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Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

Phase I Study of Th-1 Dendritic Cell Immunotherapy in Combination With Standard Chemotherapy for the Adjuvant Treatment of Pancreatic Adenocarcinoma (DECIST)

NCT04157127•Diakonos Oncology Corporation

View on ClinicalTrials.gov

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.

Detailed Description

The primary objective of this phase 1, first in human trial is to determine the safety, toxicity, and feasibility of delivering autologous DCs loaded with pancreatic adenocarcinoma lysate and mRNA to pancreatic cancer patients following surgery. After having undergone surgical resection of their PDAC (with or without prior neoadjuvant chemotherapy), patients will undergo apheresis for the manufacture of the DC therapy. Once the DC therapy has been manufactured, it will be administered by image-guided injections proximal to a lymph node near the surgical bed with concurrent use of subcutaneous peg-IFN. Patients will have the option to receive additional doses of the DC therapy and peg-IFN if they are eligible and interested.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•An individual must meet all of the following criteria:
•1. Provision of signed and dated informed consent form
•2. Male or female, aged 18 years and older
•3. 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.
•4. Adequate kidney, liver, bone marrow function, and immune function, as follows, within 28 days prior to registration:
•1. Hemoglobin ≥ 8.0 gm/dL
•2. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
•3. Platelet count ≥ 75,000 /mm3
•4. Total bilirubin ≤ 1.5 times upper limit of normal (ULN),
•5. Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 2.5 times the ULN
+5 more criteria

Exclusion Criteria

•An individual who meets any of the following criteria will be excluded from participation in this study:
•1. Unresectable or metastatic (stage IV) pancreatic cancer.
•2. Patients with known HIV and a positive viral load.
•3. 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.
•4. 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:
•1. Rash that covers less than 10 % of body surface area.
•2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids.
•3. 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.
•5. Use of nonstandard neoadjuvant chemotherapy regimen, as determined by the Investigator.
•6. 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.
+3 more criteria

Locations (3)

Baylor College of Medicine Medical Center - McNair Campus

Houston, Texas, United States

Baylor St. Lukes Medical Center

Houston, Texas, United States

Dan L. Duncan Cancer Center at Baylor College of Medicine

Houston, Texas, United States

Key Dates

Start Date

August 3, 2020

Primary Completion Date

June 1, 2026

Completion Date

December 1, 2027

Last Updated

May 25, 2025

Enrollment

ESTIMATED participants

Conditions

Pancreatic AdenocarcinomaPancreatic CancerPancreatic Adenosquamous Carcinoma

Interventions

Autologous DC Therapy

BIOLOGICAL

Contacts

Benjamin Musher, MD

CONTACT

713-798-4292 blmusher@bcm.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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