[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colorectal-cancer-locally-advanced-or-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colorectal-cancer-locally-advanced-or-metastatic":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,68,92,147],{"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":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100646391","phase-1-a-study-testing-sot109-for-the-first-time-in-patients-to-assess-how-safe-sot109-is-how-well-it-works-and-how-the-body-handles-it-in-patients-with-advanced-colorectal-cancer-that-can-not-be-removed-by-surgery-or-is-metastatic-100646391",false,"NCT07693751","A Study to Assess Safety and Efficacy of SOT109 in Patients With Advanced Unresectable or Metastatic Colorectal Cancer","A First-in-human Phase 1\u002F2 Trial to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of SOT109 in Patients With Advanced Unresectable or Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. ≥18 years of age on the day of signing the ICF\n2. Able to understand, sign, and provide written informed consent to participate in the trial\n3. Performance status: Eastern Cooperative Oncology Group (ECOG) performance score 0-1. Patients with ECOG performance score 2 will be discussed with the sponsor's medical monitor to be agreed for inclusion\n4. Estimated life expectancy ≥3 months as assessed by the investigator\n5. An appropriate candidate for experimental therapy as assessed by the investigator\n6. Agrees not to participate in other interventional clinical trial while enrolled in the present trial (with the exception of survival follow-up period)\n7. Absolute neutrophil count ≥1.5×109\u002FL, platelets ≥100×109\u002FL, hemoglobin ≥9 g\u002FdL\n8. Creatinine clearance ≥60 mL\u002Fmin calculated by Cockcroft-Gault formula\n9. Bilirubin ≤1.5× upper limits of normal (ULN), ALT and AST ≤2.5×ULN; in case of liver involvement: AST and ALT ≤5×ULN\n\n   • Participants with a documented history of Gilbert syndrome may be eligible if:\n   * Total bilirubin is ≤2.0 × ULN,\n   * Direct (conjugated) bilirubin is within normal limits (≤ULN), and\n   * There is no evidence of active liver disease, clinically significant hepatic impairment, hemolysis, or biliary obstruction, as determined by the investigator\n10. Prothrombin time\u002Finternational normalized ratio ≤1.5×ULN\n11. Albumin ≥3.0 mg\u002FdL\n12. Serum concentrations of potassium, magnesium, and calcium with abnormalities of maximum grade 1 that should be treated according to standard practice\n13. Left ventricular ejection fraction (LVEF) ≥50% as determined by echocardiography or nuclear medicine methodology (MUGA)\n14. QTcF interval ≤470 msec on screening ECG\n15. Histological or cytological evidence of advanced unresectable or metastatic colorectal cancer\n16. Participants that received and progressed on standard systemic therapies (fluoropyrimidines, oxaliplatin, irinotecan, bevacizumab, and, only when locally indicated and available, a BRAF\u002FRAS\u002FHER2 inhibitor) and who have no further standard treatment options. Participants with a known microsatellite instability-high (MSI-H) status must have received treatment with an immune checkpoint inhibitor (if locally indicated and available) unless contraindicated\n17. Measurable or non-measurable disease according to RECIST 1.1\n18. Previous cancer therapies:\n\n    18.1. Europe: previous cancer therapies and any agents that have not received regulatory approval for any indication must have been discontinued either ≥21 days prior to day 1 of cycle 1 or ≥5x half-life, whichever is longer; toxicities of earlier anticancer therapy must be grade ≤1 at the time of screening and prior to cycle 1 day 1 (exception: alopecia) 18.2. US: eligibility should be determined based on patient recovery from clinically significant adverse events from their most recent therapy or intervention prior to study enrollment\n19. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and one of the following conditions applies: 19.1. Not a woman of childbearing potential (WOCBP). A WOCBP is defined as fertile, following menarche, and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient.\n\n    19.2. A WOCBP who agrees to use a highly effective contraceptive method during the treatment period and for at least 6 months after the last dose of SOT109\n    * WOCBP can only be included after a negative serum pregnancy test at screening\n    * Highly effective contraception includes:\n\n      * Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation:\n\n        * Oral\n        * Intravaginal\n        * Transdermal\n      * Progestogen-only hormonal contraception associated with inhibition of ovulation:\n\n        * Oral\n        * Injectable\n        * Implantable\n      * Intrauterine device\n      * Intrauterine hormone-releasing system\n      * Bilateral tubal occlusion\n      * Vasectomized partner provided the partner is the sole sexual partner of the WOCBP participant and that the vasectomized partner has received medical assessment of the surgical success\n      * Sexual abstinence defined as refraining from heterosexual intercourse during the entire treatment period and for at least 6 months after the last dose of SOT109. