[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kras-g12v\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kras-g12v":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,92,144,178,203],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":59,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100499720","phase-1-phase-12-trial-of-s241656-in-selected-rasmapk-mutation--positive-malignancies-100499720",false,"NCT05786924","Phase 1\u002F2 Trial of S241656 in Selected RAS\u002FMAPK Mutation- Positive Malignancies","A Phase 1\u002F2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With KRAS, BRAF and Other Selected RAS\u002FMAPK Mutation-Positive Malignancies","Key Inclusion Criteria:\n\n* Life expectancy of ≥ 12 weeks in the opinion of the investigator.\n* Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations.\n* Adequate bone marrow and organ function.\n* Recovered from toxicity to prior anti-cancer therapy.\n\nPart 1 Dose Escalation cohort ONLY:\n\n* Part 1A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations\n* Part 1B: Advanced\u002Fmetastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1C: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1E: Other advanced\u002Fmetastatic non-GI, non-NSCLC solid tumors with KRAS, HRAS, NRAS, BRAF, CRAF (RAF1) mutations or alterations\n\nPart 2 Dose Optimization and Expansion cohorts ONLY:\n\n* Part 2A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations and\u002For BRAF mutations\n* Part 2A1: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations\n* Part 2A2: Advanced\u002Fmetastatic NSCLC with BRAF mutations\n* Part 2A3: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease\n* Part 2A4: Advanced\u002Fmetastatic NSCLC with a KRAS G12C mutation\n* Part 2B1: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B2: Advanced\u002Fmetastatic CRC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B3: Advanced\u002Fmetastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n\nKey Exclusion Criteria:\n\n* Cancer that has a known MEK1\u002F2 mutation.\n* Known allergy\u002Fhypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.\n* Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.\n* Major surgery within 4 weeks of study entry or planned during study.\n* Ongoing anticancer therapy.\n* Ongoing radiation therapy.\n* Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy.\n* Clinically significant cardiovascular disease.\n* Symptomatic spinal cord compression.\n* Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.\n* Females who are pregnant or breastfeeding.\n* Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.\n* Prior use of experimental agents that target the KRAS\u002FBRAF\u002FMEK\u002FERK pathway.","ALL","18 Years",{"count":19,"type":20},554,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","BDTX-4933-101 is a first-in-human, open-label, Phase 1\u002F2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer therapies in participants with selected advanced malignancies. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced\u002Fmetastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (Rapidly Accelerated Fibrosarcoma (RAF1)) mutations or alterations. A dose optimization part in adults with NSCLC may follow the dose escalation phase if the sponsor, in consultation with the safety review committee, decides it is necessary to further characterize the optimal dose. However, the study may also proceed directly to the expansion phase. The study population for the Dose Expansion part of the study comprises adults with advanced\u002Fmetastatic NSCLC with KRAS and\u002For BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations and alterations. All patients will self-administer S241656 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58],"Non-small Cell Lung Cancer","Histiocytic Neoplasm","Histiocytosis","BRAF Gene Mutation","BRAF V600E","BRAF V600 Mutation","BRAF Mutation-Related Tumors","BRAF","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Lung Cancer","Recurrent Lung Cancer","Recurrent Lung Non-Small Cell Carcinoma","NSCLC","Solid Tumor","Solid Carcinoma","KRAS G12D","KRAS G12V","KRAS Mutation-Related Tumors","NRAS Gene Mutation","Thyroid Cancer","Thyroid Carcinoma","Colorectal Cancer","Colorectal Carcinoma","Recurrent Histiocytic and Dendritic Cell Neoplasm","Brain Metastases","Recurrent NSCLC","KRAS G13C","Acquired Resistance to KRAS G12C Inhibitor","KRAS G12A","KRAS G12F","KRAS G12R","KRAS G13D",[60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78],"BRAF Class I","BRAF Class II","BRAF Class III","KRAS","Intolerant histiocytic neoplasm","BDTX-4933","Phase 1","dose escalation","dose expansion","MAPK","mitogen-activated protein kinase","RAS","RAF","Upstream oncogenic