Phase 1 Brain Cancer Trial, Recruiting NCT04099797 Sponsor: Baylor College of Medicine Condition: Brain Cancer
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Phase 1 Brain Cancer Trial, Recruiting

NCT04099797
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 with a confirmed brain or central nervous system (CNS) tumour that tests positive for a protein called GD2, or has a specific genetic change called H3K27 alteration — this includes newly diagnosed tumours, as well as tumours that have come back, stopped responding to treatment, or are getting worse. Tumour types may include certain high-grade brain tumours (DMG/HGG), medulloblastoma, AT/RT, ependymoma, and related tumours (confirm specific tumour type eligibility with trial site)
  • People whose tumour measures less than 5 cm at its largest point when joining the trial (tumours between 5 and 5.5 cm may still be considered if the tumour was surgically reduced in size)
  • People whose tumour showed some growth after radiation therapy may still be considered, depending on the degree of growth and follow-up scan results (confirm with trial site)
  • People whose tumour can be measured in at least two directions on an MRI scan
  • People aged between 12 months and 25 years
  • People with a functional ability score of at least 50 out of 100 on standard medical scales (or at least 60 for one specific group in the trial), reflecting the ability to carry out daily activities
  • People who have a central line (a type of intravenous access) and a specific device called an Ommaya reservoir or VP shunt already in place, or planned to be placed, for treatment delivery
  • People who completed standard radiation therapy at least 4 weeks before starting the trial treatment (and, if a drug called bevacizumab was used, that treatment must also have been finished at least 4 weeks prior)
  • People whose neurological symptoms (such as movement, speech, or thinking) have been stable for at least 7 days before joining
  • People who are on a stable or reducing dose of steroid medication, with a daily dose of dexamethasone no higher than 0.1 mg per kg of body weight over the 7 days before treatment
  • People whose blood counts, liver function, and kidney function meet specific laboratory thresholds set by the trial (confirm exact values with trial site)

Who may not be able to join:

  • People who are pregnant or breastfeeding
  • People who received another type of immunotherapy treatment within the 42 days before the trial treatment would begin
  • People who received certain blood cell-boosting medications (colony-stimulating factors) within 14 days before a specific part of the trial treatment called lymphodepletion
  • People who are currently receiving any other cancer treatment, or have not waited long enough after finishing prior cancer treatment (the required gap depends on the specific treatment used)
  • People for whom the trial investigators consider the experimental treatment to not be in their best interest due to other health risks

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 28 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

Principal Investigator: Jasia Mahdi, MD, Baylor College of Medicine

Phone: 832-822-1750

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
Registry
ClinicalTrials.gov
Start date
3 February 2020
Est. completion
1 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Dose limiting toxicity (DLT) rate

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: 28 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