Glioma of Spinal CordPhase 1NCT04196413
GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma(DMG)
A Phase 1 study testing GD2 CAR T cells, Fludarabine and Cyclophosphamide in people with Glioma of Spinal Cord and Glioma of Brainstem, run by Stanford University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- Glioma of Spinal Cord, Glioma of Brainstem
- What is being tested?
- GD2 CAR T cells, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2020to 31 Jul 2043
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Disease Status: Diagnosis of H3K27M mutant diffuse midline glioma (DMG)
- H3K27M or H3K27I mutation. Confirmed by CLIA test.
- Age: Greater than or equal to 2 year of age and less than or equal to 60 years of age.
- Prior Therapy:
- 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.
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- 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
- Performance Status:
- Subjects > 16 years of age: Karnofsky ≥ 60% OR Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Subjects ≤ 16 years of age: Lansky scale ≥ 60%.
- Subjects who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
- Normal Organ and Marrow Function (supportive care is allowed per institutional standards, i.e. filgrastim, transfusion) i. ANC ≥ 1000/uL ii. Platelet count ≥ 100,000/uL iii. Absolute lymphocyte count ≥ 150/uL iv. Hemoglobin ≥ 8 g/dL v. Adequate renal, hepatic, pulmonary and cardiac function defined as:
- Creatinine within institutional norms for age (i.e.
- ≤ 2 mg/dL in adults or according to table below in children <18 years) OR creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 60 mL/min
- Serum ALT/AST ≤ 3.0 ULN (grade 1)
- 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
- 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
- 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.
- 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.
Who cannot join
- For Dose Escalation: Bulky tumor involvement of cerebellar vermis or hemispheres (pontocerebellar peduncles involvement is acceptable), or thalamic lesions that in the investigator's assessment place the subject at unacceptable risk for herniation.
- For Dose Expansion: Bulky disease that in the investigator's assessment place the subject at unacceptable risk for herniation. Thalamic DMG is permitted.
- Clinically significant swallowing dysfunction/dysphagia or prominent medullary dysfunction, as determined by the clinical investigator; or primary cervical cord tumors above C6/7 that represent a high risk of respiratory compromise, as determined by the clinical investigator.
- Current systemic corticosteroid therapy above physiologic replacement levels.
- Ongoing use of dietary supplements, alternative therapies or extreme diet modifications or any medication not approved by the investigators
- Prior CAR therapy.
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- Prior immunomodulatory therapy, except for checkpoint inhibitor therapy after at least 3 month wash-out.
- Uncontrolled fungal, bacterial, viral, or other infection. Previously diagnosed infection for which the patient continues to receive antimicrobial therapy is permitted if responding to treatment and clinically stable.
- Diagnosed ongoing infection with:
- 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.
- 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.
- Women who are pregnant or breastfeeding.
- 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.
- Known sensitivity or allergy to any agents/reagents used in this study.
- 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.
- The method of confirmation can include, but is not limited to, laboratory test results, radiology test results, subject self-report, and medical record review.
- Anyone under 26, please contact Ashley Jacobs and anyone 26 and older, please contact Monica Reddy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lucile Packard Children's Hospital (LPCH)
Stanford, California, 94304
Ashley Jacobs, 650-497-7533, GD2CART@stanfordchildrens.org
Monica Reddy, (650) 736-2690, secure-sci-cto-neuro-crcs-nio@lists.stanford.edu
About this study
Official title: Phase 1 Clinical Trial of Autologous GD2 Chimeric Antigen Receptor (CAR) T Cells (GD2CART) for H3K27M-mutant 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), the spinal cord, or other areas of the brain such as a thalamus
Read the detailed description
Primary Objectives:
- Determine the feasibility of manufacturing autologous T cells transduced with 14g2a-CD8-BBz-iCasp9 retroviral vector expressing GD2 Chimeric Antigen Receptor (GD2CART) for administration in subjects with H3K27M-mutant diffuse midline glioma (DMG) using a retroviral vector and dasatinib in the Miltenyi CliniMACS Prodigy® system.
- Assess the safety and identify the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), route and schedule of GD2CART and lymphodepleting chemotherapy in subjects with H3K27M-mutant DMG.
- Assess the safety of the MTD/RP2D, route and schedule of GD2CART in expansion cohorts of subjects with H3K27M-mutant DMG.
