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Alkylating agents

CAR T-Cell Therapy for Pediatric Brain Cancer

Phase 1

Recruiting

Led By Leo D Wang

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

City of Hope (COH) clinical pathology confirms IL13Ralpha2+ tumor expression by immunohistochemistry (IHC) at the initial tumor presentation or recurrent disease (H-score >= 50)

Participant has a prior histologically-confirmed malignant brain neoplasm and has progressed after prior conventional therapy

Must not have

Renal: Research participant requires dialysis

Neurologic: Research participant has uncontrolled seizure activity and/or clinically evident progressive encephalopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year after the last car t cell infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for children with brain tumors that have come back or are resistant to treatment. The new treatment is a combination of chemotherapy and cellular immunotherapy, which uses brain-tumor specific cells to change the body's immune system.

Who is the study for?

This trial is for children with IL13Ralpha2 positive brain tumors that have returned or are not responding to treatment. They must have good kidney function, no severe infections, and a certain level of physical ability despite their illness. Children who are pregnant, breastfeeding, or unable to follow the study procedures cannot participate.

What is being tested?

The trial tests chemotherapy (cyclophosphamide and fludarabine) combined with cellular immunotherapy using CAR T cells targeting IL13Ralpha2 on tumor cells. It aims to see if this combination can better kill tumor cells in children whose brain cancer has come back or isn't responding.

What are the potential side effects?

Possible side effects include reactions from the immune system attacking normal tissues (autoimmunity), symptoms from cell infusions like fever and chills, low blood counts leading to increased infection risk, nausea from chemotherapy, and potential organ damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor tested positive for IL13Ralpha2 based on a specific test.

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My brain cancer has returned or worsened after standard treatment.

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I don't need extra oxygen to maintain my oxygen levels and my chest x-ray doesn’t show worsening issues.

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I take no more than 6mg/day of Dexamethasone.

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My kidney function is normal, with a creatinine level below 1.8 mg/dL.

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I do not have seizures that are currently uncontrolled.

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I don't need extra oxygen to maintain my oxygen levels above 95% and my chest x-ray shows no worsening issues.

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I don't need medication to maintain my blood pressure and I don't have irregular heartbeats that cause symptoms.

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I don't have a fever above 38.5°C, no recent infections, and no signs of meningitis.

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I have tested negative for HIV, hepatitis B, and hepatitis C recently.

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I have a frozen T cell product ready for use.

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I do not need medication to maintain my blood pressure and do not have irregular heartbeats.

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My liver tests are within twice the normal range.

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I can care for myself but may not be able to do active work.

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I don't need more than a low dose of dexamethasone during my therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on dialysis.

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I have seizures or worsening brain function that isn't under control.

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I understand the study's purpose, procedures, and the risks/benefits of participating.

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I need medication to support my blood pressure or have heart rhythm problems.

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I am not pregnant or breastfeeding.

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I do not have any other active cancers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year after the last chimeric antigen response (car) t cell infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year after the last chimeric antigen response (car) t cell infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year after the last chimeric antigen response (car) t cell infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Secondary study objectives

Circulating tumor deoxyribonucleic acid (ctDNA) assessments

Disease response

Peripheral blood and CSF cytokine levels

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (chemotherapy, IL13(EQ)BBzeta/CD19t+ T cells)Experimental Treatment3 Interventions

Patients receive cyclophosphamide intravenously IV on days -5 and -4, and fludarabine IV on days -5 to -2. Patients then receive autologous IL13(EQ)BBzeta/CD19t+ T cells intraventricularly over 5 minutes QW on day 0. Treatment with autologous IL13(EQ)BBzeta/CD19t+ T cells repeats every 7 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive additional cycles of IL13(EQ)BBzeta/CD19t+ T cells as long as they continue to meet eligibility criteria and have doses available for infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1860