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Clinical Trial Summary

Phase II study to evaluate safety and efficacy of DCP-001 in patients with AML in CR, and with presence of MRD


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03697707
Study type Interventional
Source Mendus
Contact
Status Active, not recruiting
Phase Phase 2
Start date October 15, 2018
Completion date December 2025

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