Secondary Objectives:
- In a preliminary manner, assess clinical benefit and Patient Reported Outcomes (PROs) of GD2CART at the RP2D in children and adults with H3K27M-mutant DMG.
- Evaluate the safety and impact on clinical benefit of repeat intracerebroventricular (ICV) administrations of GD2CART according to Arms A, B, C or D.
- If unacceptable toxicity occurs that is possibly, probably or likely related to GD2CART, assess the capacity for AP1903, a dimerizing agent, to mediate clearance of the genetically engineered cells and resolve toxicity.
- Conditions
- Glioma of Spinal Cord, Glioma of Brainstem
- Being tested
- GD2 CAR T cells, Fludarabine, Cyclophosphamide, Rituximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GD2 CAR T cellsDrug
Autologous T-Cells transduced with retroviral vector (14g2a-CD8.BB.z.iCasp9) expressing GD2-chimeric antigen receptor
FludarabineDrug
Fludarabine 30 mg/m2 per day IV for days -4, -3, -2
CyclophosphamideDrug
Cyclophosphamide 500 mg/m2 per day IV for days -4, -3, -2
RituximabDrug
First round: 750 mg/m2 per day IV for days -6 and -5. Subsequent rounds: 750 mg/m2 per day IV for day -5.
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Experimental | GD2CART will be administered on Day 0 in hospitalized subjects with either DIPG or spinal DMG
Intravenously, after conditioning lymphodepletion chemotherapy regimen with cyclophosphamide and fludarabine
* Dose Level -1: 3x10^5 transduced T cells/kg(± 20%)
* Dose Level 1: 1x10^6 transduced T cells/kg (± 20%)
* Dose Level 2: 3x10^6 transduced T cells/kg (± 20%) Receives: Drug: GD2 CAR T cells; Drug: Fludarabine; Drug: Cyclophosphamide |
| ARM B | Experimental | GD2CART will be administered on Day 0 in hospitalized subjects with either DIPG or spinal DMG
Intracerebroventricularly, without conditioning lymphodepletion chemotherapy
* Dose Level -1: 10x10^6 transduced T cells (±20%)
* Dose Level 1: 30x10^6 transduced T cells (±20%)
* Dose Level 2: 50x10^6 transduced T cells (±20%)
* Dose Level 3: 100x10^6 transduced T cells (±20%) Receives: Drug: GD2 CAR T cells |
| ARM C | Experimental | GD2CART will be administered in escalating doses on Day 0 in hospitalized subjects with either DIPG or spinal DMG
Intracerebroventricularly after administration of conditioning lymphodepletion chemotherapy regimen with cyclophosphamide and fludarabine
* Dose Level -1: 10x10^6 transduced T cells (±20%)
* Dose Level 1: 30x10^6 transduced T cells (±20%)
* Dose Level 2: 50x10^6 transduced T cells (±20%) Receives: Drug: GD2 CAR T cells; Drug: Fludarabine; Drug: Cyclophosphamide |
| ARM D | Experimental | GD2CART will be administered in escalating doses on Day 0 in hospitalized subjects with either DIPG, spinal DMG, or high risk features.
Intracerebroventricularly after administration of conditioning lymphodepletion chemotherapy regimen with rituximab, cyclophosphamide and fludarabine
* Dose Level -1: 10x10^6 transduced T cells (±20%)
* Dose Level 1: 30x10^6 transduced T cells (±20%)
* Dose Level 2: 50x10^6 transduced T cells (±20%) Receives: Drug: GD2 CAR T cells; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful manufacture of GD2CART using a retroviral vector in the Miltenyi CliniMACS Prodigy system
The percentage of apheresis samples (fresh or frozen) will be determined for each dose cohort.
Measured: 14 days after apheresis
Safety of the dose, route and schedule of GD2CART and lymphodepleting chemotherapy in subjects with H3K27M-mutant DMG
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
Measured: 28 days after infusion
Safety of GD2CART at RP2D, route and schedule of GD2CART in expansion cohorts of subjects with H3K27M-mutant DMG
Suspected adverse events and serious adverse events following chemotherapy preparative regimen and infusion of GD2CART."
Measured: 28 days after infusion
Secondary outcomes (5)
Radiographic Response Rate
Radiographic Response will be evaluated using the RANO 2.0 tumor response criteria.
