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CAR T-cell Therapy

CAR T-Cell Therapy for Brain Cancer

Phase 1

Recruiting

Led By Behnam Badie

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

No known contraindications to leukapheresis, steroids, or tocilizumab

Participant has a prior histologically-confirmed diagnosis of a grade IV glioblastoma, or has a prior histologically-confirmed diagnosis of a grade II or III malignant brain tumors and now has radiographic progression consistent with a grade IV glioblastoma

Must not have

Other active malignancy

Clinically significant uncontrolled illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a new cancer treatment that uses a gene-modified virus to help the body build an immune response to kill tumor cells.

Who is the study for?

This trial is for adults with a specific brain cancer called MMP2+ recurrent or progressive glioblastoma. They must have a certain level of physical function, normal liver and kidney tests, not be pregnant, and agree to use birth control. People can't join if they have uncontrolled seizures, HIV/hepatitis infections, are pregnant/breastfeeding, recently had certain therapies like bevacizumab, or any condition that makes it unsafe to participate.

What is being tested?

The study is testing CAR T cells modified with chlorotoxin to target tumor cells in patients with aggressive brain tumors. It aims to find the safest dose and see how well these engineered immune cells work against glioblastoma when delivered either directly into the tumor site or into cerebrospinal fluid.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking healthy cells by mistake (like inflammation), symptoms from cell infusion such as fever or fatigue, and potential complications from modifying the body's immune response which could lead to serious health issues.

Eligibility Criteria

Inclusion Criteria

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

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I have no allergies or adverse reactions to leukapheresis, steroids, or tocilizumab.

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I was diagnosed with a high-grade brain tumor.

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I can perform daily activities with minimal assistance.

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I can care for myself but may need occasional help.

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My tumor shows high MMP2 levels as confirmed by a test.

Exclusion Criteria

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

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I have another active cancer besides the one being studied.

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I have a serious illness that is not under control.

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I am currently experiencing diarrhea.

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I do not have uncontrolled seizures or worsening brain function.

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I am not pregnant or breastfeeding.

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I have a history of HIV or hepatitis B/C.

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I am currently taking antibiotics for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose limiting toxicity (DLT)

Secondary study objectives

Biomathematical modeling of tumor growth

CAR T cells detected in tumor tissue

Chimeric antigen receptor (CAR) T cell

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment (CAR T cell therapy) IIExperimental Treatment1 Intervention

Arm 2 participants will undergo resection/biopsy of their tumor and placement of a Rickham catheter at the site of the resection/biopsy and the lateral ventricle. Patients receive chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes NCI SYs via dual delivery starting on day 0 for 3 weekly cycles over 28 days. Each treatment cycle begins with two CAR T cell infusions (intracranial intratumoral or intracavitary \[ICT\]) and also into the lateral ventricle (intracranial intraventricular \[ICV\]) and lasts for 1 week. Beginning 1 week after cycle 3, patients may continue with CAR T treatment per principal investigator and patient discretion. Treatment continues in the absence of disease progression or unacceptable toxicity.

Group II: Treatment (CAR T cell therapy) IExperimental Treatment1 Intervention

Arm 1 participants will undergo resection/biopsy of their tumor and placement of a Rickham catheter at the site of the resection/biopsy. Patients receive chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes NCI SYs via single delivery starting on day 0 for 3 weekly cycles over 28 days. Each treatment cycle begins with one CAR T cell infusion delivered intracranial intratumoral or intracavitary \[ICT\] and lasts for 1 week. Beginning 1 week after cycle 3, patients may continue with CAR T cell treatment per principal investigator and patient discretion. Treatment continues in the absence of disease progression or unacceptable toxicity.

0 / 12Eligibility criteria met