapy (immunosuppressants, corticosteroids, or DMARDs) within 2 years and not adequately controlled.\n* History of malignancy (other than HCC) within 5 years.\n* Known hypersensitivity to study drug or its components.\n* Pregnant or lactating women.\n* Subjects deemed unsuitable for participation in this trial by the investigator.","75 Years",{"count":49,"type":21},12,[24],"This study is a \"3+3\" dose-escalation, open-label, multiple-dose clinical trial.",[53],"Advanced Hepatocellular Carcinoma","2025-09-23",{"date":56,"type":32},"2025-10-01",{"date":58,"type":21},"2025-09-25",{"date":60,"type":21},"2027-09-30",{"name":38,"class":39},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100607175","early-phase-1-mscohi-o-lenses-for-ocular-involvement-in-sjgrens-syndrome-100607175","NCT07185139","MSCohi-O Lenses for Ocular Involvement in Sjögren's Syndrome","Exploratory Clinical Trial of MSCohi-O Lenses for Ocular Involvement in Sjögren's Syndrome","Inclusion Criteria:\n\n* Aged 18-65 years old, including the boundary value, no gender restriction;\n* Subjects meeting the 2016 ACR\u002FEULAR classification criteria for Sjögren's syndrome, and also meet the diagnostic criteria for ocular involvement.\n* Ocular signs and symptoms unresponsive to at least 3 months of conventional therapy, including artificial tears and topical or systemic corticosteroids.\n* Extra-ocular manifestations of Sjögren's syndrome clinically stable.\n* Subjects and their partners agree to use effective non-pharmacological contraception from screening through 6 months after the last dose and have no plans for conception during this period.\n* Willing to participate in the study, understand and sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Known allergy to any component of the investigational drug.\n* Active ocular infection.\n* Presence of other significant ocular disease or trauma diagnosed prior to enrollment, including but not limited to glaucoma, uveitis, retinopathy, chemical injury, or thermal burns.\n* History of any ocular surgery within the preceding 6 months, including cataract surgery.\n* Participation in another interventional clinical study.\n* Use of any ophthalmic medication that may interfere with the study outcomes, such as other stem-cell-derived products.\n* Having serious underlying diseases of the heart, brain vessels, liver, kidneys, and hematopoietic system.\n* Pregnant or lactating women; women of childbearing potential must employ an effective contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study and for at least 3 months after the final dose of study drug.\n* Subjects deemed unsuitable for participation in this trial by the investigator.",{"count":49,"type":21},[24],"This study is aSingle-center, multiple-dosing, prospective, nonrandom, single-arm trial.",[73],"Sjögren's Syndrome","2025-09-17",{"date":76,"type":32},"2025-09-22",{"date":78,"type":21},"2025-09-12",{"date":80,"type":21},"2026-09-30",{"name":38,"class":39},{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":97,"locationsCount":4},"100607754","early-phase-1-exosomes-in-patients-with-ocular-involvement-of-sjgrens-syndrome-100607754","NCT07192666","Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome","Exploratory Clinical Trial of Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome","Inclusion Criteria:\n\n* Aged 18-65 years old, including the boundary value, no gender restriction;\n* Subjects meeting the 2016 ACR\u002FEULAR classification criteria for Sjögren's syndrome, and also meet the diagnostic criteria for ocular involvement.\n* The ocular involvement symptoms and signs of these patients cannot be relieved after at least 3 months of conventional therapy, including artificial tears and topical or systemic corticosteroids.\n* Extra-ocular manifestations of Sjögren's syndrome clinically stable.\n* Subjects and their partners agree to use effective non-pharmacological contraception from screening through 6 months after the last dose and have no plans for conception during this period.\n* Willing to participate in the study, understand and sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Known allergy to any component of the investigational drug.\n* Active ocular infection.\n* Presence of other significant ocular disease or trauma diagnosed prior to enrollment, including but not limited to glaucoma, uveitis, retinopathy, chemical injury, or thermal burns.\n* History of any ocular surgery within the preceding 6 months, including cataract surgery.\n* Participation in another interventional clinical study.\n* Use of any ophthalmic medication that may interfere with the study outcomes, such as other stem-cell-derived products.\n* Having serious underlying diseases of the heart, brain vessels, liver, kidneys, and hematopoietic system.\n* Pregnant or lactating women; women of childbearing potential must employ an effective contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study and for at least 3 months after the final dose of study drug.