[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"meningeal-metastasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:meningeal-metastasis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,73],{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100641388","early-phase-1-qh101-cell-injection-in-patients-with-brain-brain-spinal-meninges-and-spinal-cord-metastatic-malignant-solid-tumors-100641388",false,"NCT07656103","QH101 Cell Injection in Patients With Brain, Brain (Spinal) Meninges, and Spinal Cord Metastatic Malignant Solid Tumors","Exploratory Clinical Study of Dose Escalation for QH101 Cell Injection in Patients With Brain, Brain (Spinal) Meninges, and Spinal Cord Metastatic Malignant Solid Tumors Three Dose Groups Are Established: 1×10⁷ enTCR Vδ2T Cells Per Infusion (Low Dose), 3×10⁷ enTCR Vδ2T Cells Per Infusion (Medium Dose), and 6×10⁷ enTCR Vδ2T Cells Per Infusion (High Dose). The Dose Escalation Rules Are as Follows: The First Enrolled Subject Receives Low-dose Cell Infusion. If no Dose-limiting Toxicity (DLT) Events Occur After Infusion, the Second Enrolled Subject Receives Medium-dose Infusion; the Medium and Hig","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. ECOG ≤2 or KPS ≥60;\n3. Life expectancy ≥8 weeks as assessed by the investigator;\n4. Pathologically and\u002For histologically confirmed malignant tumors with brain, meningeal, and spinal cord metastases that have failed standard therapy or lack standard treatment options may be considered for enrollment;\n5. Intracranial metastases must meet the following characteristics:\n\n   Unresectable by craniotomy for solitary\u002Ffocal (≤3 lesions)\u002Fmultiple (\\>3 lesions) intracranial metastases; or inoperable leptomeningeal or spinal cord metastases; Inclusion Criteria Intracranial lesions that progressed after standard treatment, including whole-brain radiotherapy\u002Fstereotactic radiosurgery (WBRT\u002FSRS), and are not suitable for repeat radiotherapy;\n6. For brain\u002Fspinal cord parenchymal metastases, contrast-enhanced MRI must show at least one measurable lesion (according to iRANO criteria); for patients with meningeal lesions only, those deemed likely to benefit from this study by investigator judgment may also be considered for inclusion (efficacy assessed using RANO-LM criteria);\n7. Basic normal bone marrow reserve function and normal hepatic and renal function (laboratory tests must meet the following criteria prior to first QH101 administration):\n\n   White blood cell count (WBC) ≥ 3 × 10⁹\u002FL; Lymphocyte count (LY) ≥ 0.8 × 10⁹\u002FL; Hemoglobin (Hb) ≥ 90 g\u002FL; Platelet count (PLT) ≥ 90 × 10⁹\u002FL; Alanine aminotransferase (ALT) \\& aspartate aminotransferase (AST) \\\u003C 1.5×ULN; Serum creatinine (Cr) \\\u003C 1.5×ULN; Total bilirubin \\\u003C 1.5×ULN; PT \\& APTT ≤ 1.25×ULN.\n8. Pregnancy test must be negative for women of childbearing potential; both male and female subjects must agree to use effective contraception during treatment and for 1 year thereafter;\n9. Ability to understand trial requirements and procedures, and willingness to participate in the clinical study as required;\n10. Signing of the trial informed consent form.\n\nExclusion Criteria:\n\n1. Received central nervous system-directed radiation within 7 days prior to the first infusion of QH101;\n2. Patients with hematologic malignancies (such as lymphoma, leukemia, etc.) with central nervous system metastases;\n3. Patients with metastases in the brainstem and high cervical spinal cord, including midbrain, pons, medulla oblongata, and C1\u002F2 segments of the cervical spinal cord;\n4. Patients with significant mass effect from intracranial lesions and signs of increased intracranial pressure (such as severe headache, projectile vomiting, papilledema, altered consciousness, or imaging showing significant edema, midline shift ≥1 cm, compression of peribrain cisterns such as suprasellar cistern, quadrigeminal cistern, interpeduncular cistern, or ambient cistern);\n5. Patients with primary or secondary epilepsy\u002Fepileptic syndrome that is difficult to control with medication;\n6. Uncontrolled comorbidities, including but not limited to: ongoing or active infections, symptomatic congestive heart failure, unstable angina, arrhythmias, or psychiatric\u002Fsocial conditions limiting patient compliance with study requirements;\n7. Known psychiatric disorders or substance abuse disorders that may affect compliance with trial requirements;\n8. Currently receiving any other investigational treatments;\n9. Diagnosed with an immunodeficiency;\n10. Patients with active infections requiring systemic treatment;\n11. Inability to undergo magnetic resonance imaging (MRI);\n12. Severe cardiovascular damage: history of New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina, myocardial infarction or stroke within 6 months after first dosing, or clinically significant arrhythmias requiring treatment at screening;\n13. Allergic to immunotherapy or related cellular therapies;\n14. Previously received CAR-T or other cellular immunotherapies;\n15. Other reasons that the investigator considers make the patient unsuitable for participation in this