8R-70CAR T Cell Therapy for Pediatric High-Grade Glioma and DIPG
This study is testing a new cell therapy called 8R-70CAR T cells for children and young adults with newly diagnosed or recurrent high-grade glioma (a type of brain tumor) and newly diagnosed diffuse intrinsic pontine glioma (DIPG), another type of brain tumor. The 8R-70CAR T cells are made from your own immune cells, modified to target cancer cells that have a specific marker called CD70. Researchers want to see how safe this treatment is and if it can be successfully given to patients. You may be eligible if you are between 4 and 30 years old with one of these conditions, and your tumor has the CD70 marker. The study aims to find the safest dose of 8R-70CAR T cells. The current status of this study is unclear.
- Study design
- This is a Phase 1 study, meaning it's an early study to test safety. It plans to enroll 24 participants.
- What's involved
- You would have blood drawn to collect immune cells before starting standard treatment. After your tumor's CD70 status is confirmed, the 8R-70CAR T cells will be made. You will receive a single intravenous (IV) infusion of 8R-70CAR T cells after lymphodepletion, which is a treatment to prepare your body for the CAR T cells.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main safety outcomes will be measured for 28 days after the 8R-70CAR T cell infusion. The prevalence of participants receiving the treatment will be tracked for up to 18 weeks.
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NCT06946680
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)
Not Yet Recruiting
PHASE1Ages 4–30InterventionalTreatmentUniversity of FloridaInvestigator-initiated
~24 participants
Updated 2026-07-01 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
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of investigational treatment related severe toxicity (Dose-limiting toxicity event)
Measured over administration of 8R-70CAR T to 28 days post-infusion
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- John Ligon, MD · PRINCIPAL_INVESTIGATOR · University of Florida
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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.
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
ALT ≤ 3 times institutional upper limits of normal for age
AST ≤ 3 times institutional upper limits of normal for age
Patients with neurological deficits should have deficits that are stable for a minimum of 7 days prior to enrollment.
Signed parental permission and, as appropriate, assent from pediatric patients age ≥14. If the patient's mental status precludes their informed consent, the legally authorized representative may give informed consent. Consent or permission/assent will be obtained at screening (before PBMC collection) and before treatment with CAR T-cells.
For females with 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 the 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 the study drug.
Prior Therapy for recurrent Cohort only:
Patients with recurrent or progressive disease must have received prior radiotherapy +/- chemotherapy.
Patients must have recovered from the acute treatment related toxicities (≤ Grade 1) prior to enrollment.
Patients must have received their last dose of known myelosuppressive anticancer therapy at least 21 days prior to enrollment. Patients must have received their last dose of non-myelosuppressive chemotherapy at least 7 days prior to enrollment.
Patients must have received their last dose of the investigational or biologic agent ≥ 7 days prior to study enrollment. Monoclonal antibody treatment and agents with known prolonged half-lives: Patient must have received their last dose of the agent ≥ 28 days prior to study enrollment.
Patients with recurrent or progressive HGG must have had their last fraction of:
Craniospinal irradiation, whole brain radiation, total body irradiation or radiation to spine ≥ 6 weeks (42 days) prior to enrollment.
Focal irradiation ≥ 14 days prior to enrollment.
≥ 12 weeks (84 days) since autologous stem cell transplant prior to enrollment.
\> 42 days since completion of any other type of adoptive cellular therapy prior to enrollment
Appropriate bridging therapy (radiation/re-irradiation and/or salvage chemotherapy, dependent on cohort) was initiated within 7 weeks of surgery RT or other protocol directed anti-cancer therapy is without significant toxicity that persisted over 4 weeks.
Early postoperative progression: Patients who progress during radiation treatment that are clinically stable and meet eligibility criteria prior to the start of lymphodepletion may continue on study. If these criteria are not met, these patients will be withdrawn from the study.
Neurologic Status
In patients with neurological deficits, deficits should be stable for a minimum of 7 days prior to the start of treatment. A baseline detailed neurological exam should clearly document the neurological status of the patient prior to the start of treatment.
In patients with seizure disorders, seizures must be well controlled prior to the start of treatment.
Performance Status Karnofsky Performance Scale (KPS for \> 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age) (Appendix C) assessed within one week prior to the start of treatment must be ≥ 60%.
Organ Function Patients must have adequate organ and bone marrow function as defined in Section 3.1.
Pregnancy Testing Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to the start of treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Corticosteroids: A maximum dose of 0.75 mg/kg/day with maximum of 4mg/day.
No active infection: No fever exceeding 38.5 °C and no acute antibiotics, antiviral, or antifungal PO or IV therapy.
Exclusion
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:
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.
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.
What this trial measures
- Incidence of investigational treatment related severe toxicity (Dose-limiting toxicity event)administration of 8R-70CAR T to 28 days post-infusion
Safety is defined as the adverse events (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLT) observed throughout the trial.
- Prevalence of enrolled subjects who receive a qualified immunotherapy investigational product.Enrollment up to 18 weeks
Feasibility will be measured by the number of patients who receive 8R-70CAR T-cell that met the FDA IND defined quality assurance and quality control release criteria. A minimum of 66.7 % of enrolled subjects must achieve this criterion for the feasibility endpoint.
- Maximum tolerated dose (MTD) dose-finding endpoint based on Dose-Limiting-Toxicity (DLT) incidenceadministration of 8R-70CAR T to 28 days post-infusion
Determination of the maximum tolerated dose (MTD) of 8R-70CAR T cells based on the incidence of investigational treatment-related severe toxicity (dose-limiting toxicity events)