RecruitingPhase 1NCT04510051

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

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

Sponsor

City of Hope Medical Center

Enrollment

18 participants

Start Date

Dec 4, 2020

Study Type

INTERVENTIONAL

Conditions

Malignant Brain Neoplasm Recurrent Malignant Brain Neoplasm Refractory Malignant Brain Neoplasm

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.

Eligibility

Min Age: 4 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study tests a specialized CAR T cell therapy (immune cells engineered to fight cancer) for children with brain tumors that have come back or are not responding to treatment, specifically tumors that carry a protein called IL13Rα2 on their surface. **You may be eligible if...** - You are a child or young adult with a brain tumor that has recurred or has not responded to treatment - Your tumor tests positive for the IL13Rα2 protein - You are well enough to participate (Karnofsky performance status ≥ 60%) - You have adequate organ function (kidney, liver, heart) **You may NOT be eligible if...** - Your tumor does not have the IL13Rα2 target protein - You have uncontrolled infections - You have had a prior organ transplant (other than bone marrow) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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