Study of B7-H3, EGFR806, HER2, And IL13-Zetakine (Quad) CAR T Cell Locoregional Immunotherapy For… (NCT05768880) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of B7-H3, EGFR806, HER2, And IL13-Zetakine (Quad) CAR T Cell Locoregional Immunotherapy For Pediatric Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, And Recurrent Or Refractory Central Nervous System Tumors
United States72 participantsStarted 2023-05-05
Plain-language summary
This is a Phase 1 study of central nervous system (CNS) locoregional adoptive therapy with SC-CAR4BRAIN, an autologous CD4+ and CD8+ T cells lentivirally transduced to express to express combinations of B7-H3, EGFR806, HER2, and IL13-zetakine chimeric antigen receptors (CAR). CAR T cells are delivered via an indwelling catheter into the ventricular system in children and young adults with diffuse intrinsic pontine glioma (DIPG), diffuse midline glioma (DMG), and recurrent or refractory CNS tumors.
A child or young adult meeting all eligibility criteria, including having a CNS catheter placed into their ventricular system, and meeting none of the exclusion criteria will have their T cells collected. The T cells will then be bioengineered into a second-generation CAR T cell that target B7H3, EGFR806, HER2, and IL13-zetakine on tumor cells.
Patients will be assigned to 1 of 2 treatment Arms based on the type of their tumor:
* Arm A is for patients with DIPG (meaning primary disease localized to the pons, metastatic disease is allowed) anytime after standard radiation OR after progression.
* Arm B is for patients with non-pontine DMG (meaning DMG in other parts of the brain such as the thalamus or spine) anytime after standard radiation OR after progression. This Arm also includes other recurrent/refractory CNS tumors.
Who can participate
Age range1 Year – 26 Years
SexALL
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Inclusion criteria
✓. Subjects must be age ≥ 1 and ≤ 26 years (except for the first 3 subjects, who must be age ≥ 12 and ≤ 26 years).
✓. Subject disease classified as one of the following:
✓. DIPG at any timepoint following completion of standard radiotherapy
✓. DMG at any timepoint following completion of standard radiotherapy
✓. Evidence of refractory or recurrent CNS disease for which there is no routine therapy, defined by either of the following:
✓. Able to tolerate apheresis or already has an apheresis product available for use in manufacturing
✓. CNS reservoir catheter, such as an Ommaya or Rickham catheter, present in the proper location for CNS-directed therapy delivered as specified for BrainChild-04
✓. Life expectancy ≥ 8 weeks
Exclusion criteria
✕. Presence of ≥ Grade 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention
What they're measuring
1
Manufacturing Feasibility
Timeframe: 42 days
2
Safety of SC-CAR4BRAIN
Timeframe: 28 days post-final SC-CAR4BRAIN infusion