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CAR T-cell Therapy

GD2 CAR T Cells for Brain and Spinal Cord Gliomas

Phase 1
Recruiting
Led By Michelle Monje
Research Sponsored by Crystal Mackall, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Disease Status: Tissue diagnosis of H3K27M-mutated Diffuse Intrinsic Pontine Glioma (DIPG) with radiographically evident tumor restricted to the brainstem, OR Tissue diagnosis of H3K27M-mutated Diffuse Midline Glioma (DMG) of the spinal cord
Normal Organ and Marrow Function: Absolute neutrophil count (ANC) ≥ 1,000/uL, Platelet count ≥ 100,000/uL, Absolute lymphocyte count ≥ 150/uL, Hemoglobin ≥ 8 g/dL, Adequate renal, hepatic, pulmonary and cardiac function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ime frame: day 28, 3 months, 6 months, 9 months and 12 months and 24 months post car t cell infusion
Awards & highlights

Study Summary

This trial will test whether T cells can be successfully made from H3K27M-mutant DIPG or DMG patients, in order to better understand and treat these cancers.

Who is the study for?
This trial is for children and young adults aged 2 to 50 with H3K27M-mutant brainstem glioma (DIPG) or spinal cord glioma (DMG), post-radiation therapy, and without recent systemic treatments. US residents who can consent, practice birth control, have a negative pregnancy test if applicable, and have normal organ/marrow function are eligible. Exclusions include uncontrolled infections, certain tumor locations, ongoing corticosteroid use, significant medical conditions that could affect the study's outcome.Check my eligibility
What is being tested?
The trial tests GD2-CAR T cells made from patients' immune cells against DIPG/DMG tumors in the brainstem or spinal cord. It checks if these CAR T cells can be created successfully and includes preparatory chemotherapy with Fludarabine and Cyclophosphamide before introducing the GD2-CAR T cells.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune cell infusion such as fever or chills; effects of chemotherapy like nausea or hair loss; increased risk of infection; fatigue; blood count changes leading to bruising or bleeding risks; and possible damage to organs due to an intense immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a specific type that affects the brainstem or spinal cord and has a certain genetic mutation.
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My blood counts and organ functions are within normal ranges.
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I am over 16 and can care for myself but may not be able to do active work, or I am 16 or under and mostly active.
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I am between 2 and 50 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ime frame: day 28, 3 months, 6 months, 9 months and 12 months and 24 months post car t cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and ime frame: day 28, 3 months, 6 months, 9 months and 12 months and 24 months post car t cell infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD)/RP2D of GD2CART in subjects with H3K27M DIPG
Rate of successful manufacture of GD2CART using a retroviral vector in the Miltenyi CliniMACS Prodigy system
Safety of GD2CART in subjects with spinal H3 K27M-mutant DMG treated at the RP2D
Secondary outcome measures
Measure resolution of toxicity
Overall Survival (OS)
Post-progression survival (PPS)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: GD2-CAR TExperimental Treatment3 Interventions
Rolling-6 dose escalation design will test GD2-CAR T cells in subjects with H3K27M-mutant DIPG. GD2CART will be administered in escalating doses on Day 0 in hospitalized subjects with either DIPG or spinal DMG Intravenously 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%) 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%) 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%)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Crystal Mackall, MDLead Sponsor
4 Previous Clinical Trials
163 Total Patients Enrolled
California Institute for Regenerative Medicine (CIRM)OTHER
64 Previous Clinical Trials
3,103 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,699 Previous Clinical Trials
7,508,445 Total Patients Enrolled

Media Library

GD2 CAR T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04196413 — Phase 1
Brain Stem Glioma Research Study Groups: GD2-CAR T
Brain Stem Glioma Clinical Trial 2023: GD2 CAR T cells Highlights & Side Effects. Trial Name: NCT04196413 — Phase 1
GD2 CAR T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04196413 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining for participants in this research project?

"The trial is open for recruitment, as confirmed on clinicaltrials.gov. This study was initially posted online in June 2020 and has underwent a recent update prior to the end of June 2022."

Answered by AI

Who meets the criteria to be a participant in this experiment?

"To be considered for this clinical trial, patients must have a diagnosis of glioma and possess an age between two to thirty years. Currently 54 participants are being accepted into the study."

Answered by AI

Could you please explain the prior research regarding GD2 CAR T cells?

"Currently, 889 live GD2 CAR T cell trials are underway with 161 at Phase 3. Many of these clinical sites are in Philadelphia yet there is a total of 28443 different trial locations that have opened up to investigate this novel therapy."

Answered by AI

What are the core aims of this clinical research endeavor?

"The primary evaluation criterion of this trial, which is set to be conducted over a period of 14 days following apheresis, revolves around the Maximum Tolerated Dose (MTD)/RP2D of GD2CART in subjects with H3K27M DIPG. Secondary objectives include assessing Radiographic Response Rate via tumor response criteria, Post-progression survival time by measuring OS minus PFS and OS minus Time To Progression (TTP) for patients who have experienced progression respectively, and resolving toxicity levels down to Grade 2 or lower within 72 hours post treatment."

Answered by AI

Is there a risk of adverse effects for patients receiving GD2 CAR T cell treatments?

"As this is a Phase 1 trial, indicating there are limited results related to efficacy and safety, the team at Power assigned GD2 CAR T cells with a score of 1."

Answered by AI

How many participants can the research team accommodate in this experiment?

"Affirmative. Clinicaltrials.gov attests to this medical trial's recruiting efforts, which began on June 4th 2020 and were recently revised on the 22nd of June 2022. The study necessitates 54 participants from a single research centre."

Answered by AI

Is the upper age limit for participants in this trial eighty years or below?

"The eligibility requirements of this trial necessitate that participants are aged between two and 30. There is an abundance of trials for minors (456) as well as the elderly population (903)."

Answered by AI

To what medical conditions do doctors routinely administer GD2 CAR T cells?

"GD2 CAR T cells are most commonly used to treat individuals with multiple sclerosis, yet this immunotherapy can also prove beneficial for those struggling with mixed-cell type lymphoma, leukemia, myelocytic acute and retinoblastoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas(DIPG) & Spinal Diffuse Midline Glioma(DMG)
Crystal Mackall, MD 2020. "GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas(DIPG) & Spinal Diffuse Midline Glioma(DMG)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04196413.
~28 spots leftby Jul 2028
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