Phase 1 Brain Cancer Trial, Recruiting NCT05353530 Sponsor: University of Florida Condition: Brain Cancer
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Phase 1 Brain Cancer Trial, Recruiting

NCT05353530
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:

  • Adults aged 18 or older
  • People who have been newly diagnosed with a specific type of brain tumour called GBM (Grade IV glioma) for the first time, confirmed by laboratory testing of tumour tissue — people with a secondary form of GBM are not eligible
  • People whose tumour is located in the upper part of the brain (above the brainstem)
  • People whose tumour tissue tests positive for a protein called CD70 (at least 5% of tumour cells must show a low level or higher staining for this protein)
  • People who have had surgery to remove most of the tumour, with no more than a 3cm x 3cm area of visible tumour remaining on an MRI scan, or people who had a biopsy only for a tumour measuring less than 3cm x 3cm
  • People with a reasonable level of physical functioning, as measured by a standard medical scale called the Karnofsky Performance Status (score above 70%)
  • People with adequate bone marrow function, including sufficient white blood cells, platelets, and red blood cells, as confirmed by a blood test
  • People with adequate kidney function, based on specific blood test measurements
  • People with adequate liver function, based on specific blood test measurements
  • People who are able to give signed informed consent, or who have a legally authorised representative who can do so on their behalf
  • Women of childbearing potential who return a negative pregnancy blood test at the time of enrolment
  • Women of childbearing potential who are willing to use an acceptable form of contraception throughout the study and for at least 24 weeks after the last dose of the study treatment
  • Men with female partners of childbearing potential who agree to use adequate contraception throughout the study and for at least 24 weeks after the last dose of the study treatment

Who may not be able to join:

  • People with a history of another invasive cancer (other than certain non-melanoma skin cancers), unless they have been cancer-free for 3 or more years — non-invasive (in situ) cancers are generally permissible
  • People whose cancer has spread to the lower part of the brain or outside the skull
  • People with cancer spread to the membranes surrounding the brain beyond the skull (note: limited nearby spread may be considered at the lead doctor's discretion)
  • People with a recurrent or multiple-site malignant brain tumour
  • People assessed by the study's specialist doctor as not being a suitable candidate for the type of cell-based therapy used in this trial
  • People with a known immune system disease or HIV infection
  • People with serious active health conditions, including any of the following:
    • Unstable chest pain (angina) or heart failure requiring hospitalisation
    • A heart attack within the last 6 months
    • An active serious bacterial or fungal infection requiring intravenous antibiotics at the time treatment would start
    • A severe flare-up of a lung condition, or other breathing problems serious enough to require hospitalisation or prevent participation in the study, at the time treatment would start
    • Serious liver problems causing visible jaundice or blood clotting issues
    • An autoimmune condition that requires treatment with immune-suppressing medications
    • Major medical or mental health conditions that, in the trial doctor's view, would prevent the person from completing the treatment
    • Active connective tissue diseases such as lupus or scleroderma that, in the trial doctor's view, would put the person at high risk of harm from radiation treatment
  • Women who are pregnant or breastfeeding
  • People who have taken part in another treatment-based clinical trial within 30 days before enrolling in this 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 8 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: Ashley Ghiaseddin, MD, University of Florida

Phone: 352-273-5519

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
25 July 2023
Est. completion
1 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety of 8R-70CAR T-cell therapy in adult patients with de novo CD70+ GBM; Feasibility of 8R-70CAR T-cell therapy in adult patients with de novo CD70+ GBM

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: 8 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