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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Dose limiting toxicities (DLT)

Incidence of adverse events

Incidence of grade 3 adverse events

Secondary outcome measures

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

+4 more

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

~690

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,431 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,124 Total Patients Enrolled

Behnam BadiePrincipal InvestigatorCity of Hope Medical Center

4 Previous Clinical Trials

184 Total Patients Enrolled

Media Library

HER2(EQ)BBζ/CD19t+ T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03389230 — Phase 1

Malignant Glioma Research Study Groups: ARM III (dual delivery Tn/mem enriched), Arm II (dual delivery Tcm enriched), Arm I (intratumoral/intracavitary delivery)

Malignant Glioma Clinical Trial 2023: HER2(EQ)BBζ/CD19t+ T cells Highlights & Side Effects. Trial Name: NCT03389230 — Phase 1

HER2(EQ)BBζ/CD19t+ T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03389230 — Phase 1

Frequently Asked Questions

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

Is the use of Laboratory Biomarker Analysis accepted by regulatory agencies?

"Considering the scant data available to verify safety and effectiveness, Laboratory Biomarker Analysis received a score of 1."

Answered by AI

Is this research endeavor actively recruiting participants?

"According to clinicaltrials.gov, this medical inquiry is actively recruiting patients. This experiment was initiated on August 14th 2018 and the most recent update occurred on August 15th 2022."

Answered by AI

Is it feasible for me to take part in this research?

"This trial is recruiting 42 glioblastoma patients aged 18 to 75. The most essential criteria for eligibility are the ability to access a vein and an estimated life expectancy of at least 4 weeks."

Answered by AI

Is there an age restriction on participants of this research program?

"As outlined in the inclusion criteria, only applicants between 18 and 75 years of age are eligible for this trial. For reference, there are 262 trials targeting those below 18 and 1397 studies that focus on individuals aged 65 or over."

Answered by AI

How many people have enrolled in this experiment thus far?

"Affirmative. According to the information hosted on clinicaltrials.gov, this research trial is actively seeking participants; it was first listed on August 14th 2018 and then most recently updated on August 15th 2022. In total, 42 patients must be enrolled from one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Memory-Enriched T Cells in Treating Patients With Recurrent or Refractory Grade III-IV Glioma

2018. "Memory-Enriched T Cells in Treating Patients With Recurrent or Refractory Grade III-IV Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03389230.

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