[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing Geekgene Technology Co., LTD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":165},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,63,88,107,132],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100644763","early-phase-1-a-clinical-study-gk01-cell-injection-in-subjects-with-advanced-lung-cancer-100644763",false,"NCT07673419","A Clinical Study GK01 Cell Injection in Subjects With Advanced Lung Cancer","A Single-Arm Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Participants With Advanced Lung Cancer","Inclusion Criteria:\n\n* Ability to understand and sign a written informed consent document.\n* At the date of signing ICF, 18 \\~75 years old, male or female.\n* Histologically or cytologically confirmed recurrent, or metastatic advanced lung cancer, progressed on standard treatment, or intolerant to standard treatment.\n* At least one measurable lesion that has not been irradiated or received other local therapies.\n* At least one measurable lesion remains (RECIST 1.1 criteria).\n* ECOG 0-1 points.\n* Expected survival time more than 3 months.\n* Adequate hematologic and organ function.\n* No absolute or relative contraindications to surgery, bronchoscopy, or percutaneous procedures.\n\nExclusion Criteria:\n\n* History of severe allergy, or hypersensitivity to any component of the drugs used in this study, including but not limited to lymphodepleting chemotherapy drugs, contrast agents for radiological examinations, and excipients of GK01 (such as dimethyl sulfoxide).\n* Any investigational drug or systemic anti-tumor therapy within 28 days prior to the start of lymphodepleting chemotherapy preconditioning, or within 5 half-lives of the previous drug.\n* Major surgery within 28 days prior to signing the ICF, or planned during the study period.\n* Toxicities from previous anti-tumor therapies have not recovered to ≤ Grade 1 or baseline level (according to NCI-CTCAE version 5.0) at the time of signing the ICF, with the exception of alopecia and hyperpigmentation.\n* Any uncontrolled active infection requiring parenteral antibiotic, antiviral, or antifungal therapy within 4 weeks prior to signing the ICF or before the first infusion.\n* History of or current active autoimmune disease that has the potential to recur (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or subjects at such risk.\n* Prior history of bone marrow or organ transplantation.\n* Concurrent or prior history of interstitial lung disease or interstitial pneumonia.\n* History of active tuberculosis infection within 1 year prior to screening (subjects with a history of active tuberculosis infection more than 1 year ago may be enrolled if the investigator confirms there is no current evidence of active tuberculosis).\n* History of other primary malignancies within 5 years prior to the initiation of the study treatment.\n* Clinically significant cardiovascular disease.\n* History of bleeding within 6 months prior to signing the ICF.\n* Metabolic disorders, such as diabetes mellitus (with glycated hemoglobin \\[HbA1c\\] ≥8.5%), or other non-malignant organ or systemic diseases, or secondary reactions to cancer that may lead to high medical risk and\u002For uncertainty in survival assessment.\n* Central nervous system (CNS) metastases, leptomeningeal disease, or metastatic spinal cord compression; or a history of CNS disorders.\n* Live\u002Fattenuated or inactivated vaccine within 28 days prior to signing the ICF, or planned administration of a live\u002Fattenuated or inactivated vaccine during the screening period.\n* Systemic corticosteroid therapy (at a dose equivalent to or greater than 10 mg\u002Fday of prednisone) or other immunosuppressive medications within 14 days prior to tissue acquisition or during the study period.\n* Hepatitis B surface antigen (HBsAg) positivity; With negative HBsAg positive hepatitis B core antibody (HBcAb) ,and if peripheral blood hepatitis B virus (HBV) DNA positive; Hepatitis C virus (HCV) antibody positive and HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Both Treponema pallidum-specific and non-specific antibody tests are positive.