Actively Recruiting
CAR T Cells After Lymphodepletion for the Treatment of IL13Rα2 Positive Recurrent or Refractory Brain Tumors in Children
Led by City of Hope Medical Center · Updated on 2026-03-05
18
Participants Needed
3
Research Sites
324 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CAR T Cells After Lymphodepletion for the Treatment of IL13Rα2 Positive Recurrent or Refractory Brain Tumors in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legal representative provides documented informed consent
- Assent obtained when appropriate per institutional guidelines
- Agreement to allow use of archival tissue from tumor biopsies
- Karnofsky Performance Status (KPS) of 60% or higher except for mobility loss due to disease
- Life expectancy greater than 4 weeks
- Prior histologically confirmed malignant brain tumor with progression after conventional therapy
- Radiographic evidence of tumor progression or recurrence more than 12 weeks after initial therapy
- Confirmation of IL13Ralpha2 positive tumor expression by immunohistochemistry (H-score ≥ 50)
- If participant has a shunt, it must be programmable and tolerable to being switched off for at least 2 days
- Platelet count of at least 50,000/mm^3 within 6 weeks before consent
- Total bilirubin ≤ 2 times upper limit of normal unless Gilbert's disease
- AST and ALT ≤ 2 times upper limit of normal within 6 weeks before consent
- Creatinine clearance ≥ 75 mL/min/1.73m^2 within 6 weeks before consent
- Negative tests for HIV antigen/antibody, hepatitis C, and active hepatitis B within 6 weeks before consent
- Negative pregnancy test for women of childbearing potential within 6 weeks before consent
- Agreement to use effective birth control or abstain for men and women of childbearing potential during study and 6 months after last dose
- Not requiring more than 0.1 mg/kg/day dexamethasone on the day of blood collection
- Appropriate venous access for blood collection
- At least 2 weeks since last targeted therapy, chemotherapy, or radiation
- Serum creatinine < 1.6 mg/dL before CNS catheter placement
- White blood cell count ≥ 2,000/dL before CNS catheter placement
- Absolute neutrophil count ≥ 1,000 before CNS catheter placement
- Platelets > 50,000/dL before CNS catheter placement
- INR ≤ 1.3 before CNS catheter placement
- Bilirubin < 1.5 mg/dL before CNS catheter placement
- ALT and AST < 2 times upper limit of normal before CNS catheter placement
- KPS ≥ 60% except for mobility loss due to disease
- Second-line radiation therapy completed at least 4 weeks before surgery or catheter placement
- No need for supplemental oxygen or pressor support and no symptomatic cardiac arrhythmias before lymphodepletion
- No active infection or fever above 38.5°C and absence of positive blood cultures or meningitis before CAR T cell infusion
- Serum bilirubin or transaminases ≤ 2 times normal limit before CAR T cell infusion
- Serum creatinine < 1.8 mg/dL before CAR T cell infusion
- No uncontrolled seizure activity before CAR T cell infusion
- Platelet count ≥ 50,000 before CAR T cell infusion or transfusion given to reach this level
- Not requiring more than 0.1 mg/kg/day dexamethasone during CAR T cell therapy
- Washout periods observed for certain chemotherapy and targeted agents before starting study treatment
You will not qualify if you...
- Requires supplemental oxygen to maintain saturation > 95% not expected to improve within 2 weeks
- Requires pressor support or has symptomatic cardiac arrhythmias
- Requires dialysis
- Has uncontrolled seizure activity or clinically evident progressive encephalopathy
- Unable to understand the study protocol or risks and benefits
- Has non-malignant illnesses poorly controlled or too severe for study participation
- Has other active malignancies
- Being treated for severe infection or recovering from major surgery until fully recovered
- Has uncontrolled illness including active infection or signs of hepatitis B or C
- Confirmed HIV positive within 4 weeks before enrollment
- Pregnant or breastfeeding (females only)
- Unable to comply with study procedures as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 3 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
3
C.S. Mott Children's Hospital, University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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