drugset / Trial / NCT02799238

Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma

NCT02799238 ↗

Phase 2 Completed 62 enrolled CytoVac A/S
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomised, open-label, multi-centre, Phase II study in patients with newly diagnosed glioblastoma. 62 patients with newly diagnosed glioblastoma are enrolled in the study in a 1:2 allocation (standard of care (SOC): ALECSAT as an adjunct therapy to SOC). Patients recruited into this study will receive either: * ALECSAT as an adjunct therapy to standard of care for newly diagnosed glioblastoma (first line therapy: Stupp regimen, followed by second line therapy at the Investigator's discretion) or * Standard of care therapy for newly diagnosed glioblastoma (first line therapy: Stupp regimen, followed by second line therapy at the Investigator's discretion).

Timeline

Start
2016-03
Primary completion
2019-11-14
Completion
2020-02-24

Drugs

EvaluationDrugModalityDoseRoute
Subject ALECSAT Cell therapy — —
Background Temozolomide Small molecule — —

Indications