\n* Female subjects who are pregnant or breastfeeding.","ALL","18 Years","75 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","A Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Participants with Advanced Lung Cancer",[27],"Advanced Lung Cancer",[29,27],"GK01 Cell Injection","NOT_YET_RECRUITING","2026-06-23",{"date":33,"type":34},"2026-06-29","ACTUAL",{"date":36,"type":21},"2026-07",{"date":38,"type":21},"2028-07",{"name":40,"class":41},"Beijing Geekgene Technology Co., LTD","INDUSTRY",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":42},"100624671","early-phase-1-a-clinical-study-gk01-cell-injection-in-subjects-with-advanced-solid-tumors-100624671","NCT07412665","A Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors.","A Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Subjects With Advanced Solid Tumors.","Inclusion Criteria:\n\n* Ability to understand and sign a written informed consent document.\n* At the date of signing ICF, 18 \\~70 years old, male or female.\n* Histologically or cytologically confirmed advanced solid tumors, progressed on standard treatment, or intolerant to standard treatment, or without standard treatment; locally recurrent disease must be unsuitable for radical surgical resection or radiotherapy.\n* At least one measurable lesion that has not been irradiated or received other local therapies.\n* At least one measurable lesion remains (RECIST 1.1 criteria).\n* ECOG 0-1 points.\n* Expected survival time more than 3 months.\n* Adequate hematologic and organ function.\n* No absolute or relative contraindications to surgery, bronchoscopy, or percutaneous procedures.\n\nExclusion Criteria:\n\n* History of severe allergy, or hypersensitivity to any component of the drugs used in this study, including but not limited to lymphodepleting chemotherapy drugs, contrast agents for radiological examinations, and excipients of GK01 (such as dimethyl sulfoxide).\n* Any investigational drug or systemic anti-tumor therapy within 28 days prior to the start of lymphodepleting chemotherapy preconditioning, or within 5 half-lives of the previous drug.\n* Extensive field radiotherapy within 28 days prior to ICF signing, exception of local radiotherapy for symptomatic palliation of non-target lesions.\n* Major surgery within 28 days prior to signing the ICF, or planned during the study period.\n* Toxicities from previous anti-tumor therapies have not recovered to ≤ Grade 1 or baseline level (according to NCI-CTCAE version 5.0) at the time of signing the ICF, with the exception of alopecia and hyperpigmentation.\n* Any uncontrolled active infection requiring parenteral antibiotic, antiviral, or antifungal therapy within 4 weeks prior to signing the ICF or before the first infusion.\n* History of or current active autoimmune disease that has the potential to recur (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or subjects at such risk.\n* Prior history of bone marrow or organ transplantation.\n* Concurrent or prior history of interstitial lung disease or interstitial pneumonia.\n* History of active tuberculosis infection within 1 year prior to screening (subjects with a history of active tuberculosis infection more than 1 year ago may be enrolled if the investigator confirms there is no current evidence of active tuberculosis).\n* History of other primary malignancies within 5 years prior to the initiation of the study treatment.\n* Clinically significant cardiovascular disease.\n* History of bleeding within 6 months prior to signing the ICF.\n* Metabolic disorders, such as diabetes mellitus (with glycated hemoglobin \\[HbA1c\\] ≥8.5%), or other non-malignant organ or systemic diseases, or secondary reactions to cancer that may lead to high medical risk and\u002For uncertainty in survival assessment.\n* Central nervous system (CNS) metastases, leptomeningeal disease, or metastatic spinal cord compression; or a history of CNS disorders.\n* Live\u002Fattenuated or inactivated vaccine within 28 days prior to signing the ICF, or planned administration of a live\u002Fattenuated or inactivated vaccine during the screening period.\n* Systemic corticosteroid therapy (at a dose equivalent to or greater than 10 mg\u002Fday of prednisone) or other immunosuppressive medications within 14 days prior to tissue acquisition or during the study period.