NCT05071846

MVX-ONCO-2 in Advanced Solid Tumors

An Open Label, Single Arm, Phase I Clinical Study Assessing Safety, Tolerability, and Efficacy of MVX-ONCO-2 in Patients With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

MVX-ONCO-2 is a patient-specific, cell-based, active immunotherapy where the participant's immune response to their own tumor cells is stimulated and/or increased. MVX-ONCO-2 is composed of a cell suspension of irradiated autologous tumor cells and two capsules loaded with allogenic genetically modified cells releasing an immunomodulator, granulocyte-macrophage colony stimulating factor (GM-CSF). MVX-ONCO-2 is an evolution of MVX-ONCO-1, which was approved for clinical investigation under the same category in a phase I and a phase II clinical trials. The objectives of the trial are to investigate the safety, tolerability and signals of efficacy of MVX-ONCO-2 in participants with advanced solid tumors.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
BIOLOGICAL	MVX-ONCO-2	One administration of MVX-ONCO-2 (or vaccination) consists of the implantation of 2 capsules containing MVX-2 cells and 1 injection of 4 × 10\^6 lethally irradiated autologous tumor cells. Tumor cells will have prealably been harvested from the participant through a surgical procedure. A full treatment course with MVX-ONCO-2 consists of a total of 6 vaccinations: 4 vaccinations 1 week apart, followed by 2 boosters 2 weeks apart. Capsules are removed 1 week after implantation.

Timeline

• Start date: 2024-10-22
• Primary completion: 2026-11-01
• Completion: 2029-10-01
• First posted: 2021-10-08
• Last updated: 2026-04-14

Locations

1 site across 1 country: Switzerland