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NCT04196413 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Glioma of Spinal Cord and Glioma of Brainstem, sponsored by Stanford University.

Recruiting
Registry status
Phase 1
Development phase
97
Enrollment target
1
Study location

NCT04196413: Recruiting Phase 1 study of Glioma of Spinal Cord and Glioma of Brainstem, sponsored by Stanford University.

NCT04196413 is a Phase 1 study of Glioma of Spinal Cord and Glioma of Brainstem that is actively recruiting participants, run by Stanford University. The registered enrollment target is 97 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04196413, a Phase 1 study of Glioma of Spinal Cord and Glioma of Brainstem, is actively recruiting participants, sponsored by Stanford University.

RECRUITING
Registry status
Phase 1
Development phase
97 participants
Enrollment target
1
Study location

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

Primary Outcome

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

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Rituximab
  • DRUG GD2 CAR T cells

Study Locations (1)

California

  • Lucile Packard Children's Hospital (LPCH) - Stanford

Trial Details

FieldValue
Enrollment Target 97 participants
Start Date 2020-06-04
Est. Completion 2043-07-31
Phase Phase 1
Stanford University

1,744 total trials

What NCT04196413 shows while recruiting

NCT04196413 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher).

The record links to 2 conditions, with Glioma of Spinal Cord appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT04196413 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT04196413 about?

NCT04196413 is a clinical study titled "GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma(DMG)". 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...

What is the current status of trial NCT04196413?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2020-06-04. Estimated completion is 2043-07-31.

What conditions does trial NCT04196413 study?

This clinical trial studies the following conditions: Glioma of Spinal Cord, Glioma of Brainstem.

What interventions are being tested in trial NCT04196413?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Rituximab (DRUG), GD2 CAR T cells (DRUG).

Who is sponsoring clinical trial NCT04196413?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04196413 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04196413's enrollment target sits among peer trials

97 598th of 2000 higher than 1,401 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04196413, the US trial registry maintained by the National Library of Medicine. NCT04196413 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.