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High-grade GliomaPhase 1Peds IMPACTNCT06946680

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)

A Phase 1 study testing Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells in people with High-grade Glioma and Diffuse Intrinsic Pontine Glioma, run by University of Florida at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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) Read more about this study

Who is it for?
Ages 4 to 30 years
What is being tested?
Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Jan 2027to Dec 2045
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
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  • 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
  • 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
  • Prior to lymphodepletion and therapy:
  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer King, RN contact

352-273-9000

wells-BTC@ufl.edu

United States1 site

  • University of Florida Health Children's Hospital

    Gainesville, Florida, 32608

    Jennifer King, RN, 352-273-9000, wells-BTC@ufl.edu

    John Ligon, MD

Other trials in United States

About this study

Official title: Peds IMPACT: Phase I Study -To Assess 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)

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)

Read the detailed description

Identified newly-diagnosed or recurrent/progressive pediatric CD70+ HGG and newly diagnosed CD70+ DIPG patients (after first 2 HGG patients are treated) will be enrolled in this clinical trial study prior to initiation of standard-of-care chemo-radiation. Prior to initiation of chemoradiation, PBMCs will be collected through peripheral venipuncture. After tumor CD70 status is confirmed, the 8R-70CAR T cell production will start.

4 weeks (+/- 1) post completion of radiation, pediatric patients, based on institutional policy, will initiate adjuvant chemo with dose-intensified TMZ 75-100 mg/m2/day x 21 days for up to 3 cycles. 8R-70CAR T cells will be administered at day 21-24 of the TMZ cycle as a single intravenous (IV) infusion, or for pediatric patients not receiving adjuvant chemo once 8R-70CAR T cells. Pediatric patients will receive lymphodepletion prior to CAR T cell administration.

Being tested
Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells
Keywords
CAR T Cell, Brain Tumor, Brain Cancer, Immunotherapy, Glioblastoma
Medical subject headings
Glioma, Diffuse Intrinsic Pontine Glioma, Brain Neoplasms, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cellsBiological

    Also called 8R-70CAR T cells

    Single dose of 8R-70CAR T cells administered IV

Study groups in NCT06946680
Study groupRoleWhat they receive
Newly Diagnosed High Grade Glioma (ndHGG)ExperimentalParticipants will receive either 8R-70CAR T 1 x 10^7 cells/kg or 1 x 10^8 cells/kg
Receives: Biological: Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells
Recurrent High Grade Glioma (rHGG)ExperimentalParticipants will receive either 8R-70CAR T 1 x 10^7 cells/kg or 1 x 10^8 cells/kg
Receives: Biological: Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells
Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)ExperimentalParticipants will receive either 8R-70CAR T 1 x 10^7 cells/kg or 1 x 10^8 cells/kg
Receives: Biological: Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of investigational treatment related severe toxicity (Dose-limiting toxicity event)

    Safety is defined as the adverse events (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLT) observed throughout the trial.

    Measured: administration of 8R-70CAR T to 28 days post-infusion

  2. Prevalence of enrolled subjects who receive a qualified immunotherapy investigational product.

    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.

    Measured: Enrollment up to 18 weeks

  3. Maximum tolerated dose (MTD) dose-finding endpoint based on Dose-Limiting-Toxicity (DLT) incidence

    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)

    Measured: administration of 8R-70CAR T to 28 days post-infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2025
  2. Study startJan 2027 (estimated)
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2045 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06946680
Sponsor's protocol ID
IRB202600567
Other IDs
OCR41673/IMPACT Trial, IRB202200057-P, PCR50548/Peds IMPACT
Acronym
Peds IMPACT
Status last verified
Oct 2026
First submitted
11 Apr 2025
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells in people with High-grade Glioma and Diffuse Intrinsic Pontine Glioma, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 53 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer King, RN (352-273-9000, wells-BTC@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of investigational treatment related severe toxicity (Dose-limiting toxicity event) (time frame: administration of 8R-70CAR T to 28 days post-infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06946680.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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