[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BioSyngen Pte Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":121},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,39,59,79,99],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100565679","early-phase-1-study-on-the-safety-and-efficacy-of-bst06-injection-in-the-treatment-of-advanced-hepatocellular-carcinoma-100565679",false,"NCT06645314","Study on the Safety and Efficacy of BST06 Injection in the Treatment of Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n* 1: The age range is 18-70 years old (including the critical value);\n* 2: HCC patients diagnosed by histopathological or cytological examination, or those who meet the criteria of the American Association for the Study of the Liver (AASLD) or are clinically diagnosed with hepatocellular carcinoma according to the \"2022 Guidelines for the Diagnosis and Treatment of Primary Liver Cancer\";\n* 3: Tumor tissue pathology immunohistochemistry GPC3 positive;\n* 4: Patients who have undergone at least first-line systemic therapy and have experienced disease progression confirmed by imaging (including but not limited to systemic chemotherapy, targeted therapy, immunotherapy, etc.), have been evaluated by the researchers to have refused other standard treatments at the time of enrollment, or have been determined by the researchers to have difficulty benefiting from treatments recommended by domestic and foreign clinical guidelines or expert consensus.\n* 5: At least one tumor lesion has not received radiation therapy or other local treatments within 28 days. Moreover, according to the researchers' judgment, at least 2 intact tumor puncture samples with a length of ≥ 2cm can be obtained through surgical resection or puncture, which can be from different lesions, for the preparation of BST06 cells;\n* 6: After TIL sampling, there should be at least one measurable lesion that meets the mRECIST standard definition (RECIST 1.1 standard for subjects without intrahepatic lesions);\n* 7: Eastern Cooperative Oncology Group (ECOG) score ≤ 1 point;\n* 8: Child Pugh liver function grading score A-B7\n* 9: HBsAg positive patients must meet the requirement of HBV DNA quantification\\\u003C1 \\* 104 IU\u002Fml (or 5 \\* 104 copy\u002Fml) or receive at least one week of anti HBV treatment with a 10 fold reduction in viral index before the start of the study\n* 10: Expected survival time ≥ 3 months;\n* 11: During the screening and preparation period (within 14 days prior to TIL sampling), sufficient organ and bone marrow function was assessed\n* 12: Prior to TIL sampling, adverse reactions caused by previous treatments had already recovered to the Common Adverse Event Evaluation Criteria (CTCAE) of 5.0 ≤ 2 (excluding toxicity judged by researchers to have no safety risk, such as hair loss or peripheral neurotoxicity of grade 2 or below);\n* 13: From signing the informed consent form to agreeing to take effective contraceptive measures within 6 months after BST06 cell transfusion (subjects must use non pharmacological contraception);\n* 14: Those who fully understand this experiment and voluntarily sign the informed consent form, and are able to comply with the visit and related procedures specified in the protocol.\n\nExclusion Criteria:\n\n* 1: Pregnant or lactating women;\n* 2: Subjects with a history of severe allergies and allergies to experimental drugs including but not limited to cyclophosphamide, fludarabine, BST06 injection components, etc;\n* 3: Past or current presence of hepatic encephalopathy; Known patients with untreated or uncontrolled central nervous system metastases; Except for those who have received treatment and have stable symptoms, and have stopped glucocorticoid and anticonvulsant drug treatment for ≥ 4 weeks before pre-treatment;\n* 4: At present, clinically significant ascites exists, defined as ascites with positive physical examination signs or requiring intervention treatment control (only those with imaging showing ascites without intervention can be included);\n* 5: The proportion of liver tumors is ≥ 50%. For subjects planning to undergo liver lesion resection for specimen collection and preparation, the indocyanine green 15 minute retention rate (ICG-R15) must be ≥ 30%;\n* 6: Organ transplantation, history of hematopoietic stem cell transplantation;\n* 7: Other serious diseases that may restrict participants from participating in this trial;\n* 8: HIV positive, or positive for Treponema pallidum antibody; For patients with active hepatitis B or C, it is recommended to continue taking antiviral drugs during the study period. Active hepatitis B is defined as: positive hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg), and HBV-DNA\\>10000 IU\u002Fml. Active hepatitis C is defined as HCV RNA above the lower limit of detection;\n* 9: Within the 4 weeks prior to TIL sampling, any immunosuppressive drugs such as corticosteroids were used, or it was determined by the researcher that there were comorbidities that required the use of immunosuppressive drugs during the trial period. But it is allowed to use physiological doses of glucocorticoids (i.e. not exceeding 15mg\u002Fday of prednisone or equivalent doses of other glucocorticoids), and inhaled, intranasal, topical, or prophylactic corticosteroids are allowed to be used for contrast agent allergies;\n* 10: Received local treatments such as interventional therapy, radiotherapy, ablation, as well as systemic treatments (including small molecule targeting, anti-PD-1\u002FPD-L1 monoclonal antibodies, and chemotherapy) within 4 weeks prior to pre-treatment. Or received thymosin, interferon and other immunotherapy or any Chinese herbal medicine or traditional Chinese patent medicines and simple preparations for tumor control within 1 week before pretreatment;\n* 11: Individuals who have received a live vaccine within the first 3 months of screening or plan to receive a live vaccine during the trial period\n* 12: Individuals who have undergone major surgery (≥ grade 3 surgery) within the 4 weeks prior to screening, or who require elective surgery during the trial period (excluding TIL sampling surgery);\n* 13: Patients who experience surgical complications or delayed wound healing prior to pre-treatment, and who have been assessed by researchers to increase the risk of gonorrhea, TIL treatment, or infection;\n* 14: Diagnosed within 5 years prior to screening as coexisting with other primary malignant tumors, excluding skin basal cell carcinoma, skin squamous cell carcinoma, and\u002For carcinoma in situ that has undergone radical resection;\n* 15: Received cell therapy products within 6 months prior to pre-treatment;\n* 16: Known cases of alcohol abuse, drug use, or substance abuse, as well as those deemed unsuitable by other researchers to participate in this trial.","ALL","18 Years","70 Years",{"count":19,"type":20},16,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","The study is an exploratory clinical trial initiated by an open, single arm researcher to evaluate the safety, tolerability, and preliminary efficacy of BST06 injection in the treatment of advanced hepatocellular carcinoma in subjects. This study plans to apply Bayesian Optimal Interval (BOIN) design, with at least 2 and up to 8 DLT assessable subjects in each dose group, who must complete a 28 day DLT assessment period. The study plan includes 2 dose groups: 5x10 \\^ 9 and 3x10 \\^ 10 BST06 cells",[26],"Hepatocellular Carcinoma","NOT_YET_RECRUITING","2024-10-15",{"date":30,"type":31},"2024-10-16","ACTUAL",{"date":33,"type":20},"2024-11-30",{"date":35,"type":20},"2027-08-31",{"name":37,"class":38},"BioSyngen Pte Ltd","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":57,"leadSponsor":58,"locationsCount":4},"100565678","early-phase-1-bgt007-treatment-for-recurrentrefractory-gastrointestinal-malignancies-100565678","NCT06645301","BGT007 Treatment for Recurrent\u002Frefractory Gastrointestinal Malignancies","Exploratory Clinical Study Initiated by Researchers on the Safety and Preliminary Efficacy of BGT007 in Treating Patients with Recurrent\u002Frefractory Gastrointestinal Malignancies","Inclusion Criteria:\n\n* 1: Voluntarily sign a written informed consent form;\n* 2: Age ≥ 18 years old and ≤ 75 years old, both male and female are acceptable;\n* 3: Expected survival period ≥ 3 months;\n* 4: The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) is 0 or 