Overview of Clinical Studies
Cytovac has tested the ALECSAT therapy in several clinical trials.
The clinical development program comprises trials in prostate, pancreatic, and glioblastoma multiforme (GBM) brain cancer. Across the completed clinical trials, ALECSAT was generally found to be well tolerated with no serious side effects associated to the ALECSAT treatment. In addition, several cases of an apparent anti-tumor effect have been seen.
Cytovac has been granted Orphan drug designation by both EMA and FDA for treatment of GBM.
For technical and strategic reasons, Cytovac decided to close the first phase II brain cancer study in 2015 and initiate a new and re-designed trial based on advice from the European Medicines Agency (EMA), with the perspective of eventually obtaining regulatory approval in Europe.
In the redesigned phase II trial, the patients receive treatment very early in the course of their disease – preferably shortly after diagnosis onset.
Currently, Cytovac supports an early exploratory phase Ib trial of ALECSAT in Triple Negative Breast (TNBC) cancer patients.
An overview of performed and planned clinical studies:
| Disease indication | Title | Status | |
| CV-001
Phase Ia, |
Prostate cancer | A prospective, open-label, single arm, phase I trial to investigate the safety and tolerability of administering ALECSAT to patients with late stage castration-resistant prostate cancer – a First Dose in Man Study. | Completed |
| CV-002
Phase Ib |
Prostate cancer
Late-stage |
A prospective, open-label, single arm, single center, phase I trial to investigate the safety, tolerability and efficacy of repeated administrations of ALECSAT to patients with late stage castration-resistant prostate cancer. | Completed |
| CV-003
Phase Ib |
Glioblastoma multiforme brain (GMB) cancer
Late-stage |
A prospective open-label, single arm, single center, phase I trial to investigate safety, tolerability and efficacy of repeated administrations of ALECSAT to patients with late stage relapsed GBM; recurrence after both first- and second-line treatments | Completed |
| CV-004
Phase Ib |
Pancreatic-cancer
Late-stage |
A prospective, open-label, two-arm, single center, phase I study to investigate the safety, tolerability and efficacy of repeated administerations of ALECSAT to patients with late stage pancreas cancer; had terminated standard of care treatment due to unacceptable side effects or disease progression,or had declined standard of care. | Completed |
| CV-005
Phase II |
Glioblastoma multiforme brain (GMB) cancer
Late-stage |
A prospective open-label, randomised, two-arm, multi-center phase II trial to investigate the efficacy and safety of repeated administrations of ALECSAT in patients with GMB measured as progression free survival compared to bevacizumab/Irinotecan. | Closed |
| CV-006
Phase II |
Glioblastoma multiforme (GBM) brain cancer
Newly diagnosed |
A prospective, open-label, randomized, two-arm, multiple center, phase II trial to investigate the efficacy and safety of repeated administrations of ALECSAT treatment as an add on therapy to radiotherapy and temozolomide in patients with newly diagnosed GBM. | Closed |
| CV-007
Phase Ib |
Breast Cancer
Triple Negative |
A prospective, open-label, single-arm design, a phase Ib study to investigate the safety, tolerability and trends of efficacy of ALECSAT treatment as an add-on therapy to carboplatin and gemcitabine in patients with locally advanced or metastatic triple-negative breast cancer. | Ongoing |