\n* Subjects deemed unsuitable for participation in this trial by the investigator.",{"count":49,"type":21},[24],"This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial.",[73],{"date":58,"type":32},{"date":95,"type":21},"2025-09-15",{"date":80,"type":21},{"name":38,"class":39},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100589261","early-phase-1-a-study-of-stem-cells-lenses-in-the-cogvhd-subjects-100589261","NCT06952114","A Study of Stem Cells Lenses in the coGVHD Subjects","A Single Dose Phase I Study to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Stem Cells Lenses in the Chronic Ocular Graft-versus-Host Disease Subjects","Inclusion Criteria:\n\n1. Aged 18-65 years old, including the boundary value, no gender restriction.\n2. Subjects diagnosed with coGVHD caused by hematopoietic stem cell transplantation, with at least 3 months post-transplantation.\n3. Meet the clinical diagnostic criteria for coGVHD in the eye: presence of at least one of the following symptoms in either eye: 1) Dryness, burning sensation, foreign body sensation, ocular discomfort, or decreased vision. 2) The total score in either eye ≥ 8 in the absence of systemic chronic graft-versus-host-disease (cGVHD) symptoms, or ≥ 6 in the presence of systemic cGVHD symptoms. (Total score = Schirmer's test score + CFS score + OSDI score + conjunctival congestion).\n4. Eye-related symptoms treated conventionally for 1 week prior to screening with no improvement or inadequate response (severity not reduced based on the grading scale of coGVHD).\n5. Karnofsky Performance Status (KPS) score \\> 60.\n6. Adequate function of important organs: Absolute neutrophil count ≥ 1.0×10\\^9\u002FL, platelets count ≥ 75×10\\^9\u002FL, hemoglobin ≥ 10g\u002FdL, bilirubin ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the ULN, and serum creatinine ≤ 1.5 times the ULN.\n7. Subjects and their partners have no fertility plans from screening to 6 months after the end of the trial and agree to effective non-pharmacological non-drug contraceptive measures during the trial.\n8. Willing to participate in the study, understand and sign the ICF.\n\nExclusion Criteria:\n\n1. Known allergy to any component of the investigational product.\n2. Subjects with any unstable or uncontrolled cardiovascular, pulmonary, gastrointestinal, urogenital, coagulation, immunological, endocrine, metabolic, or other medical conditions that the investigator believes will interfere with the study results or endanger the safety of the subjects.\n3. Subjects with other ocular diseases at screening:\n\n   1. Other ocular diseases unrelated to coGVHD, such as blepharospasm.\n   2. Acute active fungal, bacterial, or viral keratitis or conjunctivitis, or other acute eye infections.\n   3. Corneal ulceration.\n   4. Glaucoma, cataracts, or other ocular diseases assessed by the investigator to potentially affect efficacy and safety evaluation.\n4. Subjects with a history of Stevens-Johnson Syndrome.\n5. Subjects with a history of corneal refractive surgery (e.g., LASIK, PRK) or other corneal surgeries.\n6. Subjects who have undergone eye surgery within the previous 3 months.\n7. Subjects with a history of corneal contact lens wear who cannot remove them during treatment.\n8. Inability to understand and complete the OSDI questionnaire.\n9. Participation in other clinical trials within 3 months prior to screening.\n10. Subjects with systemic diseases or psychiatric histories that the investigator believes may increase the risk to subjects or affect the evaluation of the study results.\n11. Positive test results for human immunodeficiency virus antibodies, Treponema pallidum-specific antibodies (syphilis), or positive hepatitis C antibodies, surface antigen of hepatitis B, history of hepatitis B, or positive hepatitis B core antibody, with recent HBV-DNA levels ≥2000IU\u002FmL in the past 3 months.\n12. Subjects with a history of solid tumors.\n13. Pregnant or lactating women.\n14. Subjects deemed unsuitable for participation in this trial by the investigator.\n15. Subjects with active infections will not be recruited.",{"count":106,"type":21},6,[24],"This study is a single dose, Phase I study to evaluate the safety, tolerability, and preliminary effectiveness of Stem cells Lenses in the coGVHD Subjects. Three subject's enrollments are Expected. Each subject will wear Stem cells Lenses loaded for four consecutive days. After a 4-day treatment period, a 14-day follow-up observation period will be conducted to monitor for potential adverse events.\n\nThis study aims to treat patients with chronic ocular graft-versus-host-disease. Currently, there are no approved drugs for the treatment of coGVHD. Three conventional treatments currently available-systemic administrations, topical treatments, and surgical therapies-have various limitations. allo-HSCT involves the transplantation of hematopoietic stem cells from a healthy donor to a recipient with malignant blood diseases such as leukemia to regenerate the hematopoietic and immune systems. A logical strategy for treating the condition directly would involve the administration of UCMSCs. Using UCMSCs to locally modulate donor T cells and prevent them from attacking the ocular surface tissues of the recipient would be a viable approach to the etiological treatment of coGVHD.",[110],"Chronic Ocular Graft-versus-host Disease","2025-05-05",{"date":113,"type":32},"2025-05-08",{"date":115,"type":21},"2025-05-20",{"date":117,"type":21},"2026-02-28",{"name":38,"class":39},""]