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CAR T-cell Therapy

CAR T-Cell Therapy for Brain Tumor

Duarte, CA

Phase 1

Waitlist Available

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

Karnofsky performance status (KPS) ≥ 70%, Eastern Cooperative Oncology Group (ECOG) ≤ 2

Participant has a prior histologically-confirmed diagnosis of a grade 3 or 4 IDH-mutant astrocytoma or glioblastoma, or has a prior histologically-confirmed diagnosis of a grade 2 or 3 astrocytoma and now has radiographic progression consistent with grade 3 or 4 IDH-mutant astrocytoma

Must not have

Uncontrolled seizure activity and/or clinically evident progressive encephalopathy

Active autoimmune disease requiring systemic immunosuppressive therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of a new type of treatment called TGFβR2KO/IL13Rα2 chimeric antigen receptor (CAR) T-cell therapy for patients

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Who is the study for?

This trial is for patients with recurrent or progressive glioblastoma or grade 3/4 IDH-mutant astrocytoma. Participants must have a tumor that has returned after treatment or is worsening. Specific eligibility criteria are not provided, but typically include factors like age, health status, and prior treatments.Check my eligibility

What is being tested?

The trial tests TGFβR2KO/IL13Rα2 CAR T-cell therapy given intracranially to see if it's safe and effective against certain brain tumors. It involves modifying the patient's own immune cells to attack tumor cells and monitoring the results using various imaging techniques.See study design

What are the potential side effects?

While specific side effects are not listed, CAR T-cell therapies can cause symptoms like fever, fatigue, headache, and neurological issues due to inflammation in the brain as well as potential complications from procedures involved in cell collection and infusion.

Eligibility Criteria

Inclusion Criteria

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

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

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I have a high-grade IDH-mutant brain tumor.

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I am 18 years old or older.

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My tumor tested positive for IL13Rα2 with a high score.

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Exclusion Criteria

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

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I have seizures or worsening brain function not controlled by medication.

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I am on medication for an autoimmune disease.

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

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I do not have any uncontrolled serious illnesses.

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I am not currently on bevacizumab due to its risk of wound complications.

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I am not pregnant or breastfeeding.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year 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 toxicities (DLTs)

Incidence of all other AEs

Incidence of cytokine release syndrome

+1 more

Secondary study objectives

Complete response rate

Maximum feasible dose (MFD)

Overall response rate

+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 (TGFβR2KO/IL13Rα2 CAR T-cells)Experimental Treatment9 Interventions

Patients undergo leukapheresis and standard of care surgical resection with or without placement of Rickham catheter. Starting on day 0, patients receive autologous TGFβR2KO/IL13Rα2-CAR T cells intracranially over approximately 5 minutes QW. Cycles repeat weekly for up to 4 cycles (28 days) in the absence of disease progression or unacceptable toxicity. Patients may receive additional cycles if they continue to meet infusion criteria and have doses available for infusion. Patients also undergo CSF and blood sample collection and fludeoxyglucose F-18 (FDG)-positron emission tomography (PET) and MRI throughout the study. Additionally, patients may undergo echocardiography at screening.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2020

Completed Phase 3

~1180

Biospecimen Collection

2004

Completed Phase 3

~1810