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

ConditionLocally Advanced Pancreatic Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEIR Biotherapies s.r.l.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • RR001

    Drug

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

Treatment groups

9 Participants
are divided into 3 treatment groups
Group A: RR001 Dose Level 1Experimental treatment 1 intervention
Group B: RR001 Dose Level 2Experimental treatment 1 intervention
Group C: RR001 Dose Level 3Experimental treatment 1 intervention

Trial outcomes

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)

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

Secondary outcomes

1

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)
2

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)

Time frame
21 days post RR001 delivery
3

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

Percentage of patient undergoing surgery and percentage of pathological resection

Time frame
At Day 24 post RR001 delivery
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EIR Biotherapies s.r.l.

Lead sponsor

Source ClinicalTrials.gov
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