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Report for Clinical Trial NCT04196413

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase 1 Clinical Trial of Autologous GD2 Chimeric Antigen Receptor (CAR) T Cells (GD2.BB.z.iCasp9-CAR T Cells) for Diffuse Intrinsic Pontine Gliomas (DIPG) and Spinal Diffuse Midline Glioma (DMG)

The primary purpose of this study is to test whether GD2-CAR T cells can be successfully made from immune cells collected from children and young adults with H3K27M-mutant diffuse intrinsic pontine glioma (DIPG) or spinal H3K27M-mutant diffuse midline glioma (DMG). H3K27Mmutant testing will occur as part of standard of care prior to enrollment.

NCT04196413 Glioma of Spinal Cord Glioma of Brainstem
MeSH:Glioma
HPO:Glioma

3 Interventions

Name: GD2 CAR T cells

Description: GD2.BB.z.iCasp9-chimeric antigen receptor (GD2 CAR) retroviral transduced autologous peripheral blood lymphocytes
Type: Drug
Group Labels: 1

GD2-CAR T

Name: Fludarabine

Description: Fludarabine 25 mg/m2 per day IV for days 4, 3, -2
Type: Drug
Group Labels: 1

GD2-CAR T

Name: Cyclophosphamide

Description: Cyclophosphamide 500 mg/m2 per day IV for days 4, 3, -2
Type: Drug
Group Labels: 1

GD2-CAR T


Primary Outcomes

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

Measure: Rate of successful manufacture of GD2.BB.z.iCasp9-CAR T cells using a retroviral vector in the Miltenyi CliniMACS Prodigy system

Time: 14 days after apheris

Description: Severity of dose limiting toxicities (DLTs) following chemotherapy and infusion of GD2.BB.z.iCasp9-CAR T cells, will be recorded and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 at each dose level tested in subjects with H3K27M-mutant DIPG and spinal H3K27M-mutant DMG following standard upfront radiation therapy.

Measure: Maximum tolerated dose (MTD)/RP2D of GD2.BB.z.iCasp9-CAR T cells with H3K27M DIPG or spinal H3 K27M-mutant DMG

Time: 28 days after infusion

Secondary Outcomes

Description: OS is defined as the time from the start of the lymphodepleting chemotherapy preparative regimen to the date of death from any cause

Measure: Overall Survival (OS)

Time: Day 28, 3 months, 6 months, 9 months and 12 months and 24 months post CAR T cell infusion.

Description: 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.

Measure: Progression-Free Survival (PFS)

Time: Day 28, 3 months, 6 months, 9 months and 12 months and 24 months post CAR T cell infusion.

Description: 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)

Measure: Post-progression survival (PPS)

Time: Day 28, 3 months, 6 months, 9 months and 12 months and 24 months post CAR T cell infusion.

Description: Radiographic Response will be evaluated using tumor response criteria: Complete Response (CR): disappearance on MR of all evaluable tumor and mass effect; stable or improving neurologic examination. If CSF was positive, it must be negative. Partial Response (PR): ≥ to 50% reduction in tumor size; stable or improving neurologic examination. Stable Disease (SD): at least stable and maintenance corticosteroid dose not increased, and MR/CT imaging meets neither PR nor PD Progressive Disease (PD): Progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression; OR a > 25% increase in the bi-dimensional measurement, OR the appearance of a new tumor lesion.

Measure: Radiographic Response Rate

Time: Day 28, 3 months, 6 months, 9 months and 12 months and 24 months post CAR T cell infusion.

Description: Resolution of toxicity ≤ grade2, in the event unacceptable toxicity considered possibly, probably or definitely related to GD2.BB.z.iCasp9-CAR T cells within 72 hours

Measure: Measure resolution of toxicity

Time: 72 hours of administration of AP1903

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 K27M

The percentage of apheresis samples (fresh or frozen) will be determined for each dose cohort.. Maximum tolerated dose (MTD)/RP2D of GD2.BB.z.iCasp9-CAR T cells with H3K27M DIPG or spinal H3 K27M-mutant DMG. --- K27M ---



HPO Nodes


HPO: