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RECRUITING
NCT04510051
PHASE1

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

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

4 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2020-12-04

Completion Date

2027-02-24

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

BIOLOGICAL

IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes

Given intraventricularly

Locations (3)

City of Hope Medical Center

Duarte, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

C.S. Mott Children's Hospital, University of Michigan

Ann Arbor, Michigan, United States