Cell-based gene therapy for advanced pancreatic cancer after chemotherapy

RR001 in Combination With Chemotherapy for Patients With Locally Advanced Pancreatic Adenocarcinoma: Open-label, Non-randomized Dose Escalation Phase I/IIa Study

This study is testing a new cell-based gene therapy called RR001 to see if it can help people with advanced pancreatic cancer feel better after chemotherapy and possibly make them eligible for surgery.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: EIR Biotherapies s.r.l. (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Modena, Italy)
• Trial ID: NCT06861452 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of RR001, a cell-based gene therapy, administered to patients with locally advanced pancreatic adenocarcinoma following chemotherapy cycles. The study is open-label and non-randomized, focusing on increasing doses of RR001 derived from the patient's own adipose tissue, genetically modified to produce a potent anti-cancer agent. The goal is to improve treatment outcomes and potentially increase the number of patients eligible for surgical resection, which is currently the only curative option for this condition.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with locally advanced pancreatic ductal adenocarcinoma who are not eligible for surgical resection and have a measurable tumor suitable for injection.

Not a fit: Patients with metastatic pancreatic cancer or those with tumors that cannot be injected or biopsied will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option that enhances the effectiveness of chemotherapy and increases the chances of surgical intervention for patients with advanced pancreatic cancer.

How similar studies have performed: While this approach is innovative, similar studies using cell-based therapies have shown promise in other cancers, suggesting potential for success in this novel application.

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)
* 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 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
* Suspected or known allergy or hypersensitivity to fluoroquinolones including but not limited to ciprofloxacin
* 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

Where this trial is running

Modena, Italy

• Azienda Ospedaliero-Universitaria (AOU) Policlinico di Modena — Modena, Italy, Italy (RECRUITING)

Study contacts

• Study coordinator: Annalisa Fontana

Conditions: Locally Advanced Pancreatic Adenocarcinoma