study.","ALL","18 Years",{"count":19,"type":20},7,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","QH101 is an allogeneic TCR-enhanced Vδ2 T cell therapy product engineered to express BTN protein-specific binding elements on the cell surface. This innovative approach harnesses the natural cytotoxic capabilities of Vδ2 T cells while augmenting their ability to recognize BTN proteins, thereby significantly improving tumor cell elimination efficiency. Notably, QH101 is designed without co-stimulatory signal domains or the CD3ζ domain, which prevents T cell exhaustion from overactivation and effectively enhances in vivo persistence.",[26,27,28],"Brain Metastasis","Meningeal Metastasis","Spinal Cord Metastasis",[30,31,32,33],"TCR","BTN","γδT","allogeneic cell therapy","NOT_YET_RECRUITING","2026-06-14",{"date":37,"type":38},"2026-06-18","ACTUAL",{"date":40,"type":20},"2026-05-31",{"date":42,"type":20},"2027-05-31",{"name":44,"class":45},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":46},"100613283","phase-1-evaluate-the-safety-tolerability-biodistribution-characteristics-and-preliminary-efficacy-of-biottt001-100613283","NCT07264569","Evaluate the Safety, Tolerability, Biodistribution Characteristics and Preliminary Efficacy of BioTTT001","Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Biodistribution Characteristics and Preliminary Efficacy of BioTTT001 in the Treatment of Patients With Recurrent\u002FProgressive Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Age between 18 and 70 years old (including boundary values);\n2. Patients diagnosed with NSCLC through pathological histology, who have experienced recurrence or progression after standard treatment, and have tumor cells found in cerebrospinal fluid or MRI diagnosis of leptomeningeal metastasis;\n3. Performance Status (PS) score ≤ 3 points;\n4. Suitable for Ommaya reservoir placement as determined by the investigator, and meet the conditions for drug administration;\n5. Expected survival ≥ 3 months;\n6. Good organ function, defined as follows:\n\n   1. Blood routine (not having received blood transfusion or other treatments within 14 days): Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL, platelet count ≥ 100 × 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL, white blood cell count ≥ 3.0 × 10\\^9\u002FL;\n   2. Coagulation function: Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times the upper limit of normal (ULN), International Normalized Ratio (INR) ≤ 1.5 times ULN;\n   3. Liver function: Total bilirubin (TBIL) ≤ 1.5 times ULN, Gilbert's syndrome participants should be ≤ 3 times ULN, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 times ULN (if there is liver metastasis, ALT or AST ≤ 5 times ULN);\n   4. Renal function: Serum creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 50 mL\u002Fmin (Cockcroft-Gault formula calculation see Appendix 3);\n7. Voluntarily participate and sign the informed consent form after being explained the study content before the start of the relevant procedures;\n8. For participants and partners with reproductive capacity and sexual activity, must agree to use medically approved effective contraception methods during treatment and for 6 months after the last dose, such as double-barrier contraception, and men agree not to donate sperm;\n9. For women with reproductive capacity, the blood pregnancy test result within 7 days before the first dose must be negative, and willing to undergo additional pregnancy tests during the study. Reproductive capacity refers to women who have not undergone surgical sterilization (i.e., bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) or are not postmenopausal; Menopause is defined as amenorrhea ≥ 12 months in women over 45 years old, excluding other causes of amenorrhea. Additionally, for women under 50 years old, serum Follicle-Stimulating Hormone (FSH) levels must be in the postmenopausal range to confirm menopause;\n10. Good compliance, willing and able to follow all study procedures and cooperate with observation and follow-up.\n11. If patients have previously received tyrosine kinase inhibitors (TKIs) treatment for more than two weeks and have only brain progression, they should continue the TKIs treatment during the enrollment period and cannot arbitrarily switch to other TKIs.\n\nExclusion Criteria:\n\n1. Patients who have received systemic antitumor therapy within two weeks, including intravenous chemotherapy, intrathecal chemotherapy, or whole-brain radiotherapy (excluding immunotherapy);\n2. immunotherapy administered within 6 weeks prior to the first dose;\n3. traditional Chinese medicine with antitumor indications administered within 2 weeks prior to the first dose;\n4. patients with uncontrolled epilepsy;\n5. those who received any other investigational drug within 4 weeks prior to the first dose;\n6. major organ surgeries (excluding biopsy) or significant trauma within 4 weeks prior to the first dose, or those requiring elective surgery during the study;\n7. patients with prior history of cell therapy, gene therapy, or oncolytic virus therapy;\n8. individuals with known or suspected allergies to active ingredients, excipients, or contrast agents in