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

Conditions

• Glioma of Brainstem
• Glioma of Spinal Cord

Eligibility Criteria

Sex

ALL

Age

2 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• GD2 CAR T cells — DRUG
  Autologous T-Cells transduced with retroviral vector (14g2a-CD8.BB.z.iCasp9) expressing GD2-chimeric antigen receptor
• Fludarabine — DRUG
  Fludarabine 30 mg/m2 per day IV for days -4, -3, -2
• Cyclophosphamide — DRUG
  Cyclophosphamide 500 mg/m2 per day IV for days -4, -3, -2
• Rituximab — DRUG
  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 Details

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

Key Dates

Start date

Jun 4, 2020

Status verified

Dec 2025

Primary completion

Jul 31, 2028

Completion

Jul 31, 2043

Study Design

Enrollment

97 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: ARM A
  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%)
• Experimental: ARM B
  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%)
• Experimental: ARM C
  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%)
• Experimental: ARM D
  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%)

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 ]

Central Contacts

• Ashley Jacobs, RN, BSN
  650-497-7533
  [email protected]
• Monica Reddy
  (650) 736-2690
  [email protected]

Locations (1)

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