Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Pancreatic Adenocarcinoma
  • Pancreatic Cancer
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: This is a single-arm, open-label study where all subjects will receive the DC vaccine. The amount of cells in the vaccine will vary based on the cohort determination and dose escalation schema. Six arms are specified to allow differentiation of the cohorts and their respective dose levels.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The primary objective of this phase 1, first in man trial is to determine the safety, toxicity, and feasibility of delivering autologous dendritic cells (DCs) loaded with pancreatic adenocarcinoma lysate plus mRNA to pancreatic cancer patients as adjuvant therapy following completion of standard che...

The primary objective of this phase 1, first in man trial is to determine the safety, toxicity, and feasibility of delivering autologous dendritic cells (DCs) loaded with pancreatic adenocarcinoma lysate plus mRNA to pancreatic cancer patients as adjuvant therapy following completion of standard chemotherapy. Patients will first complete standard treatment for pancreatic adenocarcinoma which is surgically resectable or potentially resectable and then within 3 months of finishing standard treatment, they will have three doses of the dendritic cell vaccine by perinodal injection using ultrasound (US) or computed-tomography (CT) guidance.

Tracking Information

NCT #
NCT04157127
Collaborators
Cancer Cures for Kids
Investigators
Principal Investigator: Benjamin Musher, MD Baylor College of Medicine