Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDiakonos Oncology Corporation
About this trial
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.
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form
Male or female, aged 18 years and older
Cytological or pathological confirmation of adenocarcinoma or adenosquamous carcinoma of the pancreas is deemed to be potentially resectable or borderline resectable based on tumor and host factors. This may include patients who undergo upfront resection or those who receive neoadjuvant chemotherapy +/- radiation prior to resection.
Hemoglobin ≥ 8.0 gm/dL
Disqualifiers
Unresectable or metastatic (stage IV) pancreatic cancer.
Patients with known HIV and a positive viral load.
Patients with active HBV and HCV infection. Those who are Hepatitis B sAb positive as well as those who are Hepatitis C Ab positive, but Hepatitis C RNA viral load negative will not be excluded.
Rash that covers less than 10 % of body surface area.
Trial design
Treatments tested in this trial
- Autologous DC Therapy
Treatment groups
18 Participants
are divided into 3 treatment groupsSponsors and collaborators
Diakonos Oncology Corporation
Lead sponsor
Baylor College of Medicine
Collaborator
Source ClinicalTrials.gov