\n* Hepatitis B surface antigen (HBsAg) positivity; With negative HBsAg positive hepatitis B core antibody (HBcAb) ,and if peripheral blood hepatitis B virus (HBV) DNA positive; Hepatitis C virus (HCV) antibody positive and HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Both Treponema pallidum-specific and non-specific antibody tests are positive.\n* Female subjects who are pregnant or breastfeeding.","70 Years",{"count":20,"type":21},[24],"This study is an open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors.",[55],"Advanced Solid Tumors",{"date":57,"type":34},"2026-06-25",{"date":59,"type":21},"2026-06",{"date":61,"type":21},"2028-03-31",{"name":40,"class":41},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":74,"conditions":75,"keywords":76,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100630026","phase-1-a-clinical-study-gk01-injection-in-subjects-with-advanced-malignant-solid-tumors-100630026","NCT07482319","A Clinical Study GK01 Injection in Subjects With Advanced Malignant Solid Tumors","A Phase I, Open-label, Single-arm Clinical Study of GK01 Cell Injection in Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Understanding and voluntarily signing the Informed Consent Form (ICF) prior to any study-related assessments\u002Fprocedures;\n2. Aged 18 to 70 years old (inclusive) at the time of signing the ICF;\n3. Patients with histologically or cytologically confirmed advanced solid tumors (including but not limited to advanced gastric cancer, non-small cell lung cancer, etc.), who have progressed upon the standard of care (SoC), do not tolerate the SoC, or have no SoC;\n4. At least one resectable tumor lesion that has not been treated with radiation therapy or other topical therapy, and tissue blocks with the total sum of diameter of resected lesions being 1.5-4 cm or weighing ≥ 1.0 g (sourced from a single lesion or multiple lesions) are available for preparation of autologous tumor-infiltrating lymphocytes;\n5. At least 1 measurable lesion (as per RECIST1.1 criteria) even after biopsy for tumor tissue sampling;\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at the time of signing the ICF;\n7. Estimated life expectancy\\> 3 months;\n8. Adequate hematological and organ reserve functions;\n9. Men of reproductive potential and women of child-bearing potential must agree to use effective contraception from the signing of ICF utill 2 years after the end of study treatment. Women of childbearing potential include pre-menopausal women and those within 2 years after menopause. Women of childbearing potential must have negative serum pregnancy test results at screening.\n10. No absolute or relative contraindications to surgery;\n11. Any therapy for malignant tumors, including radiotherapy, chemotherapy, endocrine therapy, targeted therapy, tumor embolization, or traditional Chinese medicine\u002Fherbal therapy with antitumor indications, must be discontinued 14 days prior to tumor tissue sampling;\n12. Volunteering to sign the written ICF, having good compliance, and being able to follow the protocol-specified visits or unscheduled visits and other relevant study procedures.\n\nExclusion Criteria:\n\n1. History of serious allergy, or hypersensitivity to any ingredients of the drug to be used in this study, including but not limited to lymphodepleting agents (nab-paclitaxel, cyclophosphamide, fludarabine), contrast agents for imaging examination, contrast media, and GK01 excipients (e.g., dimethyl sulfoxide, etc.);\n2. Use of any investigational drug or systemic anti-tumor therapy (except lymphodepleting conditioning regimen) within 28 days (or 5 half-lives of the drug, whichever is more appropriate at the discretion of the investigator) prior to reinfusion;\n3. Participation in any clinical trial of biological therapy (except for cell therapy that has been fully metabolized) within 28 days prior to the signing of ICF;\n4. Use of extensive radiotherapy within 28 days prior to the signing of ICF, with the exception of topical radiotherapy to non-target lesion(s) that has been administered within 14 days prior to the signing of ICF or is expected to be administered during the study for symptom relief;\n5. Major surgery within 28 days prior to the signing of ICF, or planned major surgery during the study period;\n6. Toxicities caused by previous anti-tumor therapy, except for alopecia and