alterations","RAF inhibitor","intracranial disease","CRAF","NRAS","RAF fusions","RECRUITING","2026-06-16",{"date":82,"type":83},"2026-06-17","ACTUAL",{"date":85,"type":83},"2023-04-18",{"date":87,"type":20},"2028-06",{"name":89,"class":90},"Institut de Recherches Internationales Servier","OTHER",27,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":114,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":143},"100586569","phase-1-bbo-11818-in-adult-subjects-with-kras-mutant-cancer-100586569","NCT06917079","BBO-11818 in Adult Subjects With KRAS Mutant Cancer","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers","Inclusion Criteria:\n\n* Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation\n* Measurable disease by RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Life expectancy \\>24 weeks\n* Adequate organ function\n\nExclusion Criteria:\n\n* Malignancy within the last 2 years as specified in the protocol\n* Untreated brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol.",{"count":100,"type":20},665,[23],"A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.",[104,39,105,106,107,108,55,109,42,110,43,111,112,113],"Non-Small Cell Lung Cancer","PDAC - Pancreatic Ductal Adenocarcinoma","CRC (Colorectal Cancer)","Metastatic Non-Small Lung Cell Cancer","Metastatic Colorectal Cancer (CRC)","KRAS G12C","KRAS G12S","Metastatic Pancreatic Ductal Adenocarcinoma","Advanced Lung Carcinoma","Solid Tumor, Adult",[115,116,117,118,39,119,120,121,122,123,124,125,126,127,128,129,130,131,132],"BBOT","BridgeBio Oncology Therapeutics","Phase1","Phase 1a\u002F1b","CRC","PDAC","Metastatic Cancer","Advanced Cancer","Pembrolizumab","Cetuximab","Platinum Chemotherapy","Pemetrexed","KONQUER","KONQUER-101","mFOLFOX6","mFOLFIRINOX","Gemcitabine","Nab-paclitaxel","2026-05-29",{"date":135,"type":83},"2026-06-02",{"date":137,"type":83},"2025-03-31",{"date":139,"type":20},"2029-09",{"name":141,"class":142},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)","INDUSTRY",17,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":152,"phases":4,"briefSummary":153,"conditions":154,"keywords":163,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":176,"locationsCount":4},"100599360","expanded-access-protocol-of-eli-002-102-in-subjects-with-krasnras-mutated-pancreatic-ductal-adenocarcinoma-100599360","NCT07083479","Expanded Access Protocol of ELI-002-102 in Subjects With KRAS\u002FNRAS Mutated Pancreatic Ductal Adenocarcinoma","Expanded Access Protocol for ELI-002 7P Immunotherapy as Treatment for Subjects With Kirsten Rat Sarcoma (KRAS)\u002FNeuroblastoma RAS Viral Oncogene Homolog (NRAS) Mutated Pancreatic Ductal Adenocarcinoma (PDAC)","AMPLIFY-EAP","Inclusion Criteria:\n\n* Has at least 1 of the 7 KRAS\u002FNRAS mutated alleles (G12D, G12R, G12V, G12A, G12C, G12S, G13D)\n* The following must be met: (1) the patient has no alternative therapy to diagnose, monitor, or treat the disease or condition; (2) enrollment in a clinical trial is not possible; and (3) the potential benefit to the patient justifies the potential risks of treatment.\n* Screening CT scan negative for recurrent disease\n* Eastern Cooperative Oncology Group performance status of 0 or 1\n\nExclusion Criteria:\n\n* Use of immunosuppressive drugs\n* Known brain metastases","EXPANDED_ACCESS","This is an open-label expanded access protocol (EAP) of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide \\[Amph-CpG-7909\\] plus a mixture of lipid-conjugated peptide-based antigens \\[Amph-Peptides 7P\\]) as adjuvant treatment in patients with KRAS\u002FNRAS-mutated pancreatic ductal adenocarcinoma who are at high risk for relapse (ie, presence of isolated tumor cells in a patient whose primary tumor has been removed and is currently without clinical signs of disease). This protocol builds on the experience being obtained with ELI-002 7P (with Amph-Peptides G12D, G12R, G12V, G12A, G12C, G12S, G13D), which is being studied in protocol ELI-002-201.",[155,42,43,110,55,109,57,58,156,157,158,159,160,161,162],"Pancreatic Ductal Adenocarcinoma","NRAS G12D","NRAS G12V","NRAS G12S","NRAS G12A","NRAS G12C","NRAS G12R","NRAS G13D",[164,165,166,167,168,169,170,171],"Pancreatic ductal adenocarcinoma (PDAC)","Kirsten rat sarcoma (KRAS)","Neuroblastoma ras viral oncogene homolog (NRAS)","Adjuvant therapy","Immunotherapy","Vaccine therapy","Expanded access","Expandd access protocol (EAP)","AVAILABLE","2026-05-18",{"date":175,"type":83},"2026-05-19",{"name":177,"class":142},"Elicio Therapeutics",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":21,"phases":188,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":192,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"100619293","early-phase-1-tcr-t-cell-therapy-for-kras-mutation-in-advanced-solid-tumors-100619293","NCT07342738","TCR-T