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RECRUITING
NCT05071846
PHASE1

MVX-ONCO-2 in Advanced Solid Tumors

Sponsor: University Hospital, Geneva

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2024-10-22

Completion Date

2029-10

Last Updated

2025-04-02

Healthy Volunteers

No

Interventions

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.

Locations (1)

Hôpitaux Universitaires de Genève

Geneva, Switzerland