Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma

Recruiting now · Phase 1

Conditions studied: Pancreatic Adenocarcinoma, Pancreatic Cancer, Pancreatic Adenosquamous Carcinoma

In brief

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.

Key facts

Study ID: NCT04157127
Run by: Diakonos Oncology Corporation
People needed: 18
Starts: 2020-08-03
Expected to finish: 2027-12-01
Last updated by the study team: 2025-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

An individual must meet all of the following 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:
Hemoglobin ≥ 8.0 gm/dL
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
Platelet count ≥ 75,000 /mm3
Total bilirubin ≤ 1.5 times upper limit of normal (ULN),
Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 2.5 times the ULN
ECOG performance status ≤ 2.
For women of childbearing potential (WOCBP): use of highly effective contraception must be discussed with participants. NOTE: Patient must agree to start contraception at least 30 days before first vaccination and continue for at least 12 weeks after her last vaccination.
WOCBP must have a negative serum pregnancy prior to vaccination
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 12 weeks following discontinuations of last vaccination.
Patient must agree to not donate blood for up to 90 days after last vaccination.

You may not qualify if…

An individual who meets any of the following criteria will be excluded from participation in this study:
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:
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.
Female patients who are pregnant, breastfeeding, or of childbearing potential without a negative pregnancy test within 28 days (or decline contraception requirements as outlined above). Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
Patients unwilling or unable to comply with the protocol or provide informed consent.
Any severe or uncontrolled medical condition or other condition that could affect participation in this study (in the opinion of the investigator), including but not limited to hyper/hypothyroidism, active systemic autoimmune disorders, untreated viral hepatitis or autoimmune hepatitis.
Requires chronic treatment with a systemic steroid (⩾10 mg/day of prednisone equivalent) or with any systemic immunosuppressive agent.

Where it is running

Baylor College of Medicine Medical Center - McNair Campus — Houston, Texas, United States (enrolling)
Baylor St. Lukes Medical Center — Houston, Texas, United States (enrolling)
Dan L. Duncan Cancer Center at Baylor College of Medicine — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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