Phase 1 Brain Cancer Trial, Recruiting NCT06254326 Sponsor: University of Florida Condition: Brain Cancer
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Phase 1 Brain Cancer Trial, Recruiting

NCT06254326
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 aged 18 years or older, of any gender.
  • Tumor tissue collected during the screening process is available for testing.
  • People who have been diagnosed with a specific type of returning or growing brain tumor called IDH-mutant 1p/19q co-deleted Oligodendroglioma (Grade 2 or Grade 3), and whose tumor has come back more than 12 weeks after finishing radiation treatment.
  • People who have a general health and ability-to-function score at or above a certain level (a measure doctors use called Karnofsky Performance Status of 60 or higher).
  • People who are considered suitable candidates for a surgical procedure or biopsy.
  • People whose blood and organ function results fall within acceptable ranges, including blood cell counts, kidney function, and liver function (the trial site can confirm the specific values required).
  • Women who could potentially become pregnant must have a negative pregnancy blood test at the time of enrolment.
  • People who are able to become pregnant, and their partners, must be willing to use acceptable methods of contraception during the trial.

Who may not be able to join:

  • People whose brain tumor continued to grow or spread while they were being treated with a specific type of drug that targets IDH-1 or IDH-2 mutations.
  • People who have had another type of cancer in the past, unless they have been cancer-free for 3 or more years (skin cancers that are not melanoma may be an exception).
  • People whose brain tumor has spread to certain areas of the brain or to the lining around the brain and spinal cord.
  • People whose brain tumor appears in more than one separate location.
  • People who are taking steroid medications at a dose equivalent to 4mg or more of dexamethasone per day.
  • People who test positive for HIV, Hepatitis B, or Hepatitis C.
  • People who have a known active infection or a condition that weakens the immune system.
  • People who have an autoimmune disease that requires treatment with medications that suppress the immune system.
  • People who are pregnant or breastfeeding, due to possible risks to the developing baby or infant.
  • People who have received another experimental drug or treatment within 30 days before the planned start of this trial.
  • People with serious active health conditions, including but not limited to: unstable heart conditions or heart failure requiring hospitalisation; a heart attack within the last 6 months; a serious bacterial or fungal infection currently requiring intravenous antibiotics; severe lung disease requiring hospitalisation; significant liver failure causing jaundice or blood clotting problems; AIDS as defined by current medical guidelines; or major physical or mental health conditions that, in the doctor's judgement, would prevent safe participation in the trial.

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 15 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: Duane Mitchell, MD, PhD, University of Florida

Phone: 352-273-9000

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
19 September 2024
Est. completion
1 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Prevalence of enrolled subject who receive qualified immunotherapy investigational product.; Incidence of investigational treatment related severe toxicity (Dose-limiting toxicity event) assessed during the period beginning with administration of ex vivo expanded TTRNA T cells through 6 weeks post infusion.

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: 15 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