1;\n* 5: Biopsy specimens or pathological paraffin sections (within 3 years prior to signing the informed consent form): target tests are both positive;\n* 6: According to the RECIST v1.1 solid tumor evaluation criteria, there must be at least one measurable lesion, and the longest diameter evaluated by CT or MRI imaging in the baseline period must be ≥ 10 mm (excluding lymph nodes, whose short diameter must be ≥ 15 mm);\n* 7: Advanced pancreatic cancer or colorectal cancer confirmed by histology or cytology, which has progressed through second-line or above standard treatment, or is intolerant of standard treatment, or has no standard treatment; Definition of intolerance: According to CTCAE V5.0, during the treatment process, there is a hematological toxicity of ≥ Grade IV, non hematological toxicity of ≥ Grade III, or damage to major organs such as the heart, liver, and kidneys of ≥ Grade II; The definition of treatment failure: disease progression (PD) during the treatment process or recurrence after treatment (including postoperative recurrence);\n* 8: Can establish a single or intravenous blood collection pathway, and there are no other contraindications for blood cell isolation;\n* 9: Having sufficient organ and bone marrow functions\n* 10: Medical contraceptive measures. Female subjects of childbearing age must undergo a pregnancy test within 72 hours before the first administration, and the result must be negative.\n\nExclusion Criteria:\n\n* 1: Active central nervous system metastases (excluding those that have been treated and stabilized);\n* 2: HIV positive, HBsAg positive with HBV DNA copy number positive (greater than the detection limit), HCV antibody positive and HCV RNA positive, syphilis non-specific antibody (RPR or TRUST) positive;\n* 3: Individuals with mental or psychological disorders who are unable to cooperate with treatment and efficacy evaluation;\n* 4: Subjects with severe autoimmune diseases and long-term use of immunosuppressants;\n* 5: Within the 14 days prior to enrollment, there were active or uncontrollable infections that required systemic treatment;\n* 6: Any unstable systemic disease (including but not limited to): active infection (excluding local infection); Unstable angina pectoris; Cerebrovascular ischemia or cerebrovascular accident (within 6 months prior to screening); Myocardial infarction (within 6 months prior to screening); Congestive heart failure (NYHA classification ≥ III); Severe arrhythmia requiring medication treatment; Heart disease requiring treatment or uncontrolled hypertension after treatment (blood pressure\\>160mmHg\u002F100 mmHg);\n* 7: Functional impairment of important organs such as lungs, brain, and kidneys;\n* 8: The subjects have undergone major surgery or severe trauma within 4 weeks prior to receiving treatment with the investigational product, or are expected to undergo major surgery during the study period;\n* 9: Received any systemic chemotherapy, immunotherapy, or small molecule targeted therapy within 2 weeks prior to single collection or within 5 half lives (whichever is shorter);\n* 10: Received treatment with chimeric antigen receptor modified T cells (including CAR-T and TCR-T) within six months;\n* 11: Severe allergies or a history of allergies;\n* 12: Subjects requiring anticoagulant therapy;\n* 13: Pregnant or lactating women, or those with a pregnancy plan within six months (for both men and women)\n* 14: Researchers believe that there are other reasons why treatment providers cannot be included.","17 Years","75 Years",{"count":49,"type":20},15,[23],"This study is an exploratory research on single arm, open, and improved \"3+3\" dose escalation. BGT007 will explore two dose groups, namely (Group A: 3.0X10 \\^ 8 3 cases, Group B: 6.0X10 \\^ 8 3 cases), and receive the same dose infusion after observing lower adverse reactions and initial benefits (SD or PR), with an interval of one month. Each subject can receive a maximum of 3 infusions in total.",[53,54],"Colorectal Cancer","Pancreatic Cancer",{"date":30,"type":31},{"date":33,"type":20},{"date":35,"type":20},{"name":37,"class":38},{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":65,"targetDuration":4,"studyType":21,"phases":67,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":77,"locationsCount":78},"100565571","a-study-on-the-safety-and-efficacy-of-bst08-in-treating-advanced-non-small-cell-lung-cancer-100565571","NCT06643910","A Study on the Safety and Efficacy of BST08 in Treating Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* 1: Age 18-70 years old (including the critical value);\n* 2: Non-small cell lung cancer diagnosed by histopathology or cytology without driver mutation progresses after receiving at least second-line systemic therapy including anti-PD-1 \u002FL1 monoclonal antibody.