AzTrials
AzTrials

Diffuse Intrinsic Pontine GliomaPhase 1/2AloCELYVIRNCT04758533

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

A Phase 1/2 study testing AloCELYVIR in people with Diffuse Intrinsic Pontine Glioma and Medulloblastoma, Childhood, Recurrent, run by Hospital Infantil Universitario Niño Jesús, Madrid, Spain at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 21 years
What is being tested?
AloCELYVIR
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteSpain
Study dates
19 Apr 2021to Apr 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients aged 1 to 21 years.
  • Written informed consent signed by the patients legal representative and, if applicable, the minor (informed consent in patients 12 years of age or older).
  • Measurable or evaluable disease according to RANO criteria.
  • Appropriate functional status, organic function (renal, hepatic) and hematological values:
  • Lanksy and karnofsky functional status ≥50%. Patients who use a wheelchair due of tumor-associated paralysis will be considered as outpatients for functional status evaluation.
  • Haematology function:
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  • Platelet count ≥75.000/µL (without support for 3 days)
  • Absolute neutrophil count (ANC) ≥500/ µL (without growth factor for 3 days)
  • Hemoglobin ≥ 8 g/dL (Transfusion allowed)
  • Liver and renal function
  • Glomerular filtration rate (GFR) (estimated by Schwartz ) >60 mL/min/1.73 m2
  • Total bilirubin ≤ 1.5 × the upper limit of normal (ULN)
  • Transaminases (GOT and GPT) ≤3 × the upper limit of normal (ULN). ≤ 5 times ULN for patients with hepatic metastasis.
  • Patient able to comply with treatment and schedule of visits and assessments
  • Life expectancy of ≥8 weeks.
  • Appropriate contraceptive methods for sexually active males and females of childbearing age
  • Negative pregnancy test in blood or urine for females of childbearing age
  • Patient with new DIPG diagnosis (clinical, radiological, or histological in case a biopsy was performed before being included in the study).
  • Not having received previous treatment with radiotherapy or chemotherapy.
  • Patient able to receive radiotherapy
  • Patient diagnosed with relapsed and/or refractory medulloblastoma. Patients must have received at least surgery, radiation therapy and chemotherapy as part of standard treatment and have failed these treatments before they can participate in this study.
  • To be recovered to ≤ G1 from the toxic effects according to CTCAE derived from the previous treatments, excluding ototoxicity, alopecia and peripheral neurotoxicity.

Who cannot join

  • Previous treatment with CELYVIR or AloCELYVIR.
  • Known active bacterial, viral, fungal or parasitic infection not controlled
  • Known active Hepatitis B or C virus or VIH infection.
  • If patients are treated with corticosteroids, they should be clinically stable and on stable or tapering doses of steroids for at least one week.
  • To be receiving another anti-cancer treatment not foreseen in this protocol or to anticipate receiving it during the patient's participation in the same concomitant with the experimental treatment.
  • Clinically significant or uncontrolled serious active and past systemic diseases that may pose an added risk to the patient
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  • Spontaneous massive intratumoral bleeding. Patients with postoperative bleeding (in case of biopsy or surgery) may be included in the study provided that the bleeding is controlled. The same rule applies for other postoperative complications (infection, loss of cerebrospinal fluid, absence of wound closure, subdural collection ...)
  • Patients who have previously received radiotherapy to the brain stem for another malignancy
  • 1. Washout period respect to previous treatments:
  • At least two weeks since the last dose of chemotherapy. For patients receiving low-dose metronomic oral chemotherapy, this period is at least one week.
  • At least four weeks since the autologous hematopoietic stem cell transplant
  • At least two weeks since the last focal radiotherapy or six weeks in case of cranio-spinal radiotherapy.
  • At least 2 weeks or 5 half-lifes (whichever occurs first) since the last dose of a biological or investigational treatment.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Infantil Universitario Niño Jesús

    Madrid, 28009

Other trials in Spain

About this study

Official title: 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 Pontine Glioma (DIPG) in Combination With Radiotherapy or Medulloblastoma in Relapse/Progression in Monotherapy

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.

Being tested
AloCELYVIR
Keywords
Icovir-5, Mesenchymal stem cells, Medulloblastoma, Diffuse Intrinsic Pontine Glioma
Medical subject headings
Diffuse Intrinsic Pontine Glioma, Medulloblastoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AloCELYVIRBiological

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

Study groups in NCT04758533
Study groupRoleWhat they receive
AloCELYVIRExperimentalPatients will received weekly infusion of AloCELYVIR during 8 weeks.
Receives: Biological: AloCELYVIR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Limiting Toxicities rate (DLTs)

    Proportion of patients who has experienced a DLT

    Measured: 1 Month

Secondary outcomes (8)

  1. Objective response rate

    Percentage of patients that achieve complete response or partial response according to RECIST 1.1 criteria

    Measured: 24 Months

  2. Feasibility of the combination/monotherapy

    Rate of patients meeting selection criteria who can receive at least one dose of AloCELYVIR

    Measured: 1 Month

  3. Incidence of treatment-Emergent Adverse Event

    Rate of related-AEs

    Measured: 2,5 Months

  4. Progression-free survival (PFS)

    Time from the date of first dose of study treatment to the date of progression or death (from ant cause).

    Measured: 24 Months

  5. Overall Survival (OS)

    Time from the date of first dose of study treatment to the date of death

    Measured: 24 Months

  6. Antiadenoviral humoral immune response in patients

    Anti-Adenovirus serotype 5 antibody titers

    Measured: 2,5 Months

  7. Antiadenoviral tumoral immune response in patients

    Number of CD8 antiadenovirus T-lymphocytes

    Measured: 2,5 Months

  8. Replication kinetics of Icovir-5

    Quantification of circulating adenoviral particles

    Measured: 2,5 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2021
  2. Study start19 Apr 2021
  3. Primary completionApr 2026 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open, non-randomized, single-center Phase I clinical trial.
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04758533
Sponsor's protocol ID
FIBHNJ-2020-01
Other IDs
2020-004838-37, 2022-502516-37-00
Acronym
AloCELYVIR
Status last verified
Dec 2024
First submitted
8 Feb 2021
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AloCELYVIR in people with Diffuse Intrinsic Pontine Glioma and Medulloblastoma, Childhood, Recurrent, run by Hospital Infantil Universitario Niño Jesús, Madrid, Spain at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicities rate (DLTs) (time frame: 1 Month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04758533.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.

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