OncoMatch/Clinical Trials/NCT04510051
CAR T Cells After Lymphodepletion for the Treatment of IL13Rα2 Positive Recurrent or Refractory Brain Tumors in Children
Is NCT04510051 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes and Cyclophosphamide for malignant brain neoplasm.
Treatment: Cyclophosphamide · Fludarabine · IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Glioblastoma
Biomarker criteria
Required: IL13RA2 positive (IHC H-score >= 50)
COH clinical pathology confirms IL13Ralpha2+ tumor expression by immunohistochemistry (IHC) at the initial tumor presentation or recurrent disease (H-score >= 50)
Demographics
Prior therapy
Lab requirements
Blood counts
Platelets >= 50,000/mm^3; WBC >= 2,000/dL; ANC >= 1,000; Platelets > 50,000/dL
Kidney function
Creatinine clearance >= 75 mL/min/1.73m^2; serum creatinine < 1.6 mg/dL; serum creatinine < 1.8 mg/dL
Liver function
Total bilirubin <= 2 x ULN (unless Gilbert's disease); AST/ALT <= 2 x ULN
Cardiac function
Does not require pressor support and/or does not have symptomatic cardiac arrhythmias
Platelets >= 50,000/mm^3 ... Total bilirubin <= 2 X ULN ... AST <= 2 x ULN ... ALT <= 2 x ULN ... Creatinine clearance of >= 75mL/min/1.73m^2 ... Serum creatinine < 1.6 mg/dL ... WBC >= 2,000/dL ... ANC >= 1,000 ... Platelets > 50,000/dL ... INR <= 1.3 ... Bilirubin < 1.5 mg/dL ... ALT and AST < 2 x upper limits of normal ... KPS >= 60% ... Pulmonary: does not require supplemental oxygen ... Cardiac: does not require pressor support and/or does not have symptomatic cardiac arrhythmias
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
- Children's Hospital Los Angeles · Los Angeles, California
- C.S. Mott Children's Hospital, University of Michigan · Ann Arbor, Michigan
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04510051 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require IL13RA2?
Yes, IL13RA2 positive is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 25 years or younger and at least 4 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages