Phase I/IIa Study: RR001 Administered Following Chemotherapy Cycles for Patients With Locally Advanced Pancreatic Carcinoma
Recruiting
Phase 1Phase 2Interventional Study
Locally Advanced Pancreatic Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
9 (estimated)
Sponsor
EIR Biotherapies s.r.l. · Industry
Who this trial is looking for
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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
Trial Locations
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Eligibility Criteria
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) ba…
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
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