\n* 3: At least one tumor lesion has not received radiation therapy or other local treatment within 28 days. In addition, according to the researchers' judgment, at least 2 tumor puncture samples (from different lesions) with good integrity and ≥2cm length can be obtained by surgical resection or puncture for the preparation of BST08.\n* 4: At least one measurable lesion as defined by the RECIST 1.1 standard;\n* 5: Eastern Cooperative Oncology Group (ECOG) score ≤1 score;\n* 6: Expected survival time ≥3 months;\n* 7: Adequate organ and bone marrow function during the screening and preparation phase (within 14 days prior to tumor tissue sampling)\n* 8: Prior to the tumor tissue sampling, the adverse reactions caused by previous treatment had returned to the Common Adverse Event Evaluation Criteria (CTCAE) 5.0≤2 (except for alopecia, peripheral neurotoxicity of grade 2 or below, and other toxicities that researchers judged to have no safety risk);\n* 9: From the signing of the informed consent to the acceptance of effective contraceptive measures within 6 months after the BST08 infusion (subjects must use non-drug contraceptive measures);\n* 10: Those who fully understand the test and voluntarily sign the informed consent, and can comply with the visit and related procedures stipulated in the program\n\nExclusion Criteria:\n\n* 1: Pregnant or lactating women;\n* 2\\. Subjects with a history of severe allergy to the experimental drug, including but not limited to cyclophosphamide, fludarabine, and BST08 components;\n* 3: Past or current presence of hepatic encephalopathy; Other patients with known uncontrolled or untreated central nervous system metastases; Patients with stable symptoms who had received treatment and stopped treatment with corticosteroids and anticonvulsants ≥4 weeks prior to preconditioning were excluded;\n* 4: Extensive liver metastasis was confirmed (imaging estimated tumor volume accounted for ≥50% of the total liver volume);\n* 5: Organ transplantation, hematopoietic stem cell transplantation history;\n* 6\\. Other serious medical conditions that may limit participants' participation in this trial\n* 7: HIV positive, or treponema pallidum antibody positive;\n* 8: Active hepatitis B infection, defined as Hepatitis B core antibody (HBcAb) or Hepatitis B surface antigen (HBsAg) positive with HBV-DNA\\> 10,000 IU\u002Fml, or 200 IU. Or hepatitis C, defined as HCV RNA above the lower limit for clinical trial center detection. These patients will need to continue taking antiviral drugs during the study period;\n* 9: Any immunosuppressive drugs, such as corticosteroids, were used in the 4 weeks prior to the tumor tissue sampling, or co-existing diseases were determined by the investigator to require the use of immunosuppressive drugs during the trial. However, the use of physiological doses of corticosteroids (i.e., no more than 15mg\u002F day of prednisone or equivalent doses of other corticosteroids) is permitted, and the use of corticosteroids for inhalation, intranasal, topical or prophylactic use of contrast media allergies is permitted;\n* 10: Local treatment such as interventional therapy, radiotherapy, ablation and systemic treatment (including small molecule targeted drugs, anti-PD-1 \u002F PD-L1 monoclonal antibodies and chemotherapy, etc.) had been received within 4 weeks before pretreatment. Or received thymosin, interferon and other immunotherapy or any Chinese herbal medicine or proprietary Chinese medicine for tumor control within 1 week prior to pretreatment;\n* 11: Those who have received live vaccine within 3 months prior to screening or plan to receive