← Back to Search

CAR T-cell Therapy

CAR T-Cell Therapy for Brain Cancer

Phase 1

Recruiting

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

No known contraindications to leukapheresis, steroids, or tocilizumab

Participant has a prior histologically-confirmed diagnosis of a grade IV glioblastoma, or has a prior histologically-confirmed diagnosis of a grade II or III malignant brain tumors and now has radiographic progression consistent with a grade IV glioblastoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

Study Summary

This trial is studying a new cancer treatment that uses a gene-modified virus to help the body build an immune response to kill tumor cells.

Who is the study for?

This trial is for adults with a specific brain cancer called MMP2+ recurrent or progressive glioblastoma. They must have a certain level of physical function, normal liver and kidney tests, not be pregnant, and agree to use birth control. People can't join if they have uncontrolled seizures, HIV/hepatitis infections, are pregnant/breastfeeding, recently had certain therapies like bevacizumab, or any condition that makes it unsafe to participate.Check my eligibility

What is being tested?

The study is testing CAR T cells modified with chlorotoxin to target tumor cells in patients with aggressive brain tumors. It aims to find the safest dose and see how well these engineered immune cells work against glioblastoma when delivered either directly into the tumor site or into cerebrospinal fluid.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking healthy cells by mistake (like inflammation), symptoms from cell infusion such as fever or fatigue, and potential complications from modifying the body's immune response which could lead to serious health issues.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have no allergies or adverse reactions to leukapheresis, steroids, or tocilizumab.

Select...

I was diagnosed with a high-grade brain tumor.

Select...

I can perform daily activities with minimal assistance.

Select...

I can care for myself but may need occasional help.

Select...

My tumor shows high MMP2 levels as confirmed by a test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Dose limiting toxicity (DLT)

Secondary outcome measures

Biomathematical modeling of tumor growth

CAR T cells detected in tumor tissue

Chimeric antigen receptor (CAR) T cell

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment (CAR T cell therapy) IIExperimental Treatment1 Intervention

Arm 2 participants will undergo resection/biopsy of their tumor and placement of a Rickham catheter at the site of the resection/biopsy and the lateral ventricle. Patients receive chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes NCI SYs via dual delivery starting on day 0 for 3 weekly cycles over 28 days. Each treatment cycle begins with two CAR T cell infusions (intracranial intratumoral or intracavitary [ICT]) and also into the lateral ventricle (intracranial intraventricular [ICV]) and lasts for 1 week. Beginning 1 week after cycle 3, patients may continue with CAR T treatment per principal investigator and patient discretion. Treatment continues in the absence of disease progression or unacceptable toxicity.

Group II: Treatment (CAR T cell therapy) IExperimental Treatment1 Intervention

Arm 1 participants will undergo resection/biopsy of their tumor and placement of a Rickham catheter at the site of the resection/biopsy. Patients receive chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes NCI SYs via single delivery starting on day 0 for 3 weekly cycles over 28 days. Each treatment cycle begins with one CAR T cell infusion delivered intracranial intratumoral or intracavitary [ICT] and lasts for 1 week. Beginning 1 week after cycle 3, patients may continue with CAR T cell treatment per principal investigator and patient discretion. Treatment continues 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

1,921,424 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,926,037 Total Patients Enrolled

Behnam BadiePrincipal InvestigatorCity of Hope Medical Center

4 Previous Clinical Trials

177 Total Patients Enrolled

Media Library

Chimeric Antigen Receptor (CAR) T Cells with a Chlorotoxin Tumor-Targeting Domain (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04214392 — Phase 1

Brain Tumor Research Study Groups: Treatment (CAR T cell therapy) II, Treatment (CAR T cell therapy) I

Brain Tumor Clinical Trial 2023: Chimeric Antigen Receptor (CAR) T Cells with a Chlorotoxin Tumor-Targeting Domain Highlights & Side Effects. Trial Name: NCT04214392 — Phase 1

Chimeric Antigen Receptor (CAR) T Cells with a Chlorotoxin Tumor-Targeting Domain (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04214392 — Phase 1

Frequently Asked Questions

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

Has the FDA sanctioned Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes for therapeutic usage?

"Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes were assigned a score of 1 on our safety scale, as this is an early stage clinical trial with limited data regarding efficacy and security."

Answered by AI

Has recruitment begun for this clinical experiment?

"Based on the information provided by clinicaltrials.gov, this medical trial is still recruiting participants. It was first posted on February 26th 2020 and had its last update occur on February 25th 2022."

Answered by AI

Can you provide a rundown of the past experiments related to Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes?

"Currently, one clinical trials is active and researching Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes with no Phase 3 studies. Most of these research projects are based in Duarte, California but there exists another site conducting similar experiments."

Answered by AI

What is the participant count for this clinical experiment?

"Affirmative. As per the details available on clinicaltrials.gov, this trial has initiated its recruitment process for 36 patients at a single site and is still ongoing since February 26th 2020. The last update to the study was done in February 25th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MMP2+ Recurrent or Progressive Glioblastoma

2020. "Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MMP2+ Recurrent or Progressive Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04214392.

All > Glioblastoma Long Beach > Gbm