Locally Advanced Pancreatic AdenocarcinomaPhase 1/2SNIPERNCT06861452
Phase I/IIa Study: RR001 Administered Following Chemotherapy Cycles for Patients With Locally Advanced Pancreatic Carcinoma
A Phase 1/2 study testing RR001 in people with Locally Advanced Pancreatic Adenocarcinoma, run by EIR Biotherapies s.r.l. at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Adenocarcinoma
- What is being tested?
- RR001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jun 2025to 29 Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria (AOU) Policlinico di Modena
Modena, Italy, 41124
Annalisa Fontana, IT + 39 0594223808/0594225165, fontana.annalisa@aou.mo.it
Annalisa Fontana
About this study
Official title: RR001 in Combination With Chemotherapy for Patients With Locally Advanced Pancreatic Adenocarcinoma: Open-label, Non-randomized Dose Escalation Phase I/IIa Study
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
Read the 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.
- Being tested
- RR001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RR001Drug
RR001, a cell-based gene therapy administered following administration of chemotherapy (Nab-PTX 125 mg/mq and GEM 1000 mg/mq)
| Study group | Role | What they receive |
|---|---|---|
| RR001 Dose Level 1 | Experimental | 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 Receives: Drug: RR001 |
| RR001 Dose Level 2 | Experimental | 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 Receives: Drug: RR001 |
| RR001 Dose Level 3 | Experimental | 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 Receives: Drug: RR001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Safety in terms of monitoring of systemic tolerance, Adverse Events (AEs) and severe AEs (SAEs) assess by CTCAE (Version 5.0)
Measured: From the signing of the informed consent onwards and during every visit till the End of Study (EOS) (90±7 days after RR001 delivery) for a total of 26 weeks
Secondary outcomes (9)
Evaluation of feasibility through the assessment of the production capacity of the Cell Factory participating in the study of an adequate quantity of autologous cellular product lots sufficient to treat 80% of the patients recruited
Measured: From Day 1 till RR001 delivery (46-57 days)
Evaluation of the Efficacy of the Drug Product: Overall response rates (ORR)
Overall response rates (ORR) per RECIST 1.1 criteria till End Of Treatment (EOT)
Measured: 21 days post RR001 delivery
Evaluation of the Efficacy of the Drug Product: percentage of pathological resection
Percentage of patient undergoing surgery and percentage of pathological resection
Measured: At Day 24 post RR001 delivery
Evaluation of the Efficacy of the Drug Product : Time to progression (TTP) till end of study
Measured: Day 90± 7 days post RR001 delivery
Evaluation of the Efficacy of the Drug Product : Progression free survival (PFS) till end of study
Measured: Day 90± 7 days post RR001 delivery
Evaluation of the Efficacy of the Drug Product : Overall survival (OS) till end of study
Measured: Day 90± 7 days post RR001 delivery
Evaluation of the Efficacy of the Drug Product : Tumoral markers evaluation
Tumoral markers evaluation CA 19.9, CEA till end of study
Measured: Day 90±7 days post RR001 delivery
Evaluation of the Efficacy of the Drug Product : Quality of Life (QoL) Questionnaire of European Organization for Research and Treatment of Cancer (EORTC) - EORTC QLQ-C30
Questionnaire on Quality of Life (QoL) collected till the end of the study. The EORTC Quality of Life Group (QLG) Core Questionnaire (EORTC QLQ-C30) is a 30 item instrument meant to assess some of the different aspects that define the QoL of cancer patients.
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Measured: Day 90± 7 days post RR001 delivery
Evaluation of the Efficacy of the Drug Product : Quality of Life (QoL) Questionnaire of European Organization for Research and Treatment of Cancer (EORTC) - EORTC QLQ-PAN26
Questionnaire on Quality of Life collected till the end of the study EORTC QLQ-PAN26 (Pancreatic Cancer Module).
This questionnaire is administered on the same module of EORTC QLQ-C30 Questionnaire.
