[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-cancer-locally-advanced\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-cancer-locally-advanced":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100612598","phase-1-a-fih-phase-iiia-trial-assessing-feasibility-of-administrations-of-til-based-immunotherapy-in-patients-with-metastatic-crc-and-pc-100612598",false,"NCT07255664","A FIH, Phase I\u002FIIa, Trial Assessing Feasibility of Administrations of TIL-based Immunotherapy in Patients With Metastatic CRC and PC","A FIH, Phase I\u002FIIa, Open-label Trial Assessing Safety, Tolerability, and Feasibility of Repeated Administrations of a Novel Autologous TIL-based Immunotherapy in Patients With Metastatic Colorectal or Prostate Cancer","ProbeTILity","Inclusion Criteria:\n\n* Patient (female or male) has signed informed consent according to ICH\u002FGCP and national\u002Flocal regulations prior to any trial-specific procedure.\n* Patient is 18 years or older at the time of signing the informed consent form.\n* Patient must live in an area where a hospital for care can be reached within a maximum of 50 km.\n* Patient has histological or cytological confirmation of:\n\n  * colorectal cancer, which is stage IV (any T \u002F any N \u002F M1), not amenable to curative surgery, OR\n  * prostate cancer, which is stage III locally advanced, not amenable to curative surgery (T3-4 \u002F N0 \u002F M0 or any T \u002F N1 \u002F M0), or stage IV metastatic (any T \u002F any N \u002F M1)\n* Patient has received all lines of therapy that\n\n  * are considered SOC for the patient's indication according to applicable European\u002Fnational professional society medical guidelines and local medical practice at time of enrollment\n  * are available via the national health insurance system and the patient is considered eligible for but led to insufficient response or were medically not justified or refused by the patient.\n* Patient has confirmed disease progression by radiologic imaging from the previous line of therapy.\n* Patient has sufficient amount of previously not irradiated tumor tissue in adequate quality for TIL harvest and expansion, i.e., either:\n\n  * Primary or metastatic lesion has been selected for surgery (e.g., to reduce tumor burden, pain relief), Or\n  * Patient has consented to surgery for the purpose of tissue harvesting for TIL expansion and is considered suitable to undergo surgery for this purpose. Note: Patients with a non-justifiable anesthesiologic and\u002For surgical risk, as determined by the investigator, should be excluded\n* Patient has a least one measurable or assessable lesion according to RECIST 1.1 remaining after tumor resection for CC-38 manufacturing has been performed.\n* Patient has ECOG performance status of 0 or 1.\n* Patient has a minimum life expectancy of 6 months in the opinion of the investigator from the time of consent date.\n* Patient has adequate bone marrow, hepatic and renal function in the opinion of the investigator:\n\n  1. Hemoglobin ≥ 9.0 g\u002FdL,\n  2. Absolute neutrophil count (ANC) ≥ 1.0 x 109 \u002FL,\n  3. Platelets ≥ 80 x 109 \u002FL,\n  4. Calculated creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula),\n  5. Serum bilirubin ≤ 1.5 x ULN (or ≤ 2.5 x ULN in the presence of documented Gilbert's Syndrome \\[unconjugated hyperbilirubinemia\\] or liver metastases),\n  6. AST\u002F ALT and alkaline phosphatase ≤ 2.5 x ULN (or ≤5 times ULN in the presence of bone and\u002For liver metastases), ALP ≤ 2.5 x ULN,\n  7. International normalized ration (INR) ≤ 1.5 or prothrombin time (PT) ≤ ULN + 4 seconds.\n* Female patients must be post-menopausal or use contraceptive methods with a failure rate of \\\u003C 1% 6 months after last administration of CC-38, whatever is later, to prevent pregnancy. Male patients with fertile female partners must be willing to use condoms with spermicide, and the fertile partner must use contraceptive methods with a failure rate of \\\u003C 1% for the same time period. Male patients must also refrain from donating sperm for the same time period.\n* Successful tumor tissue sampling by surgery, including presence of TILs in the tumor tissue in the pathological evaluation.\n* Successful TIL expansion defined as obtaining the final CC-38 drug product\n\nExclusion Criteria:\n\n* Patient as any of the following condition:\n\n  1. Congestive heart failure NYHA class III or IV,\n  2. myocardial infarction or coronary artery bypass graft within 6 months prior to enrollment,\n  3. history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration,\n  4. history of severe non-ischemic cardiomyopathy,\n  5. uncontrolled blood pressure as defined as systolic \\> 160 mmHg, diastolic \\> 100 mmHg within 3 months prior to enrollment,\n  6. left ventricular ejection fraction (LVEF) \\\u003C 45% as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan,\n  7. any other clinically significant cardiovascular events such as unstable angina, angioplasty, stroke, or transient ischemic attack (TIA) within less than 6 months before enrolment,\n  8. other conditions that the treating physicians believe may endanger the health of the patients by their participation in this clinical trial.