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

Last updated: May 23, 2025
Sponsor: EIR Biotherapies s.r.l.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Adenocarcinoma

Treatment

RR001

Clinical Study ID

NCT06861452
SNIPER
2024-516019-26-00
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with confirmed pancreatic ductal adenocarcinoma classified as locallyadvanced 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 anoncologist, radiologist and a qualified digestive surgeon and accounting forAJCC/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 suitablefor 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, imagingprocedures, laboratory tests and other study procedures, including lipoaspiratecollection (liposuction)

Exclusion

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 Palliduminfections

  • 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 includingmyocardial infarction, unstable or severe stable angina pectoris

  • Uncontrolled hypertension

  • Other malignancies within the past 2 years (not including basal cell carcinoma ofthe 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 studytreatment

  • Patient has had major open surgery prior to the administration of study treatment

  • Uncontrolled intercurrent illness including but not limited to psychiatricillness/social situations that in the opinion of the Investigator would compromisecompliance of study requirements or put the patient at unacceptable risk

Study Design

Total Participants: 9
Treatment Group(s): 1
Primary Treatment: RR001
Phase: 1/2
Study Start date:
May 01, 2025
Estimated Completion Date:
January 29, 2027

Study 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.

Connect with a study center

  • Azienda Ospedaliero-Universitaria (AOU) Policlinico di Modena

    Modena, 41124
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.