MIDRIXNEO-LUNG Dendritic Cell Vaccine in Patients With Non-small Cell Lung Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

August 26, 2019

Primary Completion Date

February 1, 2024

Study Completion Date

March 3, 2025

Conditions
Non-small Cell Lung Cancer
Interventions
BIOLOGICAL

Dendritic cell immunotherapy

Intravenous infusions of MIDRIXNEO-LUNG DCs every 2 weeks, using an intra-patient dose escalation scheme progressing along the following range: 10 x10E6 DCs (minimal dose), 20 x 10E6 DCs, 40 x 10E6 DCs, 80 x 10E6 DCs, 100 x 10E6 DCs (maximal dose), until exhaustion of the batch or occurrence of grade ≥3 toxicity event

BIOLOGICAL

Antigen-specific DTH

Intradermal injection of 1 x 10E6 MIDRIXNEO-LUNG DCs at baseline and after completion of all i.v. DC vaccination rounds. This is used for assessment of induction of antigen-specific immune responses as part of in vivo immunomonitoring (delayed-type hypersensitivity cutaneous reaction as test read-out)

BIOLOGICAL

Control DTH

Intradermal injection of 1 x 10E6 MIDRIX-CTRL DCs at baseline and after completion of all i.v. DC vaccination rounds. This is used for assessment of background (i.e. non-antigen-specific) reactivity (delayed-type hypersensitivity cutaneous reaction as test read-out)

Trial Locations (1)

9000

Ghent University Hospital, Ghent

All Listed Sponsors
collaborator

University Ghent

OTHER

collaborator

Kom Op Tegen Kanker

OTHER

lead

University Hospital, Ghent

OTHER

NCT04078269 - MIDRIXNEO-LUNG Dendritic Cell Vaccine in Patients With Non-small Cell Lung Cancer | Biotech Hunter | Biotech Hunter