[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tcr-t-cells\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tcr-t-cells":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100501647","early-phase-1-ksx01-tcrt-injection-project-in-solid-tumors-100501647",false,"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.","ALL","18 Years","70 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"TCR-T Cells","Refractory Solid Tumors","Relapsed Solid Tumors","RECRUITING","2023-03-31",{"date":33,"type":34},"2023-04-13","ACTUAL",{"date":36,"type":34},"2023-03-07",{"date":38,"type":21},"2028-12-31",{"name":40,"class":41},"TCRx Therapeutics Co.Ltd","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":25,"conditions":53,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":42},"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":20,"type":21},[24],[27,28,29],{"date":55,"type":34},"2023-04-03",{"date":57,"type":34},"2022-08-19",{"date":59,"type":21},"2027-07-31",{"name":40,"class":41}]