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

Launched by EIR BIOTHERAPIES S.R.L. · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called RR001, which is a type of cell-based gene therapy. It is being tested in patients with locally advanced pancreatic cancer, which means the cancer is still in the pancreas but has spread to nearby tissues. The trial aims to find out how safe and effective RR001 is when given after chemotherapy, a common cancer treatment that uses strong medicines to kill cancer cells. This study is currently looking for participants to help learn more about this new treatment.

To be eligible for the trial, participants must be adults over 18 years old with a confirmed diagnosis of locally advanced pancreatic adenocarcinoma and must not have any spread of cancer to other parts of the body. They also need to be able to receive chemotherapy as part of their treatment plan. Participants can expect to undergo a series of scheduled visits, tests, and procedures, including a small liposuction procedure to collect fat tissue, which is part of the treatment process. This trial is open to all genders and aims to provide valuable information that could help improve treatment options for pancreatic cancer in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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) treatment
• • Patient older than 18 years of age
• • Adequate hepatic and kidney function/Safe hematologic profile
• • Negative serum pregnancy test for females of childbearing potential
• • Willingness and ability to comply with the scheduled visits, treatment plan, imaging procedures, laboratory tests and other study procedures, including lipoaspirate collection (liposuction)
• Exclusion Criteria:
• • 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
• • Patient contraindication to use chemotherapy treatments
• • Previous of radiotherapy and chemotherapy for PDAC
• • Previous hematopoietic stem cell or organ transplantation
• • 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
• • 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
• • 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