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IL-8 Receptor-modified CD70 CAR T Cell Therapy for Glioblastoma

This study is testing a new type of immunotherapy called 8R-70CAR T cells for adults with newly diagnosed glioblastoma multiforme (a type of brain cancer). The study aims to see if this treatment is safe and practical to give. You might be able to join if you are between 18 and 80 years old, have newly diagnosed glioblastoma that has a specific marker called CD70, and have had surgery to remove as much of the tumor as possible. The treatment involves a single infusion of your own modified immune cells (T cells). Researchers will check for safety after 28 days and how practical the treatment is after 10 weeks.

Study design
This is a phase I study with a planned enrollment of 39 participants. It uses a dose-escalation design where a small group of participants receives a dose, and if it's safe, the next group might receive a higher dose.
What's involved
You would have blood drawn to collect your immune cells, then receive standard chemotherapy and radiation. After that, you would get a single intravenous (IV) dose of 8R-70CAR T cells.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured 28 days after the infusion, and feasibility will be measured at 10 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05353530

IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Adult Glioblastoma

Recruiting
PHASE1Ages 18–80InterventionalTreatment
University of Florida
~39 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of 8R-70CAR T-cell therapy in adult patients with de novo CD70+ GBM
Measured over 28 days post-infusion
+1 more outcome measured

Conditions

Glioblastoma Multiforme
Glioblastoma

Explore related trials

GlioblastomaCD70 Antigen

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Ashley Ghiaseddin, MD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Phuong Deleyrolle, RN
[email protected]
352-273-5519
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years
Newly-diagnosed de novo GBM based on the absence of previous history of brain tumor (WHO Grade IV glioma) by histopathology or molecular studies. (secondary GBM not eligible)
The tumor must have a supratentorial component
CD70 positive (≥5%, 1+)
Surgical resection of tumors with less than 3cm x 3cm (9 cm2) residual enhancing tumor as a product of longest perpendicular planes by MRI or biopsy only for tumor measuring less than 3cm x 3cm
Karnofsky Performance Status (KPS) of \> 70%
CBC with differential with adequate bone marrow function as defined below:
Absolute neutrophil count (ANC) ≥ 1500 cells/mm3.
Platelet count ≥ 100,000 cells/mm3.
Hemoglobin ≥ 10 g/dl. (The use of transfusion or other intervention to achieve Hgb ≥ 10 g/dl is acceptable.)
BUN ≤ 25 mg/dl
Creatinine ≤ 1.7 mg/dl
Bilirubin ≤ 2.0 mg/dl
ALT ≤ 5 times institutional upper limits of normal for age
AST ≤ 5 times institutional upper limits of normal for age
Signed informed consent. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the legally authorized representative.
For females of childbearing potential, a negative serum pregnancy test at enrollment.
Women of childbearing potential (WOCBP) must be willing to use an acceptable contraceptive method to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug.
Males with female partners of childbearing potential must agree to practice adequate contraceptive methods throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.

Exclusion

Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3years. (In situ cancer are permissible)
Metastases detected below the tentorium or beyond the cranial vault
Leptomeningeal disease beyond the cranial vault. (Focal, adjacent and leptomeningeal involvement is allowable at the discretion of the PI).
Recurrent or multifocal malignant gliomas.
The patient is not a candidate for cellular therapy as assessed by the study bone marrow transplant physician.
Known immunosuppressive disease or human immunodeficiency virus (HIV) infection.
Severe, active co-morbidity, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization.
Transmural myocardial infarction within the last 6 months.
Acute bacterial or fungal infection requiring intravenous antibiotics at the initiation of XRT/TMZ.
Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the initiation of XRT/TMZ.
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
Patients with an autoimmune disease requiring medical management with immunosuppressants.
Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.
Active connective tissue disorders such as lupus or scleroderma that, in the investigator's opinion, place the patient at high risk for radiation toxicity.
Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant.
Patients treated on any other therapeutic clinical protocols within 30 days prior to enrollment.

What this trial measures

  • Safety of 8R-70CAR T-cell therapy in adult patients with de novo CD70+ GBM28 days post-infusion

    Defined as ≤ 1 DLT out of 6 patients is observed at the 1x10\^8 cells/Kg dose. Dose-Limiting toxicity (DLT) will be defined as any adverse event attributable (possible, probable, or definite) to the administration of 8R-70CAR T cells and occurring from the time of infusion through 28 days post-infusion.

  • Feasibility of 8R-70CAR T-cell therapy in adult patients with de novo CD70+ GBM10 weeks

    Feasibility will be defined as the ability to infuse 8R-70CAR T-cell safely in 66.7 % of enrolled patients (patients who signed consent and were deemed eligible for the study).