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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Autologous DC Therapy
Biological/VaccineAutologous DC Therapy
Treatment groups
18 Participants
are divided into 3 treatment groupsGroup A: Autologous DC Therapy Group B Cohort 1Experimental treatment 1 intervention
Group B: Autologous DC Therapy Group B Cohort 2Experimental treatment 1 intervention
Group C: Autologous DC Therapy Group AExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of DC Therapy
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).
Time frame
From treatment start until 6 weeks after.2
Number of participants who experienced Dose Limiting Toxicities (DLTs)
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.
Time frame
From treatment start until 6 weeks after.Secondary outcomes
1
Recurrence-Free Survival
Measurement of time from resection surgery to recurrence of pancreatic adenocarcinoma.
Time frame
From surgery until recurrence or up to 3 years after surgery, whichever comes first.2
Overall Survival
Measurement of time from resection surgery to death.
Time frame
From surgery until death or up to 3 years after surgery, whichever comes first.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Diakonos Oncology Corporation
Lead sponsor
Baylor College of Medicine
Collaborator
Source ClinicalTrials.gov