IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Newly Diagnosed and Recurrent Pediatric High-grade Glioma (pHGG) and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (ndDIPG)

Starting soon · Phase 1

Conditions studied: High-grade Glioma, Diffuse Intrinsic Pontine Glioma

In brief

This is a phase I study to assess the safety and feasibility of IL-8 receptor modified patient-derived activated CD70 CAR T cell therapy in newly diagnosed and recurrent CD70+ Pediatric High-Grade Gliomas (pHGG) and Diffuse Intrinsic Pontine Glioma (ndDIPG)

Key facts

Study ID: NCT06946680
Run by: University of Florida
People needed: 24
Starts: 2026-07-01
Expected to finish: 2045-12-01
Last updated by the study team: 2026-07-01

Who can join

Age: 4 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

At enrollment:
Patients with a histologically confirmed diagnosis of:
Newly diagnosed high-grade glioma (WHO Grade III or IV)
Newly diagnosed DIPG (after first 2 HGG patients are treated)
Recurrent or progressive high-grade glioma
Age 4-18 years old for ndHGG. Age 4-30 for rHGG. Age 4-30 for nd DIPG.
Patients with M+ disease without gliomatosis cerebri (see definition under exclusion criteria) ARE eligible.
Patients with primary spinal cord tumors ARE eligible.
CD70 positive (≥5%, 1+) The tumors from the surgical resection by immunohistochemistry will be confirmed by validated assay performed at UF Health Pathology, CLIA certified Lab.
CD70 tumor expression performed on paraffin-embedded tumor specimens will be evaluated. Tumor expression will be scored on a scale of 0 to 3 staining intensity:
0 = Negative
= Low level
= Moderate level
= High level The criteria for inclusion will be at least 5% of the cells scoring 1+ staining intensity (> 5%, 1+).
Karnofsky Performance Status (KPS, for patients >16yo) or Lansky Performance Score (LPS, for patients ≤16yo) of > 60% (Appendix C)
Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score provided the neurological deficit is stable.
Organ Function:
CBC with differential with adequate bone marrow function as defined below:
Absolute neutrophil count (ANC) ≥ 1000 cells/mm3.
Platelet count ≥ 75,000 cells/mm3. (Unsupported, no transfusion within 4 days.)
Hemoglobin ≥ 8 g/dl. (May receive transfusions)
Adequate renal function as defined below:
Serum creatinine < 1.5 x institutional upper limit of normal for age and gender. Patients who do not meet the criteria but have a 24-hour Creatinine Clearance or GFR (radioisotope or iothalamate) ≥ 70 mL/min/1.73 m2 are eligible.
Adequate hepatic function as defined below:
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) for age

You may not qualify if…

Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease-free for ≥ 3 years. (In situ cancer is permissible)
Spinal metastasis or gliomatosis cerebri. Gliomatosis cerebri - clear tumor involvement of multiple areas (>3 lobes), OR presence of clinical and/or radiographic evidence of impending herniation or spinal cord compression.
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.
HIV-positive patients are ineligible due to the unknown safety and efficacy of infusing these patients with CAR T cells genetically modified using retroviral vectors. Additionally, the immunosuppression used for treatment in this study will pose an unacceptable risk.
Concurrent illness: Patients with active autoimmune disease, documented history of autoimmune disease/syndrome, or any other condition that requires ongoing systemic steroids or systemic immunosuppressive agents, except
Patients with vitiligo or resolved asthma/atopy
Patients with hypothyroidism stable on hormone replacement or Sjogren's syndrome
Patients requiring physiologic doses of corticosteroids (up to 0.5 mg/m2/day dexamethasone equivalent)
History of or ongoing pneumonitis or significant interstitial lung disease.
Ongoing or active uncontrolled infection.
Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator, would compromise the patient's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.
Patients with any of the following cardiac diseases:
New York Heart Association (NYHA) functional class III or IV
Clinically significant cardiac arrhythmia including, but not limited to, Torsade de pointes or requiring a pacemaker
Left ventricular ejection fraction below 50% as determined by echocardiography (ECHO)
Pregnant or lactating women due to possible adverse effects on the developing fetus or infant.
Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.
Patients who have received the last vaccination of a live vaccine ≤ 30 days prior to enrollment are ineligible.
Patients who have received an inactivated virus, peptide, or mRNA vaccine within 14 days of the start of protocol therapy are ineligible.
Inability to participate: Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity of therapy or to adhere to drug administration plan, other study procedures, and study restrictions.
Patients treated on any other therapeutic clinical protocols within 30 days prior to enrollment.
For females of childbearing potential, a negative serum pregnancy test at enrollment.

Where it is running

University of Florida Health Children's Hospital — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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