Phase IB clinical trial to assess the safety, tolerability, and preliminary efficacy of AloCELYVIR (Mesenchymal allogenic cells + ICOVIR-5) in children, adolescent and young adults with newly diagnosed diffuse intrinsic pointine glioma (DIPG) in combination with radiotherapy or medulloblastoma in relapse/progression in monotherapy.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502516-37-00

Acronym

FIBHNJ-2020-01

Enrollment

Registered

2023-03-15

Start date

2021-07-12

Completion date

Unknown

Last updated

2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adolescents and young adults., Newly diagnosed Diffuse Intrinsic Pointine Glioma (DIPG) or Medulloblastoma in relapse/progression in children

Brief summary

Dose-Limiting Toxicities rate

Detailed description

Objective response rate, Rate of patients meeting selection criteria who can receive at least one cycle of Alo-Celyvir, Progression-free survival, Overall survival, To compare the progression-free survival and overall survival of cohort A and B with a historical cohort of newly diagnosed DIPG patients and with a historical cohort of patients with relapse medulloblastoma, Adverse Events Rate, Kinetics of anti-Adenovirus serotype 5 antibody titers, Kinetics of the number of CD8 antiadenovirus T-lymphocytes, Kinetics of circulating adenoviral particles

Interventions

DRUGAloCelyvir

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Dose-Limiting Toxicities rate	—

Secondary

Measure	Time frame
Objective response rate, Rate of patients meeting selection criteria who can receive at least one cycle of Alo-Celyvir, Progression-free survival, Overall survival, To compare the progression-free survival and overall survival of cohort A and B with a historical cohort of newly diagnosed DIPG patients and with a historical cohort of patients with relapse medulloblastoma, Adverse Events Rate, Kinetics of anti-Adenovirus serotype 5 antibody titers, Kinetics of the number of CD8 antiadenovirus T-lymphocytes, Kinetics of circulating adenoviral particles	—

Measure

Time frame

—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026