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RR001, a cell-based gene therapy administered in combination with chemotherapy 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.
EU CTIS ID: 2024-516019-26-00
What this study is testing
1. To determine the safety of intra-tumoral injection of the RR001 administered by ultrasound (US) guided injections in combination with standard of care therapy based on GEM/Nab-PTX 2. To establish the maximal tolerated dose (MTD) and recommended phase IIb dose (RP2D) of intratumoral injections of RR001 after three dose levels delivery in combination with standard of chemotherapy
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with confirmed pancreatic ductal adenocarcinoma
- Patient older than 18 years of age
- Adequate hepatic and kidney function
- Willingness and ability to comply with the scheduled visits, treatment plan, imaging procedures, laboratory tests and other study procedures, including lipoaspirate collection (liposuction)
- Safe hematologic profile
- Negative serum pregnancy test for females of childbearing potential within days of starting treatment
You likely can't join if
- Patient with pancreatic cystic tumor or pancreatic pseudocyst
- 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)
See the full eligibility criteria
- Patients with confirmed pancreatic ductal adenocarcinoma
- Patient older than 18 years of age
- Adequate hepatic and kidney function
- Willingness and ability to comply with the scheduled visits, treatment plan, imaging procedures, laboratory tests and other study procedures, including lipoaspirate collection (liposuction)
- Safe hematologic profile
- Negative serum pregnancy test for females of childbearing potential within days of starting treatment
- 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 with pancreatic cystic tumor or pancreatic pseudocyst
- 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 within the 3 months 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
- Patient with pancreatic tumor different from adenocarcinoma (endocrine, metastases)
- 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
- 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 chemoterapy treatments
- Previous radiotherapy and/or chemotherapy for PDAC
- Previous haematopoietic stem cell or organ transplantation
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.