[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"TCRx Therapeutics Co.Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":185},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,66,88,106,123,146,164],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100644421","apheresis-collection-for-new-drug-development-and-evaluation-research-100644421",false,"NCT07663565","Apheresis Collection for New Drug Development and Evaluation Research","Inclusion Criteria:\n\n* Aged between 18 and 40 (inclusive), male or non-pregnant female, regardless of nationality.\n\nWeight: Male ≥ 50kg; Female ≥ 45kg, and 19kg\u002Fm2 ≤ BMI ≤ 30kg\u002Fm2 (BMI, Body Mass Index = weight (kg) ÷ height (m)2).\n\nBlood pressure: Measurement results are either normal or abnormal, but without clinical significance.\n\nPulse rate: Measurement of normal or abnormal pulse rate has no clinical significance.\n\nTemperature (ear temperature): 35.4-37.2℃. The patient's general condition is good: there is no damage to vital organs such as the heart, lungs, liver, and kidneys, no severe or uncontrolled infections, and no history of severe mental disorders.\n\nClinical examination must meet the following criteria: • Hemoglobin (Hb) measurement is normal or abnormal without clinical significance • White blood cell count (WBC) measurement is normal or abnormal without clinical significance • Platelet count (PLT) measurement is normal or abnormal without clinical significance • Neutrophil count (NEU) measurement is normal or abnormal without clinical significance • Liver function test indicators \\\u003C1.5ULN • Coagulation function is normal or abnormal without clinical significance • 12-lead electrocardiogram results are normal or abnormal without clinical significance • Hepatitis A virus antibody (HAV) is negative.\n\nHepatitis B virus surface antigen (HBsAg) negative Hepatitis C virus antibody (HCV antibody) negative.\n\nHuman immunodeficiency virus antibody (HIV-1 and HIV-2 antibody) negative. Treponema pallidum antibody test is negative. The test result for CMV IgM antibody is negative.\n\nExclusion Criteria:\n\n* Previously had adverse reactions to blood donation. The following diseases are considered clinically significant by researchers: autoimmune diseases, severe endocrine and metabolic diseases, malignant tumors, neuropsychiatric diseases; Creutzfeldt-Jakob disease and those with a family history, or those who have received treatment with tissues or tissue derivatives that may have been infected with the Creutzfeldt-Jakob pathogen; chronic skin diseases, especially infectious, allergic, or inflammatory systemic skin diseases; those with allergic diseases or recurrent allergies; those who have undergone surgical operations in the past three months.\n\nWomen who are in their menstrual period, pregnancy, less than 6 months after abortion, or less than 1 year since the end of childbirth and lactation period.\n\nIndividuals who have recovered from an upper respiratory infection within the past week, or those who have recovered from pneumonia within the past three months.\n\nIndividuals with urinary system infections less than 3 months old, or those experiencing an acute episode of urinary system stones.\n\nEquipment contaminated by blood or tissue fluid causing injury or contaminating wounds, or individuals who have undergone tattooing less than one year ago.\n\nLong-term uninterrupted use of hormone drugs or immunosuppressants exceeding physiological replacement doses is required, including but not limited to glucocorticoids and steroids, hydroxyurea, and immunomodulatory drugs (such as alpha or gamma interferon, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.) in doses exceeding physiological replacement levels.\n\nThose who have received whole blood and blood component transfusions within 1 year.\n\nThose who have received their last dose of antitoxin or immune serum within 1 year, or those who have received their last dose of hepatitis B immunoglobulin injection within 1 year.\n\nIndividuals who have received the last dose of live attenuated vaccines such as measles, mumps, or polio vaccines within 2 weeks, or the last dose of live rubella vaccines or live attenuated Japanese encephalitis vaccines within 4 weeks.\n\nIndividuals who have received the final immunization dose of rabies vaccine within one year after being bitten by an animal.\n\nPoor conditions for vascular puncture, unable to tolerate venipuncture, or history of fainting at the sight or touch of blood. Upon inquiry, individuals with a history of drug use, drug abuse, or positive drug abuse screening (morphine, methamphetamine, ketamine, tetrahydrocannabinolic acid, MDMA) within the previous 12 months prior to screening. Healthy volunteers who have participated in intervention drug clinical studies and have used study drugs within 7 days prior to screening.\n\nOther situations where the researcher believes participation in this study is not appropriate.",true,"ALL","18 Years","40 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","Peripheral Blood Mononuclear Cells (PBMC) are a mixed population of cells with a single nucleus found in peripheral blood (i.e., blood outside the bone marrow), including natural killer cells (NK), T lymphocytes (70% - 90%), and B lymphocytes. They can be further isolated and purified and are the main source of immune cells. This study will be conducted at our hospital, with a planned recruitment of 200 subjects. Subjects who meet the inclusion criteria and do not meet the exclusion criteria will have their peripheral blood mononuclear cells collected via apheresis. Each subject will need to provide an apheresis sample containing approximately 8×10\\^9 mononuclear cells (with a sample volume of about 150 mL).",[25],"PBMCs",[27],"PBMC","RECRUITING","2026-06-16",{"date":31,"type":32},"2026-06-23","ACTUAL",{"date":34,"type":21},"2026-06-22",{"date":36,"type":21},"2028-12-31",{"name":38,"class":39},"TCRx Therapeutics Co.Ltd","INDUSTRY",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100640658","phase-1-kxv01-injection-in-patients-with-advanced-solid-tumor-including-osteosarcoma-and-sarcoma-100640658","NCT07596693","KXV01 Injection in Patients With Advanced Solid Tumor (Including Osteosarcoma and Sarcoma)","A Phase I Clinical Study on the Safety, Tolerability, and Efficacy of KXV01 Injection in Patients With Advanced Solid Tumor (Including Osteosarcoma and Sarcoma)","Screening Period 1\n\nInclusion Criteria 1:\n\n1. Voluntarily participate in the clinical study; fully understand the study and voluntarily sign the informed consent form; be willing to comply with and able to complete all trial procedures.\n2. Aged 18 to 70 years (inclusive).\n3. Histologically or cytologically confirmed incurable or metastatic solid tumors that have failed standard treatment, or for which no standard treatment is currently available.\n4. Expected survival time \\> 6 months.\n5. ECOG performance status of 0 or 1.\n6. Sufficient organ function.\n7. Patients whose tumor lesions can be collected and from whom tumor-reactive TCR sequences can be identified may enter the study.\n8. Women of childbearing age must have a negative urine\u002Fblood pregnancy test during the screening period and agree to use contraceptive measures for at least 1 year after administration; male subjects whose partners are of childbearing potential must agree to use effective barrier contraception for at least 1 year after administration.\n\nExclusion Criteria 1:\n\n1. A history of other malignant tumors within 2 years prior to signing the informed consent form, except for non-melanoma skin cancer, some in situ carcinomas (e.g., cervical cancer, bladder cancer, breast cancer), or low-risk prostate cancer.\n2. Uncontrolled infectious diseases within 4 weeks prior to signing the informed consent form.\n3. Active hepatitis B or hepatitis C virus infection.\n4. Patients with HIV infection.\n5. Patients with positive Treponema pallidum.\n6. A history of any of the following cardiovascular diseases within the past 6 months: New York Heart Association (NYHA) Class III or IV heart failure, coronary angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant heart diseases.\n7. Tumor lesions invading the heart or major blood vessels.\n8. Abnormal pulmonary function indicated by a ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) \\\u003C 70% in pulmonary function tests.\n9. A history of clinically significant central nervous system (CNS) disorders, including but not limited to epilepsy, paresis, aphasia, stroke, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar disease, and organic brain syndrome.\n10. Females who are pregnant or breastfeeding.\n11. A history of primary immunodeficiency or autoimmune disease.\n12. Patients whose disease or condition renders them unable to understand, participate in, and\u002For comply with the study protocol.