Dendritic Cell Immunotherapy for Pancreatic Cancer After Surgery
This study is testing a new treatment called Autologous DC Therapy for people with pancreatic adenocarcinoma or adenosquamous carcinoma that can be removed by surgery. This therapy uses your own immune cells (dendritic cells) to help your body fight cancer. After surgery, your cells will be collected to create the Autologous DC Therapy. This therapy will then be injected near a lymph node, along with another medication called peg-IFN. The main goal of this study is to see if Autologous DC Therapy is safe and how well people tolerate it. We are looking for about 18 participants who are 18 years or older and have had their pancreatic cancer surgically removed.
- Study design
- This is a Phase 1 study, meaning it's the first time this treatment is being tested in humans. It will involve about 18 participants.
- What's involved
- You would undergo a procedure to collect your cells (apheresis) to make the DC therapy. After the therapy is made, you would receive injections near a lymph node and also peg-IFN. You may have the option for additional doses.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure safety and side effects from the start of treatment until 6 weeks after.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma
At a glance
Conditions
NCT04157127
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Baylor College of Medicine Medical Center - McNair Campus
Houston, Texasstudy coordinator listed
Recruiting
Baylor St. Lukes Medical Center
Houston, Texasstudy coordinator listed
Recruiting
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Benjamin Musher, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Safety of DC TherapyFrom treatment start until 6 weeks after.
To determine the safety (measured by the frequency/duration of adverse events as defined by the Common Terminology Criteria for Adverse Events Version 5.0) and feasibility of delivering autologous dendritic cells loaded with pancreatic adenocarcinoma lysate and mRNA after surgical resection (evaluated by the ease of administering the study drug product proximal to a lymph node near the surgical bed).
- Number of participants who experienced Dose Limiting Toxicities (DLTs)From treatment start until 6 weeks after.
A DLT is defined as any non-hematologic toxicity of grade 3 or 4 by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0) that was probably or definitely DC-therapy related. Certain grade 4 hematologic toxicities that are probably or definitely DC-therapy related are also considered DLTs. Grade 2 or 3 myelosuppression that does not resolve or recover (with supportive measures) to grade 1 within 2 weeks that is probably or definitely DC-vaccine related is also considered a DLT. Grade 2 non-hematologic toxicities that do not resolve or recover (with supportive measures) to grade 1 within 2 weeks that are probably or definitely DC-therapy related are also considered DLTs. Any toxicity, regardless of grade, where systemic steroids are used as supportive care for management that is probably or definitely DC-therapy related is also considered a DLT.