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.\n20. Male participants must agree to use a condom during the treatment period and for at least 6 months after the last dose of SOT109. Male participants wishing to become a father during or after the trial should consider sperm preservation. WOCBP partners of male participants should use highly effective contraception methods for 6 months after SOT109 discontinuation.\n\nExclusion Criteria:\n\n1. Received radiation therapy ≤14 days before day 1 of cycle 1 or not recovered to grade ≤1 from treatment-related side effects\n2. Any prior systemic therapy for metastatic cancer other than colorectal cancer; exception:\n\n   stable disease under hormonal treatment for prostate cancer, stable disease under hormonal treatment for breast cancer; radiochemotherapy is allowed if such treatment is completed at least 4 weeks prior to day 1 of cycle 1; participants must have recovered to grade ≤1 from all side effects (exception: alopecia)\n3. Participants must not receive any concurrent antitumor therapy while participating in the trial. In exceptional circumstances where urgent palliative radiotherapy to symptomatic non-target lesions is clinically indicated, the case must be reviewed with the Principal Investigator (PI) and the intervention must receive prior approval from the sponsor\n4. Vaccination with a live or live-attenuated vaccine within 30 days prior to the first dose of trial interventions; the full series (e.g., both doses of a two dose vaccination series) should be completed prior to dosing if feasible\n5. Time since last transfusion of red blood cells ≤14 days before day 1 of cycle 1\n6. Severe preexisting medical conditions as per judgment of the investigator\n7. History of interstitial pneumonitis or pulmonary fibrosis\n8. Symptomatic central nervous system malignancy. Participants with asymptomatic or treated central nervous system metastases may be eligible if they are not treated with corticosteroids or anticonvulsants and the disease is stable for at least 60 days\n9. Peripheral sensory neuropathy grade ≥2\n10. Active infection requiring systemic therapy that is not clinically controlled before the signature of the ICF\n11. Known symptomatic HIV positive, symptomatic active HBV, or symptomatic active HCV\n\nNote:\n\n* Participants with HIV will be eligible if:\n\n  * CD4+ T-cell counts ≥350 cells\u002FμL\n  * They have no history of AIDS-defining opportunistic infections\n  * They are not currently on HIV therapy\n* Participants with HBV will be eligible if there is serologic evidence of a resolved prior HBV infection (HBsAg-negative and HBcAb-positive)\n* Participants with HCV will be eligible if they have completed curative antiviral treatment and have HCV viral load below the limit of quantification 12. Alcohol or drug abuse as determined by the investigator 13. Psychiatric condition or social situation that, in the opinion of the investigator, preclude that the participant is able to comply with trial requirements 14. New York Heart Association class ≥2 heart failure, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, myocardial infarction, cerebrovascular accident or hypertensive crisis within 6 months prior to day 1 of cycle 1 15. History of major ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, Torsades de Pointes) 16. History or family history of congenital long QT syndrome 17. Bradycardia (\\\u003C50 beats per minute) 18. Family history of sudden cardiac death before age 50 19. Major surgical intervention ≤28 days prior to ICF signature or incomplete wound healing after surgical intervention 20. Hypersensitivity or intolerance to any component of trial intervention 21. Medical history of inflammatory bowel disease or active inflammatory bowel disease (IBD)\n* Participants with signs or symptoms suggestive of IBD who have not undergone colonoscopy to rule out IBD will be excluded","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","SOT109 is a special cancer medicine designed to find and kill certain cancer cells that carry a marker called CDH17, while causing less harm to healthy cells. The study consists of two parts, Part A and Part B. The goal of Part A is to collect information about SOT109, understand its effects, and see whether it is safe and well tolerated at different dose levels. Part B of the study collects information on which of the two selected safe dose levels