Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma (NCT04157127) | Clinical Trial Compass
RecruitingPhase 1
Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma
United States18 participantsStarted 2020-08-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Adequate kidney, liver, bone marrow function, and immune function, as follows, within 28 days prior to registration:
✓. Total bilirubin ≤ 1.5 times upper limit of normal (ULN),
Exclusion criteria
✕. 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.
✕. Patients with any active autoimmune disease or immune deficiency or previous Guillain-Barre syndrome. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g. patient with psoriatic arthritis are excluded) are eligible provided all of the following conditions are met:
What they're measuring
1
Safety of DC Therapy
Timeframe: From treatment start until 6 weeks after.
2
Number of participants who experienced Dose Limiting Toxicities (DLTs)
Timeframe: From treatment start until 6 weeks after.
✕. Rash that covers less than 10 % of body surface area.
✕. Disease is well controlled at baseline and requires only low-potency topical corticosteroids.
✕. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.
✕. Use of nonstandard neoadjuvant chemotherapy regimen, as determined by the Investigator.