Measured: Time Frame: Day 28, 3 months, 6 months, 9 months and 12 months and 24 months post CAR T cell infusion.
Overall Survival (OS)
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.
Measured: Time Frame: Day 28, 3 months, 6 months, 9 months and 12 months and 24 months post CAR T cell infusion.
Progression-Free Survival (PFS)
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.
Measured: Time Frame: Day 28, 3 months, 6 months, 9 months and 12 months and 24 months post CAR T cell infusion
Post-progression survival (PPS)
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)
Measured: ime Frame: Day 28, 3 months, 6 months, 9 months and 12 months and 24 months post CAR T cell infusion
Measure resolution of toxicity
Resolution of toxicity ≤ grade2, in the event unacceptable toxicity considered possibly, probably or definitely related to GD2CART cells within 72 hours
Measured: 72 hours of administration of AP1903
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start4 Jun 2020
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma of Spinal CordStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- California Institute for Regenerative Medicine (CIRM), CureSearch, National Cancer Institute (NCI), Alex's Lemonade Stand Foundation, Parker Institute for Cancer Immunotherapy
- Responsible party
- Sponsor
- Investigators
- Michelle Monje, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196413
- Sponsor's protocol ID
- IRB-52934
- Other IDs
- PEDSCCT6005, NCI-2020-05891, 5R01CA263500-05
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2019
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial of Autologous GD2 Chimeric Antigen Receptor (CAR) T Cells (GD2CART) for H3K27M-mutant Diffuse Midline Glioma (DMG)
- ClinicalTrials.gov ID
- NCT04196413
- Acronym / sponsor ID
- IRB-52934
- Conditions
- Glioma of Spinal Cord, Glioma of Brainstem
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- California Institute for Regenerative Medicine (CIRM), CureSearch, National Cancer Institute (NCI), Alex's Lemonade Stand Foundation, Parker Institute for Cancer Immunotherapy
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2043 (estimated)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Primary Objectives:
- Determine the feasibility of manufacturing autologous T cells transduced with 14g2a-CD8-BBz-iCasp9 retroviral vector expressing GD2 Chimeric Antigen Receptor (GD2CART) for administration in subjects with H3K27M-mutant diffuse midline glioma (DMG) using a retroviral vector and dasatinib in the Miltenyi CliniMACS Prodigy® system.
- Assess the safety and identify the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), route and schedule of GD2CART and lymphodepleting chemotherapy in subjects with H3K27M-mutant DMG.
- Assess the safety of the MTD/RP2D, route and schedule of GD2CART in expansion cohorts of subjects with H3K27M-mutant DMG.
Secondary Objectives:
- In a preliminary manner, assess clinical benefit and Patient Reported Outcomes (PROs) of GD2CART at the RP2D in children and adults with H3K27M-mutant DMG.
- Evaluate the safety and impact on clinical benefit of repeat intracerebroventricular (ICV) administrations of GD2CART according to Arms A, B, C or D.
- If unacceptable toxicity occurs that is possibly, probably or likely related to GD2CART, assess the capacity for AP1903, a dimerizing agent, to mediate clearance of the genetically engineered cells and resolve toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ARM A | Experimental | Drug: GD2 CAR T cells, Drug: Fludarabine, Drug: CyclophosphamideGD2CART will be administered on Day 0 in hospitalized subjects with either DIPG or spinal DMG Intravenously, after conditioning lymphodepletion chemotherapy regimen with cyclophosphamide and fludarabine * Dose Level -1: 3x10^5 transduced T cells/kg(± 20%) * Dose Level 1: 1x10^6 transduced T cells/kg (± 20%) * Dose Level 2: 3x10^6 transduced T cells/kg (± 20%) |
| ARM B | Experimental | Drug: GD2 CAR T cellsGD2CART will be administered on Day 0 in hospitalized subjects with either DIPG or spinal DMG Intracerebroventricularly, without conditioning lymphodepletion chemotherapy * Dose Level -1: 10x10^6 transduced T cells (±20%) * Dose Level 1: 30x10^6 transduced T cells (±20%) * Dose Level 2: 50x10^6 transduced T cells (±20%) * Dose Level 3: 100x10^6 transduced T cells (±20%) |
| ARM C | Experimental | Drug: GD2 CAR T cells, Drug: Fludarabine, Drug: CyclophosphamideGD2CART will be administered in escalating doses on Day 0 in hospitalized subjects with either DIPG or spinal DMG Intracerebroventricularly after administration of conditioning lymphodepletion chemotherapy regimen with cyclophosphamide and fludarabine * Dose Level -1: 10x10^6 transduced T cells (±20%) * Dose Level 1: 30x10^6 transduced T cells (±20%) * Dose Level 2: 50x10^6 transduced T cells (±20%) |
| ARM D | Experimental | Drug: GD2 CAR T cells, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: RituximabGD2CART will be administered in escalating doses on Day 0 in hospitalized subjects with either DIPG, spinal DMG, or high risk features. Intracerebroventricularly after administration of conditioning lymphodepletion chemotherapy regimen with rituximab, cyclophosphamide and fludarabine * Dose Level -1: 10x10^6 transduced T cells (±20%) * Dose Level 1: 30x10^6 transduced T cells (±20%) * Dose Level 2: 50x10^6 transduced T cells (±20%) |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (20 listed)
- Disease Status: Diagnosis of H3K27M mutant diffuse midline glioma (DMG)
- H3K27M or H3K27I mutation. Confirmed by CLIA test.
