Clinical trial · Interventional
Phase I/IIa Study: RR001 Administered Following Chemotherapy Cycles for Patients With Locally Advanced Pancreatic Carcinoma
RR001 in Combination With Chemotherapy for Patients With Locally Advanced Pancreatic Adenocarcinoma: Open-label, Non-randomized Dose Escalation Phase I/IIa Study
NCT06861452CI-TRIAL-00099674SNIPERrecruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RR001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- RR001 Dose Level 1
- description
- 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
- interventionNames
- Drug: RR001
- type
- EXPERIMENTAL
- label
- RR001 Dose Level 2
- description
- 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
- interventionNames
- Drug: RR001
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.