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GD2 CAR T Cells for DIPG and Spinal Diffuse Midline Glioma

This study is testing a new treatment called GD2 CAR T cells for people aged 2 to 60 years old with a specific type of brain or spinal cord tumor called H3K27M-mutant diffuse midline glioma (DMG), which includes DIPG. GD2 CAR T cells are your own immune cells that are specially trained to fight the cancer. Before receiving these cells, you would get chemotherapy with fludarabine, cyclophosphamide, and rituximab. The main goals are to see if the GD2 CAR T cells can be successfully made and given safely, and to find the best dose. This study is currently recruiting up to 97 participants.

Study design
This is an interventional study with a planned enrollment of 97 participants. The phase is not specified, and the status is unclear.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures safety at 14 days after your cells are collected and at 28 days after you receive the GD2 CAR T cells.

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

NCT04196413

GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma(DMG)

Recruiting
PHASE1Ages 2–60InterventionalTreatment
Stanford University
~97 participants
Updated 2026-01-26 on ClinicalTrials.gov
What's tested:GD2 CAR T cellsFludarabineCyclophosphamideRituximab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of successful manufacture of GD2CART using a retroviral vector in the Miltenyi CliniMACS Prodigy system
Measured over 14 days after apheresis
+2 more outcomes measured

Conditions

Glioma of Spinal Cord
Glioma of Brainstem

Explore related trials

Diffuse Midline GliomaHistone H3 Lysine 28

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Michelle Monje · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Ashley Jacobs, RN, BSN
[email protected]
650-497-7533
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

At least 4 weeks following completion of standard upfront radiation therapy.
At least 3 weeks post chemotherapy or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy, except for systemic inhibitory/stimulatory immune checkpoint therapy that requires 3 months.
Dordaviprone (Modeyso), previously known as ONC201, may be taken as prior therapy but - just as with other anti-cancer medications - administration must cease at least 5 half-lives prior to enrollment 5. Performance Status:
Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert's syndrome.
Cardiac ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an ECHO, and no clinically significant ECG findings
Baseline oxygen saturation \> 92% on room air 7. Pregnancy Test Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization are not considered to be of childbearing potential) or NA 8. Contraception Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four (4) months after receiving the preparative regimen or for as long as GD2CART cells are detectable in peripheral blood or CSF. 9. Ability to give informed consent. All subjects ≥ 18 years of age must be able to give informed consent. For subjects \<18 years old their legal authorized representative (LAR) (i.e. parent or guardian) must give informed consent. Pediatric subjects will be included in age appropriate discussion and written assent will be obtained for those \> 7 years of age, when appropriate. If a minor becomes of age during participation of this study, he/she will be asked to reconsent as an adult.

Exclusion

HIV,
Hepatitis B (HBsAg positive) or
Hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing. 9. Clinically significant systemic illness or medical condition (e.g. significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the judgement of the principal investigator is likely to interfere with assessment of safety or efficacy of the investigational regimen and its requirements. 10. Women who are pregnant or breastfeeding. 11. In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation. 12. Known sensitivity or allergy to any agents/reagents used in this study. 13. Primary immunodeficiency or history of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
All subject files must include supporting documentation to confirm subject eligibility.

What this trial measures

  • Rate of successful manufacture of GD2CART using a retroviral vector in the Miltenyi CliniMACS Prodigy system14 days after apheresis

    The percentage of apheresis samples (fresh or frozen) will be determined for each dose cohort.

  • Safety of the dose, route and schedule of GD2CART and lymphodepleting chemotherapy in subjects with H3K27M-mutant DMG28 days after infusion

    Incidence and severity of dose limiting toxicities (DLTs) after initial dose of GD2.BB.z.iCasp9-CAR T cells (GD2CART) in each Arm, at each dose level tested by disease cohort

  • Safety of GD2CART at RP2D, route and schedule of GD2CART in expansion cohorts of subjects with H3K27M-mutant DMG28 days after infusion

    Suspected adverse events and serious adverse events following chemotherapy preparative regimen and infusion of GD2CART."