Cell Therapy for KRAS Mutation in Advanced Solid Tumors","A Cliniacl Study of T Cell Receptor-engineered T-Cell (TCR-T) Injection in Patients With Advanced Solid Tumors Induced by Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutations.","Inclusion Criteria:\n\n1. Voluntary signing of an informed consent form (ICF)；\n2. Males or females, aged 18-70 years (inclusive);\n3. Subjects with advanced solid tumors confirmed by histology\u002Fcytology, have failed with standard treatment, or intolerant to standard treatment, or no standard treatment exists：1）Colorectal cancer：failed or intolerant to at least two lines of standard treatment.2）Non-small cell lung cancer：Absence of the following gene mutations (Epidermal Growth Factor Receptor\\[EGFR\\]、Anaplastic Lymphoma Kinase\\[ALK\\] 、 Proto-oncogene tyrosine-protein kinase 1\\[ROS1\\]) and having failed or intolerant to platinum-based chemotherapy and\u002For immunotherapy and\u002For anti-angiogenic therapy.3）Other advanced solid tumors：failed with standard treatment, or intolerant to standard treatment, or no standard treatment exist.\n4. At least one measurable lesion (according to Response Evaluation Criteria in Solid Tumors\\[RECIST\\], version 1.1);\n5. Patients with tumor tissue or peripheral blood testing positive for KRAS-G12V or G12D mutations and expression of matching HLA-A\\*11:01 or HLA-C\\*01:02 subtypes;\n6. ECOG (Eastern Cooperative Oncology Group)≤2;\n7. Life expectancy ≥3 months;\n8. Adequate functional reserve of organs：1）Hematology (no intensive blood transfusion, platelet transfusion or cell growth factor performed within 14 days before the test)：·Absolute neutrophil count ≥1×10E9\u002FL;·Platelet count ≥50×10E9\u002FL, hemoglobin\\>90g\u002FL;·Absolute lymphocyte count ≥0.5×10E9\u002FL;2）Blood chemistry：·Alanine aminotransferase (ALT) ≤3×Upper Limit of Normal (ULN);·Aspartate aminotransferase (AST) ≤3×ULN（patients with hepatic metastasis, ALT and AST ≤5×ULN）;·Serum creatinine ≤1.5×ULN or Creatinine clearance ≥50 mL\u002Fmin;·Total bilirubin (TB) ≤1.5×ULN；3）Blood chemistry：·APTT≤1.5×ULN，INR≤1.5×ULN4）The subject has left ventricular ejection fraction (LVEF) ≥ 50% and no clinically significant pericardial effusion diagnosed by echocardiography;5）No clinically significant electrocardiographic abnormality;6）Basic oxygen saturation is \\>92% under the indoor natural air environment.\n9. Women of childbearing age must be negative for blood HCG (Human Chorionic Gonadotropin) pregnancy test (by immunofluorescence method) at screening and baseline periods, and agree to use effective contraception for at least 1 year after infusion; and male subjects whose partners are women of childbearing age must agree to use effective barrier contraception methods and avoid sperm donation for at least 1 year after infusion.\n\nExclusion Criteria:\n\n1. Other malignancies (except non-melanoma skin cancer with the disease-free survival of more than 5 years and cervical carcinoma in situ, bladder cancer, or breast cancer);\n2. History of organ transplantation；\n3. A history of mental disorders, which may affect compliance with this protocol or lead to failure in signing the ICF;\n4. A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis and systemic lupus erythematosus) requiring systemic immunosuppressive\u002Fsystemic disease-modulating drugs；\n5. Poorly controlled hypertension with drug (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg) or occurrence of grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stent placement, unstable angina pectoris, or other clinically significant heart diseases within one year prior to signing the ICF; Corrected QT Interval (QTc) interval \\>450 ms for males or QTc interval \\>470 ms for females during screening (QTc interval calculated using the Fridericia formula)；\n6. Patients with intestinal obstruction or obstructive jaundice and are deemed ineligible for enrollment by the investigator；\n7. Symptomatic intracranial metastases, or moderate to severe ascites or pleural effusion requiring drainage to relieve symptoms；\n8. A history of or any central nervous system disorders, such as epileptic seizure, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system within the past 6 months；\n9. A positive result obtained in any of the following virological tests:1）Antibody to human immunodeficiency virus (HIV antibody); 2）Hepatitis C virus antibody (HCV antibody), with a positive result for hepatitis C virus ribonucleic acid (HCV RNA); 3）Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) copies ≥2000 IU\u002FmL; 4）Treponema pallidum antibody (TP antibody) and positive for unheated serum reagin test;\n10. Fungal, bacterial, viral or other infections or suspected fungal, bacterial, viral or other infections that cannot be controlled or require intravenous administration；\n11. Significant tendency for bleeding, such as active gastrointestinal bleeding, coagulation disorders；\n12. Deep vein thrombosis requiring treatment within the past 6 months, unless the risk of thrombosis is acceptable after treatment, as assessed by the investigator；\n13. Interstitial lung disease (such as interstitial pneumonia, pulmonary fibrosis), or a history of clinically significant respiratory system diseases at screening；\n14. Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 2 weeks prior to leukapheresis；\n15. Participation in any other clinical studies within 1 month prior to signing the master informed consent form；\n16. Patients with poor compliance due to physiological, family, social, geographic and other factors, and failure to follow the study protocol and the follow-up plan；\n17. Patients with contraindications to drugs used in the study；\n18. Comorbidities requiring treatment with systemic corticosteroids (dexamethasone at a dose of ≥ 5 mg\u002Fday or other corticosteroids at the equivalent dose) or other immunosuppressive drugs after initiation of the study treatment, as judged by the investigator；\n19. Women who are breastfeeding and are unwilling to stop breastfeeding；\n20. Any other conditions that are, in the opinion of the investigator, not suitable for enrollment.","75 Years",{"count":187,"type":20},25,[189],"EARLY_PHASE1","This is a single-arm, Multicenter, open-label clinical study aimed at evaluating the safety and efficacy of TCR-T injection in patients with advanced solid tumors induced by KRAS mutations.",[43,42,40],"NOT_YET_RECRUITING","2026-01-14",{"date":195,"type":83},"2026-01-15",{"date":197,"type":20},"2026-02-01",{"date":199,"type":20},"2029-02-01",{"name":201,"class":90},"Sun Yat-sen University",1,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":185,"enrollmentInfo":210,"targetDuration":4,"studyType":21,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":192,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":202},"100557983","phase-1-re001-t-cell-injection-for-the-treatment-of-kras-g12v-mutated-solid-tumors-100557983","NCT06545201","RE001 T Cell Injection for the Treatment of KRAS G12V Mutated Solid Tumors","RE001 T Cell Injection for the Treatment of KRAS G12V Mutated Solid Tumors, an Open-label Single-center Phase I Clinical Trial","Inclusion Criteria:\n\n1. Subjects voluntarily participate in the study and sign informed consent;\n2. Age ≥18 years old and ≤75 years old;\n3. Advanced malignant solid tumors with clear pathological diagnosis;\n4. Standard therapies failed or cannot be tolerated or lacks effective treatments;\n5. Have at least one measurable lesion;\n6. During the trial screening period, the following two indicators must be met (the sponsor is responsible):\n\n   HLA-A\\* 11:01 positive; Tumor gene testing carries KRAS G12V mutation;\n7. ECOG score 0-1 and expected survival time greater than 6 months;\n8. Cardiac color ultrasound shows left ventricular ejection fraction ≥50%;\n9. Laboratory examination results should meet the following specified indicators:\n\n   White blood cell count ≧ 3.0×109\u002FL;\n   1. Absolute neutrophil count ≧ 1.5×109\u002FL (without G-CSF and GM-CSF support, enter at least 14 days before group);\n   2. Absolute lymphocyte count ≧ 0.5×109\u002FL;\n   3. Platelets (PLT) ≧ 75×109\u002FL (no blood transfusion treatment in the first 14 days);\n   4. Hemoglobin ≧ 100g\u002FL (no blood transfusion treatment in the first 14 days);\n   5. Prothrombin time international normalized ratio INR ≦ 1.5×upper limit of normal time, unless anticoagulant therapy was received;\n   6. Partial prothrombin time (APTT) ≦ 1.5×upper limit of normal time, unless receiving antibiotics coagulation therapy;\n   7. Serum creatinine ≦ 1.5mg\u002FdL (or 132.6μmol\u002FL);\n   8. Aspartate aminotransferase (AST\u002FSGOT) ≦ 2.5×ULN;\n   9. Alanine aminotransferase (ALT\u002FSGPT) ≦ 2.5×ULN;\n   10. Total bilirubin (TBIL) ≦ 1.5×ULN;\n   11. In patients with liver metastasis, aspartate aminotransferase and alanine aminotransferase need to be ≦ 5×ULN.\n10. Women of childbearing age who have not undergone sterilization before menopause must agree to use effective contraception within at least 12 months from the beginning of the study to T cell infusion, and the serum pregnancy test is negative within 14 days before the first treatment;\n11. Men who have not undergone sterilization must agree to use effective contraception from the beginning of the study to at least 12 months after T cell infusion;\n12. During the entire trial period, you can regularly visit the participating research institutions for relevant testing, evaluation and management.