\n13. Any other disease that the investigator believes would impair the subject's ability to tolerate protocol treatment or significantly increase the risk of complications.\n14. Current or past history of psychoactive substance abuse or dependence.\n15. Subjects whose underlying condition, in the investigator's judgment, may increase the risk of receiving the investigatory drug or confound the interpretation of toxic reactions and adverse events.\n16. Other conditions deemed unsuitable for participation in the study by the investigator.\n\nScreening Period 2\n\nInclusion Criteria 2:\n\nThe patient's organ function and key test items at this stage should not have significant changes compared with their test results in Screening Period 1. If the patient's test results in Screening Period 2 exceed the following criteria, they should not receive administration of KXV01 Injection until the abnormal items return to the normal range.\n\n1. The patient's KXV01 Injection has been successfully prepared.\n2. Expected survival time \\> 6 months.\n3. ECOG performance status of 0 or 1.\n4. Sufficient organ function.\n5. Females of childbearing potential have a negative blood pregnancy test within 7 days prior to administration of the study drug (Non-childbearing potential: surgically sterilized or postmenopausal for at least 2 years). In addition, female subjects of childbearing potential must use medically approved contraceptive measures for 12 months after the start of study treatment and have no egg retrieval during this period.\n6. Male subjects are willing to use medically approved contraceptive measures from the time of signing the informed consent form until 12 months after the start of study treatment, and will not donate sperm during this period.\n7. At least one measurable lesion according to RECIST v1.1 criteria.\n8. Toxicities and adverse reactions caused by prior therapy should have resolved to Grade ≤ 1 (except for toxicities considered clinically insignificant, such as chemotherapy-induced alopecia).\n\nExclusion Criteria 2:\n\n1. Prior to administration of the study drug, the subject's anti-tumor therapy has not been sufficiently washed out (2 weeks or 5 half-lives, whichever is shorter).\n2. Uncontrolled infectious diseases within the previous 4 weeks.\n3. Active hepatitis B or hepatitis C virus infection.\n4. Patients with HIV infection.\n5. Patients with positive Treponema pallidum.\n6. Tumor lesions invading the heart or major blood vessels.\n7. A history of clinically significant central nervous system (CNS) disorders, including but not limited to epilepsy, paresis, aphasia, stroke, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar disease, and organic brain syndrome.\n8. Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases.\n9. Use of the restricted drugs or treatments between Screening Period 1 and Screening Period 2 per the protocol.\n10. Females who are pregnant or breastfeeding.\n11. Subjects whose underlying condition, in the investigator's judgment, may increase the risk of receiving the investigatory drug or confound the interpretation of toxic reactions and adverse events.\n12. Receipt of major surgery (excluding diagnostic surgery) between Screening Period 1 and Screening Period 2, or expected to undergo major surgery during the study period. Subjects with planned or ongoing minor surgical procedures (such as venous access placement, etc.) are eligible for enrollment.","70 Years",{"count":50,"type":21},30,"INTERVENTIONAL",[53],"PHASE1","This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KXV01 TCR Lentinvivo for patients with advanced solid tumors.",[56],"Advanced Solid Tumors","2026-05-13",{"date":59,"type":32},"2026-05-19",{"date":61,"type":32},"2025-12-19",{"date":63,"type":21},"2029-12-31",{"name":38,"class":39},1,{"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":51,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":87,"locationsCount":65},"100612994","phase-1-ksv01-injection-for-the-treatment-of-relapsedrefractory-diffuse-large-b-cell-lymphoma-100612994","NCT07260812","KSV01 Injection for the Treatment of Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","A Phase I Clinical Study on the Safety, Tolerability, and Efficacy of KSV01 Injection in Patients With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n1. Patients or their legal guardians voluntarily participate in the study and provide written informed consent.\n2. Aged 18 to 80 years (inclusive), male or female.\n3. ECOG performance status score of ≤ 1.\n4. Life expectancy \\> 3 months.\n5. KPS score ≥ 70.\n6. Patients with diffuse large B-cell lymphoma (DLBCL) diagnosed according to the 2016 WHO classification. Patients with DLBCL should have been diagnosed as relapsed or refractory after at least one prior line of systemic therapy.\n7. CD19 positivity confirmed by flow cytometry and\u002For histopathology.\n8. According to the Lugano 2014 criteria, the presence of PET-positive target lesions for tumor assessment is required (Deauville 5-Point Scale \\[5-PS\\] ≥ 4).\n9. Adequate organ function.\n10. Female patients of childbearing potential must have a negative urine\u002Fblood pregnancy test during the screening period and agree to use effective contraception for at least 1 year after infusion; male subjects with partners of childbearing potential must agree to use effective barrier contraception for at least 1 year after infusion.\n\nExclusion Criteria:\n\n1. History of another primary malignancy that has not been in continuous remission for at least 2 years, except for the following conditions which are exempt from the 2-year limit: non-melanoma skin cancer, Stage I solid tumors treated with curative intent and low risk of recurrence, cured localized prostate cancer, biopsy-confirmed carcinoma in situ of the cervix, or squamous intraepithelial lesion identified on Pap smear.\n2. Uncontrolled infectious disease within 4 weeks prior to enrollment.\n3. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n4. HIV infection.\n5. Positive for Treponema pallidum(syphilis).\n6. Severe autoimmune disease or immunodeficiency, with the exception of well-controlled Type I diabetes and thyroid disorders.\n7. History of severe allergy or hypersensitivity to macromolecular biologic agents (e.g., antibodies, cytokines).\n8. Participation in any other clinical trial within 4 weeks prior to enrollment.\n9. History of clinically significant central nervous system (CNS) diseases, including but not limited to epilepsy, paresis, aphasia, stroke, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome.\n10. Presence of isolated CNS involvement by lymphoma, or any ongoing CNS condition that precludes accurate neurological evaluation.\n11. History of severe cardiovascular conditions within the past 6 months.\n12. Presence of psychiatric illness.\n13. History of drug abuse or addiction.\n14. Use of the following medications or therapies:\n\n    1. Corticosteroids (physiologic replacement doses, and topical or inhaled steroids are permitted).\n    2. Chemotherapy.\n    3. GvHD Therapy.\n    4. Allogeneic hematopoietic stem cell transplantation.\n    5. Gene therapy.\n15. Women who are breastfeeding.\n16. In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures (including follow-up visits) or unlikely to comply with the requirements for participation in this study.","65 Years",{"count":75,"type":21},18,[53],"This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KSV01 Injection for patients with diffuse large B-cell lymphoma.",[79,80],"Non-Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma (DLBCL)","2026-04-07",{"date":83,"type":32},"2026-04-13",{"date":85,"type":32},"2025-09-01",{"date":36,"type":21},{"name":38,"class":39},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":95,"targetDuration":4,"studyType":51,"phases":96,"briefSummary":54,"conditions":97,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":105,"locationsCount":65},"100614150","phase-1-personalized-kxv01-lentinvivo-tcr-injection-as-the-therapy-for-advanced-solid-tumors-100614150","NCT07275853","Personalized KXV01 Lentinvivo (TCR) Injection as the Therapy for Advanced Solid Tumors","A Phase I Clinical Study of KXV01 TCR Lentinvivo Injection on Safety, Tolerability, and Efficacy in Patients With Advanced Solid Tumors","Screening Period 1\n\nInclusion Criteria 1:\n\n1. Voluntarily participate in the clinical study; fully understand the study and voluntarily sign the informed consent form; be willing to comply with and able to complete all trial procedures.\n2. Aged 18 to 70 years (inclusive).\n3. Histologically or cytologically confirmed incurable or metastatic solid tumors that have failed standard treatment, or for which no standard treatment is currently available.\n4. Expected survival time \\> 6 months.