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CAR T-cell Therapy

CAR T-Cell Therapy + Immunotherapy for Glioblastoma

Phase 1

Recruiting

Led By Behnam Badie, MD

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

Ages ≥18 years

COH Clinical Pathology confirms IL13Rα2+ tumor expression by IHC at the initial tumor presentation or recurrent disease (H-score > 50; reference Appendix B)

Must not have

Females only: Pregnant or breastfeeding

Other active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing IL13Ralpha2-CAR T cells, given alone or with nivolumab and ipilimumab, to treat patients with glioblastoma.

Who is the study for?

This trial is for adults over 18 with grade IV glioblastoma (GBM) or those whose lower-grade glioma has progressed to GBM after standard treatment. Participants must have a life expectancy of at least 4 weeks, be able to use birth control, and not require high doses of steroids. They can't join if they've had certain heart issues without clearance, uncontrolled seizures, active infections needing antibiotics, or are pregnant/breastfeeding.

What is being tested?

The study is testing IL13Ralpha2-CAR T cells alone or combined with nivolumab and ipilimumab in patients with recurrent or refractory GBM. It aims to see how well these treatments work together compared to when the CAR T cells are used by themselves.

What are the potential side effects?

Possible side effects include immune system reactions that may affect normal organs, infusion-related symptoms like fever and chills, fatigue, potential worsening of autoimmune diseases for those predisposed, and risks associated with live vaccines due to immune suppression.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My tumor tests positive for IL13Rα2.

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

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My brain tumor is confirmed as grade IV GBM or has progressed to this after treatment.

Exclusion Criteria

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

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I am not pregnant or breastfeeding.

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I do not have any other active cancer.

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I am currently experiencing diarrhea.

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

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

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I have previously received immunotherapy targeting CTLA-4, PD-1, or PD-L1.

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I am currently taking antibiotics for an infection.

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I do not have any uncontrolled serious illnesses.

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I need more than 6 mg of dexamethasone daily.

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

Dose-limiting toxicity (DLT)

Feasibility (adjuvant therapy)

Feasibility (neoadjuvant therapy)

+2 more

Secondary study objectives

Area under the curve (AUC) for CD3, IFNgamma, and IP-10 levels over time for the DLT evaluation period

Biomathematical modeling of tumor growth

CAR T and endogenous cells detected in tumor tissue

+9 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm III (IL13Ra2 CAR T cells)Experimental Treatment3 Interventions

Patients receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (ICV/ICT) every week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly at the discretion of the principal investigator and oncologist.

Group II: Arm II (nivolumab, IL13Ra2 CAR T cells)Experimental Treatment4 Interventions

Patients receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (ICV/ICT) every week and nivolumab IV over 30 minutes every other week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly and nivolumab IV every other week or monthly at the discretion of the principal investigator and oncologist.

Group III: Arm I (nivolumab, ipilimumab, IL13Ralpha2 CAR T cells)Experimental Treatment5 Interventions

Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90 minutes on day -14. Patients then receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (ICV/intracranital ICT) every week and nivolumab IV over 30 minutes every other week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly and nivolumab IV every other week or monthly at the discretion of the principal investigator and oncologist.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2015

Completed Phase 3

~3420

Nivolumab

2015

Completed Phase 3

~4010