pigmentation, have not resolved to grade 1 or baseline level (as per NCI-CTCAE Version 6.0) at the time of signing ICF;\n7. Any uncontrolled active infection requiring parenteral antibiotic, antiviral, or antifungal treatment at the time of signing the ICF or within 4 weeks prior to the first reinfusion;\n8. Subjects with active autoimmune disorders, or history of autoimmune disorders that may relapse (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or at risk of such diseases;\n9. A history of previous bone marrow or organ transplantation;\n10. Concomitant or history of interstitial lung disease or interstitial pneumonia;\n11. History of active pulmonary tuberculosis within 1 year before screening (excluding subjects with a history of active pulmonary tuberculosis infection more than 1 year ago, who have no evidence of active pulmonary tuberculosis as determined by the investigators at present);\n12. History of other primary malignancy within 5 years prior to study treatment\n13. Clinically significant cardiovascular diseases; significant, obvious risk or tendency of bleeding (any grade ≥ 3 bleeding or hemorrhage events within 28 days prior to screening, including esophageal variceal bleeding);\n\n15\\) Metabolic disorders, such as poorly controlled diabetes mellitus (HbA1c ≥ 8.5%) or other non-malignant organ or systemic diseases or secondary reactions to cancer, which may lead to a higher medical risk and\u002For uncertainty in survival evaluation; 16) Central nervous system (CNS) metastases, leptomeningeal disease, or metastatic CNS compression; or history of CNS diseases, including but not limited to epilepsy, paralysis, aphasia, stroke, serious brain injury, dementia, Parkinson's disease, etc.; 17) Immunization with attenuated\u002Finactivated vaccine within 28 days prior to the signing of ICF, or planning to receive immunization with attenuated\u002Finactivated vaccine during the screening period; 18) Subjects who need to receive systemic corticosteroids at a dose equivalent to or higher than 10 mg\u002Fday of prednisone or other immunosuppressive drugs within 14 days before tumor tissue sampling or during the study period； 19) At screening, subjects who are tested positive for hepatitis B surface antigen (HBsAg) should be excluded; if HBsAg is negative but hepatitis B core antibody (HBcAb) is positive, subjects with hepatitis B virus (HBV) DNA above the lower limit of detection in peripheral blood should be excluded; subjects with positive hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody positive, or both Treponema pallidum-specific and unspecific antibodies positive should also be excluded; 20) Pregnant or lactating women; 21) Presence of complications or other conditions that, in the investigator's opinion, could compromise compliance with the protocol or make the subject otherwise unsuitable for the study.",{"count":71,"type":21},15,[73],"PHASE1","An Open-label, Single-arm, Phase I Clinical Study of GK01 Cell Injection in the Treatment of Patients with Advanced Malignant Solid Tumors",[55],[77,29,78],"solid tumors","dose escalation","2026-03-19",{"date":81,"type":34},"2026-03-23",{"date":83,"type":21},"2026-04",{"date":85,"type":21},"2028-04",{"name":40,"class":41},1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":48,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":87},"100624798","early-phase-1-a-single-arm-open-label-clinical-study-gk01-cell-injection-in-subjects-with-advanced-solid-tumors-100624798","NCT07414316","A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors.","Inclusion Criteria:\n\n* Ability to understand and sign a written informed consent document.\n* At the date of signing ICF, 18 \\~75 years old, male or female.\n* Advanced lung cancer or esophageal squamous cell carcinoma confirmed by cytology or histopathology, failed or intolerant to standard therapy.\n* At least one measurable lesion that has not been irradiated or received other local therapies.\n* At least one measurable lesion remains (RECIST 1.1 criteria).\n* ECOG 0-1 points.\n* Expected survival time more than 3 months.\n* Adequate hematologic and organ function.\n* No absolute or relative contraindications to surgery, bronchoscopy, or percutaneous procedures.\n\nExclusion Criteria:\n\n* History of severe allergy, or hypersensitivity to any component of the drugs used in this study, including but not limited to lymphodepleting chemotherapy drugs, contrast agents for radiological examinations, and excipients of GK01 (such as dimethyl sulfoxide).\n* Any investigational drug or systemic anti-tumor therapy within 28 days prior to the start of lymphodepleting chemotherapy preconditioning, or within 5 half-lives of the previous drug.\n* Major surgery within 28 days prior to signing the ICF, or planned during the study period.\n* Toxicities from previous anti-tumor therapies have not recovered to ≤ Grade 1 or baseline level (according to NCI-CTCAE version 5.0) at the time of signing the ICF, with the exception of alopecia and hyperpigmentation.\n* Any uncontrolled active infection requiring parenteral antibiotic, antiviral, or antifungal therapy within 4 weeks prior to signing the ICF or before the first infusion.\n* History of or current active autoimmune disease that has the potential to recur (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc.), or subjects at such risk.\n* Prior history of bone marrow or organ transplantation.\n* Concurrent or prior history of interstitial lung disease or interstitial pneumonia.\n* History of active tuberculosis infection within 1 year prior to screening (subjects with a history of active tuberculosis infection more than 1 year ago may be enrolled if the investigator confirms there is no current evidence of active tuberculosis).\n* History of other primary malignancies within 5 years prior to the initiation of the study treatment.\n* Clinically significant cardiovascular disease.\n* History of bleeding within 6 months prior to signing the ICF.\n* Metabolic disorders, such as diabetes mellitus (with glycated hemoglobin \\[HbA1c\\] ≥8.5%), or other non-malignant organ or systemic diseases, or secondary reactions to cancer that may lead to high medical risk and\u002For uncertainty in survival assessment.\n* Central nervous system (CNS) metastases, leptomeningeal disease, or metastatic spinal cord compression; or a history of CNS disorders.\n* Live\u002Fattenuated or inactivated vaccine within 28 days prior to signing the ICF, or planned administration of a live\u002Fattenuated or inactivated vaccine during the screening period.\n* Systemic corticosteroid therapy (at a dose equivalent to or greater than 10 mg\u002Fday of prednisone) or other immunosuppressive medications within 14 days prior to tissue acquisition or during the study period.\n* Hepatitis B surface antigen (HBsAg) positivity; With negative HBsAg positive hepatitis B core antibody (HBcAb) ,and if peripheral blood hepatitis B virus (HBV) DNA positive; Hepatitis C virus (HCV) antibody positive and HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Both Treponema pallidum-specific and non-specific antibody tests are positive.\n* Female subjects who are pregnant or breastfeeding.",{"count":20,"type":21},[24],"A Single-Center, Open-Label Clinical Study to Evaluate the Safety, Preliminary Efficacy of GK01 Cell Injection in Subjects with Advanced Solid Tumors Refractory or Intolerant to Standard Therapy",[55],"RECRUITING","2026-02-10",{"date":101,"type":34},"2026-02-17",{"date":103,"type":21},"2026-02-13",{"date":105,"type":21},"2028-02-12",{"name":40,"class":41},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":87},"100622039","early-phase-1-a-clinical-study-of-gk02-in-malignant-ascites-100622039","NCT07378436","A Clinical Study of GK02 in Malignant Ascites","A Single-Arm, Single-Center, Open-Label Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Autologous Tumor-Reactive T Cells(GK02) Derived From Malignant Ascites Caused by Advanced Solid Tumors","Inclusion Criteria:\n\n1. Ability to understand and sign a written informed consent document；\n2. At the date of signing ICF, 18 \\~75 years old, male or female；\n3. Patients with advanced solid tumors confirmed by histology or pathology to have failed at least second-line treatment (treatment failure is defined as progression after treatment or intolerance after treatment), including but not limited to gastric cancer, colorectal cancer, pancreatic cancer, ovarian cancer, etc.