Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma
Last updated on July 2021Recruitment
- 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