Phase I/IIa Study: RR001 Administered Following Chemotherapy Cycles for Patients With Locally Advanced Pancreatic Carcinoma

NCT06861452 | Recruiting Phase 1

• 2 other identifiers: SNIPER2024-516019-26-00
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Locally Advanced Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Evaluation of Safety in terms of monitoring of systemic tolerance, Adverse Events (AEs) and severe AEs (SAEs) assess by CTCAE (Version 5.0)

  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

  From Day 1 till RR001 delivery (46-57 days)

• Evaluation of the Efficacy of the Drug Product: Overall response rates (ORR)

  21 days post RR001 delivery

• Evaluation of the Efficacy of the Drug Product: percentage of pathological resection

  At Day 24 post RR001 delivery

• Evaluation of the Efficacy of the Drug Product : Time to progression (TTP) till end of study

  Day 90± 7 days post RR001 delivery

• Evaluation of the Efficacy of the Drug Product : Progression free survival (PFS) till end of study

  Day 90± 7 days post RR001 delivery

Study Arms (3)

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

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

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

Drug: RR001

Interventions

RR001 DRUG

RR001, a cell-based gene therapy administered following administration of chemotherapy (Nab-PTX 125 mg/mq and GEM 1000 mg/mq)

RR001 Dose Level 1; RR001 Dose Level 2; RR001 Dose Level 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• EIR Biotherapies s.r.l.: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria (AOU) Policlinico di Modena

Modena, Italy, 41124, Italy

RECRUITING

Central Study Contacts

Annalisa Fontana

CONTACT

IT + 39 0594223808/0594225165; fontana.annalisa@aou.mo.it

Andrea Spallanzani

CONTACT

IT +39 0594223310/0594225646; spallanzani.andrea@aou.mo.it

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: March 6, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): July 29, 2026
• Study Completion (Estimated): January 29, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

IT (1)