[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"claudin182-positive-advanced-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:claudin182-positive-advanced-solid-tumors":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100613416","early-phase-1-car-t-for-claudin182-positive-solid-tumors-100613416",false,"NCT07266311","CAR-T for Claudin18.2 Positive Solid Tumors","Clinical Study on the Safety and Efficacy of CAR T-cell Therapy for Claudin18.2 Positive Advanced Solid Malignant Tumors","Inclusion Criteria:\n\n* Aged 18 to 75 years at the time of signing the the informed consent form (ICF).\n* Pathologically confirmed advanced solid tumor and patients have failed at least 2 prior lines of systemic therapy; or patients with advanced pancreatic cancer who have failed at least 1 prior line of systemic therapy.\n* Tumor tissue testing meets the requirement: Positive for Claudin 18.2 (CLDN18.2) by immunohistochemistry (IHC) staining.\n* Estimated life expectancy ≥ 12 weeks from the time of screening.\n* Presence of measurable tumor lesions in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 at screening, within 24 hours prior to apheresis, and at baseline.\n* Has adequate venous access to allow successful collection of peripheral blood mononuclear cells (PBMCs).\n* Meets the specified laboratory test criteria at screening and pre-treatment (see Appendix for detailed parameters). For abnormal laboratory results that do not meet the criteria, a retest is permitted within 1 week; if the retest still fails to meet the criteria, the patient is deemed ineligible for screening.\n* Female patients of childbearing potential must have a negative serum pregnancy test at screening and pre-treatment. They must agree to use a highly effective and reliable contraceptive method for 1 year after the last study treatment.\n* Male patients who are sexually active with women of childbearing potential must agree to use barrier contraception (unless they have undergone vasectomy) during the study and for 1 year after the last study treatment.\n* Voluntarily agrees to participate in the clinical trial, has been fully informed of the study details, signs the ICF, and is willing to comply with and capable of completing all study procedures.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Serologically positive for human immunodeficiency virus (HIV), Treponema pallidum, or hepatitis C virus (HCV); or positive for Epstein-Barr virus (EBV)-DNA, cytomegalovirus (CMV)-DNA, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid.\n* Presence of any uncontrolled active infection, including but not limited to active tuberculosis and active hepatitis B virus (HBV) infection (defined as HBsAg positive with detectable HBV-DNA).\n* Persistent toxicities from prior anti-tumor therapy that have not resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 1, except for tolerable events such as alopecia as determined by the investigator.\n* Known history of active autoimmune diseases (including but not limited to psoriasis, rheumatoid arthritis) or other conditions requiring long-term immunosuppressive therapy.\n* History of hypersensitivity to immunotherapeutic agents or related drugs, history of severe allergies, or hypersensitivity to any component of CAR-T injection.\n* Presence of brain metastases or symptoms related to brain metastases.\n* Patients at high risk of bleeding or perforation (e.g., active gastrointestinal ulcer, recent gastrointestinal bleeding within 3 months).\n* Patients requiring anticoagulant therapy.\n* Patients requiring continuous antiplatelet therapy.\n* History of organ transplantation or awaiting organ transplantation.\n* History of major surgery or significant trauma within 4 weeks prior to apheresis, or planned major surgery during the study period.\n* Presence of other serious pre-existing medical conditions that may limit the patient's participation in the study (e.g., severe cardiac, hepatic, or renal dysfunction).\n* Assessed by the investigator as unable or unwilling to comply with the study protocol requirements.\n* Presence of clinically significant central nervous system (CNS) disease signs or abnormally significant neurological test results.