TrialBridgeNCT06861452
Phase I/IIa Study: RR001 Administered Following Chemotherapy Cycles for Patients With Locally Advanced Pancreatic Carcinoma
Recruiting · Phase 1, Phase 2 · EIR Biotherapies s.r.l. · registry updated 2026-09-08
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
RR001, a cell-based gene therapy administered following chemotherapy cycles for the treatment of patients with locally advanced pancreatic cancer. Phase I /IIa clinical trial (open label and non-randomized) to test the effects (safety \& efficacy) of increasing doses of RR001
Inclusion
- Patients with confirmed pancreatic ductal adenocarcinoma classified as locally advanced pancreatic adenocarcinoma (LPAC)
- Patients with no evidence of peritoneal or hematogenous metastasis
- 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/UICC TNM and clinical staging
- Measurable tumor according RECIST criteria v 1.1
- Low tumor burden with at least one lesion equal/less than 3,5 cm that is suitable for US guided injection (and needle biopsy).
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Exclusion
- Patient with pancreatic cystic tumor or pancreatic pseudocyst
- Patient with pancreatic tumor different from adenocarcinoma (endocrine, metastases)
- Patients with unknown stage or recurrent pancreatic cancer
- Patients with immunosuppression or susceptibility to viral infection
- Patients with HIV, hepatitis B, hepatitis C, HTLV-I/II, Treponema Pallidum infections
- Patients with liver cirrhosis or other documented liver diseases