Clinical Trial to Assess the Safety and Efficacy of AloCELYVIR With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) in Combination With Radiotherapy or Medulloblastoma in Monotherapy

Phase 1

Active, not recruiting

• Conditions: Medulloblastoma, Childhood, Recurrent; Diffuse Intrinsic Pontine Glioma
• Interventions: Biological: AloCELYVIR

• Registration Number: NCT04758533
• Lead Sponsor: Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-17
• Study Start: 2021-04-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AloCELYVIR	AloCELYVIR	Patients will received weekly infusion of AloCELYVIR during 8 weeks.

Primary Outcome Measures

Name	Time	Method
Dose-Limiting Toxicities rate (DLTs)	1 Month	Proportion of patients who has experienced a DLT

Secondary Outcome Measures

Name	Time	Method
Objective response rate	24 Months	Percentage of patients that achieve complete response or partial response according to RECIST 1.1 criteria
Feasibility of the combination/monotherapy	1 Month	Rate of patients meeting selection criteria who can receive at least one dose of AloCELYVIR
Progression-free survival (PFS)	24 Months	Time from the date of first dose of study treatment to the date of progression or death (from ant cause).
Antiadenoviral tumoral immune response in patients	2,5 Months	Number of CD8 antiadenovirus T-lymphocytes
Incidence of treatment-Emergent Adverse Event	2,5 Months	Rate of related-AEs
Overall Survival (OS)	24 Months	Time from the date of first dose of study treatment to the date of death
Antiadenoviral humoral immune response in patients	2,5 Months	Anti-Adenovirus serotype 5 antibody titers
Replication kinetics of Icovir-5	2,5 Months	Quantification of circulating adenoviral particles

Trial Locations

Locations (1)

Hospital Infantil Universitario Niño Jesús; 🇪🇸 Madrid, Spain