[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idiopathic-pulmonary-fibrosisipf\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idiopathic-pulmonary-fibrosisipf":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100602277","phase-2-a-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-immunogenicity-of-sv001-in-patients-with-idiopathic-pulmonary-fibrosis-100602277",false,"NCT07121413","A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis","A Phase IIa, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis","Inclusion Criteria:\n\n1. Subjects with a confirmed diagnosis of IPF and pulmonary function meeting the protocol-specified criteria;\n2. Subjects must agree to use highly effective contraception during the study and for 6 months after the last administration of the study drug;\n3. Subjucts must be able to understand the study, voluntarily provide written informed consent, and be willing and able to comply with all study-related procedures.\n\nExclusion Criteria:\n\n1. Subjects with a history of drug or other allergies, or those judged by the investigator to be potentially allergic to the study drugs;\n2. Presence of any other clinically significant pulmonary diseases besides IPF at screening;\n3. Any known contraindications to performing pulmonary function tests at screening;\n4. Respiratory or systemic infections requiring anti-infective therapy within 1 month prior to randomization;\n5. Acute exacerbation of IPF within 4 months prior to randomization;\n6. Use of any medication known to cause or worsen pulmonary fibrosis, as assessed by the investigator, within 3 months prior to screening;\n7. History of smoking within 3 months prior to screening, or unwillingness to quit smoking throughout the study period;\n8. Presence of clinically significant cardiovascular, cerebrovascular, hematological, neurological, psychiatric, or metabolic disease at screening, or plans for major surgery during the study period;\n9. Presence of specified abnormal laboratory test results at screening;\n10. Evidence of renal impairment or end-stage renal disease requiring dialysis at screening;\n11. Active hepatitis virus infection; history of acquired or congenital immunodeficiency disease;\n12. History of malignancy within 5 years prior to screening;\n13. Difficulty with venipuncture or a history of needle phobia or blood phobia;\n14. Positive pregnancy tests or currently lactating at screening;\n15. Participation in another clinical trial and receipt of other investigational drugs within 3 months prior to randomization;\n16. Any other condition that the investigator consider unsuitable for participation in the study.","ALL","40 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.",[26],"Idiopathic Pulmonary Fibrosis(IPF)","RECRUITING","2026-02-08",{"date":30,"type":31},"2026-02-11","ACTUAL",{"date":33,"type":31},"2025-11-04",{"date":35,"type":20},"2026-12-31",{"name":37,"class":38},"Shanghai Synvida Biotechnology Co.,Ltd.","INDUSTRY",12,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100618310","phase-1-car-dc-for-end-stage-ipf-100618310","NCT07329959","CAR-DC for End-Stage IPF","Safety and Efficacy of Immunosuppressive CAR-DC Targeting FAP in the Treatment of End-stage Idiopathic Pulmonary Fibrosis","Inclusion Criteria:\n\n1\\. Aged between 18 and 75 years, inclusive, with a diagnosis of idiopathic pulmonary fibrosis (IPF).\n\n2\\. Ability to verbally confirm understanding of the risks, benefits, and alternative treatments associated with immunosuppressive CAR-DC therapy. Provision of written informed consent by the patient or their legally authorized representative prior to participation.\n\n3\\. Evidence of disease progression (worsening pulmonary fibrosis and declining lung function) despite treatment with standard therapies such as pirfenidone, nintedanib, or other appropriate regimens.\n\n4\\. Meets at least one criterion indicating eligibility for lung transplantation due to interstitial lung disease, while not consenting to a transplant. The criteria include:\n\n1. A decline in forced vital capacity (FVC) ≥10% over a 6-month follow-up period.\n2. A decline in diffusing capacity of the lungs for carbon monoxide (DLCO) ≥10% of predicted value over 6 months.\n3. Six-minute walk test results showing oxygen saturation \\\u003C88%, a distance walked \\\u003C250 meters, or a decline of \\>50 meters in distance over 6 months.\n4. Presence of pulmonary hypertension (PH) confirmed by right heart catheterization or transthoracic echocardiography.\n5. Hospitalization due to respiratory functional decline, pneumothorax, or acute exacerbation.\n\n5\\. No prior cellular immunotherapy within the last 3 months. 6. Hematological parameters meeting the following thresholds: hematocrit \\>30%, lymphocyte count \\>0.5 × 10⁹\u002FL, and platelet count \\>60 × 10⁹\u002FL.\n\nExclusion Criteria:\n\n1. History of acute exacerbation of IPF within 4 weeks prior to screening or during the screening period.\n2. Presence of interstitial lung disease (ILD) other than IPF, including but not limited to: other forms of idiopathic interstitial pneumonia; ILD associated with fibrogenic agents, environmental exposures, or drug toxicity; other occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; or ILD related to systemic diseases (e.g., vasculitis, infections such as tuberculosis, connective tissue diseases). Cases with uncertain diagnosis require serological testing and\u002For multidisciplinary team review for confirmation.\n3. Presence of significant active infection.\n4. History of malignancy, except for malignancies treated with curative intent and with no recurrence for ≥5 years, resected basal cell or squamous cell skin carcinoma, carcinoma in situ of the cervix, or resected colonic polyps.\n5. Significant history of infectious diseases.