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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

NCT04758533 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-12-27

No results posted yet for this study

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.

Conditions

  • Diffuse Intrinsic Pontine Glioma
  • Medulloblastoma, Childhood, Recurrent

Interventions

BIOLOGICAL

AloCELYVIR

Mesenchymal allogenic cells + ICOVIR-5: 500.000 cells/kg

Sponsors & Collaborators

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • Hospital Infantil Universitario Niño Jesús, Madrid, Spain

    lead OTHER

Principal Investigators

  • Álvaro Lassaletta Atienza, MD · Hospital Infantil Universitario Niño Jesús

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04758533 on ClinicalTrials.gov