Actively Recruiting
Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma
Led by Diakonos Oncology Corporation · Updated on 2025-05-25
18
Participants Needed
3
Research Sites
382 weeks
Total Duration
On this page
Sponsors
D
Diakonos Oncology Corporation
Lead Sponsor
B
Baylor College of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 1, first in human, dose escalation study for safety and feasibility of multi-dose dendritic cell (DC) therapy for pancreatic ductal adenocarcinoma (PDAC) including adenosquamous carcinoma administered after surgical resection of PDAC.
CONDITIONS
Official Title
Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Male or female aged 18 years and older
- Cytological or pathological confirmation of pancreatic adenocarcinoma or adenosquamous carcinoma considered potentially resectable or borderline resectable
- Adequate kidney, liver, bone marrow, and immune function within 28 days prior to registration:
- Hemoglobin 28 8.0 gm/dL
- Absolute neutrophil count 28 1,500 cells/mm3
- Platelet count 28 75,000 /mm3
- Total bilirubin 24 1.5 times upper limit of normal
- AST and ALT 24 2.5 times upper limit of normal
- ECOG performance status 24 2
- Women of childbearing potential must discuss and agree to use highly effective contraception starting 30 days before first vaccination through 12 weeks after last vaccination
- Women of childbearing potential must have a negative serum pregnancy test prior to vaccination
- Males of reproductive potential must use effective contraception during the study and for 12 weeks after last vaccination
- Agree not to donate blood for up to 90 days after last vaccination
You will not qualify if you...
- Unresectable or metastatic (stage IV) pancreatic cancer
- Known HIV infection with positive viral load
- Active hepatitis B or hepatitis C infection (except those with hepatitis B surface antibody positive or hepatitis C antibody positive but RNA negative)
- Active autoimmune disease, immune deficiency, or previous Guillain-Barre syndrome; patients with certain skin conditions eligible if rash covers less than 10% body surface area, disease is well controlled, and no recent acute exacerbations requiring systemic treatment
- Use of nonstandard neoadjuvant chemotherapy regimen
- Pregnant, breastfeeding, or women of childbearing potential without negative pregnancy test or who decline contraception
- Unable or unwilling to comply with protocol or provide informed consent
- Severe or uncontrolled medical conditions affecting study participation, including thyroid disorders, active systemic autoimmune or untreated viral hepatitis
- Chronic use of systemic steroids 2a10 mg/day prednisone equivalent or systemic immunosuppressive agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Baylor College of Medicine Medical Center - McNair Campus
Houston, Texas, United States, 77030
Actively Recruiting
2
Baylor St. Lukes Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
3
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
B
Benjamin Musher, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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