The module comprises 26 questions assessing pain, dietary changes, jaundice, altered bowel habit, emotional problems related to pancreatic cancer, and other symptoms (cachexia, indigestion, flatulence, dry mouth, taste changes).
All of the scales and single-item measures range in score from 0 to 100, where zero corresponds to the lowest possible score and 100 to the highest possible score.
Measured: Day 90± 7 days post RR001 delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start25 Jun 2025
- Primary completion29 Jul 2027 (estimated)
- Study completion29 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EIR Biotherapies s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861452
- Sponsor's protocol ID
- SNIPER
- Other IDs
- 2024-516019-26-00
- Acronym
- SNIPER
- Status last verified
- Sep 2026
- First submitted
- 28 Jan 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RR001 in Combination With Chemotherapy for Patients With Locally Advanced Pancreatic Adenocarcinoma: Open-label, Non-randomized Dose Escalation Phase I/IIa Study
- ClinicalTrials.gov ID
- NCT06861452
- Acronym / sponsor ID
- SNIPER / SNIPER
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- EIR Biotherapies s.r.l.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 29 Jul 2027 (estimated)
- Study completion
- 29 Jan 2028 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RR001 Dose Level 1 | Experimental | Drug: RR001Treatment 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 |
| RR001 Dose Level 2 | Experimental | Drug: RR001Treatment 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 |
| RR001 Dose Level 3 | Experimental | Drug: RR001Treatment 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RR001RR001, a cell-based gene therapy administered following administration of chemotherapy (Nab-PTX 125 mg/mq and GEM 1000 mg/mq) | Drug | RR001 Dose Level 1, RR001 Dose Level 2, RR001 Dose Level 3 |
Primary outcome
Evaluation of Safety in terms of monitoring of systemic tolerance, Adverse Events (AEs) and severe AEs (SAEs) assess by CTCAE (Version 5.0)
Time frame: From the signing of the informed consent onwards and during every visit till the End of Study (EOS) (90±7 days after RR001 delivery) for a total of 26 weeks
9 secondary outcomes
Evaluation of feasibility through the assessment of the production capacity of the Cell Factory participating in the study of an adequate quantity of autologous cellular product lots sufficient to treat 80% of the patients recruited
Time frame: From Day 1 till RR001 delivery (46-57 days)
Evaluation of the Efficacy of the Drug Product: Overall response rates (ORR)
Time frame: 21 days post RR001 delivery
Evaluation of the Efficacy of the Drug Product: percentage of pathological resection
Time frame: At Day 24 post RR001 delivery
Evaluation of the Efficacy of the Drug Product : Time to progression (TTP) till end of study
Time frame: Day 90± 7 days post RR001 delivery
Evaluation of the Efficacy of the Drug Product : Progression free survival (PFS) till end of study
Time frame: Day 90± 7 days post RR001 delivery
Evaluation of the Efficacy of the Drug Product : Overall survival (OS) till end of study
Time frame: Day 90± 7 days post RR001 delivery
Evaluation of the Efficacy of the Drug Product : Tumoral markers evaluation
Time frame: Day 90±7 days post RR001 delivery
Evaluation of the Efficacy of the Drug Product : Quality of Life (QoL) Questionnaire of European Organization for Research and Treatment of Cancer (EORTC) - EORTC QLQ-C30
Time frame: Day 90± 7 days post RR001 delivery
Evaluation of the Efficacy of the Drug Product : Quality of Life (QoL) Questionnaire of European Organization for Research and Treatment of Cancer (EORTC) - EORTC QLQ-PAN26
Time frame: Day 90± 7 days post RR001 delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RR001 in people with Locally Advanced Pancreatic Adenocarcinoma, run by EIR Biotherapies s.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annalisa Fontana (IT + 39 0594223808/0594225165, fontana.annalisa@aou.mo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Safety in terms of monitoring of systemic tolerance, Adverse Events (AEs) and severe AEs (SAEs) assess by CTCAE (Version 5.0) (time frame: From the signing of the informed consent onwards and during every visit till the End of Study (EOS) (90±7 days after RR001 delivery) for a total of 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.