live vaccine during the trial;\n* 12: Patients who underwent major surgery (≥ Grade 3 surgery) within 4 weeks prior to screening, or who required elective surgery during the trial period (other than tumor tissue sampling surgery\u002Fpuncture);\n* 13: Patients who had surgical complications or delayed wound healing prior to pretreatment, and who were judged by the investigators to increase the risk of eluviation, TIL treatment, or infection;\n\n  14: diagnosed with other primary malignancies within 5 years prior to screening, excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For radical resection of carcinoma in situ;\n* 15: Genetically modified cell therapy products received 6 months before pretreatment;\n* 16: Participants with known alcohol, drug, or substance abuse and other conditions deemed inappropriate by the researchers to participate in this study.",{"count":66,"type":20},12,[68],"NA","This study is an exploratory clinical trial initiated by an open, single arm researcher to evaluate the safety, tolerability, and preliminary efficacy of BST08 in the treatment of advanced non-small cell lung cancer in subjects. This study plans to set up two experimental groups: monotherapy group A: 9x10 \\^ 10 BST08 (3 cases) and combination therapy group B: 9x10 \\^ 10 BST08+Pabolizhu 200mg Q3W (6 cases).",[71],"Non-small Cell Lung Cancer","2024-10-14",{"date":30,"type":31},{"date":75,"type":20},"2024-10-24",{"date":35,"type":20},{"name":37,"class":38},1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":47,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":78},"100529434","early-phase-1-investigator-initiated-phase-i-exploratory-clinical-study-of-the-safety-tolerability-and-efficacy-of-bst02-injection-in-the-treatment-of-locally-advancedmetastatic-liver-cancer-100529434","NCT06173726","Investigator-initiated Phase I Exploratory Clinical Study of the Safety, Tolerability, and Efficacy of BST02 Injection in the Treatment of Locally Advanced\u002FMetastatic Liver Cancer","Inclusion Criteria:\n\n1. Age 18-75 years old (including the critical value).\n2. Patients with histologically or cytologically confirmed locally advanced \u002F metastatic liver cancer (including hepatocellular carcinoma, intrahepatic bile duct carcinoma, and metastatic liver cancer). Hepatocellular carcinoma (HCC) and cholangiocarcinoma (BCLC) are either stage C or stage B that is not suitable for local treatment\u002Flocal treatment progression according to Barcelona Clinic Liver Cancer (BCLC). Metastatic liver cancer is not suitable for radical surgical treatment according to the TNM stage of the primary cancer.\n3. For locally advanced liver cancer, guidelines should recommend at least first-line systemic therapy (atrilizumab + bevacizumab, sindilizumab + bevacizumab analogues; Donafenib, Renvastinib, sorafenib; FOLFOX4) after failure (disease progression or intolerance), or as determined by the investigator to be unsuitable, or the patient refused to receive the standard treatment recommended by the guidelines. For metastatic liver cancer, failure (disease progression or intolerance) of at least second-line treatment recommended by guidelines, or inappropriate treatment determined by the investigator, or refusal of standard treatment is required.\n4. At least one operation without radiation or other local treatment within 28 days to remove the tumor lesion with an estimated lesion volume of at least 8 cm\\^3, excluding necrotic areas, for the preparation of BST02 cells.\n5. There is at least one measurable lesion after sampling that meets the definition of RECIST 1.1 standard, and the intrahepatic target lesion requires arterial phase enhanced imaging.\n6. The Eastern Cooperative Oncology Group (ECOG) score ≤1 score.\n7. Child-Pugh score of cirrhosis ≤7 points.\n8. Expected survival time ≥3 months.\n9. Adequate organ and bone marrow function in the assessment conducted during the screening period (within 14 days prior to TIL sampling), as defined below:\n\n   * Blood routine: Absolute Neutrophil Count (ANC) ≥1.5×10\\^9\u002FL, Blood Platelet count (PLT) ≥90×10\\^9\u002FL, Hemoglobin (Hemoglobin, ANC) ≥1.5×10\\^9\u002FL HGB) ≥80 g\u002FL (no blood transfusion or erythropoietin treatment within 14 days).