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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
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I have no allergies or adverse reactions to leukapheresis, steroids, or tocilizumab.
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I was diagnosed with a high-grade brain tumor.
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I can perform daily activities with minimal assistance.
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I can care for myself but may need occasional help.
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My tumor shows high MMP2 levels as confirmed by a test.

Timeline

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.

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,540 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,721 Previous Clinical Trials
40,965,018 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
~1 spots leftby Sep 2024
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