This expanded access program provides a potential pathway for eligible patients with resected pancreatic ductal adenocarcinoma (PDAC) to receive PCNAT-01, an investigational, personalized tumor neoantigen peptide vaccine, outside of the ongoing clinical trial when participation in the clinical trial is not possible or feasible. PCNAT-01 is intended for use in disease-free patients following surgical resection and completion of standard adjuvant therapy to reduce the risk of recurrence. Access is subject to Sponsor review, regulatory authorization, institutional review board approval, physician oversight, successful patient-specific vaccine manufacture, and confirmation that treatment under expanded access will not interfere with the ongoing clinical development program.
Adult patients aged 18 years or older.
Histologically confirmed pancreatic ductal adenocarcinoma.
Prior R0 or R1 surgical resection of PDAC.
Completion of standard adjuvant therapy, unless discontinued early due to intolerable toxicity as permitted after Sponsor and physician review.
Ability to participate in the ongoing PCNAT-01 clinical trial, if trial participation is feasible and appropriate.
Evidence of recurrent, metastatic, or unresectable disease before planned PCNAT-01 administration, unless specifically accepted after Sponsor and physician review.
Known hypersensitivity or intolerance to PCNAT-01, Poly-ICLC, or any component of the vaccine.
Active uncontrolled infection or clinically significant viral infection.
PCNAT-01
Biological/VaccinePCNAT-01 is an investigational, personalized tumor neoantigen peptide vaccine composed of patient-specific synthetic peptides and Poly-ICLC. Each dose contains 7 to 25 linear neoantigen peptides, 0.3mg/peptide/vial, assigned into 4 predefined peptide pools. PCNAT-01 is administered by subcutaneous injection after surgical resection and completion of standard adjuvant therapy on Days 1, 4, 8, 15, and 22, followed by booster doses at Weeks 12 and 20, for up to 7 total doses. At each visit, the 4 peptide pools are administered as separate subcutaneous injections to fixed anatomical areas: right upper arm, left upper arm, right thigh, and left thigh. For each subject, the peptide pool assigned to each injection area remains consistent across all doses.
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