Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Ductal Adenocarcinoma

Laborértékek

• History of chronic comorbidities that would significantly limit participation in the study, including severe heart failure (NYHA Class III-IV), end-stage renal disease, substance dependence, or inadequate venous access, as determined by the investigator.
  • Candidate for curative-intent surgical resection.
  • Surgery within 2 weeks prior to first study treatment.
  • Evidence of hepatic cirrhosis or clinically/radiographically significant ascites.
  • Blood transfusion within 14 days prior to study treatment or requirement for frequent blood transfusions (>2 per month).
  • Treatment with systemically active corticosteroids within 28 days before study treatment (except low-dose dexamethasone ≤2 mg/day or prednisone ≤10 mg/day).
  • Systemic antibiotic therapy within 14 days prior to first dose of Lm-LLO-TT.
  • Receipt of another investigational product or vaccine within 28 days prior to first study treatment.
  • Receipt of any vaccine other than the protocol-required tetanus toxoid booster within 4 weeks before study treatment or during the initial DLT evaluation period.
  • Major surgery, significant traumatic injury, unhealed surgical wounds, or planned surgery requiring general anesthesia within 28 days before study treatment.
  • Active, uncontrolled HIV, hepatitis B, hepatitis C, or HTLV-1 infection, or CD4 count <400 cells/µL.
  • Presence of implanted prosthetic devices, including orthopedic prostheses, pacemakers, or prosthetic heart valves.
  • Chronic immunosuppressive therapy for autoimmune or rheumatologic conditions.
  • Pregnant or breastfeeding individuals.
  • Active uncontrolled bacterial infection requiring intravenous antibiotics, fever >38.1°C, or unexplained fever within 7 days before Day 1.
  • History of Guillain-Barré syndrome within 6 weeks of a previous tetanus toxoid vaccination or prior Arthus-type hypersensitivity reaction to tetanus vaccine.

• Able and willing to provide written informed consent. Adults aged 18 years or older. Histologically confirmed pancreatic ductal adenocarcinoma (PDAC) with measurable disease per RECIST v1.1.
• Previously treated with at least one line of chemotherapy for metastatic or unresectable disease, including a fluoropyrimidine-based or gemcitabine-based regimen, or have a contraindication to these therapies.
• No radiation therapy, targeted therapy, or chemotherapy within 14 days prior to first study treatment; no immunotherapy or biologic therapy within 28 days prior to first study treatment.
• Recovery to ≤ Grade 2 from clinically significant toxicities of prior therapy. ECOG Performance Status 0-2. Estimated life expectancy greater than 3 months. Adequate organ function, including adequate hematologic, hepatic, and renal function.
• Participants with treated brain metastases may be enrolled if clinically stable for at least 1 month.
• Willing to comply with study procedures and contraceptive requirements. Participants with HIV may be enrolled if receiving antiretroviral therapy and CD4 count is >400 cells/µL.
• Participants with hepatitis B may be enrolled if viral load is undetectable and appropriately treated; participants with hepatitis C may be enrolled following curative treatment.
• Demonstrated tetanus toxoid (TT) immune responsiveness, either at baseline or following administration of a tetanus toxoid booster during screening.