- Age: Greater than or equal to 2 year of age and less than or equal to 60 years of age.
- Prior Therapy:
- Performance Status:
Key exclusion criteria (20 listed)
- For Dose Escalation: Bulky tumor involvement of cerebellar vermis or hemispheres (pontocerebellar peduncles involvement is acceptable), or thalamic lesions that in the investigator's assessment place the subject at unacceptable risk for herniation.
- For Dose Expansion: Bulky disease that in the investigator's assessment place the subject at unacceptable risk for herniation. Thalamic DMG is permitted.
- Clinically significant swallowing dysfunction/dysphagia or prominent medullary dysfunction, as determined by the clinical investigator; or primary cervical cord tumors above C6/7 that represent a high risk of respiratory compromise, as determined by the clinical investigator.
- Current systemic corticosteroid therapy above physiologic replacement levels.
- Ongoing use of dietary supplements, alternative therapies or extreme diet modifications or any medication not approved by the investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GD2 CAR T cellsAutologous T-Cells transduced with retroviral vector (14g2a-CD8.BB.z.iCasp9) expressing GD2-chimeric antigen receptor | Drug | ARM A, ARM B, ARM C, ARM D |
| FludarabineFludarabine 30 mg/m2 per day IV for days -4, -3, -2 | Drug | ARM A, ARM C, ARM D |
| CyclophosphamideCyclophosphamide 500 mg/m2 per day IV for days -4, -3, -2 | Drug | ARM A, ARM C, ARM D |
| RituximabFirst round: 750 mg/m2 per day IV for days -6 and -5. Subsequent rounds: 750 mg/m2 per day IV for day -5. | Drug | ARM D |
Primary outcome
Rate of successful manufacture of GD2CART using a retroviral vector in the Miltenyi CliniMACS Prodigy system
Time frame: 14 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 DMG
Time frame: 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
Safety of GD2CART at RP2D, route and schedule of GD2CART in expansion cohorts of subjects with H3K27M-mutant DMG
Time frame: 28 days after infusion
Suspected adverse events and serious adverse events following chemotherapy preparative regimen and infusion of GD2CART."
5 secondary outcomes
Radiographic Response Rate
Time frame: Time Frame: Day 28, 3 months, 6 months, 9 months and 12 months and 24 months post CAR T cell infusion.
Overall Survival (OS)
Time frame: Time Frame: Day 28, 3 months, 6 months, 9 months and 12 months and 24 months post CAR T cell infusion.
Progression-Free Survival (PFS)
Time frame: Time Frame: Day 28, 3 months, 6 months, 9 months and 12 months and 24 months post CAR T cell infusion
Post-progression survival (PPS)
Time frame: ime Frame: Day 28, 3 months, 6 months, 9 months and 12 months and 24 months post CAR T cell infusion
Measure resolution of toxicity
Time frame: 72 hours of administration of AP1903
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Monje principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GD2 CAR T cells, Fludarabine and Cyclophosphamide in people with Glioma of Spinal Cord and Glioma of Brainstem, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Jacobs, RN, BSN (650-497-7533, gd2cart@stanfordchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful manufacture of GD2CART using a retroviral vector in the Miltenyi CliniMACS Prodigy system (time frame: 14 days after apheresis). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.