IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated

PRIMARY OBJECTIVE: I. To assess the feasibility and safety of lymphodepleting chemotherapy followed by cellular immunotherapy utilizing IL13Ralpha2-specific hinge-optimized 41BB-co-stimulatory chimeric antigen receptor \[CAR\] truncated CD19-expressing autologous T-lymphocytes (IL13\[EQ\]BBzeta/CD19t+ Tn/mem cells) administered by intraventricular (ICV) delivery for pediatric participants with IL13Ralpha2+ recurrent/refractory brain tumors. SECONDARY OBJECTIVES: I.

To describe persistence and expansion of CAR T cells in peripheral blood (PB) and cerebrospinal (CSF). II. To describe cytokine levels (PB, and CSF) over the study period. III. In research participants who receive the full schedule of 4 CAR T cell cycles: IIIa. To estimate 6-month progression free survival (PFS) rate per disease. IIIb. To estimate disease response rates per disease. IIIc. To estimate 1-year overall survival rate per disease. IV.

This phase I trial investigates the side effects of chemotherapy and cellular immunotherapy in treating children with IL13Ralpha2 positive brain tumors that have come back after a period of improvement (recurrent) or do not respond to treatment (refractory). Cellular immunotherapy (IL13(EQ)BBzeta/CD19t+ T cells) are brain-tumor specific cells that may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.

Chemotherapy drugs, such as as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Many patients with brain tumor respond to treatment, but then the tumor starts to grow again. Giving chemotherapy in combination with cellular immunotherapy may kill more tumor cells and improve the outcome of treatment.

Live record on ClinicalTrials.gov →

• Documented informed consent of the participant and/or legally authorized representative.
• Assent, when appropriate, will be obtained per institutional guidelines
• Agreement to allow the use of archival tissue from diagnostic tumor biopsies
• Karnofsky Performance Status (KPS) \>= 60% except for loss of mobility due to disease involvement; e.g., confinement to a wheelchair due to spinal cord compression
• Life expectancy \> 4 weeks
• Participant has a prior histologically-confirmed malignant brain neoplasm and has progressed after prior conventional therapy

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.