Actively Recruiting
RR001 Combined With Chemotherapy for Patients With Locally Advanced Pancreatic Adenocarcinoma: Open-label, Non-randomized Dose Escalation Phase I/IIa Study
Led by EIR Biotherapies s.r.l. · Updated on 2025-12-26
9
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new cell-based gene therapy called RR001 for patients with locally advanced pancreatic ductal adenocarcinoma, a type of pancreatic cancer that is not eligible for surgery. This Phase I/IIa open-label, non-randomized clinical trial aims to test the safety and effects of increasing doses of RR001, which uses the patient's own genetically modified cells to target cancer cells. The study addresses the need for new treatments to increase the chances of surgery and improve outcomes in this challenging condition. The treatment involves two cycles of chemotherapy using Nab-paclitaxel and gemcitabine given on days 1, 8, and 15 of a 28-day cycle. After completing chemotherapy, participants receive an injection of RR001 directly into the tumor at one of three escalating dose levels. This approach combines chemotherapy with a novel gene therapy delivered locally to the tumor. The trial evaluates the safety and feasibility of producing and administering this personalized cellular product. Participants will be monitored from the time they consent through 26 weeks after RR001 delivery, including regular visits to assess side effects, tumor response, and quality of life. Evaluations consist of clinical exams, imaging scans, laboratory tests, and questionnaires. Researchers will measure safety by tracking adverse events, and efficacy by tumor response, progression, survival, and quality of life scores. The study includes careful ongoing safety monitoring and follow-up to understand how the treatment affects patients over time.
CONDITIONS
Brief Title
Phase I/IIa Study: RR001 Administered Following Chemotherapy Cycles for Patients With Locally Advanced Pancreatic Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed pancreatic ductal adenocarcinoma classified as locally advanced pancreatic adenocarcinoma
- No evidence of peritoneal or blood-borne metastasis
- Classified as non-resectable locally advanced pancreatic cancer based on imaging and multidisciplinary evaluation
- Measurable tumor according to RECIST criteria version 1.1
- Low tumor burden with at least one lesion 3.5 cm or smaller suitable for ultrasound-guided injection
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Eligible for chemotherapy treatment per standard care
- Age 18 years or older
- Adequate liver and kidney function and safe blood profile
- Negative pregnancy test for females of childbearing potential before treatment
- Willing and able to comply with study visits, treatment plan, imaging, lab tests, and procedures including fat tissue collection by liposuction
You will not qualify if you...
- Pancreatic cystic tumor or pancreatic pseudocyst
- Pancreatic tumors other than adenocarcinoma (such as endocrine tumors or metastases)
- Unknown stage or recurrent pancreatic cancer
- Immunosuppression or susceptibility to viral infection
- Infection with HIV, hepatitis B or C, HTLV-I/II, or Treponema Pallidum
- Liver cirrhosis or other documented liver diseases
- Contraindication to chemotherapy
- Previous radiotherapy or chemotherapy for pancreatic ductal adenocarcinoma
- Previous hematopoietic stem cell or organ transplantation
- Irreversible cardiac arrhythmias requiring permanent medication
- Heart failure grade greater than II by NYHA criteria
- Recent history (within one year) of acute or subacute coronary syndromes
- Uncontrolled high blood pressure
- Other malignancies within the past two years (except certain skin, prostate, or cervical cancers)
- Active autoimmune disease
- Use of investigational agents within 21 days before study treatment
- Major open surgery prior to study treatment
- Uncontrolled illness including psychiatric or social situations that may risk compliance
- Known allergy or hypersensitivity to fluoroquinolones or protamine-containing products
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 46 to 57 days
Participants receive two cycles of chemotherapy followed by an intra-tumoral administration of RR001 at assigned dose levels.
Chemotherapy on days 1, 8, and 15 of each 28-day cycle; RR001 administered after 2 cycles
Duration - Approximately 90 days (90 ± 7 days after RR001 delivery)
Participants are monitored for safety, efficacy, and quality of life after RR001 administration.
Visits up to 26 weeks total from RR001 delivery
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliero-Universitaria (AOU) Policlinico di Modena
Modena, Italy, Italy, 41124
Actively Recruiting
Research Team
A
Annalisa Fontana
A
Andrea Spallanzani
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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