；\n4. Pathological diagnosis or clinical diagnosis of malignant ascites, and the researcher determines that treatment for malignant ascites is necessary; During screening, the ascites volume was confirmed to be above the medium level by ultrasound (the maximum depth of ascites in the supine position was ≥3.0cm, and the total volume was ≥500ml);\n5. ECOG 0-2 points;\n6. Adequate organ functions;\n7. There are no absolute or relative contraindications for puncture；\n8. No peritoneal treatment for malignant ascites has been carried out within 14 days prior to the collection of malignant ascites;\n9. Female of childbearing age who have a negative urine pregnancy test during the screening period and agree to take effective contraceptive measures for at least 6 months after perfusion; Male subjects whose partners are fertile must agree to use effective contraceptive methods and avoid sperm donation for at least six months after perfusion.\n\nExclusion Criteria:\n\n1. Those with a history of severe allergies or allergic reactions to any components of the drugs to be used in this study, including but not limited to NMA-LD drugs, contrast agents and contrast agents used in imaging examinations, excipients such as dimethyl sulfoxide (DMSO) and antibiotics in cell products;\n2. Central nervous system (CNS) metastasis is present;\n3. Toxicity from previous antitumor therapy did not return to grade 1 or baseline levels (CTCAE version 5.0);\n4. Accompanied or prior to interstitial lung disease or interstitial pneumonia;\n5. Uncontrolled metabolic disorders, such as those in patients with diabetes (glycated hemoglobin ≥8.5%), or secondary reactions to other non-malignant organ or systemic diseases or cancer, which can lead to higher medical risks and\u002For uncertainties in survival assessment;\n6. An autoimmune disease that is active or has previously suffered from and is likely to recur;\n7. Uncontrolled comorbidities include but are not limited to uncontrolled hypertension (systolic blood pressure ≥160mmHg and\u002For diastolic blood pressure ≥100mmHg) or any unstable cardiovascular and cerebrovascular diseases that occurred within 6 months prior to treatment enrollment;\n8. Ultrasound indicates the separation of peritoneal effusion;\n9. Patients with intestinal obstruction;\n10. Patients with comorbidities or active autoimmune diseases that require the use of glucocorticoids or other immunosuppressive drugs during the trial period, excluding local transdermal absorption of glucocorticoids (i.e., no more than 5mg\u002F day of prednisone or equivalent doses of other glucocorticoids);\n11. Women who are pregnant or breastfeeding.",{"count":115,"type":21},9,[24],"A single-arm, single-center, open-label clinical study comprising three cohorts, evaluating the safety, preliminary efficacy, and pharmacokinetic\u002F pharmacodynamic (PK\u002FPD) characteristics of autologous tumor-reactive T cells (GK02) derived from malignant ascites caused by advanced solid tumors.\n\nThe trial initially plans to enroll 9 subjects with malignant ascites caused by advanced solid tumors.",[119],"Malignant Ascites Caused by Advanced Solid Tumors",[121,122,123],"Advanced solid tumor","Malignant ascites","Gastric cancer","2026-01-27",{"date":126,"type":34},"2026-01-30",{"date":128,"type":34},"2025-09-16",{"date":130,"type":21},"2027-12-17",{"name":40,"class":41},{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":140,"targetDuration":141,"studyType":142,"phases":4,"briefSummary":143,"conditions":144,"keywords":150,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":87},"100549214","a-single-arm-single-center-open-clinical-study-100549214","NCT06431100","a Single-arm, Single-center, Open Clinical Study","Clinical Study on the Safety and Efficacy of GK01 Autologous Tumor-reactive T Cells (TRT) in Patients With Advanced Solid Tumors","GK-01","Inclusion Criteria:\n\n* Participants who meet all of the following criteria are eligible for admission to the study:\n\n  1. 18≤ age ≤75 years old, male or female;\n  2. Patients with incurable advanced gastric cancer, esophageal cancer, cervical cancer, triple-negative breast cancer, non-small cell lung cancer, and other malignancies who have failed standard treatment (standard treatment failure is defined as those treated according to the 2022 CSCO Guidelines and whose tumor efficacy is assessed as disease progression (PD) or tumor recurrence or inability to tolerate existing treatment options);\n  3. There are tumor tissues or cancerous exudative thoracoabdominal fluid that can be used to isolate TRTs: the total volume of the solid tissue taken must be \\> 0.5cm3 or the weight must be \\>0.5g, the cancerous exudative thoracoabdominal fluid taken should contain at least 5×10\\^8 total cells, and the lesions taken have not been treated with oncolytic virus.