\n\nExclusion Criteria:\n\n1. Those who have received major surgery, conventional chemotherapy, large-area radiotherapy, immunotherapy or biological therapy anti-tumor treatment within 4 weeks before entering the trial;\n2. Previous use of drugs targeting KRAS G12V mutations, including previous participation in cell therapy with similar targets Cellular testing and small molecule inhibitors targeting KRAS G12V mutations, etc.;\n3. Allergic reactions are known to occur to any ingredient (such as dimethyl sulfoxide, cyclophosphamide, fludarabine) or structurally similar compounds treated in this trial;\n4. Failure to recover from adverse reactions related to previous surgery or treatment to \\\u003C Grade 2 CTCAEV5.0;\n5. Hypertension that remains uncontrolled after combined treatment with 2 drugs or clinically significant (such as active) Cardiovascular and cerebrovascular diseases, such as cerebrovascular accident (within 6 months before signing the informed consent form), myocardial infarction (within 6 months before signing the informed consent form), unstable angina, congestive heart failure classified as class II or above by the New York Heart Association, or severe arrhythmia that cannot be controlled with medication or has a potential impact on study treatment; the electrocardiogram showed obvious abnormality or average QTc interval ≧ 450ms for 3 consecutive times (at least 5 minutes interval);\n6. Combined with other serious organic diseases and mental disorders;\n7. Suffering from systemic active infections requiring treatment, including but not limited to active tuberculosis, known HIV positive patients or patients with clinically active hepatitis A, B, or C include virus carriers;\n8. Have a history of inflammatory bowel disease and autoimmune diseases judged by the researcher to be unsuitable for this study (such as systemic lupus erythematosus, vasculitis, etc.);\n9. Those who plan to use the following drugs within 4 weeks before cell therapy and during the study: long-term systemic use steroid hormones, hydroxyurea, immunomodulatory drugs (such as interleukin 2, alpha or gamma interferon, GM-CSF, mTOR inhibitors, cyclosporins, thymosin, etc.);\n10. People with brain metastasis:\n\n    1. Symptomatic brain metastasis should be ruled out. Patients with a previous history of symptomatic brain metastasis and stable symptoms after local treatment were enrolled in the group who did not need antiepileptic drugs and steroids at least 14 days before lymphocyte clearance.\n    2. Subjects with asymptomatic brain metastasis without tumor-related brain edema, displacement, steroids or antiepileptic drugs can be enrolled.\n    3. Subjects with meningitis or meningeal metastasis need to be excluded.\n11. People with bleeding or thromboembolism tendency:\n\n    1. Have clinically significant bleeding symptoms or obvious bleeding tendency within 2 weeks before the study;\n    2. Have inherited or acquired bleeding and thrombosis tendencies;\n    3. A serious arterial\u002Fvenous thromboembolic event within the past 6 months.\n12. Suffering from massive pericardial effusion or symptomatic thoracic or abdominal effusion;\n13. Have received live attenuated vaccines within 4 weeks before cell infusion, or plan to receive this type of vaccine during the study;\n14. History of organ allogeneic transplantation, allogeneic stem cell transplantation and renal replacement therapy;\n15. Uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure;\n16. Known alcohol and\u002For drug abusers;\n17. Pregnant or breastfeeding women;\n18. Have any coexisting medical conditions or diseases that the researcher determines may impair the conduct of this trial subjects;\n19. No legal capacity\u002Frestricted capacity;\n20. Have previously received any gene or cell therapy products.",{"count":211,"type":20},30,[23],"At present, there is an urgent need for new drugs for kirsten rat sarcoma viral oncogene (KRAS) mutant tumors in clinic. Preclinical studies support the specificity, safety and anti-tumor activity of RE001. Previous similar studies suggest the feasibility of T cell receptor engineered T cell therapy (TCR-T) treatment, and measures have been taken to ensure the safe administration of RE001 and the close monitoring and management of adverse events. To sum up, RE001 has controllable safety and anti-tumor activity on KRAS mutant solid tumor, which can be preliminarily studied to provide support for clinical research of patients with advanced solid tumor.",[43,215],"T Cell Therapy","2024-08-06",{"date":218,"type":83},"2024-08-09",{"date":220,"type":20},"2024-08-01",{"date":222,"type":20},"2027-04-01",{"name":224,"class":225},"Henan Cancer Hospital","OTHER_GOV"]