\n5. ECOG performance status of 0 or 1.\n6. Sufficient organ function, defined as follows:\n\n   6.1) Hematological system: 6.1.1) Hemoglobin ≥ 90 g\u002FL (no blood transfusion within 14 days prior to the test); 6.1.2) Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL (no granulocyte colony-stimulating factor treatment within 14 days prior to the test); 6.1.3) Platelet count ≥ 100 × 10⁹\u002FL in the absence of significant hepatic lesions (primary or metastatic) (no platelet transfusion within 14 days prior to the test), or ≥ 75 × 10⁹\u002FL in the presence of hepatic lesions (no platelet transfusion within 14 days prior to the test); 6.1.4) Absolute lymphocyte count (ALC) ≥ 0.7 × 10⁹\u002FL; 6.2) Hepatic function: 6.2.1) Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) in the absence of significant hepatic lesions (primary or metastatic), and ≤ 3 × ULN in subjects with hepatic lesions or Gilbert's disease; 6.2.2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in subjects with liver metastasis or liver cancer); alkaline phosphatase (ALP) ≤ 2.5 × ULN (≤ 5 × ULN in subjects with bone metastasis); 6.3) Renal function: Creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula: (\\[140 - age\\] × weight \\[kg\\] × \\[0.85, for females only\\]) \u002F (72 × creatinine (mg\u002Fdl))); 6.4) Baseline oxygen saturation \\> 92% during natural breathing (without auxiliary oxygen supply).\n7. Patients whose tumor lesions can be collected and from whom tumor-reactive TCR sequences can be identified may enter the study. If a patient has obtained individualized TCR sequences from previously collected archived tumor tissue in other studies, they may directly enter Screening Period 2, provided that the archived tissue was collected within one year prior to signing the informed consent form for this study.\n8. Women of childbearing age must have a negative urine\u002Fblood pregnancy test during the screening period and agree to use contraceptive measures for at least 1 year after administration; male subjects whose partners are of childbearing potential must agree to use effective barrier contraception for at least 1 year after administration.\n\nExclusion Criteria 1:\n\n1. A history of other malignant tumors within 2 years prior to signing the informed consent form, except for non-melanoma skin cancer, some in situ carcinomas (e.g., cervical cancer, bladder cancer, breast cancer), or low-risk prostate cancer.\n2. Uncontrolled infectious diseases within 4 weeks prior to signing the informed consent form.\n3. Active hepatitis B or hepatitis C virus infection.\n4. Patients with HIV infection.\n5. Patients with positive Treponema pallidum.\n6. A history of any of the following cardiovascular diseases within the past 6 months: New York Heart Association (NYHA) Class III or IV heart failure, coronary angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant heart diseases.\n7. Tumor lesions invading the heart or major blood vessels.\n8. Abnormal pulmonary function indicated by a ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) \\\u003C 70% in pulmonary function tests.\n9. A history of clinically significant central nervous system (CNS) disorders, including but not limited to epilepsy, paresis, aphasia, stroke, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar disease, and organic brain syndrome.\n10. Use of the following drugs or treatments:\n\n    1. Hormones: Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent \\> 20 mg\u002Fday) within 72 hours prior to administration of the study drug; physiologic replacement doses, topical, and inhaled steroids are permitted;\n    2. Chemotherapy: Receipt of salvage chemotherapy within 2 weeks prior to administration of the study drug;\n    3. GvHD treatment: Receipt of anti-GvHD therapy within 4 weeks prior to administration of the study drug;\n    4. Allogeneic bone marrow transplantation;\n    5. Gene therapy;\n    6. Adoptive cell therapy;\n11. Females who are pregnant or breastfeeding.\n12. A history of primary immunodeficiency or autoimmune disease, except for the following:\n\n    * History of hypothyroidism with stable thyroid hormone replacement therapy;\n    * Patients with well-controlled type 1 diabetes mellitus.\n13. Patients whose disease or condition renders them unable to understand, participate in, and\u002For comply with the study protocol.\n14. Any other disease that the investigator believes would impair the subject's ability to tolerate protocol treatment or significantly increase the risk of complications.\n15. Current or past history of psychoactive substance abuse or dependence.\n16. Subjects whose underlying condition, in the investigator's judgment, may increase the risk of receiving the investigational drug or confound the interpretation of toxic reactions and adverse events.\n17. Other conditions deemed unsuitable for participation in the study by the investigator.\n\nScreening Period 2\n\nInclusion Criteria 2:\n\nThe patient's organ function and key test items at this stage should not have significant changes compared with their test results in Screening Period 1. If the patient's test results in Screening Period 2 exceed the following criteria, they should not receive administration of KXV01 Injection until the abnormal items return to the normal range.\n\n1. The patient's KXV01 Injection has been successfully prepared.\n2. Expected survival time \\> 6 months.\n3. ECOG performance status of 0 or 1.\n4. Sufficient organ function.\n5. Females of childbearing potential have a negative blood pregnancy test within 7 days prior to administration of the study drug (Non-childbearing potential: surgically sterilized or postmenopausal for at least 2 years). In addition, female subjects of childbearing potential must use medically approved contraceptive measures for 12 months after the start of study treatment and have no egg retrieval during this period.\n6. Male subjects are willing to use medically approved contraceptive measures from the time of signing the informed consent form until 12 months after the start of study treatment, and will not donate sperm during this period.\n7. At least one measurable lesion according to RECIST v1.1 criteria.\n8. Toxicities and adverse reactions caused by prior therapy should have resolved to Grade ≤ 1 (except for toxicities considered clinically insignificant, such as chemotherapy-induced alopecia).\n\nExclusion Criteria 2:\n\n1. Prior to administration of the study drug, the subject's anti-tumor therapy has not been sufficiently washed out (2 weeks or 5 half-lives, whichever is shorter):\n\n   Except for the following:\n   * Gonadotropin (GnRH) agonists or antagonists used for the treatment of prostate cancer\n   * Hormone replacement therapy, or oral contraceptives.\n2. Uncontrolled infectious diseases within the previous 4 weeks.\n3. Active hepatitis B or hepatitis C virus infection.\n4. Patients with HIV infection.\n5. Patients with positive Treponema pallidum.\n6. Tumor lesions invading the heart or major blood vessels.\n7. A history of clinically significant central nervous system (CNS) disorders, including but not limited to epilepsy, paresis, aphasia, stroke, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar disease, and organic brain syndrome.\n8. Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases.\n9. Use of the following drugs or treatments between Screening Period 1 and Screening Period 2:\n\n   1. Hormones: Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent \\> 20 mg\u002Fday) within 72 hours prior to administration of the study drug; physiologic replacement doses, topical, and inhaled steroids are permitted;\n   2. Chemotherapy: Receipt of salvage chemotherapy within 2 weeks prior to administration of the study drug;\n   3. GvHD treatment: Receipt of anti-GvHD therapy within 4 weeks prior to administration of the study drug;\n   4. Allogeneic bone marrow transplantation;\n   5. Gene therapy;\n   6. Adoptive cell therapy;\n   7. Use of alemtuzumab within 6 months prior to administration of the study drug, or clofarabine or cladribine within 3 months prior to administration;\n   8. Receipt of radiotherapy between Screening Period 1 and Screening Period 2. Patients are eligible only if lesions within the radiation field show progressive disease (PD), or there are measurable lesions outside the radiation field meeting RECIST v1.1 criteria on imaging assessment; if there are measurable lesions outside the radiation field, radiotherapy to other lesions must be at least 2 weeks apart from the administration date of the study drug.\n10. Females who are pregnant or breastfeeding.\n11. Subjects whose underlying condition, in the investigator's judgment, may increase the risk of receiving the investigational drug or confound the interpretation of toxic reactions and adverse events.