Phase I Study of Combined Chemotherapy and Cellular Immunotherapy Using IL13Ralpha2-Targeted CAR T Cells for Children and Young Adults With Recurrent or Refractory Malignant Brain Tumors

What this Trial Is About

Researchers are evaluating the side effects of combining chemotherapy and cellular immunotherapy in children and young adults with IL13Ralpha2 positive brain tumors that have returned after improvement or do not respond to treatment. This phase I trial focuses on using specialized immune cells called IL13EQBBzetaCD19t T cells, designed to target brain tumors, alongside chemotherapy drugs cyclophosphamide and fludarabine. The goal is to study the safety and feasibility of this combination treatment in this patient group. Participants receive chemotherapy with cyclophosphamide intravenously on days -5 and -4, and fludarabine intravenously on days -5 to -2. Following chemotherapy, patients are given their own modified immune cells IL13EQBBzetaCD19t T cells by intraventricular delivery once a week for up to four cycles, each administered over five minutes. Additional cycles may be given if the patient remains eligible and doses are available. The study uses a dose-escalation design to evaluate different levels of this cellular immunotherapy. During the trial, participants are closely monitored for side effects for up to one year after their last immune cell infusion. Follow-up visits occur at 30 days, then at 3, 6, 9, and 12 months, and yearly for up to 15 years. Researchers assess immune cell persistence in the blood and cerebrospinal fluid, tumor response, survival rates, and changes in tumor DNA. Safety is the primary focus, including recording any adverse events during and after treatment.

CAR T Cells After Lymphodepletion for the Treatment of IL13Rα2 Positive Recurrent or Refractory Brain Tumors in Children