\n  4. There is at least one measurable lesion (according to RECIST1.1 criteria) even after TRTs sampling\u002Fpuncture biopsy;\n  5. ECOG score 0-1;\n  6. The expected survival period is greater than 3 months;\n  7. Sufficient hematology and end-organ function, as defined by the following laboratory test results, should be completed within 14 days prior to TRTs tumor tissue collection:\n\n     1. Blood routine: white blood cell count ≥2.5×10\\^9\u002FL; Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; Absolute lymphocyte count (ALC) ≥1.0×10\\^9\u002FL; Platelet (PLT) ≥80×10\\^9\u002FL; Hemoglobin (HGB) ≥90g\u002FL;\n     2. Coagulation function: International standardized ratio of prothrombin time (INR) ≤1.5×ULN; Partial prothrombin time (APTT) ≤1.5×ULN, unless anticoagulant therapy has been received within the previous 7 days;\n     3. Renal function: serum creatinine ≤1.5mg\u002FdL (or 132.6μmol\u002FL) or creatinine clearance ≥60mL\u002F min;\n     4. Liver function: aspartate aminotransferase (AST\u002FSGOT) ≤3×ULN; Alanine transaminase (ALT\u002FSGPT) ≤3×ULN; Total bilirubin (TBIL) ≤1.5×ULN; Note: In patients with liver metastasis or primary liver tumor, aspartate and alanine aminotransferase should be ≤5×ULN; For patients with a history of Gilbert syndrome or suspected Gilbert syndrome, total bilirubin (TBIL) should be ≤3×ULN;\n     5. Urine routine: urinary protein \\<2+, or 24-hour urinary protein quantity \\<1g;\n     6. Left ventricular ejection fraction (LVEF) ≥50% by echocardiography;\n     7. Pulmonary function tests with FEV1\\>60% or FEV1\u002FFVC\\>0.7;\n     8. Blood oxygen saturation ≥ 93%.\n  8. Women of childbearing age who have a negative urine pregnancy test during screening and baseline and agree to use highly effective contraception for at least 1 year after the infusion; Male subjects whose partners are fertile must agree to use effective contraceptive methods and refrain from sperm donation for at least 1 year after the infusion;\n  9. No absolute or relative contraindications to surgery or puncture;\n  10. Any treatment for malignant tumors, including radiotherapy, chemotherapy, endocrine therapy, targeted therapy, tumor embolization, or Chinese medicine\u002Fherbal therapy with anti-tumor indications, must be discontinued 7 days before TRT sampling;\n  11. Sign a written informed consent (ICF) voluntarily, and have good compliance with the protocol requirements for visits or planned visits and other relevant research procedures.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following criteria will not be eligible to participate in this clinical trial:\n\n  1. Prior allergy to cyclophosphamide, fludarabine and interleukin-2 contraindications or to any component of the infusion product formulation or to other drugs to be used during the study (antibiotics, human serum albumin, dextran 40, etc.);\n  2. Any NCI CTCAE5.0 immune-related adverse reaction (irAE) grade \\>3 that has been permanently discontinued during any previous immunotherapy;\n  3. Patients with prior primary immunodeficiency and active autoimmune disease;\n  4. Previous history of organ allotransplantation, allogeneic stem cell transplantation and kidney replacement therapy;\n  5. Patients with current or past irreversible interstitial lung disease (except those caused by radiotherapy);\n  6. Combined with 2 or more malignant tumors; (Except for the following cases: malignant tumors that have been cured, such as non-melanoma skin cancer and in situ cervical cancer, bladder cancer, breast cancer, thyroid cancer, etc. that have survived more than 5 years without disease.)