At a glance
ClinicalIndex Comparison Record- ✓Histologically-confirmed malignant brain neoplasm with progression after prior conventional therapy
- ✓Radiographic evidence of progression/recurrence >12 weeks after end of initial conventional therapy
- ✓IL13Rα2+ tumor expression by IHC (H-score ≥50) confirmed at initial presentation or recurrent disease
- ✓KPS ≥60% (except mobility loss from disease)
- ✕Requires supplemental oxygen (not expected to resolve within 2 weeks)
- ✕Requires pressor support or has symptomatic cardiac arrhythmias
- ✕Requires dialysis
- ✕Uncontrolled seizure activity or progressive encephalopathy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Study of Cellular Immunotherapy Using Memory Enriched T Cells Lentivirally Transduced to Express an IL13Rα2-Targeting, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Children With Recurrent/Refractory Malignant Brain Tumors
In Brief
A Phase 1 clinical trial evaluating Cyclophosphamide, Fludarabine, and 1 other intervention for Malignant Brain Neoplasm and 2 related conditions. Currently recruiting, targeting 18 participants across 3 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Given IV
Given IV
Given intraventricularly