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Long-term safety follow-up of patients with pancreatic cancer receiving autologous adipose perivascular stromal cells secreting TNF‑related apoptosis‑inducing ligand(RR001)

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on patients with pancreatic adenocarcinoma, a type of cancer that starts in the pancreas and in these cases cannot be removed by surgery. The treatment being examined is a therapy called RR001. This therapy uses cells taken from the patient’s own body fat, which are then altered in a laboratory so that they produce a natural protein that can help trigger cancer cell death. The modified cells are given directly into the tumor (intratumoral), meaning the injection is made right where the cancer is located. “Autologous” means the cells come from the same person receiving the treatment, reducing the chance of rejection.

The purpose of the study is to assess the long‑term safety of this approach. After completing the initial treatment phase, participants are followed for up to 93 months. During this period, they return for regular visits where doctors perform standard imaging scans, take blood samples, and ask about any hospital stays, new cancer treatments, or side effects. Information on how long patients live, how quickly the disease may grow again, and overall health status is also collected, providing a comprehensive picture of the therapy’s safety over many years.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Baseline Assessment

    You will be enrolled in the long‑term follow‑up study after completing the parent SNIPER trial.

    At enrollment, you will provide basic health information and undergo initial examinations to establish a baseline for future comparisons.

  2. Step 2

    Review of Prior Treatment with <b>RR001</b>

    You will receive a summary of the treatment you previously received, which was an autologous cell therapy consisting of your own adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor‑related apoptosis‑inducing ligand.

    The therapy was administered as a single intratumoral infusion (directly into the tumor). No additional doses of RR001 are planned during the follow‑up period.

  3. Step 3

    Scheduling of Follow‑Up Visits

    You will be scheduled for regular visits that will continue for up to 93 months (approximately 7 years and 9 months).

    The frequency of visits will follow the schedule defined by your study team and may include visits every few months or as required by standard medical practice.

  4. Step 4

    Safety Monitoring at Each Visit

    During every visit, you will be asked about any new symptoms, side effects, or health problems that have occurred since the previous visit.

    The study team will record any long‑term safety events that may be related to the previous treatment.

  5. Step 5

    Radiological Assessment of Disease Progression

    You will undergo imaging tests, such as CT or MRI scans, according to standard medical care to evaluate whether the pancreatic cancer has changed.

    These scans help determine disease progression and are part of the study’s secondary objectives.

  6. Step 6

    Collection of Blood Samples

    At scheduled visits, a small amount of blood will be drawn to analyze biomarkers and monitor the activity of the therapy over time.

    The blood analysis supports the study’s goal of understanding the long‑term effects of the treatment.

  7. Step 7

    Collection of Tumor Samples (If Required)

    If clinically indicated, a tumor tissue sample may be obtained to further assess the mechanism of action of the therapy.

    The procedure will be performed using standard medical techniques and only when necessary.

  8. Step 8

    Documentation of Additional Cancer Treatments

    You will be asked to report any new anticancer therapies you start during the follow‑up period, including participation in other clinical trials.

    These details are recorded to understand how additional treatments may interact with the prior therapy.

  9. Step 9

    Recording of Hospitalizations

    Any hospital stays that are related to the underlying pancreatic disease or to complications possibly linked to the original study will be documented.

    Information about the reason for admission, duration, and outcomes will be collected.

  10. Step 10

    Final Study Completion

    After the 93‑month follow‑up period ends, the study will be concluded for you.

    A final summary of safety, survival, and disease‑progression data will be prepared based on the information gathered throughout the study.

Who can join the trial?

5 criteria

  • You must have taken part in the SNIPER study and received the treatment called RR001.
  • You must have finished the final visit of the SNIPER study, no matter what the treatment outcome was.
  • You must sign an informed consent form that allows long‑term follow‑up and data collection, and you must be able to follow the study’s requirements.
  • If you are able to have children (or have a partner who can have children), you must agree to use a highly effective birth control method for at least 12 months after receiving RR001.
  • The study includes both men and women who are adults (the age range defined for the trial).

Who cannot join the trial?

2 criteria

  • Unable to be contacted for follow‑up visits or unable to travel to the clinic for the usual treatment and care (Standard of Care). Follow‑up means checking on your health after the study ends, and Standard of Care is the regular treatment doctors normally give.
  • Women who are pregnant or are breastfeeding. Pregnant means carrying a baby, and breastfeeding means feeding a baby with breast milk.
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Investigated drugs

RR001 is a special therapy made from a small amount of your own fat tissue. Scientists take cells called perivascular stromal cells from the fat, then they modify these cells in the lab so they produce a protein that can help trigger death of cancer cells. After the cells are prepared, they are placed in a liquid solution and injected directly into the tumor (intratumoral infusion). This approach is being tested as a new treatment in the SNIPER study, and it is classified as an orphan drug because it targets a condition with limited treatment options.

What is already known about the treatment

RR001 - This medication is given as an intratumoral infusion, where a patient’s own fat‑derived cells are injected directly into the tumor after being genetically altered to release a special protein that helps kill cancer cells. It is still experimental and is being studied in clinical trials, with no market approval yet. The treatment is aimed at patients with locally advanced, non‑resectable pancreatic adenocarcinoma. It works by the released protein attaching to cancer cells and activating a natural cell‑death process, and it is classified as a cell‑based gene therapy.

Investigated diseases

  • Locally advanced, unresectable pancreatic adenocarcinoma

    This is a cancer that originates in the pancreas and has grown into nearby blood vessels or organs, making surgical removal impossible. It remains confined to the region around the pancreas without distant spread at the time of diagnosis. Over time the tumor can continue to enlarge and infiltrate surrounding tissues, and may involve regional lymph nodes. The disease may eventually progress to distant sites if cancer cells enter the bloodstream. Monitoring focuses on changes in tumor size and spread as seen on imaging studies.

  • Pancreatic ductal adenocarcinoma

    This is a malignant growth that starts in the ducts that carry digestive enzymes within the pancreas. It typically begins as a small lesion and gradually expands, invading the surrounding pancreatic tissue. As it grows, it can spread to nearby lymph nodes and blood vessels. In later stages, cancer cells may travel to distant organs such as the liver or lungs. The progression is usually assessed by imaging and clinical observation of tumor growth.

Trial detailsLast updated 13 Oct 2026
Age18+ yearsPhasePhase ITrial ID2026-525714-59-00Protocol codeSNIPER-LTFUEstimated enrolment18 patientsSponsorEir Biotherapies S.r.l.

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