\n12. Receipt of major surgery (excluding diagnostic surgery) between Screening Period 1 and Screening Period 2, or expected to undergo major surgery during the study period. Subjects with planned or ongoing minor surgical procedures (such as venous access placement, etc.) are eligible for enrollment.",{"count":50,"type":21},[53],[56],"NOT_YET_RECRUITING","2025-11-27",{"date":101,"type":32},"2025-12-10",{"date":103,"type":21},"2025-12-01",{"date":36,"type":21},{"name":38,"class":39},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":112,"targetDuration":4,"studyType":51,"phases":113,"briefSummary":54,"conditions":114,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":122,"locationsCount":65},"100608055","phase-1-personalized-kxv01-tcr-lentinvivo-injection-as-the-therapy-for-advanced-solid-tumors-100608055","NCT07196579","Personalized KXV01 TCR Lentinvivo Injection as the Therapy for Advanced Solid Tumors","Screening Period 1\n\nInclusion Criteria 1:\n\n1. Voluntarily participate in the clinical study; fully understand the study and voluntarily sign the informed consent form; be willing to comply with and able to complete all trial procedures.\n2. Aged 18 to 70 years (inclusive).\n3. Histologically or cytologically confirmed incurable or metastatic solid tumors that have failed standard treatment, or for which no standard treatment is currently available.\n4. Expected survival time \\> 6 months.\n5. ECOG performance status of 0 or 1.\n6. Sufficient organ function, defined as follows:\n\n   6.2.1) Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) in the absence of significant hepatic lesions (primary or metastatic), and ≤ 3 × ULN in subjects with hepatic lesions or Gilbert's disease; 6.2.2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in subjects with liver metastasis or liver cancer); alkaline phosphatase (ALP) ≤ 2.5 × ULN (≤ 5 × ULN in subjects with bone metastasis); 6.3) Renal function: Creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula: (\\[140 - age\\] × weight \\[kg\\] × \\[0.85, for females only\\]) \u002F (72 × creatinine (mg\u002Fdl))); 6.4) Baseline oxygen saturation \\> 92% during natural breathing (without auxiliary oxygen supply).\n7. Patients whose tumor lesions can be collected and from whom tumor-reactive TCR sequences can be identified may enter the study. If a patient has obtained individualized TCR sequences from previously collected archived tumor tissue in other studies, they may directly enter Screening Period 2, provided that the archived tissue was collected within one year prior to signing the informed consent form for this study.\n8. Women of childbearing age must have a negative urine\u002Fblood pregnancy test during the screening period and agree to use contraceptive measures for at least 1 year after administration; male subjects whose partners are of childbearing potential must agree to use effective barrier contraception for at least 1 year after administration.\n\n6.1) Hematological system: 6.1.1) Hemoglobin ≥ 90 g\u002FL (no blood transfusion within 14 days prior to the test); 6.1.2) Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL (no granulocyte colony-stimulating factor treatment within 14 days prior to the test); 6.1.3) Platelet count ≥ 100 × 10⁹\u002FL in the absence of significant hepatic lesions (primary or metastatic) (no platelet transfusion within 14 days prior to the test), or ≥ 75 × 10⁹\u002FL in the presence of hepatic lesions (no platelet transfusion within 14 days prior to the test); 6.1.4) Absolute lymphocyte count (ALC) ≥ 0.7 × 10⁹\u002FL; 6.2) Hepatic function:\n\nExclusion Criteria 1:\n\n1. A history of other malignant tumors within 2 years prior to signing the informed consent form, except for non-melanoma skin cancer, some in situ carcinomas (e.g., cervical cancer, bladder cancer, breast cancer), or low-risk prostate cancer.\n2. Uncontrolled infectious diseases within 4 weeks prior to signing the informed consent form.\n3. Active hepatitis B or hepatitis C virus infection.\n4. Patients with HIV infection.\n5. Patients with positive Treponema pallidum.\n6. A history of any of the following cardiovascular diseases within the past 6 months: New York Heart Association (NYHA) Class III or IV heart failure, coronary angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant heart diseases.\n7. Tumor lesions invading the heart or major blood vessels.\n8. Abnormal pulmonary function indicated by a ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) \\\u003C 70% in pulmonary function tests.\n9. A history of clinically significant central nervous system (CNS) disorders, including but not limited to epilepsy, paresis, aphasia, stroke, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar disease, and organic brain syndrome.\n10. Use of the following drugs or treatments:\n\n    1. Hormones: Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent \\> 20 mg\u002Fday) within 72 hours prior to administration of the study drug; physiologic replacement doses, topical, and inhaled steroids are permitted;\n    2. Chemotherapy: Receipt of salvage chemotherapy within 2 weeks prior to administration of the study drug;\n    3. GvHD treatment: Receipt of anti-GvHD therapy within 4 weeks prior to administration of the study drug;\n    4. Allogeneic bone marrow transplantation;\n    5. Gene therapy;\n    6. Adoptive cell therapy;\n11. Females who are pregnant or breastfeeding.\n12. A history of primary immunodeficiency or autoimmune disease, except for the following:\n\n    * History of hypothyroidism with stable thyroid hormone replacement therapy;\n    * Patients with well-controlled type 1 diabetes mellitus.\n13. Patients whose disease or condition renders them unable to understand, participate in, and\u002For comply with the study protocol.\n14. Any other disease that the investigator believes would impair the subject's ability to tolerate protocol treatment or significantly increase the risk of complications.\n15. Current or past history of psychoactive substance abuse or dependence.\n16. Subjects whose underlying condition, in the investigator's judgment, may increase the risk of receiving the investigational drug or confound the interpretation of toxic reactions and adverse events.\n17. Other conditions deemed unsuitable for participation in the study by the investigator.\n\nScreening Period 2\n\nInclusion Criteria 2:\n\nThe patient's organ function and key test items at this stage should not have significant changes compared with their test results in Screening Period 1. If the patient's test results in Screening Period 2 exceed the following criteria, they should not receive administration of KXV01 Injection until the abnormal items return to the normal range.\n\n1. The patient's KXV01 Injection has been successfully prepared.\n2. Expected survival time \\> 6 months.\n3. ECOG performance status of 0 or 1.\n4. Sufficient organ function.\n5. Females of childbearing potential have a negative blood pregnancy test within 7 days prior to administration of the study drug (Non-childbearing potential: surgically sterilized or postmenopausal for at least 2 years). In addition, female subjects of childbearing potential must use medically approved contraceptive measures for 12 months after the start of study treatment and have no egg retrieval during this period.\n6. Male subjects are willing to use medically approved contraceptive measures from the time of signing the informed consent form until 12 months after the start of study treatment, and will not donate sperm during this period.\n7. At least one measurable lesion according to RECIST v1.1 criteria.\n8. Toxicities and adverse reactions caused by prior therapy should have resolved to Grade ≤ 1 (except for toxicities considered clinically insignificant, such as chemotherapy-induced alopecia).\n\nExclusion Criteria 2:\n\n1. Prior to administration of the study drug, the subject's anti-tumor therapy has not been sufficiently washed out (2 weeks or 5 half-lives, whichever is shorter):\n\n   Except for the following:\n   * Gonadotropin (GnRH) agonists or antagonists used for the treatment of prostate cancer\n   * Hormone replacement therapy, or oral contraceptives.\n2. Uncontrolled infectious diseases within the previous 4 weeks.\n3. Active hepatitis B or hepatitis C virus infection.\n4. Patients with HIV infection.\n5. Patients with positive Treponema pallidum.\n6. Tumor lesions invading the heart or major blood vessels.\n7. A history of clinically significant central nervous system (CNS) disorders, including but not limited to epilepsy, paresis, aphasia, stroke, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar disease, and organic brain syndrome.\n8. Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases.\n9. Use of the following drugs or treatments between Screening Period 1 and Screening Period 2:\n\n   1. Hormones: Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent \\> 20 mg\u002Fday) within 72 hours prior to administration of the study drug; physiologic replacement doses, topical, and inhaled steroids are permitted;\n   2. Chemotherapy: Receipt of salvage chemotherapy within 2 weeks prior to administration of the study drug;\n   3. GvHD treatment: Receipt of anti-GvHD therapy within 4 weeks prior to administration of the study drug;\n   4. Allogeneic bone marrow transplantation;\n   5. Gene therapy;\n   6. Adoptive cell therapy;\n   7. Use of alemtuzumab within 6 months prior to administration of the study drug, or clofarabine or cladribine within 3 months prior to administration;\n   8. Receipt of radiotherapy between Screening Period 1 and Screening Period 2. Patients are eligible only if lesions within the radiation field show progressive disease (PD), or there are measurable lesions outside the radiation field meeting RECIST v1.1 criteria on imaging assessment; if there are measurable lesions outside the radiation field, radiotherapy to other lesions must be at least 2 weeks apart from the administration date of the study drug.\n10. Females who are pregnant or breastfeeding.\n11. Subjects whose underlying condition, in the investigator's judgment, may increase the risk of receiving the investigational drug or confound the interpretation of toxic reactions and adverse events.\n12. Receipt of major surgery (excluding diagnostic surgery) between Screening Period 1 and Screening Period 2, or expected to undergo major surgery during the study period. Subjects with planned or ongoing minor surgical procedures (such as venous access placement, etc.) are eligible for enrollment.",{"count":50,"type":21},[53],[115],"Advanced Solid Cancer","2025-09-20",{"date":118,"type":32},"2025-09-29",{"date":120,"type":21},"2025-10-01",{"date":36,"type":21},{"name":38,"class":39},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":130,"targetDuration":4,"studyType":51,"phases":132,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":145,"locationsCount":65},"100501647","early-phase-1-ksx01-tcrt-injection-project-in-solid-tumors-100501647","NCT05811975","KSX01-TCRT Injection Project in Solid Tumors","IIT Clinical Trial on Tolerance, Safety, and Preliminary Efficacy of KSX01-TCRT Injection in Solid Tumor Subjects","Inclusion Criteria:\n\n* 1\\) Voluntary participation in clinical research; Fully understand the study and voluntarily sign an informed consent form; Willing to follow and capable of completing all test procedures.\n* 2\\) Age: 18 to 70 years old (including boundary value).\n* 3\\) Malignant solid tumors that have failed standard treatment or currently have no standard treatment available.\n* 4\\) Patients with tumor lesions that can be punctured and can be screened for a pharmaceutically acceptable TCR sequence can be enrolled in the study.\n* 5\\) Remission from previous surgical or treatment related adverse events to a level of 0-1, stable, or acceptable for inclusion\u002Fexclusion criteria (according to NCI CTCAE Version 5.0), or to an acceptable level for inclusion\u002Fexclusion criteria; Except for other toxicity that researchers believe does not pose a safety risk to the subject, such as hair loss, pigmentation, and peripheral neuropathy.\n* 6\\) Adequate organ function (without medical support such as blood transfusion, granulocyte colony stimulating factor, etc. during pre harvest and baseline periods) is defined as follows:\n* 6.1) Blood system:\n* 6.1.1) Hemoglobin 90 g\u002FL (no blood transfusion or erythropoietin treatment within 14 days before the first administration);\n* 6.1.2) The absolute value of neutrophils is 1.5 109\u002FL (no treatment with granulocyte colony stimulating factor or granulocyte macrophage colony stimulating factor within at least 14 days before chemotherapy);\n* 6.1.3) Platelet count is 100 109\u002FL in the absence of significant liver lesions (primary or metastatic), or 75 109\u002FL in the presence of liver lesions (no platelet transfusion, thrombopoietin, or interleukin-11 treatment was received within 14 days before the first administration);\n* 6.1.4) Absolute lymphocyte count (ALC) 0.7 109\u002FL;\n* 6.2) Liver function:\n* 6.2.1) Total bilirubin (TBIL) ≤ 2.0 in the absence of significant liver lesions (primary or metastatic) × Upper limit of normal (ULN), subjects with liver lesions or Gilbert disease ≤ 3 × ULN；\n* 6.2.2) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3 × ULN (liver metastasis or hepatocellular carcinoma can be ≤ 5 × ULN）； Alkaline phosphatase (ALP) ≤ 2.5 × ULN (bone metastasis subject, ALP ≤ 5 × ULN）；\n* 6.3) Renal function:\n* 6.3.1) Creatinine clearance ≥ 50 ml\u002Fmin (Cockcroft Gault formula: (\\[140 age\\] × Body weight \\[kg\\] × \\[0.85, female only\\])\u002F(72 × Creatinine (mg\u002Fdl));\n* 6.3.2) Qualitative determination of urinary protein ≤ 1+; If the qualitative analysis of urine protein is ≥ 2+, a 24-hour urine protein quantitative test is required. If the 24-hour urine protein quantitative analysis is\\\u003C1 g, it is acceptable;\n* 6.4) Coagulation function: Activated partial thromboplastin time and international standardized ratio of 1.5 in patients who did not receive anticoagulant therapy × ULN, or patients receiving anticoagulation therapy, have a stable anticoagulation treatment regimen; Patients with liver metastasis or liver cancer are acceptable 2 × ULN。\n* 7\\) The Eastern United States Cancer Collaborative Group (ECOG) score for physical fitness is 0-1.\n* 8\\) The expected survival period is ≥ 12 weeks.\n* 9\\) According to the RECIST 1.1 standard, there is at least one evaluable lesion (dose increasing stage) or measurable lesion (dose expanding stage).\n* 10\\) After evaluation, sufficient PBMC cells can be collected from the subjects to prepare autologous TCR-T cells; The peripheral superficial venous blood path of the subject is unobstructed, suitable for single blood collection and separation, with sufficient venous access to collect cells, and can meet the requirements of intravenous infusion.\n* 11\\) After evaluation, the prepared autologous TCR-T cells are sufficient in quantity and qualified in quality, and can be used for corresponding doses of clinical reinfusion.\n* 12\\) \"The blood pregnancy test for women of childbearing age within 7 days before the first cell transfusion was negative, and the subjects of childbearing age used medically approved contraceptives from the beginning of research treatment (chemotherapy) until 1 year after the last cell transfusion, and no eggs were recovered during this period.\".\n* 13\\) Male subjects are willing to take medically approved contraceptive measures within 6 months after signing the informed consent form and the last cell transfusion, and do not donate sperm during this period.\n\nExclusion Criteria:\n\n* 1\\) A history of severe allergic diseases, allergies to severe drugs (including unlisted investigational drugs), or known allergies to any component of the drugs recommended for use in this protocol (including pre-treatment drugs).\n* 2\\) Persons who have previously received treatment with other cell\u002Fgene products.\n* 3\\) Evidence of significant bleeding or coagulation disorders or other significant bleeding risks:\n* 3.1) Previous history of intracranial hemorrhage or spinal cord hemorrhage;\n* 3.2) Tumor lesions that invade large blood vessels and have a significant risk of bleeding;\n* 3.3) Thrombosis or embolism occurred within 6 months before cell transfusion;\n* 3.4) Clinically significant hemoptysis or tumor bleeding occurred within 1 month before cell reinfusion;\n* 3.5) Within 2 weeks before cell reinfusion, anticoagulation therapy for therapeutic purposes has been used (except for those requiring a stable treatment regimen and judged appropriate by the researcher).\n* 4\\) Within 28 days before enrollment, there were no healed wounds, ulcers, or fractures.\n* 5\\) The following treatments or drugs have been received before enrollment, pre harvest, pre clearance, or cell reinfusion:\n* 5.1) Have received any live or attenuated vaccine within 4 weeks before enrollment, or are expected to receive live or attenuated vaccine during the study period;\n* 5.2) Preharvest use of any cytotoxic chemotherapy or small molecule targeted therapy\\\u003C2 weeks or 5 half lives, whichever is longer;\n* 5.3) Have undergone major surgery (excluding diagnostic surgery) within 4 weeks before single collection, or are expected to undergo major surgery during the study period;\n* 5.4) Planned systemic use (if long-term use is expected) of systemic steroids (\\>10 mg\u002Fday of prednisone or equivalent), hydroxyurea, and immunomodulators (e.g.: α or γ Interferons, GM-CSF, mTOR inhibitors, cyclosporin, thymosin, etc.), this standard is not applicable when the following conditions occur:\n\n  * Intranasal, inhalation, topical steroids, or local steroid injections (such as intra articular injections);\n  * Physiological doses of systemic steroids as an alternative therapy (such as physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction);\n  * Steroids are used as prophylaxis for hypersensitivity reactions (such as computed tomography (CT) prophylaxis).