\n* Current diagnosis or history of other incurable malignant tumors within the past 3 years, except for in situ cervical cancer or basal cell carcinoma of the skin (which are considered cured after appropriate treatment).","ALL","18 Years","75 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","The purpose of this clinical trial is to learn if autologous claudin18.2-directed chimeric antigen receptor T-cell (CAR-T) therapy works to treat claudin18.2 positive solid tumors in adults. It will also learn about the safety and efficacy of the autologous claudin18.2 CAR-T cell product.\n\nThe main questions it aims to answer are:\n\n1. What CAR-T-related adverse events (AEs) occur within 3 months after the autologous CAR-T cell infusion?\n2. What is the Objective Response Rate (ORR), Progression-free survival (PFS), duration of response (DOR), and overall survival (OS)?\n\nParticipants will:\n\n1. Undergo leukapheresis for collection of autologous T cells for CAR-T cell manufacturing.\n2. May receive lymphodepletion chemotherapy (fludarabine plus cyclophosphamide) for 3 consecutive days if clinically needed.\n3. If lymphodepletion chemotherapy is administered, rest for 2 days on Day -2 and Day -1.\n4. Receive autologous CAR-T cells infusion on Day 0.\n5. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days.\n6. Visit the clinic at Day 14, Day 28, then monthly for up to 12 months after CAR-T cells infusion, with continued long-term follow-up for safety and persistence.",[27],"Claudin18.2 Positive Advanced Solid Tumors",[29,30,31],"claudin18.2","CAR-T","CAR T-cell therapy","NOT_YET_RECRUITING","2025-12-03",{"date":35,"type":36},"2025-12-05","ACTUAL",{"date":38,"type":21},"2025-12-15",{"date":40,"type":21},"2037-12-31",{"name":42,"class":43},"Chengdu Ucello Biotechnology Co., Ltd.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":44},"100576217","phase-1-treating-claudin182-positive-advanced-solid-tumors-with-xkdct225targeting-claudin182-car-t-100576217","NCT06782425","Treating Claudin18.2-positive Advanced Solid Tumors with XKDCT225(Targeting Claudin18.2-CAR-T)","A Single-center, Single-arm, Dose-escalation Exploratory Clinical Trial of the Safety, Efficacy, and Pharmacokinetics of XKDCT225 (Targeting Claudin18.2-CAR-T) Cell Injectionin Claudin18.2-positive Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age 18-75 (including the critical value), regardless of gender;\n2. Patients with advanced solid tumors (including but not limited to gastric adenocarcinoma, esophagogastric junction adenocarcinoma, esophageal adenocarcinoma) with moderate to high expression of Claudin18.2 (expression intensity ≥ 2+ and tumor cell positive rate ≥ 50 %), and whose condition cannot be completely relieved or continues to progress after adequate treatment;\n3. At least one measurable lesion according to RECIST 1.1 criteria (non-lymph node lesion with long diameter ≥10 mm, lymph node lesion with short diameter ≥15 mm);\n4. Estimated life expectancy \\> 12 weeks;\n5. ECOG physical status score 0 \\~ 1;\n6. Laboratory test values for screening must meet the following criteria:\n\nRoutine blood test:\n\n* WBC≥3.0×10\\^9 \u002FL\n* ANC≥1.5×10\\^9 \u002FL\n* LYMPH≥0.5×10\\^9 \u002FL\n* HB≥90g\u002FL\n* PLT≥75×10\\^9 \u002FL\n\nBlood biochemistry examination:\n\n* ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN if liver metastasis is present)\n* ALB≥30g\u002FL\n* Serum creatinine ≤1.5×ULN or GFR\\>50mL\u002Fmin (GFR = \\[(140-age)×weight×(0.85female)\\]\u002F(72×Scr))\n* TBIL≤1.5×ULN\n\nCoagulation function test:\n\n* APTT ≤ 1.5 ULN, with INR or PT ≤ 1.5 ULN (not receiving anticoagulation therapy) 7. Female subjects of childbearing age must undergo a serum pregnancy study with negative results at screening and before purging, and be willing to use medically approved highly effective contraceptive methods during the study and for at least 1 year after the last study treatment. Male subjects whose partners are female subjects of childbearing age should undergo surgical sterilization or agree to use effective contraceptive methods during the study and for at least 1 year after the last study treatment, and are prohibited from donating sperm within 1 year.