drugset / Trial / NCT01844661
Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.
Phase 1/2
Completed
20 enrolled
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Instituto de Salud Carlos III · collab
NaSingle-groupOpen-labelTreatment
Summary
The investigators will evaluate the safety of weekly infusions (n=6) of CELYVIR in children and adults with metastatic and refractory solid tumors. CELYVIR consists in bone marrow-derived autologous mesenchymal stem cells (MSCs) infected with ICOVIR5, an oncolytic adenovirus. In addition to data on toxicities the investigators will evaluate clinical response.
Timeline
- Start
- 2013-01
- Primary completion
- 2014-12
- Completion
- 2016-01
Publications
- Morales-Molina A, Gambera S, Leo A, Garcia-Castro J. Combination immunotherapy using G-CSF and oncolytic virotherapy reduces tumor growth in osteosarcoma. J Immunother Cancer. 2021 Mar;9(3):e001703. doi: 10.1136/jitc-2020-001703.
- Ruano D, Lopez-Martin JA, Moreno L, Lassaletta A, Bautista F, Andion M, Hernandez C, Gonzalez-Murillo A, Melen G, Alemany R, Madero L, Garcia-Castro J, Ramirez M. First-in-Human, First-in-Child Trial of Autologous MSCs Carrying the Oncolytic Virus Icovir-5 in Patients with Advanced Tumors. Mol Ther. 2020 Apr 8;28(4):1033-1042. doi: 10.1016/j.ymthe.2020.01.019. Epub 2020 Jan 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CELYVIR | Cell therapy | 500000 cells/kg | Intravenous |
| Subject | CELYVIR | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | CELYVIR | Cell therapy | 2e+06 cells/kg | Intravenous |