the study drug or imaging contrast agents;\n9. patients with organ transplant history or planned organ transplant during the study;\n10. active infections requiring systemic intravenous treatment or uncontrolled infections, or unexplained fever\\>38.5℃ occurring during screening or before the first dose;\n11. patients with severe coagulation disorders or evidence of significant bleeding risk; history of gastrointestinal bleeding; any other CTCAE 2-level or higher bleeding events within 6 months;\n12. participants who received immunosuppressants (e.g., azathioprine, cyclophosphamide, methotrexate, thalidomide) within 14 days prior to the first dose;\n13. patients whose adverse reactions from previous antitumor therapy have not resolved to a CTCAE 5.0 grade ≤1 (excluding non-safety-related toxicities like alopecia as determined by investigators);\n14. patients with immunodeficiency history, including HIV antibody-positive status;\n15. Active hepatitis B (HBsAg-positive with HBV-DNA\\> 500 IU\u002FmL or laboratory test lower limit \\[only when the laboratory test lower limit exceeds 500 IU\u002FmL\\]); Active hepatitis C (HCV antibody positive with HCV-RNA\\> laboratory test lower limit); Positive Treponema pallidum antibody;\n16. Hypertension poorly controlled by investigators (uncontrolled arterial hypertension despite standardized treatment: systolic blood pressure ≥160mmHg and\u002For diastolic blood pressure ≥100 mmHg);\n17. History of severe cardiovascular disease: such as clinically managed ventricular arrhythmias; QTc interval\\> 480 ms; Acute coronary syndrome, congestive heart failure, stroke, or other Grade III or higher cardiovascular events within 6 months prior to first dose; New York Heart Association (NYHA) class II or left ventricular ejection fraction (LVEF) \\\u003C50%;\n18. Concurrent presence of other uncured malignancies within 3 years (excluding clinically curable precancerous conditions like cervical carcinoma in situ and basal cell carcinoma);\n19. Active or recurrent autoimmune diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) except clinically stable autoimmune thyroiditis;\n20. Vaccination history within 4 weeks prior to first dose (live attenuated vaccines\u002Frecombinant vaccines) or within 2 weeks prior to first dose (inactivated vaccines);\n21. Previous immunotherapy with irAE grade ≥3;\n22. Patients with intracranial brainstem metastases or rapidly progressing diffuse cerebral parenchymal metastases;\n23. those showing tumor enhancement margins invading ventricular walls on cranial MRI or postoperative ventricular communication;\n24. history of encephalitis, multiple sclerosis, or other CNS infections;\n25. cerebral herniation syndrome;\n26. confirmed alcohol\u002Fdrug dependence;\n27. psychiatric disorders or poor compliance;\n28. Pregnant or lactating women;\n29. Researchers believe that due to other serious systemic diseases or other reasons, the subjects are not suitable to participate in this clinical study.","70 Years",{"count":56,"type":20},42,[58,59],"PHASE1","PHASE2","Phase Ib\u002FII clinical study on evaluating the safety, tolerance, biodistribution characteristics and preliminary efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTT001) in the treatment of meningeal metastasis in recurrent\u002Fprogressive non-small cell lung cancer",[27],"RECRUITING","2025-11-24",{"date":65,"type":38},"2025-12-04",{"date":67,"type":38},"2025-06-25",{"date":69,"type":20},"2027-12-30",{"name":71,"class":72},"Henan Cancer Hospital","OTHER_GOV",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100571339","a-real-world-study-on-the-treatment-of-non-small-cell-lung-cancer-with-leptomeningeal-metastasis-in-china-100571339","NCT06718972","A Real-world Study on the Treatment of Non-small Cell Lung Cancer With Leptomeningeal Metastasis in China","Database of Real-world Study on the Treatment of Non-small Cell Lung Cancer With Leptomeningeal Metastasis in China","CLM-tree datab","Inclusion Criteria:\n\n* non-small cell lung cancer patients with Leptomeningeal metastases diagnosed after January 2018;\n* Patients who underwent antitumor therapy after diagnosis of LM.\n\nExclusion Criteria:\n\n* Patients with small cell lung cancer components;\n* complicated with tumors other than non-small cell lung cancer.",{"count":82,"type":20},1000,"OBSERVATIONAL","This is a retrospective and prospective study planned to include NSCLC patients with Leptomeningeal metastasis (LM) and treated with antitumor therapy after 2018, from multiple centers such as the First Affiliated Hospital of Guangzhou Medical University, Guangdong Sanjiu Brain Hospital, etc., aiming to establish a database related to the treatment strategies of LM patients, and to evaluate the efficacy (eg. Overall Survival\u002FTime to Failure) and safety of different treatment strategies of LM patients, etc., as well as the significance of concomitant testing in LM patients.",[27,86],"Non-Small Cell Lung Cancer",[86,88,89,90],"meningeal metastasis","real-world study","database","2025-04-24",{"date":93,"type":38},"2025-04-27",{"date":95,"type":38},"2024-09-01",{"date":97,"type":20},"2028-12-31",{"name":99,"class":45},"Guangzhou Medical University",2]