Phase I/IIa Study: RR001 Administered Following Chemotherapy Cycles for Patients With Locally Advanced Pancreatic Carcinoma

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEIR Biotherapies s.r.l.

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • RR001

Treatment groups

9 Participants
are divided into 3 treatment groups

Sponsors and collaborators