\n   * Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) levels ≤5× upper limit of normal value (ULN), Serum Total Bilirubin (TBil) ≤1.5×ULN, if diagnosed with Gilbert syndrome: TBil≤3×ULN.\n   * Coagulation function: Activated partial thromboplastin time (APTT) ≤1.5×ULN, while International Normalized Ratio, INR), Prothrombin Time (PT) ≤1.5×ULN.\n   * Renal function: Serum Creatinine (Cr) ≤1.5×ULN or Creatinine Clearance (Ccr) ≥60 mL\u002Fmin (Cockcroft-Gault formula).\n   * Cardiac function examination: Left ventricular Ejection Fraction (LVEF) ≥50% by echocardiography; No arrhythmias requiring treatment, Fridericia QT correction formulas (QTcF) ≤470 ms (QTcF is calculated using Fridericia's formula, That is, QTcF = QT\u002F (RR\\^0.33), RR is the standardized heart rate value, RR=60\u002F heart rate; If the first check is abnormal, the interval of at least 5 minutes, retest twice, take the comprehensive result\u002Faverage value to judge the conformity);\n   * Lung function: FEV1 percentage of predicted value (FEV1%) ≥60%.\n10. Prior to tumor sampling, the adverse reactions caused by previous treatment had returned to the Common Adverse Event Evaluation Criteria (CTCAE) 5.0≤1 (except for alopecia, peripheral neurotoxicity of grade 2 or below, and other toxicities that the investigators judged to have no safety risk).\n11. Consent to take effective contraceptive measures within 6 months from the signing of informed consent to TIL cell transfusion (subjects must use non-drug contraceptive measures).\n12. Those who fully understand the test and voluntarily sign the informed consent and can comply with the visit and related procedures stipulated in the program.\n\n    \\-\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Subjects with a history of severe allergy to the experimental drugs including but not limited to cyclophosphamide, fludarabine, IL-2, and TIL injection components.\n3. Patients with past or current hepatic encephalopathy, known to have other central nervous system metastases not effectively controlled by treatment or untreated, except those who have been treated and whose symptoms are stable, and who discontinue glucocorticoid and anticonvulsant therapy ≥4 weeks prior to preconditioning.\n4. There is currently clinically significant ascites, which are defined as ascites with positive signs of ascites in physical examination or requiring intervention treatment (only those who show ascites on imaging without intervention can be included).\n5. The proportion of liver occupied by tumor ≥50%, or ICG-R15≥30%.\n6. Organ transplantation, hematopoietic stem cell transplantation history;\n7. Other serious medical conditions that may limit participants' participation in the study, including but not limited to:\n\n   * Poorly controlled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg after medication).\n   * Poorly controlled diabetes: Fasting blood glucose levels remained above 11.1mmol\u002FL after standard insulin treatment.\n   * Unstable cardiovascular and cerebrovascular diseases: uncontrolled congestive heart failure, myocardial infarction or unstable arrhythmia or unstable angina within the last 6 months, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; Cerebrovascular accident, transient ischemic attack, cerebral embolism, deep vein thrombosis, etc.\n   * Poorly controlled respiratory diseases: pulmonary embolism, chronic obstructive pulmonary disease, interstitial lung disease, etc.\n   * Active autoimmune diseases requiring systemic treatment during the study: Subjects with eczema, vitiligo, psoriasis, alopecia, or Grave's disease that will not require systemic treatment within the next 2 years, other autoimmune diseases that are not expected to recur, and type 1 diabetes requiring insulin replacement therapy only were enrolled.\n   * Have an active infection or active tuberculosis infection that requires systemic treatment.\n   * Mental illness, other than mild depression.\n8. HIV positive, or treponema pallidum antibody positive; Patients with active hepatitis B or C; Active hepatitis B is defined as hepatitis B core antibody (HBcAb) or Hepatitis B surface antigen (HBsAg) positive with HBV-DNA \\\u003C 2000 IU\u002Fml. HBsAg positive patients must receive antiviral treatment according to the \"Chronic Hepatitis B Prevention and Treatment Guidelines 2019\"; Active hepatitis C was defined as HCV RNA higher than the lower limit of detection.