\n  7. Uncontrolled co-morbidity includes, but is not limited to, uncontrolled hypertension (systolic blood pressure ≥160mmHg and\u002For diastolic blood pressure ≥100mmHg) even after standard treatment, or any unstable cardiovascular and cerebrovascular disease, including transient ischemic attack, cerebrovascular accident, myocardial infarction, and unstable angina pectoral, that has occurred in the 6 months prior to treatment induction; Congestive heart failure rated III or IV by the New York Heart Association (NYHA); Ejection fraction \\< 50%; Severe heart rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block, etc. Electrocardiogram results show clinically significant abnormalities, or QTcF≥450ms (if the first examination is abnormal, the interval of at least 5 minutes, retest twice, using the comprehensive result\u002Faverage value to judge eligibility);\n  8. Patients with esophageal or gastric varices that require immediate intervention (such as ligation or sclerotherapy) or are considered by the investigator or gastroenterologist or hepatologist to be at high risk of bleeding, have evidence of portal hypertension (including splenomegalysis on imaging), or have a history of varicose bleeding must undergo endoscopic evaluation within 3 months prior to enrollment;\n  9. Uncontrolled metabolic disorders, such as in patients with diabetes, or other non-malignant organ or systemic disease or cancer secondary reactions that can lead to higher medical risk and\u002For uncertainty in the evaluation of survival;\n  10. Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade C or more severe cirrhosis, liver failure;\n  11. Clinically uncontrollable third space effusion, such as pleural fluid and ascites that could not be controlled by drainage or other methods before enrollment;\n  12. Combined with other serious organic disease or mental illness;\n  13. Patients with central nervous system metastasis;\n  14. Uncontrolled systemic active infection;\n  15. Receive vaccination within 2 months before signing the informed consent, or plan to receive vaccination during the study;\n  16. Currently or within 30 days before signing the informed consent to participate in clinical trials of other drugs or biotherapeutics, except cell therapy that has been fully metabolized;\n  17. have used within 4 weeks prior to the treatment, or have concomitant disease or active autoimmune disease that the investigator determined required the use of glucocorticoids or other immunosuppressive drugs during the trial period, excluding local percutaneous absorption of glucocorticoids (i.e., no more than 5 mg\u002F day of prednisone or equivalent doses of other glucocorticoids);\n  18. Surgical treatment, interventional therapy, radiotherapy, chemotherapy and immunotherapy for the studied disease were performed within 2 weeks before the treatment;\n  19. HIV positive, serological test positive for syphilis, or clinically active hepatitis B or C, including carriers of the virus (for hepatitis B, HBsAg positive persons should be excluded; For hepatitis C, HCVAB-positive patients need to be excluded);\n  20. Women who are breastfeeding during pregnancy or lactation;\n  21. Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan;\n  22. Other conditions deemed unsuitable for participation in this experiment by the researcher.",{"count":20,"type":21},"36 Months","OBSERVATIONAL","This trial plans to enroll many patients with advanced solid tumors to complete GK01 cell transfusion, including but not limited to advanced gastric cancer, esophageal cancer, cervical cancer, triple-negative breast cancer, and non-small cell lung cancer. For patients with advanced solid tumors eligible for inclusion, autologous tumor-reactive T cells (experimental drug GK01) were cultured and prepared, and a certain dose of GK01 cells was given according to the cell transfusion plan, and the safety and tolerability of the patients after transfusion were observed. Exploratory evaluation of pharmacokinetic\u002Fpharmacodynamic profiles following reinfusion and initial evaluation of efficacy of investigational drug GK01 cells according to RECIST 1.1 criteria.",[145,146,147,148,149],"Gastric Cancer","Esophageal Cancer","Cervical Cancer","Non-Small Cell Lung Cancer NSCLC","Triple Negative Breast Cancer TNBC",[151,152,153,154,155,156],"TRT","cell therapy","advanced tumor","safety","efficiency","adverse event","2024-05-24",{"date":159,"type":34},"2024-05-28",{"date":161,"type":34},"2023-07-19",{"date":163,"type":21},"2026-11-19",{"name":40,"class":41},""]