chosen in Part A gives the best balance between benefit and risk.",[27],"Colorectal Cancer (Locally Advanced or Metastatic)",[29],"Colorectal Cancer","NOT_YET_RECRUITING","2026-08-14",{"date":33,"type":34},"2026-08-18","ACTUAL",{"date":36,"type":20},"2026-08-29",{"date":38,"type":20},"2028-07-04",{"name":40,"class":41},"SOTIO Biotech a.s.","INDUSTRY",3,{"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":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100632108","phase-2-fmt-combined-with-standard-first-line-therapy-in-initially-unresectable-colorectal-cancer-100632108","NCT07509398","FMT Combined With Standard First-Line Therapy in Initially Unresectable Colorectal Cancer","Efficacy and Safety of Fecal Microbiota Transplantation Combined With First-Line Standard Therapy in Patients With Initially Unresectable Colorectal Cancer: A Multicenter, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n* (1) Subjects must volunteer to participate in this study, sign the informed consent form (ICF), and demonstrate good compliance.\n\n  (2) Patients aged 18 to 75 years (inclusive). (3) Meet the defined criteria for initially unresectable advanced metastatic colorectal cancer (mCRC) for this project.\n\n  (4) Have not received first-line standard therapy. (5) Prior radiotherapy is permitted, provided it was completed more than 4 weeks prior to enrollment.\n\n  (6) ECOG performance status of 0 to 1. (7) Life expectancy of ≥ 24 weeks. (8) Adequate major organ function meeting the following criteria (without the use of any blood components or cell growth factors within 2 weeks prior to enrollment): (9) Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL, white blood cell (WBC) count ≥ 4.0 × 10\\^9\u002FL, platelets ≥ 100 × 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL.\n\n  (10) Hepatic function: Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); if total bilirubin \\> 1.5 × ULN, direct bilirubin must be ≤ ULN. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (allowed up to 5 × ULN for patients with liver metastases).\n\n  (11) Renal function: Blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN (and creatinine clearance rate (CCr) ≥ 50 mL\u002Fmin).\n\n  (12) Cardiac function: Normal cardiac function with a left ventricular ejection fraction (LVEF) ≥ 50%.\n\n  (13) Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\n  (14) Male or female patients of childbearing potential must volunteer to use effective contraceptive methods (e.g., double-barrier methods, condoms, oral or injectable contraceptives, intrauterine devices) during the study and for 6 months after the last dose of study medication. All female patients are considered to be of childbearing potential unless they are naturally postmenopausal, artificially postmenopausal, or surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or pelvic irradiation). Otherwise, female patients must have a negative serum pregnancy test (within 7 days prior to study enrollment) and must not be lactating.\n\nExclusion Criteria:\n\n* (1) Presence of symptoms such as bleeding, perforation, or obstruction at the primary tumor site.\n\n  (2) Presence of secondary intracranial tumors (brain metastases). (3) History of severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc.\n\n  (4) Symptomatic interstitial lung disease, or active infectious\u002Fnon-infectious pneumonitis.\n\n  (5) Risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or other known risk factors for intestinal perforation.\n\n  (6) Patients who have undergone other surgeries must wait for complete wound healing before being considered for enrollment.\n\n  (7) History of other malignancies; except for cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, and carcinoma in situ of the prostate, cervix, or breast, which are permitted for enrollment.\n\n  (8) Patients planning to undergo or who have previously undergone organ transplantation or allogeneic bone marrow transplantation.\n\n  (9) Moderate to severe ascites with clinical symptoms requiring therapeutic paracentesis or drainage, or a Child-Pugh score \\> 2 (excluding cases with only a small amount of ascites shown on imaging without clinical symptoms); uncontrolled or moderate to large pleural or pericardial effusions.\n\n  (10) History of gastrointestinal bleeding within 6 months prior to the start of study treatment or a clear tendency for gastrointestinal bleeding, such as esophageal\u002Fgastric varices with bleeding risk or severe varices, localized active gastrointestinal ulcer lesions, or persistently positive fecal occult blood (if fecal occult blood is positive at baseline, it can be retested; if still positive, an esophagogastroduodenoscopy (EGD) is required. If EGD indicates esophageal\u002Fgastric varices with a risk of bleeding, the patient cannot be enrolled).