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CAR T-cell Therapy

Engineered T Cell Therapy for Brain Cancer

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

Research participant does not require supplemental oxygen to keep saturation greater than 95% and/or does not have presence of any radiographic abnormalities on chest x-ray that are progressive

Research participant must not require more than 2 mg three times daily (TID) of dexamethasone on the day of PBMC collection

Must not have

Research participants with any other active malignancies

Research participants being treated for severe infection or who are recovering from major surgery are ineligible until recovery is deemed complete by the investigator

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a new way to treat patients with glioma that has come back or does not respond to treatment. In this trial, patients will be given memory-enriched T cells, which are immune cells that have been engineered in the laboratory to better recognize and kill glioma cells. The goal of this trial is to find out if this new treatment is safe and effective.

Who is the study for?

This trial is for adults with recurrent or treatment-resistant Grade III-IV glioma. They must have good venous access, understand and consent to the study, not suffer from severe heart issues or uncontrolled seizures, and have certain blood levels within normal ranges. Participants need a confirmed diagnosis of HER2+ glioma, be able to tolerate minimal steroids during therapy, and agree to use contraception.

What is being tested?

The trial tests memory-enriched T cells (HER2(EQ)BBζ/CD19t+ T cells), which are engineered immune cells designed to target and kill glioma tumor cells. It's in phase I to determine side effects and optimal dosing. The process includes leukapheresis (blood filtering) and laboratory biomarker analysis.

What are the potential side effects?

Potential side effects may include reactions related to immune response such as inflammation in various organs due to targeted cell destruction, infusion-related reactions like fever or chills, fatigue from the body's response to treatment, potential infection risk increase due to immune system modification.

Eligibility Criteria

Inclusion Criteria

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

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I don't need extra oxygen to breathe normally and my chest x-ray doesn't show worsening issues.

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I take 2 mg or less of dexamethasone three times a day.

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I do not have uncontrolled seizures after surgery before starting T cell therapy.

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I was diagnosed with a high-grade glioma or my grade II glioma has progressed to a higher grade.

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I can care for myself but may need occasional help.

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I don't need more than 2 mg of dexamethasone three times a day during my therapy.

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My tumor is confirmed to be HER2 positive by a specific test.

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I have a stored CAR T cell therapy product ready for use.

Exclusion Criteria

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

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I have no other active cancers.

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I am not currently being treated for a severe infection or recovering from major surgery.

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

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I understand the study's details and the risks/benefits of participating.

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I need dialysis.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Incidence of adverse events

Incidence of grade 3 adverse events

Secondary study objectives

Chimeric antigen receptor (CAR) T cells detected in tumor cyst fluid, peripheral blood, and cerebrospinal fluid (CSF)

Chimeric antigen receptor (CAR) T cells detected in tumor tissue

Disease response

+3 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 II (dual delivery Tcm enriched)Experimental Treatment3 Interventions

Patients receive autologous HER2(EQ)BBzeta/CD19t+ Tcm cells via intratumoral/intracavitary catheter and intraventricular catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available. Based on clinical response after the first 3 infusions, the study principal investigator may decide to continue with the optional infusions at either one or both sites (instead of requiring injections at both sites).

Group II: Arm I (intratumoral/intracavitary delivery)Experimental Treatment3 Interventions

Patients receive autologous HER2(EQ)BBzeta/CD19t+ Tcm cells via intratumoral/intracavitary catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients remain eligible and there is product available. Patients who progress on intracavitary or intratumoral administration may move to alternative delivery routes for the optional infusions.

Group III: ARM III (dual delivery Tn/mem enriched)Experimental Treatment3 Interventions

Patients receive autologous HER2(EQ)BBzeta/CD19t+ Tn/mem cells via intratumoral/intracavitary catheter and intraventricular catheter over 5 minutes weekly for 3 weeks. Beginning as early as 1 week later, patients may receive additional T cell infusions as long as patients continue to remain eligible and there is product available. Based on clinical response after the first 3 infusions, the study principal investigator may decide to continue with the optional infusions at either one or both sites (instead of requiring injections at both sites).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leukapheresis

2016

Completed Phase 2

~710

0 / 14Eligibility criteria met