The aim of this study is to assess the safety and efficacy of AloCELYVIR, which consist in bone marrow-derived allogenic mesenchymal stem cells infected with an oncolytic Adenovirus, ICOVIR-5. It has recently been proven that this type of cells are able of transporting oncolytic substances to tumor targets that are difficult to reach, such as medulloblastomas and gliomas, youth cancers located in the cranial cavity that have a poor prognosis and a fatal outcome. In addition, to exerting an anti-tumor action, this virus has the ability to stimulate the immune response, making the therapy even more effective. Thus, the diffuse intrinsic pontine glioma and the medulloblastoma in relapse/progression have been chosen to study the potential of this new advanced therapy through a weekly infusion for 8 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Mesenchymal allogenic cells + ICOVIR-5: 500.000 cells/kg
Hospital Infantil Universitario Niño Jesús
Madrid, Spain
Dose-Limiting Toxicities rate (DLTs)
Proportion of patients who has experienced a DLT
Time frame: 1 Month
Objective response rate
Percentage of patients that achieve complete response or partial response according to RECIST 1.1 criteria
Time frame: 24 Months
Feasibility of the combination/monotherapy
Rate of patients meeting selection criteria who can receive at least one dose of AloCELYVIR
Time frame: 1 Month
Incidence of treatment-Emergent Adverse Event
Rate of related-AEs
Time frame: 2,5 Months
Progression-free survival (PFS)
Time from the date of first dose of study treatment to the date of progression or death (from ant cause).
Time frame: 24 Months
Overall Survival (OS)
Time from the date of first dose of study treatment to the date of death
Time frame: 24 Months
Antiadenoviral humoral immune response in patients
Anti-Adenovirus serotype 5 antibody titers
Time frame: 2,5 Months
Antiadenoviral tumoral immune response in patients
Number of CD8 antiadenovirus T-lymphocytes
Time frame: 2,5 Months
Replication kinetics of Icovir-5
Quantification of circulating adenoviral particles
Time frame: 2,5 Months
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