Actively Recruiting
Phase I/IIa Study: RR001 Administered Following Chemotherapy Cycles for Patients With Locally Advanced Pancreatic Carcinoma
Led by EIR Biotherapies s.r.l. · Updated on 2025-12-26
9
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 locally advanced pancreatic ductal adenocarcinoma
- No evidence of peritoneal or blood metastasis
- Classified as non-resectable locally advanced pancreatic carcinoma by imaging and expert evaluation
- Measurable tumor by RECIST criteria version 1.1
- Tumor lesion suitable for ultrasound-guided injection and biopsy, 3.5 cm or smaller
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Eligible for chemotherapy treatment
- Age 18 years or older
- Adequate liver, kidney, and blood function
- Negative pregnancy test for women of childbearing potential
- Willing and able to follow study visits, treatments, imaging, lab tests, and liposuction for cell collection
You will not qualify if you...
- Pancreatic cystic tumor or pancreatic pseudocyst
- Pancreatic tumor other than adenocarcinoma (such as endocrine tumor or metastases)
- Unknown stage or recurrent pancreatic cancer
- Immunosuppression or vulnerability to viral infections
- Infection with HIV, hepatitis B, hepatitis C, HTLV-I/II, or Treponema Pallidum
- Liver cirrhosis or other liver diseases
- Contraindication to chemotherapy
- Prior chemotherapy or radiotherapy for pancreatic ductal adenocarcinoma
- Previous hematopoietic stem cell or organ transplant
- Irreversible cardiac arrhythmias requiring permanent medication
- Heart failure greater than grade II (NYHA criteria)
- Acute or subacute coronary syndromes within past year
- Uncontrolled high blood pressure
- Other malignancies within past 2 years except certain skin, prostate, or cervical cancers
- Active autoimmune disease
- Use of investigational drugs within 21 days before study treatment
- Major open surgery before study treatment
- Uncontrolled illnesses or psychiatric/social issues compromising study compliance
- Allergy or hypersensitivity to fluoroquinolones or protamine sulfate or related products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
A
Andrea Spallanzani
CONTACT
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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