\n\n  (11) Occurrence of an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to the start of study treatment.\n\n  (12) Patients who presented with signs\u002Fsymptoms of incomplete obstruction\u002Fobstructive syndrome\u002Fileus at initial diagnosis may be enrolled if the symptoms have completely resolved following definitive (surgical) treatment.\n\n  (13) Known hereditary or acquired bleeding disorders (e.g., coagulopathy) or thrombotic tendency, such as hemophilia; current or recent (within 10 days prior to study treatment) use of full-dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (prophylactic use of low-dose aspirin or low molecular weight heparin is allowed).\n\n  (14) Current or recent (within 10 days prior to study treatment) use of aspirin (\\> 325 mg\u002Fday, maximum antiplatelet dose), dipyridamole, ticlopidine, clopidogrel (≥ 75 mg), or cilostazol.\n\n  (15) Occurrence of thrombotic or embolic events within 6 months prior to the start of study treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.\n\n  (16) Active infection, heart failure, myocardial infarction within 6 months, unstable angina, or unstable arrhythmias.\n\n  (17) Lactating or pregnant women. (18) History of hepatic encephalopathy. (19) Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes (dose \\> 10 mg\u002Fday of prednisone or equivalent) within 14 days prior to the start of study treatment.\n\n  (20) Known severe allergic reaction to any monoclonal antibodies or anti-angiogenic targeted drugs.\n\n  (21) Any other factors that, in the judgment of the investigator, may affect the study results or lead to premature termination of the study, such as alcohol abuse, drug abuse, other severe diseases (including psychiatric disorders) requiring concomitant treatment, or severe laboratory abnormalities.","75 Years",{"count":52,"type":20},220,[24,54],"PHASE3","This clinical trial evaluates the efficacy and safety of adding fecal microbiota transplantation (FMT) to first-line standard of care for patients with initially unresectable colorectal cancer (CRC).\n\nFMT is an established procedure designed to restore intestinal microbiome homeostasis by transferring processed fecal microbiota from a rigorously screened healthy donor into the patient's gastrointestinal tract. The standard first-line treatment regimen typically consists of chemotherapy, with or without targeted therapy.\n\nApproximately 220 patients across 13 participating centers will be randomly assigned to receive either standard therapy alone or standard therapy combined with FMT. The primary endpoint is the objective response rate (ORR). Secondary endpoints include the conversion to resectability rate, progression-free survival (PFS), safety and adverse events, quality of life (QoL), anxiety and depression scales, as well as dynamic changes in the gut microbiome and circulating biomarkers.\n\nThe ultimate goal of this trial is to determine whether microbiome modulation via FMT can synergistically enhance the antitumor efficacy of standard first-line therapies and mitigate treatment-related toxicities in this patient population.",[57,27],"Unresectable Colorectal Cancer","2026-03-29",{"date":60,"type":34},"2026-04-03",{"date":62,"type":20},"2026-04",{"date":64,"type":20},"2031-12",{"name":66,"class":67},"Shanghai 10th People's Hospital","OTHER",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100627271","phase-4-folfox-chemotherapy-combined-with-fruquintinib-and-serplulimab-as-first-line-conversion-therapy-for-initially-unresectable-pmmrmss-colorectal-cancer-100627271","NCT07446465","FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR\u002FMSS Colorectal Cancer","Exploratory Clinical Study of FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR\u002FMSS Colorectal Cancer","Inclusion Criteria:\n\n* Age 18-75 years;\n* Histologically confirmed adenocarcinoma of colorectal cancer, initially unresectable locally advanced or metastatic\u002Frecurrent disease;\n* Expected survival ≥12 weeks;\n* No prior systemic antitumor therapy for colorectal cancer;\n* Confirmed pMMR by IHC or MSS\u002FMSI-L by PCR or NGS;\n* ECOG PS 0-1;\n* At least one measurable lesion per RECIST v1.1;\n* Adequate organ and bone marrow function;\n* Controlled viral hepatitis status as specified;\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Prior immune checkpoint inhibitor therapy;\n* CNS or leptomeningeal metastases;\n* Uncontrolled cardiovascular disease or hypertension;\n* Active autoimmune disease requiring systemic therapy;\n* Active infection including tuberculosis;\n* Recent major surgery;\n* Pregnancy or lactation;\n* Any condition deemed by investigators to compromise safety or study compliance.",{"count":76,"type":20},42,[78],"PHASE4","To evaluate the efficacy and safety of immune checkpoint inhibitor-based