\n* Patient has any of the following pulmonary conditions:\n\n  1. Forced expiratory volume in 1 second (FEV1)\\\u003C60%,\n  2. Active obstructive chronic pulmonary disease,\n  3. oxygen dependence as defined by a blood oxygen saturation that can only be maintained above 92% by oxygen inhalation (finger oxygen detection method),\n  4. other pulmonary conditions that increase the anesthesiologic risk.\n* Patient has a current or history of central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression,\n* Patient has ulcers in the upper GI tract, untreated or incompletely treated esophageal varices with high risk of bleeding in the investigator's discretion.\n* Patient requiring therapeutic anticoagulant therapy or having other increased risk of bleeding events.\n* Patient has any severe acute or chronic medical condition that places the patient at increased risk or interferes with the interpretation of trial results in the opinion of the investigator.\n* Patient has any form of primary immunodeficiency (such as severe combined immunodeficiency disease \\[SCID\\] and acquired immune deficiency syndrome \\[AIDS\\]).\n* Patient has active or history of autoimmune or inflammatory disorders. Note: Patients may be eligible if they have been assessed in discussion between Principal Investigator, Chief Medical Officer and Senior Medical Consultant as not posing an increased risk to the patient.\n* Patient receiving immunosuppressive concomitant medications (≥ 10 mg prednisone daily or other equivalent). Steroid medications are allowed if they are used as substitution or are administrated topically or as inhalations.\n* Patient has received an organ and\u002For allogenic stem cell transplant.\n* Patient has known acute or chronic infection with hepatitis B or C virus.\n* Patient has known HIV infection (seropositive for HIV antibody).\n* Patient has known infection with syphilis.\n* Patient has known bone-marrow aplasia.\n* Patient has known (chronical) urinary tract infection and\u002F or acute urothelial toxicity from previous cytotoxic chemotherapy or radiation therapy or urinary flow obstructions.\n* Female patient, who is pregnant or breast-feeding, or plan to become pregnant within 12 months after cyclophosphamide or 6 months after last dose of CC-38, whichever last. Women of childbearing potential must have a negative pregnancy test at screening and before every CC-38 application.\n* Patient is unable to comply with trial procedures, restrictions, or requirements.\n* Patient received last previous systemic cancer treatment (including anti-testosterone treatment) within less than 4 weeks prior enrollment.\n\nNote: Bridging therapies (specified in trial design \\[section 2 - subsection: screening and TIL harvesting\\]) after TIL harvesting and before CC-38 administration are permitted after consultation between Principal Investigator, Chief Medical Officer and Senior Medical Consultant.\n\n* Patient received last palliative radiotherapy within less than 4 weeks prior enrollment - where RECIST 1.1 evaluable metastases are within the radiation area.\n* Patient received minor surgery (as judged by the investigator, i.e., port implantation) within less than 3 weeks prior enrollment.\n* Patient with AEs from previous treatment that have not recovered to CTCAE v5.0 ≤ grade 1 Note: Clinically insignificant grade 2 AEs that may be allowable if discussed between and approved by Principal Investigator, Chief Medical Officer and Senior Medical Consultant.\n* Patient participates in any other interventional clinical trial or has been treated with any investigational research products within 4 weeks prior to the initiation of screening.\n* Patient has bone metastasis only.\n* Patient has known hypersensitivity to any component of the trial regimen.\n* For colorectal cancer: Patient has been diagnosed with histologically or cytologically proven BRAF-V600 positive CRC.\n* Patient has any further contraindication to the IMP pembrolizumab or any of the auxiliary medicinal products (i.e., IL-2, cyclophosphamide, uromitexan) as per current EU SmPCs to the respective product.","ALL","18 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a First-In-Human trial investigating a novel expansion protocol of an ATIMP (CC-38), composed of autologous TIL.",[28,29,30],"Metastatic Colorectal Cancer","Prostate Cancer Metastatic","Prostate Cancer Locally Advanced",[32,33,34,35],"mCRC","aPC","TIL","Immunotherapy","RECRUITING","2026-06-18",{"date":39,"type":40},"2026-06-22","ACTUAL",{"date":42,"type":40},"2025-11-13",{"date":44,"type":21},"2029-04",{"name":46,"class":47},"CuraCell TX AB","INDUSTRY"]