\n* 5.5) The washout period of previous anticancer treatment before the first administration of the study drug is insufficient, as defined below:\n\n  * Any cytotoxic chemotherapy or small-molecule targeted therapy\\\u003C2 weeks or 5 half lives, whichever is shorter, except for clearance chemotherapy;\n  * Endocrine therapy\\\u003C3 weeks;\n  * Monoclonal antibody or other biological therapy\\\u003C3 weeks;\n  * Herbal therapy with anti-tumor indications\\\u003C2 weeks;\n  * Whole brain radiotherapy\\\u003C2 weeks, or stereotactic brain radiotherapy\\\u003C1 week;\n  * More than 30% of bone marrow radiotherapy or accompanied by wide field irradiation for\\\u003C4 weeks, or palliative radiotherapy for\\\u003C2 weeks.\n* 6\\) Patients with systemic bone metastases.\n* 7\\) A history of leptomeningeal cancer.\n* 8\\) Brain metastases or spinal cord compression, unless asymptomatic, or symptoms stabilize after treatment and do not require treatment with steroids and anticonvulsants for at least 2 weeks prior to the first administration of the study drug.\n* 9\\) Presence of any form of primary immune deficiency.\n* 10\\) Subjects with any active autoimmune disease, or a history of autoimmune disease, and expected recurrence (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), vasculitis, invasive lung disease, and asthma requiring medical intervention with bronchodilators). The following cases are excluded: type 1 diabetes; Skin diseases that do not require systemic treatment \\[such as vitiligo, psoriasis, alopecia, Grave's disease, Hashimoto's disease, psoriasis patients\\]; Hypothyroidism requiring only hormone replacement therapy; Asthma that has completely remitted in childhood does not require any intervention in adulthood; Or other people who are not expected to have a relapse without external triggers.\n* 11\\) Active liver or biliary disease (excluding Gilbert syndrome or asymptomatic gallstones, liver metastases, or other stable chronic liver disease, as assessed by the investigator).\n* 12\\) Within 6 months before cell reinfusion, the following conditions occurred: myocardial infarction, severe\u002Funstable angina, clinically significant arrhythmias requiring clinical intervention, cerebrovascular accident\u002Fstroke, transient ischemic attack, subarachnoid hemorrhage, and cardiac insufficiency with a New York Heart Association (NYHA) rating of ≥ II.\n* 13\\) There is currently uncontrolled pleural, pericardial, and abdominal effusion.\n* 14\\) Before cell reinfusion, there are:\n* 14.1) Congenital long QT syndrome;\n* 14.2) Using a cardiac pacemaker;\n* 14.3) Received coronary artery reconstruction;\n* 14.4) Acute coronary syndrome (angina pectoris or myocardial infarction, within 6 months before signing the informed consent form);\n* 14.5) The electrocardiogram showed clinically significant abnormalities or an average QTcF of\\>450 ms for men and\\>470 ms for women (\\>480 ms for patients with bundle branch block (BBB)) in three consecutive times (at least 5 minutes between each time interval);\n* 14.6) Severely uncontrollable diabetes;\n* 14.7) Hypertension with poor drug control (systolic blood pressure\\>160 mmHg and\u002For diastolic blood pressure\\>90 mmHg);\n* 14.8) Severe aortic stenosis or symptomatic mitral stenosis;\n* 14.9) Interstitial pneumonia or pulmonary fibrosis can be seen on chest radiographs (subjects with pneumonia due to radiation are not excluded, but they cannot rely on oxygen);\n* 14.10) Any other disease that the researcher believes will impair the subject's tolerance to the treatment regimen or significantly increase the risk of complications;\n* 15\\) During screening or before cell transfusion, fever of unknown origin\\>38.5 ° C occurred (according to the judgment of the researcher, fever caused by tumor can be included in the group).\n* 16\\) There are severe active viral and bacterial infections, or uncontrolled systemic fungal infections within 4 weeks prior to enrollment, single collection, and pre treatment with cleaning and administration.\n* 17\\) Virological examination results (HIV, Treponema pallidum antibody Tp-Ab) were positive.\n* 18\\) Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive, and hepatitis B virus DNA (HBV-DNA) is higher than the lower limit of detection in the research center; HCV-Ab is positive and HCV-RNA is higher than the lower detection limit of the research center.\n* 19\\) It is expected that any other form of anti-tumor drug treatment will be required during the study period after cell transfusion.\n* 20\\) There is a known history of organ transplantation.\n* 21\\) Women during pregnancy or lactation.\n* 22\\) Known history of alcohol abuse, psychotropic substance abuse, or drug abuse.\n* 23\\) Have a clear history of neurological or mental disorders, such as epilepsy, dementia, schizophrenia, etc.\n* 24)According to the judgment of the researcher, the underlying condition of the subject may increase the risk of receiving treatment with the investigational drug, or may cause confusion in the interpretation of the toxic reactions and adverse events that occur.\n* 25\\) Other situations where the researcher considers it inappropriate to participate in this study.",{"count":131,"type":21},50,[133],"EARLY_PHASE1","1\\) Safety and efficacy of TCR-T cells in subjects with refractory\u002Frelapsed solid tumors. 2) The activation and proliferation of TCR-T cells in the subject, and the survival time.",[136,137,138],"TCR-T Cells","Refractory Solid Tumors","Relapsed Solid Tumors","2023-03-31",{"date":141,"type":32},"2023-04-13",{"date":143,"type":32},"2023-03-07",{"date":36,"type":21},{"name":38,"class":39},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":154,"targetDuration":4,"studyType":51,"phases":155,"briefSummary":134,"conditions":156,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":65},"100480734","early-phase-1-ksh01-tcrt-solid-tumors-100480734","NCT05539833","KSH01-TCRT Solid Tumors","A Single-arm, Prospective Clinical Study of KSH01-TCR-T in the Treatment of Refractory\u002FRecurrent Solid Tumors","KSH01-TCRT","1. Inclusion Criteria:\n\n   * Voluntarily participate in clinical research; fully understand this research and sign informed consent voluntarily; be willing to follow and have the ability to complete all experimental procedures;\n   * Male or female, aged 18 to 70 years (inclusive);\n   * Subjects with advanced malignant solid tumors confirmed by histology or cytology;\n\n     * Dose escalation phase: subjects who have no standard treatment, or who have failed or relapsed after standard treatment, or who cannot tolerate standard treatment with positive target expression;\n     * Dose expansion phase: target-positive subjects who progressed on first-line therapy;\n   * HLA-A\\*02 positive and tumor target positive (target tumor cell staining intensity is divided into 0, 1+, 2+, 3+, \\>30% of cancer cells express 2+ or 3+ positive positive for the target)\n   * All toxicities caused by previous anti-tumor therapy were relieved to grade 0-1 (according to NCI CTCAE version 5.0) or to an acceptable level for inclusion\u002Fexclusion criteria. Except for other toxicities such as alopecia and vitiligo that the researchers believe do not pose a safety risk to the subjects;\n   * Sufficient organ function (without receiving medical support such as blood transfusion and granulocyte colony-stimulating factor within 14 days before cell reinfusion), defined as follows:\n   * Blood system:\n\n     * The neutrophil count (ANC) is not lower than the lower limit of the normal value of the center;\n     * White blood cells (WBC) are not lower than the lower limit of the normal value of the center;\n     * Platelet count (PLT) is not lower than the lower limit of normal value in our center;\n     * Hemoglobin (Hb) not less than 0.8\\*LLN (lower limit of normal);\n   * Liver function:\n\n     * Total bilirubin (TBIL) ≤ 2.0 × upper limit of normal (ULN), Gilbert disease subjects should be ≤ 3 × ULN;\n     * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤3×ULN (in the dose expansion phase, subjects with liver metastases or liver cancer can be ≤5×ULN); alkaline phosphatase (ALP) ≤2.5× ULN (subjects with bone metastases, ALP≤5×ULN);\n   * Renal function:\n\n     * Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 ml\u002Fmin (Cockcroft-Gault formula: (\\[140-age\\]×weight \\[kg\\]×\\[0.85, for women only\\])\u002F(72×creatinine (mg\u002Fdl)));\n     * The qualitative urine protein is ≤1+; if the qualitative urine protein is ≥2+, a 24-hour urine protein quantitative examination is required, and if the 24-hour urine protein quantitative \\\u003C1 g, it is acceptable;\n   * Coagulation function:\n\n   Those who did not receive anticoagulation therapy: International normalized ratio (INR), activated partial thromboplastin time (APTT) should be less than or equal to 1.5×ULN; patients with liver metastasis or liver cancer should be less than or equal to 2×ULN;\n   * Physical status: Eastern Cooperative Oncology Group (ECOG) score of 0-1;\n   * Expected survival period ≥ 12 weeks;\n   * According to RECIST 1.1 criteria, there is at least one measurable lesion (dose expansion phase) or an evaluable lesion (dose escalation phase);\n   * After assessment, enough PBMC cells can be collected in the subject to prepare autologous TCR-T cells;\n   * After evaluation, the prepared autologous TCR-T cells are of sufficient quantity and qualified quality, and can be used for clinical reinfusion of the corresponding dose;\n   * Female subjects with fertile potential have a negative blood pregnancy result within 3 days before the cell reinfusion, and are willing to abstain from sex or take medically approved high-efficiency drugs from the time of signing the informed consent to 6 months after the end of the last medication. contraceptive measures (eg, IUDs, condoms);\n   * Male subjects are willing to keep abstinence or take medically approved high-efficiency contraceptive measures from the time of signing the informed consent to 6 months after the end of the last medication, and do not donate sperm during this period.\n   * All subjects are required to provide tumor tissue specimens that can be used for target analysis, which must be archived specimens or fresh biopsy specimens (bone biopsy specimens are not accepted). Only those with positive target expression can enter the study.\n2. Exclusion Criteria:\n\n   * History of severe allergic diseases, severe drug allergy (including unmarketed test drugs), or known allergy to any component of the recommended drugs (including pretreatment drugs) in this program;\n   * Those who have received coronary artery reconstruction in the past;\n   * Evidence of significant bleeding disorders or other significant bleeding risk:\n   * History of intracranial hemorrhage or intraspinal hemorrhage;\n   * Tumor lesions invade large blood vessels and have obvious bleeding risk;\n   * Thrombosis or embolism occurred within 6 months before cell reinfusion;\n   * Clinically significant hemoptysis or tumor hemorrhage occurred within 1 month before cell reinfusion;\n   * Anticoagulant therapy for therapeutic purposes (except low molecular weight heparin) has been used within 2 weeks before cell reinfusion;\n   * Antiplatelet drugs, such as aspirin (\\>325 mg\u002Fday), clopidogrel (\\>75 mg\u002Fday), dipyridamole, ticlopidine or cilostazine, were used within 10 days before cell reinfusion azoles, etc.;\n   * Received the following treatments or drugs before cell reinfusion:\n\n     * Unhealed wounds, ulcers or fractures within 28 days before cell reinfusion;\n     * Inoculated with live attenuated vaccine within 28 days before cell reinfusion;\n     * Received nitrosourea or mitomycin C treatment within 6 weeks before cell infusion; received oral fluorouracil treatment 2 weeks before cell infusion or within ●half-lives of the drug (whichever is longer) ;\n   * Received corticosteroids within 2 weeks before cell reinfusion, or it is expected that corticosteroid treatment may be required during blood collection, cell collection or cell reinfusion; except for the following cases: short time (≤7 days), dose not higher than 10 mg\u002Fd prednisone or equivalent dose of corticosteroids for the prevention or treatment of non-autoimmune conditions; topical, intranasal, intraocular, intraarticular or inhaled corticosteroids;\n   * Known leptomeningeal metastases, or uncontrolled or symptomatic central nervous system metastases manifested by clinical symptoms, cerebral edema, spinal cord compression, and\u002For progressive growth. Subjects with a history of central nervous system metastasis or spinal cord compression are acceptable if they have clearly received treatment and are clinically stable after 8 weeks of discontinuation of anticonvulsants and steroids before cell reinfusion;\n   * The existence of any form of primary immunodeficiency;\n   * There is any active autoimmune disease, or there is a history of autoimmune disease and relapse is expected (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, need for bronchial Asthma subjects medically intervened with dilators, except for the following: type 1 diabetes; skin conditions not requiring systemic therapy \\[eg, vitiligo, psoriasis, alopecia\\]; hypothyroidism only receiving hormone replacement therapy; childhood Asthma in complete remission without any intervention in adulthood; or others not expected to relapse in the absence of external triggers);\n   * Within 6 months before cell reinfusion, the following conditions have occurred: myocardial infarction, severe\u002Funstable angina, clinically significant arrhythmia requiring clinical intervention, cerebrovascular accident\u002Fstroke, transient ischemic attack, Subarachnoid hemorrhage, cardiac insufficiency with New York Heart Association (NYHA) class ≥ II;\n   * There is currently uncontrollable pleural, pericardial, and ascites effusion;\n   * Before cell reinfusion, there are:\n\n     * Congenital Long QT Syndrome\n     * Use of a pacemaker\n     * Left Ventricular Ejection Fraction (LVEF) \\\u003C 50%\n     * QTcF interval\\>480 msec (QTcF=QT\u002F(RR\\^0.33))\n     * Cardiac troponin I or T \\>2.0 ULN\n     * Poorly controlled diabetes (fasting blood glucose ≥ 13.3 mM)\n     * Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg);\n     * Forced expiratory volume in the first second (FEV1) ≤ 60% or those who need supplemental oxygen therapy;\n   * Unexplained fever \\>38.5°C during screening or before cell reinfusion (fever due to tumor can be included in the group as judged by the investigator);\n   * Known history of allogeneic organ transplantation;\n   * Known history of alcohol abuse, psychotropic substance abuse or drug abuse;\n   * Have a clear history of neurological or mental disorders, such as epilepsy, dementia, schizophrenia, etc.;\n   * Known to have acquired immunodeficiency syndrome (AIDS);\n   * Known severe active viral, bacterial infection, or uncontrolled systemic fungal infection;\n   * Positive virological test results (HIV, CMV, HSV, HPV, EBV, syphilis);\n   * HBsAg positive or HBcAb positive, and HBV-DNA \\> 200 IU\u002FmL; HCV-Ab positive, and HCV-RNA higher than the detection limit of the research center;\n   * According to the judgment of the investigator, the underlying condition of the subject may increase the risk of receiving the experimental drug treatment, or cause confusion in the interpretation of the toxic reactions and adverse events;\n   * Expected to receive any other form of antitumor drug treatment during the study period;\n   * Women who are pregnant or breastfeeding;\n   * Other investigators deem it inappropriate to participate in this study.",{"count":131,"type":21},[133],[136,137,138],{"date":158,"type":32},"2023-04-03",{"date":160,"type":32},"2022-08-19",{"date":162,"type":21},"2027-07-31",{"name":38,"class":39},{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":171,"targetDuration":4,"studyType":51,"phases":172,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":65},"100483881","early-phase-1-ksh01-r02-101-solid-tumors-100483881","NCT05580796","KSH01-R02-101 Solid Tumors","Investigator Initiated Clinical Trial on the Tolerance, Safety and Preliminary Efficacy of KSH01-TCRT Injection in Solid Tumor Subjects","Inclusion Criteria:\n\n* 1\\) Voluntary participation in clinical research; Fully understand the study and voluntarily sign the informed consent form; Willing to follow and able to complete all test procedures;\n* 2\\) Male or female, 18 to 70 years old (including boundary value);\n* 3\\) Malignant solid tumors failed to receive standard treatment;\n* 4\\) HLA-A \\* 02 is positive and tumor target is positive (the staining intensity of target tumor cells is divided into 0, 1+, 2+, 3+, and more than 30% of cancer cells express 2+or 3+positive as the target is positive)\n* 5). All toxic reactions caused by previous anti-tumor treatment are alleviated to grade 0-1 (according to NCI CTCAE version 5.0) or to an acceptable level of inclusion\u002Fexclusion criteria. Other poisons such as alopecia and vitiligo that researchers believe do not pose a safety risk to subjects\n* 6\\) There is sufficient organ function (no medical support such as blood transfusion and