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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Secondary outcome measures

Biomathematical modeling of perfusion/diffusion

Neoplasms

CAR T and endogenous cells detected in tumor tissue

+8 more

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,430 Total Patients Enrolled

3 Trials studying Ependymoma

38 Patients Enrolled for Ependymoma

National Cancer Institute (NCI)NIH

13,661 Previous Clinical Trials

40,924,392 Total Patients Enrolled

81 Trials studying Ependymoma

8,850 Patients Enrolled for Ependymoma

Lisa A FeldmanPrincipal InvestigatorCity of Hope Medical Center

Media Library

IL13Ralpha2-CAR T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04661384 — Phase 1

Ependymoma Research Study Groups: Treatment (IL13Ralpha2-CAR T cells)

Ependymoma Clinical Trial 2023: IL13Ralpha2-CAR T Cells Highlights & Side Effects. Trial Name: NCT04661384 — Phase 1

IL13Ralpha2-CAR T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04661384 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities currently open to join this research endeavor?

"According to information found on the clinicaltrials.gov website, enrollment for this trial is still open. The study was initially posted in March 5th 2021 and has been amended as ofMarch 9th 2022."

Answered by AI

What is the upper limit of people participating in this investigation?

"Affirmative. According to the clinicaltrials.gov website, this research initiative is actively seeking participants and was initially published on March 5th 2021; it has since been updated on March 9th 2022. The study requires 30 volunteers to be sourced from a single site."

Answered by AI

Has the FDA approved IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes for therapeutic use?

"Due to the limited clinical data available, our team has assigned a score of 1 for the safety of IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes in this Phase 1 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Brain Tumor-Specific Immune Cells (IL13Ralpha2-CAR T Cells) for the Treatment of Leptomeningeal Glioblastoma, Ependymoma, or Medulloblastoma

2021. "Brain Tumor-Specific Immune Cells (IL13Ralpha2-CAR T Cells) for the Treatment of Leptomeningeal Glioblastoma, Ependymoma, or Medulloblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04661384.

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