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

NCT ID: NCT06861452

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-25
• Study Completion Date: 2027-01-29

Brief Summary

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

Detailed Description

This study is intended for people diagnosed with locally advanced pancreatic ductal adenocarcinoma.

Currently, surgical resection is the only treatment that offers a chance to cure this type of tumor, but only a few percentage of locally advanced pancreatic adenocarcinoma patients is able to benefit from this approach. Thus, research is aimed at identifying new treatment strategies based on innovative approaches that can increase the number of people who can access surgery as radically as possible.

The SNIPER study aims to evaluate for the first time in humans the applicability and safety of a new drug (called RR001) based on autologous cells, that are, cells taken from the same subject who receives them. These cells are derived from adipose tissue and are genetically modified to deliver a potent anti-cancer death ligand normally produced by the body with the role to kill tumoral cells.

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RR001 Dose Level 1

Treatment consists of two cycles of Nab-PTX 125 mg/mq followed by GEM 1000 mg/mq administered on days 1, 8, and 15, every 28 days. At the end of the 2 cycles patients will undergo to an intra-tumoral administration of RR001 at Dose Level (DL) 1: 80 x 10\^6 cells

Group Type: EXPERIMENTAL

RR001

Intervention Type: DRUG

RR001, a cell-based gene therapy administered following administration of chemotherapy (Nab-PTX 125 mg/mq and GEM 1000 mg/mq)

RR001 Dose Level 2

Treatment consists of two cycles of Nab-PTX 125 mg/mq followed by GEM 1000 mg/mq administered on days 1, 8, and 15, every 28 days. At the end of the 2 cycles patients will undergo to an intra-tumoral administration of RR001 at Dose Level (DL) 2: 160 x 10\^6 cells

Group Type: EXPERIMENTAL

RR001

Intervention Type: DRUG

RR001, a cell-based gene therapy administered following administration of chemotherapy (Nab-PTX 125 mg/mq and GEM 1000 mg/mq)

RR001 Dose Level 3

Treatment consists of two cycles of Nab-PTX 125 mg/mq followed by GEM 1000 mg/mq administered on days 1, 8, and 15, every 28 days. At the end of the 2 cycles patients will undergo to an intra-tumoral administration of RR001 at Dose Level (DL) 3: 240 x 10\^6 cells

Group Type: EXPERIMENTAL

RR001

Intervention Type: DRUG

RR001, a cell-based gene therapy administered following administration of chemotherapy (Nab-PTX 125 mg/mq and GEM 1000 mg/mq)

Interventions

RR001

RR001, a cell-based gene therapy administered following administration of chemotherapy (Nab-PTX 125 mg/mq and GEM 1000 mg/mq)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EIR Biotherapies s.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Azienda Ospedaliero-Universitaria (AOU) Policlinico di Modena

Modena, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Annalisa Fontana

Role: CONTACT

Phone: IT + 39 0594223808/0594225165

Email: fontana.annalisa@aou.mo.it

Andrea Spallanzani

Role: CONTACT

Phone: IT +39 0594223310/0594225646

Email: spallanzani.andrea@aou.mo.it

Facility Contacts

Annalisa Fontana

Role: primary

Other Identifiers

2024-516019-26-00

Identifier Type: CTIS

Identifier Source: secondary_id

SNIPER

Identifier Type: -

Identifier Source: org_study_id