Phase 1 Brain Cancer Trial, Recruiting NCT05298995 Sponsor: Bambino Gesù Hospital and Research Institute Condition: Brain Cancer
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Phase 1 Brain Cancer Trial, Recruiting

NCT05298995
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People between 6 months and 30 years of age
  • People whose brain tumour can be measured or assessed on at least two dimensions using MRI scans taken at the time of joining the trial
  • People who have had imaging scans done within 14 days before starting treatment
  • People with a functional ability score (a measure of how well someone can carry out daily activities) of at least 60 out of 100 on standard scales used for adults and children
  • People who have recovered sufficiently from side effects of previous radiation or chemotherapy, meaning serious side effects have improved to a mild level, or if ongoing complications exist, the person is considered stable by their treating doctors
  • People who have had a small device surgically placed in the brain to allow fluid access, along with a specific monitoring probe (confirm with trial site for exact device details)
  • People (or their parents or legal guardians) who have given written, signed consent to participate. Children under 18 must have a parent or legal guardian provide consent. Children aged 7 and older will also be asked to give their own written agreement where appropriate
  • People who are able to have their own immune cells collected to make the study treatment, and whose collected cells meet specific quality standards set by the laboratory
  • People who are capable of having children and are willing to use birth control from the time of joining the trial and for four months after receiving the treatment
  • Females who are capable of becoming pregnant must have a negative pregnancy test before joining

Who may not be able to join:

  • Women who are pregnant or breastfeeding
  • People with severe, uncontrolled active infections
  • People with HIV, or active Hepatitis C (HCV) or Hepatitis B (HBV) infection
  • People whose disease is progressing very rapidly and whose life expectancy is less than 6 weeks
  • People who have had a severe allergic reaction (grade 3 or 4) to products containing mouse-derived proteins in the past
  • People whose liver is not functioning adequately, based on specific blood test results being above set limits
  • People whose kidneys are not functioning adequately, based on a specific blood test result being above the set limit for their age
  • People whose blood oxygen level is below 90%
  • People whose heart pumping function (measured by an ultrasound of the heart) is below 45%
  • People whose blood counts are too low — specifically, a type of infection-fighting white blood cell count below 500/mm³, and/or platelet count below 20,000 (not achieved through a transfusion)
  • People with heart failure, irregular heart rhythms, psychiatric illness, or personal or social circumstances that the lead investigator believes would make safe participation in the study too risky or make it difficult to follow study requirements
  • People currently receiving steroid medications unless the dose has been stable or reducing for at least 7 days before treatment (inhaled, topical, or non-absorbed steroids are generally not excluded; confirm with trial site)
  • People who have received systemic chemotherapy within 3 weeks before the planned treatment infusion
  • People who have received immune-suppressing medications within the past 30 days
  • People who have not completed radiation therapy at least 6 weeks before joining
  • People who are currently receiving, or have received within the past 30 days, another experimental anti-cancer treatment
  • People whose specially prepared immune cells (made from their own cells for this trial) do not meet the required quality and safety standards set by the laboratory

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 00396859

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Bambino Gesù Hospital and Research Institute
Registry
ClinicalTrials.gov
Start date
9 November 2023
Est. completion
1 November 2027

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Safety and definition of the MTD/RD

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov