Trial · NCT04196413
GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma(DMG)
NCT04196413, Phase 1, Recruiting, Stanford University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma(DMG). Trials, record NCT04196413. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04196413
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma(DMG)
- NCT number
- NCT04196413
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 97 participants, estimated
- Lead sponsor
- Stanford University
- Conditions
- Glioma of Spinal Cord, Glioma of Brainstem
- Interventions
- GD2 CAR T cells, Fludarabine, Cyclophosphamide, Rituximab
- First posted
- 2019-12-12
- Last updated
- 2026-01-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of successful manufacture of GD2CART using a retroviral vector in the Miltenyi CliniMACS Prodigy system | 14 days after apheresis | The percentage of apheresis samples (fresh or frozen) will be determined for each dose cohort. |
| Primary | Safety of the dose, route and schedule of GD2CART and lymphodepleting chemotherapy in subjects with H3K27M-mutant DMG | 28 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 |
| Primary | Safety of GD2CART at RP2D, route and schedule of GD2CART in expansion cohorts of subjects with H3K27M-mutant DMG | 28 days after infusion | Suspected adverse events and serious adverse events following chemotherapy preparative regimen and infusion of GD2CART." |
| Secondary | Radiographic Response Rate | Time Frame: Day 28, 3 months, 6 months, 9 months and 12 months and 24 months post CAR T cell infusion. | Radiographic Response will be evaluated using the RANO 2.0 tumor response criteria. |
| Secondary | Overall Survival (OS) | Time Frame: Day 28, 3 months, 6 months, 9 months and 12 months and 24 months post CAR T cell infusion. | Overall survival (OS) is defined as the time from date of initial diagnosis to date of death from any cause. Treatment OS is defined as the time from Cycle 1 Day 0 to date of death from any cause. |
| Secondary | Progression-Free Survival (PFS) | Time Frame: Day 28, 3 months, 6 months, 9 months and 12 months and 24 months post CAR T cell infusion | PFS is defined as the time from the start of the lymphodepleting chemotherapy preparative regimen to the date of radiographic progression or death from any cause. |
| Secondary | Post-progression survival (PPS) | ime Frame: Day 28, 3 months, 6 months, 9 months and 12 months and 24 months post CAR T cell infusion | PPS is measured for each subject with DIPG as OS minus PFS, and for each patient with recorded progression as OS minus Time to Progression (TTP) |
| Secondary | Measure resolution of toxicity | 72 hours of administration of AP1903 | Resolution of toxicity ≤ grade2, in the event unacceptable toxicity considered possibly, probably or definitely related to GD2CART cells within 72 hours |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01CA263500 | Developing Safe and Effective GD2-CAR T Cell Therapy for Diffuse Midline Gliomas | MACKALL, CRYSTAL; MONJE-DEISSEROTH, MICHELLE | STANFORD UNIVERSITY | NATIONAL CANCER INSTITUTE | 2021 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04196413
GET https://conductscience.org/api/trials/v1/NCT04196413/registered