[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582295":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":39,"responsibleParty":57,"collaborators":28,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":28,"enrollmentInfo":69,"targetDuration":28,"studyType":72,"phases":73,"briefSummary":76,"conditions":77,"keywords":28,"overallStatus":42,"whyStopped":28,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"EIR Biotherapies s.r.l.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"RR001 Dose Level 1","EXPERIMENTAL","Treatment consists of two cycles of Nab-PTX 125 mg\u002Fmq followed by GEM 1000 mg\u002Fmq administered on days 1, 8, and 15, every 28 days. At the end of the 2 cycles patients will undergo to an intra-tumoral administration of RR001 at Dose Level (DL) 1: 80 x 10\\^6 cells",[13],"Drug: RR001",{"label":15,"type":10,"description":16,"interventionNames":17},"RR001 Dose Level 2","Treatment consists of two cycles of Nab-PTX 125 mg\u002Fmq followed by GEM 1000 mg\u002Fmq administered on days 1, 8, and 15, every 28 days. At the end of the 2 cycles patients will undergo to an intra-tumoral administration of RR001 at Dose Level (DL) 2: 160 x 10\\^6 cells",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"RR001 Dose Level 3","Treatment consists of two cycles of Nab-PTX 125 mg\u002Fmq followed by GEM 1000 mg\u002Fmq administered on days 1, 8, and 15, every 28 days. At the end of the 2 cycles patients will undergo to an intra-tumoral administration of RR001 at Dose Level (DL) 3: 240 x 10\\^6 cells",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","RR001","RR001, a cell-based gene therapy administered following administration of chemotherapy (Nab-PTX 125 mg\u002Fmq and GEM 1000 mg\u002Fmq)",[9,15,19],null,[30,35],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Annalisa Fontana","CONTACT","IT + 39 0594223808\u002F0594225165","fontana.annalisa@aou.mo.it",{"name":36,"role":32,"phone":37,"phoneExt":28,"email":38},"Andrea Spallanzani","IT +39 0594223310\u002F0594225646","spallanzani.andrea@aou.mo.it",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":44,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Azienda Ospedaliero-Universitaria (AOU) Policlinico di Modena","RECRUITING","Modena","Italy","41124","IT",{"type":48,"coordinates":49},"Point",[50,51],10.92539,44.64783,{"lat":51,"lon":50},[54,55],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},{"name":31,"role":56,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100582295","phase-1-phase-iiia-study-rr001-administered-following-chemotherapy-cycles-for-patients-with-locally-advanced-pancreatic-carcinoma-100582295",false,"NCT06861452","Phase I\u002FIIa Study: RR001 Administered Following Chemotherapy Cycles for Patients With Locally Advanced Pancreatic Carcinoma","RR001 in Combination With Chemotherapy for Patients With Locally Advanced Pancreatic Adenocarcinoma: Open-label, Non-randomized Dose Escalation Phase I\u002FIIa Study","SNIPER","Inclusion Criteria:\n\n* Patients with confirmed pancreatic ductal adenocarcinoma classified as locally advanced pancreatic adenocarcinoma (LPAC)\n* Patients with no evidence of peritoneal or hematogenous metastasis\n* Patients classified as non-resectable locally advanced pancreatic carcinoma (LAPC) based on imaging (TC and NMR), on multidisciplinary staff evaluation by at least an oncologist, radiologist and a qualified digestive surgeon and accounting for AJCC\u002FUICC TNM and clinical staging\n* Measurable tumor according RECIST criteria v 1.1\n* Low tumor burden with at least one lesion equal\u002Fless than 3,5 cm that is suitable for US guided injection (and needle biopsy).\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n* Patients must be eligible for chemotherapy treatment (based on standard of care)\n* Patient older than 18 years of age\n* Adequate hepatic and kidney function\u002FSafe hematologic profile\n* Negative serum pregnancy test for females of childbearing potential within days of starting treatment\n* Willingness and ability to comply with the scheduled visits, treatment plan, imaging procedures, laboratory tests and other study procedures, including lipoaspirate collection (liposuction)\n\nExclusion Criteria:\n\n* Patient with pancreatic cystic tumor or pancreatic pseudocyst\n* Patient with pancreatic tumor different from adenocarcinoma (endocrine, metastases)\n* Patients with unknown stage or recurrent pancreatic cancer\n* Patients with immunosuppression or susceptibility to viral infection\n* Patients with HIV, hepatitis B, hepatitis C, HTLV-I\u002FII, Treponema Pallidum infections\n* Patients with liver cirrhosis or other documented liver diseases\n* Patient contraindication to use chemotherapy treatments\n* Previous of radiotherapy and chemotherapy for PDAC\n* Previous hematopoietic stem cell or organ transplantation\n* Irreversible cardiac arrhythmias requiring permanent medication\n* Heart insufficiency (\\> grade II, New York Heart Association NYHA criteria)\n* History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris\n* Uncontrolled hypertension\n* Other malignancies within the past 2 years (not including basal cell carcinoma of the skin, prostate cancer or in situ cervix carcinoma, in situ melanoma).\n* Active autoimmune disease\n* Use of any investigational agents within 21 days from the administration of study treatment\n* Patient has had major open surgery prior to the administration of study treatment\n* Uncontrolled intercurrent illness including but not limited to psychiatric illness\u002Fsocial situations that in the opinion of the Investigator would compromise compliance of study requirements or put the patient at unacceptable risk\n* Suspected or known allergy or hypersensitivity to fluoroquinolones including but not limited to ciprofloxacin\n* Suspected or known allergy or hypersensitivity to protamine sulfate or protamine containing products. Including but not limited to patients who have previously undergone procedures such as coronary angioplasty or cardio-pulmonary bypass, which may involve the use of protamine, diabetics who have been treated with protamine insulin, patients allergic to fish, and men who have undergone a vasectomy or are infertile and may have antibodies to protamine","ALL","18 Years",{"count":70,"type":71},9,"ESTIMATED","INTERVENTIONAL",[74,75],"PHASE1","PHASE2","RR001, a cell-based gene therapy administered following chemotherapy cycles for the treatment of patients with locally advanced pancreatic cancer. Phase I \u002FIIa clinical trial (open label and non-randomized) to test the effects (safety \\& efficacy) of increasing doses of RR001",[78],"Locally Advanced Pancreatic Adenocarcinoma","2025-12-19",{"date":81,"type":82},"2025-12-26","ACTUAL",{"date":84,"type":82},"2025-06-25",{"date":86,"type":71},"2027-01-29",{"name":5,"class":6},1]