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ACTIVE NOT RECRUITING
NCT05964361
PHASE1/PHASE2

First-in-human Interleukin-15-transpresenting Wilms' Tumor Protein 1-targeting Autologous Dendritic Cell Vaccination in Cancer Patients

Sponsor: University Hospital, Antwerp

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to investigate a new type of dendritic cell vaccine in patients with refractory or advanced solid tumors of the esophagus, liver, pancreas and ovaries. The main questions it aims to answer are: * is it feasible to produce and administer these dendritic cell vaccines? * is treatment with these dendritic cell vaccines safe? Participants will first need to undergo a leukapheresis procedure to collect the cellular starting material for the dendritic cell vaccine production. The treatment consists of 6 vaccines, administered at biweekly intervals. Participants will be followed-up until 90 days after the last vaccine.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2023-12-06

Completion Date

2025-09-28

Last Updated

2025-04-25

Healthy Volunteers

No

Interventions

BIOLOGICAL

IL15-transpresenting WT1-targeted Dendritic Cell Vaccine

IL15/IL15Ra/WT1 DC vaccines (8-10 x 10\^6 cells in 500 μL saline solution with 5% human albumin) will be administered through intradermal injection at 5 sites (100 μL/site) in the ventromedial region of the upper arm (5-10 cm from the axillary lymph nodes). Injection sites will alternate between left and right arms. WT1/DC vaccines are administered every 2 weeks (+- 3 days) for a total of 6 administrations.

Locations (1)

Antwerp University Hospital

Edegem, Belgium