Phase II study to evaluate safety and efficacy of DCP-001 in patients with AML in CR, and with presence of MRD
International, multicentre, open-label proof of concept study exploring two different dose groups of the allogeneic dendritic cell vaccine, DCP-001. Cohort 1 consists of 10 patients that will receive 25E6 DCP-001 cells per vaccination and Cohort 2 consists of 10 patients who will receive 50E6 DCP-001 cells per vaccination. All patients will be given two additional booster vaccinations of 10E6 cells. Each patient will be followed up for 12 months after the 4th vaccination. Safety will be monitored throughout the study. Sera and cell samples (blood and bone marrow) will be collected for assessment of efficacy (MRD evaluation) and immune response monitoring.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
allogeneic dendritic cell vaccine
Helsinki University Hospital
Helsinki, Finland
Universitats Klinikum Bonn
Bonn, Germany
Marien Hospital
Düsseldorf, Germany
Universitats Klinikum Leipzig
Leipzig, Germany
minimal residual disease (MRD)
Any change in MRD (flow cytometric) as compared to baseline MRD
Time frame: up to 32 weeks
Treatment emergent adverse events (TEAEs)
adverse event
Time frame: up to 56 weeks
Serious Adverse Events (SAEs)
adverse events
Time frame: up to 56 weeks
Relapse-free survival
efficacy
Time frame: up to 56 weeks
Overall survival
efficacy
Time frame: up to 56 weeks
Immune responses
Any change in immunoreactivity (specific and non-specific) as compared to baseline
Time frame: up to 32 weeks
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Universitätsmedizin Mainz
Mainz, Germany
VUmc
Amsterdam, Netherlands
UMCG
Groningen, Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
Haukeland universitetssjukehus
Bergen, Norway
Uppsala University Hospital
Uppsala, Sweden