Clinical trial · Interventional
Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.
Phase 1 Trial of Celyvir in Children and Adults With Metastatic and Refractory Solid Tumors.
NCT01844661CI-TRIAL-00020990completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Children | — | UNRESOLVED | — |
| Metastases | — | UNRESOLVED | — |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CELYVIR | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CELYVIR
- description
- Patients will received weekly (n=6) IV infusion of Celyvir.
- interventionNames
- Biological: CELYVIR
Primary outcomes (1)
- measure
- Adverse effects after intravenous infusions
- timeFrame
- 48 hours after each infusion
- description
- We will record any sign or symptom that could be related to the infusion of Celyvir.
Secondary outcomes (1)
- measure
- Clinical outcome
- timeFrame
- Up to 2 months after the last infusion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Children: Up to 18 yrs. Refractory to at least 2 previous therapy lines. Life expectancy more than 6 months. Measurable disease. * Adults: 18-75 yrs. Refractory to at least 2 previous therapy lines. ECOG (Eastern Cooperative Oncology Group) \<2. Measurable disease. Exclusion Criteria: * Pregnancy. * Central Nervous System metastasis. * Experimental therapy during the previous month. * Chemotherapy less than 3 weeks previous. * Any organ functionally impaired. * Concurrent infectious disease.
References
Publications (2)
- DERIVEDMorales-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. PMID 33737338
- DERIVEDRuano 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. PMID 32053771