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

NCT04196413 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2026-01-26

No results posted yet for this study

Summary

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

  • Glioma of Spinal Cord
  • Glioma of Brainstem

Interventions

DRUG

GD2 CAR T cells

Autologous T-Cells transduced with retroviral vector (14g2a-CD8.BB.z.iCasp9) expressing GD2-chimeric antigen receptor

DRUG

Fludarabine

Fludarabine 30 mg/m2 per day IV for days -4, -3, -2

DRUG

Cyclophosphamide

Cyclophosphamide 500 mg/m2 per day IV for days -4, -3, -2

DRUG

Rituximab

First round: 750 mg/m2 per day IV for days -6 and -5. Subsequent rounds: 750 mg/m2 per day IV for day -5.

Sponsors & Collaborators

  • California Institute for Regenerative Medicine (CIRM)

    collaborator OTHER

  • CureSearch

    collaborator UNKNOWN

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alex's Lemonade Stand Foundation (ALSF)

    collaborator UNKNOWN

  • Parker Institute for Cancer Immunotherapy

    collaborator OTHER

  • Stanford University

    lead OTHER

Principal Investigators

  • Michelle Monje · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-04
Primary Completion
2028-07-31
Completion
2043-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04196413 on ClinicalTrials.gov