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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 from surgery to death from any cause or six months, whichever occurred first
Awards & highlights
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~an average of 11 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 11 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Experiencing a Dose Limiting Toxicity (DLT)
Number of Participants With Grade 3 or Higher Toxicity Related to CAR T Cells
Secondary study objectives
Number of Participants Alive at 6 Months
Number of Participants With Active Response Determined by Response Assessment in Neuro-Oncology (RANO) Criteria

Side effects data

From 2019 Phase 1 trial • 9 Patients • NCT03565367
33%
Anosmia
33%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Healthy Volunteers
Known CNS Malignancy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Arm 5 (Tn/mem-derived CAR T cells, Dual delivery: both ICTb/r AND ICV)Experimental Treatment5 Interventions
Arm 5 (Tn/mem-derived CAR T cells, Dual delivery: both ICTb/r AND ICV)
Group II: Arm 4 (Tcm-derived CAR T cells, Dual delivery: both ICTb/r AND ICV)Experimental Treatment5 Interventions
Arm 4 (Tcm-derived CAR T cells, Dual delivery: both ICTb/r AND ICV)
Group III: Arm 3 (Tcm-derived CAR T cells, Intraventricular [ICV])Experimental Treatment5 Interventions
Arm 3 (Tcm-derived CAR T cells, Intraventricular \[ICV\])
Group IV: Arm 2 (Tcm-derived CAR T cells, ICTb/r)Experimental Treatment5 Interventions
Arm 2 (Tcm-derived CAR T cells, Intratumoral a/f biopsy \[ICTb\] or Intracavitary a/f resection \[ICTr\])
Group V: Arm 1 (Tcm-derived CAR T cells, Intratumoral a/f biopsy [ICTb])Experimental Treatment5 Interventions
Arm 1 (Tcm-derived CAR T cells, Intratumoral a/f biopsy \[ICTb\]
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Magnetic Resonance Spectroscopic Imaging
2012
Completed Phase 1
~430

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,388 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,515 Total Patients Enrolled
Food and Drug Administration (FDA)FED
181 Previous Clinical Trials
1,548,713 Total Patients Enrolled

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
Brain Tumor Research Study Groups: Arm 1 (Tcm-derived CAR T cells, Intratumoral a/f biopsy [ICTb]), Arm 2 (Tcm-derived CAR T cells, ICTb/r), Arm 3 (Tcm-derived CAR T cells, Intraventricular [ICV]), Arm 4 (Tcm-derived CAR T cells, Dual delivery: both ICTb/r AND ICV), Arm 5 (Tn/mem-derived CAR T cells, Dual delivery: both ICTb/r AND ICV)
Brain Tumor 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
~6 spots leftby Nov 2025
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