\n6. Presence of psychiatric illness or other conditions that would compromise the patient's ability to cooperate with study requirements, comply with treatment, or undergo monitoring.\n7. Known hypersensitivity to any component of the immunosuppressive CAR-DC cell product.\n8. History of severe renal failure requiring renal dialysis, or serum creatinine level \\>2.5 mg\u002FdL.\n9. Any contraindication to the investigational product or study procedures.\n10. Pregnancy or lactation.\n11. History of pulmonary embolism (PE), deep vein thrombosis (DVT), or recurrent thromboembolic events.\n12. Uncorrected thrombocytopenia (platelet count \\\u003C50,000\u002FμL) or systemic coagulopathy (INR \\>2.5 or aPTT \\>2.5 times the control value in the absence of anticoagulant therapy), or active bleeding with uncorrectable coagulopathy.\n13. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels \\>5.0 times the upper limit of normal (ULN), or total bilirubin \\>3 mg\u002FdL.","18 Years","75 Years",{"count":50,"type":20},8,[52],"PHASE1","Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fatal interstitial lung disease characterized by irreversible scarring, leading to respiratory failure. With limited treatment options and a poor prognosis, new therapies are urgently needed. This study investigates a novel cell therapy targeting pathological fibroblasts, a key driver of fibrosis.\n\nSingle-cell analyses identify CTHRC1+FAP+ fibroblasts as a collagen-producing subpopulation crucial in IPF progression. Chimeric antigen receptor (CAR) technology enables precise targeting of these cells. While CAR-Treg therapy has shown promise in preclinical models, its clinical translation requires careful safety evaluation regarding infection risk, potential tumor promotion, and immune reconstitution.\n\nThis trial employs an innovative approach using engineered dendritic cells (DCs). CAR technology is applied to generate immunosuppressive CAR-DCs (iCAR-DCs) designed to target FAP, localize to fibrotic lung areas, and attenuate fibrosis without eliciting a detrimental immune response. Preliminary mouse studies demonstrated that iCAR-DC administration following lung injury significantly reduced fibrosis without apparent organ toxicity and improved survival.\n\nThis single-arm trial aims to evaluate the efficacy and safety of this immunosuppressive CAR-DC therapy in patients with end-stage IPF. Key assessments will include changes in lung function, fibrosis extent on imaging, and comprehensive monitoring of potential adverse effects, particularly infections, tumor markers, and immune parameters.",[26],"NOT_YET_RECRUITING","2026-01-08",{"date":58,"type":31},"2026-01-09",{"date":60,"type":20},"2026-02-01",{"date":62,"type":20},"2029-02-28",{"name":64,"class":65},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100586387","jin-shui-huan-xian-formula-for-retarding-the-decline-of-pulmonary-function-in-ipf-100586387","NCT06914713","Jin-shui Huan-xian Formula for Retarding the Decline of Pulmonary Function in IPF","Efficacy Evaluation of Jin-shui Huan-xian Formula in Retarding the Decline of Pulmonary Function in IPF","Inclusion Criteria:\n\n1. Patients who meet the diagnostic criteria for IPF.\n2. Pulmonary function: The percentage of forced vital capacity (FVC) to the predicted value is ≥ 50%; and the percentage of the diffusing capacity of the lung for carbon monoxide (DLCO) to the predicted value is ≥ 30%.\n3. Patients who meet the syndrome - differentiation criteria for lung - qi deficiency syndrome, lung - and - kidney qi deficiency syndrome, etc.\n4. Aged between 40 and 85 years old.\n5. Patients who voluntarily accept the treatment and sign the informed consent\n\nExclusion Criteria:\n\n1. Patients in the acute exacerbation phase of IPF.\n2. Patients complicated with other pulmonary diseases such as chronic obstructive pulmonary disease (COPD), lung cancer, active pulmonary tuberculosis, bronchiectasis, and pulmonary embolism.\n3. Patients with severe joint, peripheral nerve, and peripheral vascular diseases that affect limb movement and who are bed - ridden for a long time and cannot complete the six - minute walk test.\n4. Patients complicated with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, heart function grade 3 or above, stroke, cerebral hemorrhage, etc.).\n5. Patients complicated with liver diseases such as cirrhosis or secondary portal hypertension, bleeding caused by esophageal and gastric varices, patients with kidney diseases requiring dialysis or kidney transplantation, or patients with abnormal liver and kidney functions (ALT, AST, and BUN are 1.5 times higher than the upper limit of the normal range, and blood Cr is higher than the upper limit of the normal range).\n6. Patients with unclear consciousness, various mental illnesses, etc., who cannot communicate normally.\n7. Pregnant or lactating women and patients with a recent plan for pregnancy.\n8. Patients who have participated in other clinical trials within 1 month before enrollment.\n9. Patients known to be allergic to any of the test medications and their components.","85 Years",{"count":75,"type":20},384,[77],"NA","This study is to evaluate the clinical efficacy and safety of Jin-shui Huan-xian Formula in retarding the decline of pulmonary function in IPF, generate high - quality clinical evidence, and establish a treatment plan of Jin-shui Huan-xian Formula for retarding the decline of pulmonary function in Idiopathic Pulmonary Fibrosis（IPF）",[26],[81,82,83,84],"Idiopathic Pulmonary Fibrosis","traditional Chinese medicine","randomized controlled trial","pulmonary function","2025-07-31",{"date":87,"type":31},"2025-08-05",{"date":89,"type":20},"2025-08-01",{"date":91,"type":20},"2028-11-30",{"name":93,"class":65},"Henan University of Traditional Chinese Medicine",1]