Expanded Access to PCNAT-01 for Patients With Resected Pancreatic Ductal Adenocarcinoma Following Surgical Resection and Adjuvant Therapy

Eligibility for expanded access will be determined on a case-by-case basis by the Sponsor and treating physician. Key criteria may include the following:

Inclusion Criteria

1. Adult patients aged 18 years or older.
2. Histologically confirmed pancreatic ductal adenocarcinoma.
3. Prior R0 or R1 surgical resection of PDAC.
4. Completion of standard adjuvant therapy, unless discontinued early due to intolerable toxicity as permitted after Sponsor and physician review.
5. No evidence of disease recurrence before PCNAT-01 administration.
6. ECOG performance status of 0 or 1, or otherwise acceptable functional status based on treating physician and Sponsor assessment.
7. Adequate organ and marrow function to receive PCNAT-01.
8. Availability of adequate tumor tissue for sequencing and neoantigen identification.
9. Successful identification of sufficient patient-specific neoantigens for PCNAT-01 manufacture.
10. Ability to provide informed consent and comply with expanded access procedures.
11. For patients of reproductive potential, willingness to comply with pregnancy testing and contraception requirements.

Exclusion Criteria

1. Ability to participate in the ongoing PCNAT-01 clinical trial, if trial participation is feasible and appropriate.
2. Evidence of recurrent, metastatic, or unresectable disease before planned PCNAT-01 administration, unless specifically accepted after Sponsor and physician review.
3. Known hypersensitivity or intolerance to PCNAT-01, Poly-ICLC, or any component of the vaccine.
4. Active uncontrolled infection or clinically significant viral infection.
5. Active or suspected autoimmune disease requiring systemic treatment, except protocol-permitted conditions.
6. Immunodeficiency disease, organ transplantation requiring immunosuppression, or chronic systemic immunosuppressive therapy.
7. Clinically significant cardiovascular disease, uncontrolled hypertension, clinically significant arrhythmia, or other uncontrolled medical condition.
8. Recent live or live-attenuated vaccination, recent prohibited anticancer therapy, or recent major surgery within a timeframe considered unsafe by the treating physician and Sponsor.
9. Unresolved clinically significant toxicity from prior anticancer therapy.
10. Pregnancy or breastfeeding.
11. Any condition that, in the opinion of the treating physician or Sponsor, would make expanded access treatment unsafe, interfere with patient monitoring, or compromise the ongoing clinical development program.