combination therapy with targeted therapy and chemotherapy in patients with locally advanced unresectable or metastatic colorectal cancer.",[27,81],"Colorectal Cancer Microsatellite Stable (MSS)","2026-02-28",{"date":84,"type":34},"2026-03-03",{"date":86,"type":20},"2026-03-01",{"date":88,"type":20},"2027-01-31",{"name":90,"class":67},"Ye Xu",1,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":105,"conditions":106,"keywords":119,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":91},"100624504","phase-1-biomarker-guided-allogeneic-single-target-or-dual-target-car-nk-cell-therapy-for-advanced-solid-tumors-100624504","NCT07410494","Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors","A Phase 1\u002F2, Open-Label, Biomarker-Driven Study of Allogeneic Donor-Derived CAR-NK Cells With Antigen Selection by Tissue Biopsy and\u002For Liquid Biopsy Profiling in Participants With Relapsed\u002FRefractory Advanced Solid Tumors (Single-Target vs Dual-Target Strategy)","SELECT-CAR-NK","Inclusion Criteria:\n\n* Age 18-75 years.\n* Histologically or cytologically confirmed advanced\u002Funresectable or metastatic solid tumor that is relapsed\u002Frefractory after standard therapy, or no standard therapy available.\n* Targetable antigen positivity from the protocol target menu based on:\n\ntissue biopsy and\u002For liquid biopsy platform (as defined in the lab manual).\n\n* Arm assignment rules :\n* Arm A: ≥1 antigen meets \"positive\" threshold\n* Arm B: ≥2 antigens meet \"positive\" threshold\n* ECOG performance status 0-1 (or 0-2 ).\n* At least one measurable lesion by RECIST 1.1.\n* Adequate organ function (hematologic, renal, hepatic, cardiac) within protocol-defined limits.\n* Willingness to undergo blood draws and required biopsies (when medically feasible).\n* Negative pregnancy test for participants of childbearing potential; agreement to effective contraception during and after study treatment.\n\nExclusion Criteria:\n\n* Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period .\n* Active, uncontrolled infection requiring IV antibiotics; known uncontrolled HIV; active HBV\u002FHCV with detectable viral load (per local policy).\n* Active CNS metastases requiring escalating steroids or urgent intervention (stable treated CNS disease may be allowed ).\n* Active autoimmune disease requiring systemic immunosuppression, or chronic systemic steroids above protocol threshold.\n* Clinically significant cardiovascular disease (e.g., recent MI, unstable arrhythmia), uncontrolled pulmonary disease, or other serious comorbidity that increases risk.\n* Major surgery or anticancer therapy too close to lymphodepletion (protocol-defined washout).\n* Pregnant or breastfeeding.","8 Years","85 Years",{"count":103,"type":20},85,[23,24],"This Phase 1\u002F2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and\u002For liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.",[107,108,109,27,110,111,112,113,114,115,116,117,118],"Cancer","Breast Cancer","Non-Small Cell Lung Cancer (NSCLC)","Prostate Cancer - Recurrent","Pancreatic Ductal Adenocarcinoma (PDAC)","Ovarian Cancer","Glioblastoma","Melanoma (Skin Cancer)","Acute Myeloid Leukemia (AML)","Non Hodgkin Lymphoma","Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma","Liver Cancer",[120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136],"CAR-NK","Solid tumor","Dual-target CAR","ctDNA","CAR-T","Breast cancer","Non-small cell lung cancer (NSCLC)","Colorectal cancer (CRC)","Prostate cancer","Pancreatic ductal adenocarcinoma (PDAC)","Ovarian, fallopian tube, and primary peritoneal cancers","Glioblastoma and other high-grade gliomas","Melanoma","Acute myeloid leukemia (AML)","Non-Hodgkin lymphoma (NHL), especially DLBCL and follicular lymphoma","Multiple myeloma (especially relapsed\u002Frefractory)","Liver cancer (hepatocellular carcinoma, HCC)","RECRUITING","2026-02-14",{"date":140,"type":34},"2026-02-18",{"date":142,"type":34},"2026-02-01",{"date":144,"type":20},"2028-12-28",{"name":146,"class":67},"Essen Biotech",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":157,"conditions":158,"keywords":163,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":4},"100612936","phase-1-immune-cell-therapy-for-advanced-solid-tumors-100612936","NCT07260058","Immune Cell Therapy for Advanced Solid Tumors","Clinical Study on the Safety and Efficacy of Autologous Immune Cell Therapy for Advanced Solid Tumors","Inclusion Criteria:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. The participant must voluntarily participate in the study and provide written informed consent。\n2. Age ≥ 18 years, male or female.\n3. Histologically and\u002For cytologically confirmed locally advanced or metastatic solid tumor: lung cancer, liver cancer, colorectal cancer, or breast cancer.