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CAR T-cell Therapy

Genetically Modified 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

Study Summary

This trial is testing a new immunotherapy for brain cancer. T cells from the patient's blood are modified in the lab to better recognize and kill cancer cells. This may also help the body build an immune response against the tumor.

Who is the study for?

This trial is for patients with malignant glioma that has returned or hasn't responded to treatment. They must have had progression after initial radiation, be able to consent, not need excessive steroids during therapy, and meet specific blood and organ function criteria. Pregnant women can't participate, nor those needing dialysis, with other active cancers, severe infections or major surgery recovery.Check my eligibility

What is being tested?

The trial tests genetically modified T-cells designed to target and kill glioma cells in the brain. Patients' own T-cells are engineered in a lab to recognize tumor cells better. The study also includes MRI scans and quality-of-life assessments to monitor effects.See study design

What are the potential side effects?

Potential side effects may include immune reactions where the body attacks its own tissues, symptoms similar to flu (fever, fatigue), possible damage at the infusion site or allergic reactions due to cell modification process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

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

Incidence of dose limiting toxicity (DLT), graded using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0

Incidence of grade 3 toxicity

Incidence of toxicities, graded using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0 as well as the modified neurological grading system

Secondary outcome measures

CAR T cell detection (stratum 1 and 2)

Changes in chimeric antigen receptor (CAR) T levels

Changes in cytokine levels

+10 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Stratum V (T lymphocytes intratumoral and intraventricular)Experimental Treatment5 Interventions

Patients receive IL13 [EQ]BBzeta/truncated CD19[t]+ Tn/mem via intratumoral 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: Stratum IV (T lymphocytes intratumoral and intraventricular)Experimental Treatment5 Interventions

Patients receive IL13R alpha 2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing T lymphocytes via intratumoral 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 III: Stratum III (T lymphocytes intraventricular)Experimental Treatment5 Interventions

Patients receive IL13R alpha 2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing T lymphocytes via intraventricular catheter over 5-10 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.

Group IV: Stratum II (T lymphocytes intracavitary)Experimental Treatment5 Interventions

Patients receive IL13R alpha 2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing T lymphocytes via intracavitary catheter over 5-10 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. Patients who progress on intracavitary or intratumoral administration may move to intraventricular catheter for the optional infusions

Group V: Stratum I (T lymphocytes intratumoral)Experimental Treatment5 Interventions

CLOSED TO ACCRUAL 03/02/2018. Patients receive IL13R alpha 2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing T lymphocytes via intratumoral 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 intraventricular catheter for the optional infusions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Magnetic Resonance Spectroscopic Imaging

2012

Completed Phase 1

~430

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,585 Total Patients Enrolled

322 Trials studying Glioblastoma

23,033 Patients Enrolled for Glioblastoma

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,378 Total Patients Enrolled

12 Trials studying Glioblastoma

274 Patients Enrolled for Glioblastoma

Food and Drug Administration (FDA)FED

171 Previous Clinical Trials

1,331,524 Total Patients Enrolled

6 Trials studying Glioblastoma

235 Patients Enrolled for Glioblastoma

Media Library

IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02208362 — Phase 1

Glioblastoma Research Study Groups: Stratum III (T lymphocytes intraventricular), Stratum V (T lymphocytes intratumoral and intraventricular), Stratum II (T lymphocytes intracavitary), Stratum IV (T lymphocytes intratumoral and intraventricular), Stratum I (T lymphocytes intratumoral)

Glioblastoma Clinical Trial 2023: IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes Highlights & Side Effects. Trial Name: NCT02208362 — Phase 1

IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02208362 — Phase 1

Frequently Asked Questions

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

Are there any openings remaining for this experiment?

"As per clinicaltrials.gov, this trial has ceased recruiting participants as of February 17th 2022. Although the study is no longer accepting patients, there are presently 1610 other medical trials that may require volunteers."

Answered by AI

Has the FDA sanctioned Magnetic Resonance Spectroscopic Imaging as a legitimate diagnostic tool?

"Our team at Power ranked Magnetic Resonance Spectroscopic Imaging a 1, as this is the introductory phase of testing and there remains limited evidence in support of its safety."

Answered by AI

Is it possible to partake in this trial?

"This clinical trial is recruiting 82 people aged 12 to 75 with glioma, who meet the following requirements: ability and willingness to sign an informed consent form; prior diagnosis of grade II or IV glioma confirmed histologically or radiographic progression consistent with grade III/IV malignant glioma after standard therapy; Karnofsky performance status at least 60%; life expectancy more than four weeks; men and women of child-bearing potential must agree to use adequate contraception for six months post-study participation; IL13R alpha 2+ expression by immunohistochemistry greater than 20%, 1+ as per COH Clinical Pathology confirmation"

Answered by AI

Is this research project open to participants under the age of eight decades?

"According to the eligibility guidelines for this trial, those aged 12 and over may apply; however, individuals must not exceed 75 years of age."

Answered by AI

What are the primary goals of this investigation?

"This long-term medical study, which is set to span over 15 years, will be measuring the incidence of dose limiting toxicity (DLT) using NCI's CTCAE version 4.0 as its main outcome metric. Secondary outcomes include changes in cytokine levels detected from cerebral spinal fluid and peripheral blood samples, response assessment according to Response Assessment in Neuro-Oncology criteria, and alterations in cytokine concentrations throughout the duration of the trial that will be evaluated through statistical methods."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Regression of Glioblastoma After Chimeric Antigen Receptor T-cell Therapy

Brown, Christine E., Darya Alizadeh, Renate Starr, Lihong Weng, Jamie R. Wagner, Araceli Naranjo, Julie R. Ostberg, et al.. 2016. “Regression of Glioblastoma After Chimeric Antigen Receptor T-cell Therapy”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1610497.

clinicaltrials.govStudy

Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma

2015. "Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02208362.