granulocyte colony stimulating factor within 14 days before cell transfusion), which is defined as follows:\n* 6.1) Blood system:\n* 6.1.1) Neutrophil count (ANC) is not lower than the lower limit of normal value of the center;\n* 6.1.2) White blood cell (WBC) shall not be lower than the lower limit of normal value of the center;\n* 6.1.3) Platelet count (PLT) shall not be lower than the lower limit of normal value of the center;\n* 6.1.4) Hemoglobin (Hb) shall not be lower than 0.8 \\* LLN (lower limit of normal value);\n* 6.2) Liver function:\n* 6.2.1) Total bilirubin (TBIL) ≤ 2.0 × Upper limit of normal (ULN), Gilbert disease subjects should be ≤ 3 × ULN；\n* 6.2.2) AST, ALT ≤ 3 × ULN (in the dose expansion stage, the subjects with liver metastasis or liver cancer can be ≤ 5 × ULN）； Alkaline phosphatase (ALP) ≤ 2.5 × ULN (bone metastasis subject, ALP ≤ 5 × ULN）；\n* 6.3) Renal function:\n* 6.3.1) Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 ml\u002Fmin (Cockcroft Gault formula: (\\[140 age\\] × Weight \\[kg\\] × \\[0.85 for women only\\])\u002F(72 × Creatinine (mg\u002Fdl));\n* 6.3.2) Qualitative urine protein ≤ 1+; If the urine protein is qualitative ≥ 2+, a 24-hour urine protein quantitative test is required. If the 24-hour urine protein quantitative test is less than 1 g, it is acceptable;\n* 6.4) Coagulation function: those not receiving anticoagulation treatment: International normalized ratio (INR), activated partial thromboplastin time (APTT) should be ≤ 1.5 × ULN； Subjects with liver metastasis or liver cancer should be ≤ 2 × ULN；\n* 7\\) Physical condition: The score of the Eastern American Cooperative Oncology Group (ECOG) was 0-1;\n* 8\\) Expected survival time ≥ 12 weeks;\n* 9\\) According to RECIST 1.1, there is at least one measurable lesion (dose expansion stage) or evaluable lesion (dose increase stage);\n* 10\\) After evaluation, enough PBMC cells can be collected from the subjects to prepare autologous TCR-T cells;\n* 11\\) After evaluation, the prepared autologous TCR-T cells are sufficient in quantity and qualified in quality, and can be used for clinical reinfusion of corresponding dose;\n* 12\\) The blood pregnancy result of female subjects with fertility within 3 days before cell transfusion was negative, and they were willing to sign informed consent from the end of the last medication to 6 months, keep abstinence or take medically approved effective contraceptive measures (such as intrauterine device, pregnancy avoidance device);\n* 13\\) Male subjects are willing to keep abstinence or take medically approved effective contraceptive measures within 6 months from signing the informed consent form to the end of the last medication, and do not donate sperm during this period;\n* 14\\) All subjects should provide tumor tissue samples that can be used for target analysis, which should be archived samples or fresh biopsy samples (bone biopsy samples are not accepted). Only those with positive target expression can enter the study.\n\nExclusion Criteria:\n\n* 1\\) History of serious allergic diseases, allergic history of serious drugs (including non marketed test drugs) or known allergy to any component of the proposed drugs (including pre-treatment drugs) in this protocol;\n* 2\\) Previous coronary artery reconstruction;\n* 3\\) Evidence of major haemorrhagic disorder or other obvious bleeding risks:\n* 3.1) Previous history of intracranial hemorrhage or intracerebral hemorrhage;\n* 3.2) The tumor focus invades large vessels and has obvious risk of bleeding;\n* 3.3) Thrombosis or embolism occurred within 6 months before cell transfusion;\n* 3.4) Clinically significant hemoptysis or tumor hemorrhage occurred within 1 month before cell transfusion;\n* 3.5) Anticoagulant therapy (except low molecular weight heparin) for therapeutic purposes was used within 2 weeks before cell transfusion;\n* 3.6) Within 10 days before cell reinfusion, they have used antiplatelet drugs, such as aspirin (\\>325 mg\u002Fday), clopidogrel (\\>75 mg\u002Fday), dipyridamole, ticlopidine or cilostazol;\n* 4\\) Have received the following treatments or drugs before cell reinfusion:\n* 4.1) Unhealed wound, ulcer or fracture within 28 days before cell reinfusion;\n* 4.2) Inoculate live attenuated vaccine within 28 days before cell reinfusion;\n* 4.3) The cells were treated with nitrosourea or mitomycin C within 6 weeks before reinfusion; Oral fluorouracil therapy was received 2 weeks before cell reinfusion or within 5 half lives of the drug (whichever is longer);\n* 4.4) Within 2 weeks before cell reinfusion, the patient has received corticosteroids, or it is estimated that corticosteroids may be required during blood collection, cell collection or cell reinfusion; Except for the following cases: short-term (≤ 7 days) prednisone with a dose not higher than 10 mg\u002Fd or equivalent dose is used to prevent or treat non autoimmune conditions; Corticosteroids for local, nasal, intraocular, articular cavity or inhalation;\n* 5\\) It is known that there is leptomeningeal metastasis, or uncontrolled or symptomatic central nervous system metastasis, with clinical symptoms, brain edema, spinal cord compression and\u002For progressive growth. Subjects with a history of central nervous system metastasis or spinal cord compression can be accepted if they have definitely received treatment and stopped using anticonvulsants and steroids 8 weeks before cell reinfusion, and their clinical manifestations are determined to be stable by the investigator;\n* 6\\) Presence of any form of primary immunodeficiency;\n* 7\\) Presence of any active autoimmune disease, Or asthmatic subjects who have a history of autoimmune diseases and are expected to relapse (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, and asthma requiring medical intervention with bronchodilators. The following cases are excluded: type 1 diabetes; skin diseases that do not require systemic treatment \\[such as vitiligo, psoriasis, alopecia\\] ； Hypothyroidism requiring only hormone replacement therapy; Asthma that has been completely relieved in childhood does not need any intervention in adulthood; Or other patients who are expected to have no relapse under the condition of no external trigger);\n* 8\\) Within 6 months before cell reinfusion, the following conditions occurred: myocardial infarction, severe\u002Funstable angina, arrhythmia with clinical significance and requiring clinical intervention, cerebrovascular accident\u002Fstroke, transient ischemic attack, subarachnoid hemorrhage, and cardiac insufficiency with NYHA grade ≥ II;\n* 9\\) At present, there are uncontrollable pleural, pericardial and peritoneal effusion;\n* 10\\) Before cell reinfusion, there were:\n* 10.1) congenital long QT syndrome\n* 10.2) pacemaker use\n* 10.3) left ventricular ejection fraction (LVEF)\\\u003C50%\n* 10.4) QTcF interval\\>480 msec (QTcF=QT\u002F(RR \\^ 0.33)\n* 10.5) cardiac troponin I or T\\>2.0 ULN\n* 10.6) poorly controlled diabetes mellitus (fasting glucose ≥ 13.3 mM)\n* 10.7) poorly controlled hypertension (systolic pressure ≥ 160 mmHg and\u002For diastolic pressure ≥ 100 mmHg);\n* 10.8) Forced expiratory volume in the first second (FEV1) ≤ 60% or oxygen therapy is required;\n* 11\\) During screening or before cell reinfusion, fever of unknown cause occurred\\>38.5 ° C (according to the judgment of the investigator, fever caused by tumor can be included in the group);\n* 12\\) History of allograft transplantation is known;\n* 13\\) Known history of alcohol abuse, psychotropic substance abuse or drug abuse;\n* 14\\) Have a clear history of neurological or mental disorders, such as epilepsy, dementia, schizophrenia, etc;\n* 15\\) Known to have acquired immunodeficiency syndrome (AIDS);\n* 16\\) Serious active virus, bacterial infection or uncontrolled systemic fungal infection are known;\n* 17\\) Virology test results (HIV, CMV, HSV, HPV, EBV, syphilis) are positive;\n* 18\\) HBsAg positive or HBcAb positive, and HBV-DNA\\>200 IU\u002FmL; HCV Ab is positive, and HCV RNA is higher than the lower detection limit of the research center;\n* 19\\) According to the judgment of the investigator, the basic condition of the subject may increase the risk of receiving the test drug treatment, or the interpretation of the toxic reaction and adverse event may cause confusion;\n* 20\\) It is expected to receive any other form of anti-tumor drug treatment during the study period;\n* 21\\) Women in pregnancy or lactation;\n* 22\\) Other investigators consider it inappropriate to participate in this study.",{"count":131,"type":21},[133],"1. . safety and tolerance\n2. . objective response rate",[175],"Solid Tumor",[177],"Genetic engineering of T-cells","2023-03-29",{"date":158,"type":32},{"date":181,"type":32},"2022-10-11",{"date":183,"type":21},"2027-10-11",{"name":38,"class":39},""]