\n9. Use of any immunosuppressive drugs, such as corticosteroids, in the 4 weeks prior to the tumor tissue sampling, or the presence of co-existing diseases that the investigator determined required the use of immunosuppressive drugs during the trial. However, the use of physiological doses of corticosteroids (i.e., no more than 15mg\u002F day of prednisone or equivalent doses of other corticosteroids) is permitted, and the use of corticosteroids for inhalation, intranasal, topical or prophylactic use of contrast media allergies is permitted.\n10. Anti-tumor therapy was received before pretreatment, including anti-PD-1 \u002F PD-L1 monoclonal antibodies, targeted drugs, chemotherapy, surgery, etc., and the last administration\u002Ftreatment distance from pretreatment was less than 2 weeks. Or the above treatment-related adverse events, CTCAE classification does not return to grade 1 or stable.\n11. Those who have received live vaccine within 3 months prior to screening or plan to receive live vaccine during the trial.\n12. Those who had undergone major surgery within 4 weeks prior to screening or required elective surgery during the trial period (except TIL sampling).\n13. Patients who had surgical complications or delayed wound healing prior to pretreatment and were judged by the investigators to be at increased risk of eluviation, TIL therapy, IL-2 adjuvant therapy, or infection.\n14. diagnosed with other primary malignancies within 5 years prior to screening, excluding radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For radical resection of carcinoma in situ.\n15. Known alcohol, drug, or substance abuse, and other subjects deemed unsuitable for participation in the study.\n\n    \\-",{"count":86,"type":20},6,[23],"This is an open, single-arm, investigator-initiated Phase I clinical trial to evaluate the safety, tolerability, and initial efficacy of BST02 injection in patients with locally advanced \u002F metastatic liver cancer. This study includes a dose escalation study and a dose extension study, which will observe the effects of different IL-2 injection doses on the safety and efficacy of BST02.\n\nAfter signing the informed consent, the subjects will roughly go through two periods: the main study period and the long-term follow-up period. The main study period includes screening period, treatment and safety observation period, and follow-up period",[90],"Locally Advanced\u002FMetastatic Liver Cancer","2023-12-14",{"date":93,"type":31},"2023-12-18",{"date":95,"type":20},"2023-12-05",{"date":97,"type":20},"2026-12-05",{"name":37,"class":38},{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":78},"100527822","early-phase-1-bgt007h-cells-for-the-treatment-of-recurrentrefractory-gastrointestinal-tumors-100527822","NCT06152757","BGT007H Cells for the Treatment of Recurrent\u002FRefractory Gastrointestinal Tumors","Clinical Study on the Safety and Preliminary Efficacy of BGT007H Cell Therapy in Patients With Recurrent\u002FRefractory Gastrointestinal Tumors","Inclusion Criteria:\n\n* 1\\. Resources sign written informed consent;\n* 2, age ≥18, male and female can;\n* 3\\. Expected survival ≥3 months;\n* 4\\. The Eastern Cancer Collaboration (ECOG) physical status score was 0-1;\n* 5\\. Biopsy specimen or pathological wax section test (within 3 years before accepting the signed informed consent) : positive target test;\n* 6\\. According to RECISTv1.1 solid tumor evaluation criteria, there is at least one measurable lesion;\n* 7\\. Patients with advanced gastrointestinal tumors (esophageal cancer, gastric cancer, pancreatic cancer or colorectal cancer, etc.) who have been diagnosed by histology\u002Fcytology as having failed the standard of second-line or above treatment or are not suitable for\u002Frefuse to accept the standard treatment or cannot tolerate the standard treatment; The definition of intolerance: according to CTCAE V5.0, the occurrence of ≥Ⅳ hematological toxicity or ≥Ⅲ non-hematological toxicity or ≥Ⅱ damage to the heart, liver, kidney and other important organs during treatment; Treatment failure is defined as disease progression (PD) during treatment or recurrence after the end of treatment (including postoperative recurrence);\n* 8, can establish monopexy or venous blood collection venous access, and there are no other contraindications for blood cell separation;\n* 9, with adequate organ and bone marrow function;\n* 10\\. During the study period and for 6 months after the end of dosing, fertile subjects (both male and female) must use effective medical contraception. For female subjects of reproductive age, a pregnancy test should be performed within 72 hours before the first dose, and the result is negative.\n\nExclusion Criteria:\n\n* 1\\. Active central nervous system metastasis (except stable after treatment);\n* 2, HIV positive, HBsAg positive simultaneously detected HBV DNA copy number positive (quantitative detection ≥1000cps\u002Fml), HCV antibody positive and HCV RNA positive;\n* 3, mental or mental illness can not cooperate with treatment and efficacy evaluation;\n* 4\\. Subjects with severe autoimmune diseases and long-term use of immunosuppressants;\n* 5\\. Active or uncontrollable infection requiring systemic treatment within 14 days prior to enrollment;\n* 6\\. Any unstable systemic disease (including but not limited to: Active infections (except local infections); Unstable angina pectoris Cerebral ischemia or cerebrovascular accident (within 6 months prior to screening) Myocardial infarction (within 6 months prior to screening) Congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥Ⅲ; Severe arrhythmias requiring medical treatment; Have heart disease that requires treatment or uncontrolled hypertension after treatment (blood pressure \\> 160mmHg\u002F100mmHg);\n* 7, combined with lung, brain, kidney and other important organ dysfunction;\n* 8\\. The subject has undergone major surgery or severe trauma within 4 weeks prior to receiving cell therapy, or is expected to undergo major surgery during the study period;\n* 9\\. Received any systemic chemotherapy, immunotherapy or small molecule targeted therapy within 1-2 weeks or 5 half-lives (whichever is shorter) before anapheresis;\n* 10\\. The subject currently has or has had other malignant tumors that cannot be cured within 3 years, except cervical cancer or basal cell carcinoma of the skin, and other malignant tumors with a disease-free survival of more than 5 years;\n* 11, received chimeric antigen receptor modified T cells (including CAR-T, CTT-T) treatment within half a year;\n* 12\\. Combined graft-versus-host disease (GVHD)\n* 13\\. Subjects who were receiving systemic steroid therapy prior to screening and who were determined by the investigator to require long-term use of systemic steroid therapy during treatment (except for inhalation or topical use); And subjects treated with systemic steroids within 72 hours prior to cell transfusion (except for inhalation or topical use);\n* 14\\. Severe allergy or history of allergy;\n* 15\\. Subjects requiring anticoagulation therapy;\n* 16, pregnant or breastfeeding women, or six months within the pregnancy plan (unisex;\n* 17\\. Researchers believe that there are other reasons for not being included in the treatment.",{"count":107,"type":20},14,[23],"This study is an exploratory single-arm, open, modified \"3+3\" dose escalation study with BGT007H injection. Approximately 11 to 14 subjects with recurrent\u002Frefractory gastrointestinal tumors will be enrolled to evaluate the safety of BGT007H injection.\n\nFour dose levels were designed for this study: 1.0×10\\^8cells, 3.0×10\\^8cells, 1.0×10\\^9cells, and 3.0×10\\^9cells. The primary objective of this study was to evaluate the safety, tolerability and pharmacokinetic profile of BGT007H cell therapy in patients with recurrent\u002Frefractory digestive tract tumors, to determine the maximum tolerated dose or the best effective dose, and to initially evaluate the effectiveness of BGT007H cell products.",[111],"Gastrointestinal Tumors","RECRUITING","2023-11-22",{"date":115,"type":31},"2023-12-01",{"date":117,"type":31},"2023-10-09",{"date":119,"type":20},"2027-07-19",{"name":37,"class":38},""]