Actively Recruiting

Phase 1
Age: 2Years - 60Years
All Genders
NCT04196413

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

Led by Stanford University · Updated on 2026-01-26

97

Participants Needed

1

Research Sites

1208 weeks

Total Duration

On this page

Sponsors

S

Stanford University

Lead Sponsor

C

California Institute for Regenerative Medicine (CIRM)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The primary purpose of this study is to test whether CAR T cells targeting GD2 (GD2CART) can be successfully made and safely given to children and adults with H3K27M-mutant diffuse midline glioma (DMG). Eligible subjects may have DMG arising in the pons (called difuse intrinisic pontine glioma, DIPG), the spinal cord, or other areas of the brain such as a thalamus

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of H3K27M mutant diffuse midline glioma (DMG)
  • Confirmed H3K27M or H3K27I mutation by CLIA test
  • Age between 2 and 60 years
  • At least 4 weeks since completing standard radiation therapy
  • At least 3 weeks since chemotherapy or 5 half-lives since prior systemic therapy (except immune checkpoint therapy requiring 3 months)
  • Prior use of Dordaviprone (Modeyso) allowed if stopped at least 5 half-lives before enrollment
  • Karnofsky score 60% or ECOG 0-1 for subjects >16 years; Lansky score 60% for subjects 616 years
  • Normal organ and marrow function with specified blood counts and organ function parameters
  • Negative pregnancy test for females of childbearing potential
  • Willingness to use contraception during study and for 4 months after preparative regimen
  • Ability to give informed consent or assent with legal guardian consent for minors
Not Eligible

You will not qualify if you...

  • Bulky tumor involvement in cerebellar vermis or hemispheres (dose escalation) or bulky disease risking herniation (dose expansion)
  • Significant swallowing dysfunction or medullary dysfunction or high risk of respiratory compromise from cervical cord tumors above C6/7
  • Current systemic corticosteroid use above physiologic replacement
  • Use of dietary supplements, alternative therapies, extreme diets, or unapproved medications
  • Prior CAR T cell therapy
  • Prior immunomodulatory therapy except checkpoint inhibitors with 3-month washout
  • Uncontrolled infections
  • Active HIV, Hepatitis B or C infection (unless viral load undetectable)
  • Significant systemic illness interfering with safety or efficacy assessments
  • Pregnant or breastfeeding women
  • Unlikely to complete all study visits or comply with requirements
  • Known allergies to study agents
  • Primary immunodeficiency or autoimmune disease requiring systemic immunosuppression within 2 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Lucile Packard Children's Hospital (LPCH)

Stanford, California, United States, 94304

Actively Recruiting

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Research Team

A

Ashley Jacobs, RN, BSN

CONTACT

M

Monica Reddy

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

4

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