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CAR T-cell Therapy

CAR T-Cell Therapy for Glioblastoma

Phase 1

Recruiting

Led By Lisa A Feldman

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

Participant must have a Karnofsky performance status (KPS) >= 60

If participant has a ventriculoperitoneal shunt, the valve must be programmable, and must be able to tolerate their shunts being turned off for 48 hours

Must not have

Participant is unwilling to stop treatment with chemotherapy or endocrine therapy and/or radiation one week prior and during the first 4 cycles of the IL13Ralpha2-CAR T cell study

Research participant requires supplemental oxygen to keep saturation greater than 95% and the situation is not expected to resolve within 2 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effects of brain tumor-specific immune cells on patients with leptomeningeal disease from glioblastoma, ependymoma or medulloblastoma.

Who is the study for?

This trial is for patients with leptomeningeal disease from glioblastoma, ependymoma, or medulloblastoma. They must have a life expectancy of at least 8 weeks, be able to tolerate certain medical procedures and medications, not require dialysis or supplemental oxygen, and agree to use birth control. Those with other active cancers or infections like hepatitis B/C or HIV can't join.

What is being tested?

The trial tests IL13Ralpha2-CAR T cells designed to target brain tumor-specific immune cells in patients with specific types of brain tumors that have spread. It's a phase I study focusing on the safety and how well these engineered immune cells work against the cancer.

What are the potential side effects?

Potential side effects include reactions related to the immune system attacking normal tissues (autoimmune responses), infusion-related reactions where the treatment is given, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, and possible unknown risks to fetuses.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but may need occasional help.

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My shunt valve is programmable and can be turned off for 48 hours.

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My cancer has spread to the lining of my brain and spinal cord.

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

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My tumor tests positive for IL13Ralpha2.

Exclusion Criteria

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

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I am willing to pause my current cancer treatments for the study.

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I need extra oxygen to maintain my oxygen levels above 95%, and this won't improve in 2 weeks.

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I have seizures that medication can't control or worsening brain function.

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I have a bleeding disorder or cannot stop my blood thinner safely for a procedure.

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I have a long-lasting or active virus infection in my brain or spinal cord.

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I have another active cancer besides the one being studied.

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I require dialysis.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Incidence of adverse events

Overall survival

Secondary study objectives

Biomathematical modeling of perfusion/diffusion

Neoplasms

CAR T and endogenous cells detected in tumor tissue

+6 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 (IL13Ralpha2-CAR T cells)Experimental Treatment1 Intervention

Patients receive IL13Ralpha2-CAR T cells ICV over 5 minutes on day 1. Treatment repeats every 7 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

0 / 13Eligibility criteria met