\n\n  8\\. If the patient is using the following medications, the corresponding conditions must be met:\n* Steroids: Therapeutic doses of steroids must be discontinued 4 weeks prior to XKDCT 225 cell injection. However, physiological replacement doses of steroids are allowed: hydrocortisone or equivalent \\\u003C6\\~ 12mg \u002F mm\\^2 \u002F day ;\n* Immunosuppression: Any immunosuppressive drugs must be stopped ≥ 4 weeks before enrollment; 9. Volunteer to participate in the clinical trial and sign the informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women;\n2. Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive, and HBV DNA copy number positive; Hepatitis C antibody (HCV-Ab) positive; Anti-Treponema pallidum antibody (TP-Ab) positive; Human immunodeficiency virus antibody (HIV-Ab) positive; Those who meet any of the following conditions;\n3. Any active infection requiring antibiotic treatment;\n4. Received any immune cell therapy within one year;\n5. Previously received Claudin18.2 targeted therapy ;\n6. Live vaccine or live attenuated vaccine received within 4 weeks before single collection;\n7. Surgery has been performed within 2 weeks before apheresis and the researchers believe that it may affect the patient's safety;\n8. Active coronary heart disease (including angina pectoris, myocardial infarction) within 6 months before enrollment;\n9. Within 6 months before study entry, the subject had a history of clinically significant arrhythmias or current abnormalities requiring antiarrhythmic treatment other than beta-blockers or digoxin and\u002For conduction drugs, excluding atrial fibrillation and paroxysmal supraventricular tachycardia;\n10. Left ventricular ejection fraction (LVEF) \\\u003C50% or congestive heart failure (New York Heart Association NYHA classification ≥3) at screening;\n11. Uncontrolled diabetes (glycosylated hemoglobin\\>8%), uncontrolled hypertension (systolic blood pressure\u002Fdiastolic blood pressure\\>160mmHg\u002F100mmHg while taking medication);\n12. Patients with active autoimmune diseases within 3 months before screening, such as systemic lupus erythematosus, who need to continue taking medication during the entire trial period;\n13. Other malignancies occurred within 5 years before enrollment, excluding cervical carcinoma in situ, skin squamous cell carcinoma, or basal cell carcinoma that had been treated with radical cure;\n14. Have a known symptomatic central nervous system (CNS) disease;\n15. Tumor cells infiltrate the central nervous system, and tumor cells are detected in the cerebrospinal fluid or the tumor is detected by cranial imaging;\n16. The tumor has extensive metastasis and involves more than two organs at the same time, which the investigator believes may significantly change the baseline assessment; or the tumor has progressed rapidly and has reached PD between enrollment and lymph node clearance;\n17. Difficult airway (tumor growth blocking the airway or airway deformity, etc.);\n18. before apheresis, lymph node ablation, and XKDCT 225 cell injection to maintain fingertip blood oxygen saturation \\> 95%;\n19. The subject has unstable or active gastric ulcer or active gastrointestinal bleeding, or other conditions that may require emergency treatment during the trial, including but not limited to gastrointestinal obstruction, perforation, and rupture of giant tumors;\n20. Patients with pleural and abdominal effusion greater than grade 2 during screening and unable to be controlled by drainage or diuretics;\n21. The subject is currently taking anticoagulants and cannot stop taking them during the entire trial;\n22. Allergy or intolerance to the research drugs tocilizumab, fludarabine, cyclophosphamide and other lymphoproliferative drugs selected by the investigator;\n23. Those who are allergic to common emergency and anesthetic drugs, and have life-threatening allergic reactions, hypersensitivity reactions, or intolerance to XKDCT 225 cell preparations or their components; Patients who were deemed unsuitable for participation in this study by the investigator.",{"count":20,"type":21},[54],"PHASE1","A single-center, single-arm, dose-escalation exploratory clinical trial of the safety, efficacy, and pharmacokinetics of XKDCT225 cell injection in Claudin18.2-positive advanced solid tumors",[27],"RECRUITING","2025-01-14",{"date":60,"type":36},"2025-01-17",{"date":62,"type":21},"2025-01",{"date":64,"type":21},"2028-01",{"name":66,"class":43},"Shenzhen Celconta Life Science Co., Ltd."]