Taking people in ItalyPhase 1/2

Tests RR001 with chemotherapy in locally advanced pancreatic cancer

Tests increasing doses of RR001 after chemotherapy in adults with pancreatic cancer.

Plain-language title generated from the registry record
Registry title: Phase I/IIa Study: RR001 Administered Following Chemotherapy Cycles for Patients With Locally Advanced Pancreatic Carcinoma

Key facts

Where: Modena, ItalySee the site
Phase: Phase 1/2

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with locally advanced pancreatic cancer (ductal adenocarcinoma) that cannot be removed by surgery and has not spread to other organs. They must be able to have chemotherapy.

Age: 18 years or older
Sex: All sexes can join
Disease stage: Confirmed pancreatic ductal adenocarcinoma, locally advanced, cannot be removed by surgery, no spread to the abdominal lining or through the blood. A tumour that can be measured by RECIST v 1.1, with at least one lesion of 3,5 cm (1.4 in) or smaller that can be injected under ultrasound guidance. Fit enough for daily activities (ECOG 0, 1 or 2).
Earlier treatment: No earlier radiotherapy or chemotherapy for this cancer. No stem-cell or organ transplant before. No other trial drug within 21 days before the study treatment. Must be able to have chemotherapy as standard care.

Main reasons for not taking part

Pancreatic cyst or a tumour that is not adenocarcinoma, or unknown stage or recurrent cancer
HIV, hepatitis B, hepatitis C, HTLV-I/II or Treponema Pallidum infection, or weakened immune system
Liver cirrhosis or other documented liver disease
Serious heart disease, heart attack or angina within the last year, or uncontrolled high blood pressure
Allergy to fluoroquinolones such as ciprofloxacin, or to protamine sulfate

Read by machine on 9 November 2026.

Where in Italy

Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it: EIR Biotherapies s.r.l.
Trial code: NCT06861452 EU 2024-516019-26-00
Record updated: 8 September 2026
Original description: 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 RR001Read full original descriptionShow less
RR001 in Combination With Chemotherapy for Patients With Locally Advanced Pancreatic Adenocarcinoma: Open-label, Non-randomized Dose Escalation Phase I/IIa Study
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; Patients must be eligible for chemotherapy treatment (based on standard of care); Patient older than 18 years of age; Adequate hepatic and kidney function/Safe hematologic profile; Negative serum pregnancy test for females of childbearing potential within days of starting treatment; Willingness and ability to comply with the scheduled visits, treatment plan, imaging procedures, laboratory tests and other study procedures, including lipoaspirate collection (liposuction).
Exclusion: Patient contraindication to use chemotherapy treatments; Previous of radiotherapy and chemotherapy for PDAC; Previous hematopoietic stem cell or organ transplantation; Use of any investigational agents within 21 days from the administration of study treatment; Patient has had major open surgery prior to the administration of study treatment; 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; 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; Irreversible cardiac arrhythmias requiring permanent medication; Heart insufficiency (> grade II, New York Heart Association NYHA criteria); History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris; Uncontrolled hypertension; 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); Active autoimmune disease; Uncontrolled intercurrent illness including but not limited to psychiatric illness/social situations that in the opinion of the Investigator would compromise compliance of study requirements or put the patient at unacceptable risk; Suspected or known allergy or hypersensitivity to fluoroquinolones including but not limited to ciprofloxacin; Patient with pancreatic cystic tumor or pancreatic pseudocyst; Patient with pancreatic tumor different from adenocarcinoma (endocrine, metastases).
ClinicalTrials.gov NCT06861452 · EU CTIS 2024-516019-26-00