\n4. ECOG (Eastern Cooperative Oncology Group) performance status score ≤ 2.\n5. Life expectancy ≥ 3 months.\n6. Has not received any other cellular immunotherapy within 3 months prior to enrollment.\n7. Has at least one measurable lesion according to RECIST (Response Evaluation Criteria in Solid Tumors) Version 1.1.\n8. Adequate organ function, defined as follows:\n\nHematology:\n\nWhite Blood Cell (WBC) count \\> 3.5 × 10⁹\u002FL Lymphocyte count \\> 0.9 × 10⁹\u002FL Monocyte count \\> 0.16 × 10⁹\u002FL Absolute Neutrophil Count (ANC) \\> 1.5 × 10⁹\u002FL Platelet (PLT) count \\> 75 × 10⁹\u002FL Hemoglobin (HB) \\> 75 g\u002FL Blood Biochemistry： Total bilirubin ≤ 1.5 × ULN (Upper Limit of Normal) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present)\n\nCoagulation:\n\nProthrombin Time (PT) and International Normalized Ratio (INR) ≤ 1.5 × ULN\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Prior receipt of any salvage chemotherapy, implanted intraperitoneal chemotherapy, targeted therapy, or biological immunotherapy (except: patients whose disease progressed more than 6 months after completing adjuvant, neoadjuvant, or radiosensitizing chemotherapy, or more than 1 month after intraperitoneal chemoperfusion\u002Fwash, are eligible, provided chemotherapy-related toxicities have recovered to Grade 1 or below, excluding alopecia).\n2. Major surgical procedure within 4 weeks prior to enrollment, with incomplete recovery from side effects.\n3. History of any active malignancy within 5 years, except for the specific cancer under investigation in this trial and cured localized tumors such as carcinoma in situ of the cervix, basal cell carcinoma of the skin, and prostate carcinoma in situ.\n4. Presence of more than a small amount of pericardial effusion, or uncontrolled pleural or peritoneal effusion, defined as: detectable by physical examination at screening, or requiring therapeutic paracentesis during the screening period.\n5. Inability to tolerate peripheral blood collection due to various reasons (e.g., severe coronary heart disease, inability to establish peripheral venous access).\n6. Severe cardiovascular disease, including uncontrolled hypertension, unstable angina, history of myocardial infarction within the past 6 months, congestive heart failure \\> NYHA (New York Heart Association) Class III, or severe arrhythmia.\n7. Active infection, unexplained fever ≥ 38.5°C within 7 days prior to medication, or baseline white blood cell count \\> 15×10⁹\u002FL; OR any severe acute or chronic infection requiring systemic antibacterial, antifungal, or antiviral therapy at screening (except for active hepatitis).\n8. Any active autoimmune disease or history of autoimmune diseases (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Patients with vitiligo; Patients with childhood asthma that has completely resolved in adulthood without any intervention are eligible; Asthma requiring bronchodilator medical intervention is excluded). Patients are eligible if: they have a history of autoimmune-related hypothyroidism and are on stable thyroid hormone replacement therapy; or have type I diabetes controlled by insulin therapy.\n9. History of drug allergy.\n10. Pregnant or lactating women; OR women of childbearing potential or men with pregnant partners who are unwilling to use adequate contraception during the planned trial period (from the screening visit until 120 days after the last study treatment).\n11. History of organ transplantation.\n12. Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.",{"count":155,"type":20},48,[23,24],"The autologous immune cell induction technology used in this project involves transforming peripheral blood mononuclear cells (PBMC) into autologous DC cells, NK cells, CIK cells and other immune cells through cytokine induction, and then re-administering them to the patients. This therapy utilizes biotechnology to culture the immune cells of cancer patients in vitro and then re-infuse them back into the body, stimulating and enhancing the body's own immune function, killing and inhibiting cancer cells, eliminating small and residual lesions, or achieving the goal of treating cancer by significantly inhibiting the proliferation of residual cancer cells.",[159,160,27,161,162],"Lung Cancer (Locally Advanced or Metastatic)","Liver Cancer (Locally Advanced or Metastatic)","Breast Cancer (Locally Advanced or Metastatic)","Advanced Solid Tumors",[162,164,165,166,167,168,169,170,171],"Metastatic Lung Cancer","Metastatic Liver Cancer","Metastatic Colorectal Cancer","Metastatic Breast Cancer","Autologous Immune Cell Therapy","Dendritic Cell Vaccine","CIK Cells","NK Cells","2025-11-20",{"date":174,"type":34},"2025-12-02",{"date":176,"type":20},"2025-12-01",{"date":178,"type":20},"2027-12-31",{"name":180,"class":41},"Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd."]