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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
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 moreTrial 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
~1160
Magnetic Resonance Spectroscopic Imaging
2012
Completed Phase 1
~430
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,232 Total Patients Enrolled
324 Trials studying Glioblastoma
23,090 Patients Enrolled for Glioblastoma
City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,458 Total Patients Enrolled
12 Trials studying Glioblastoma
274 Patients Enrolled for Glioblastoma
Food and Drug Administration (FDA)FED
174 Previous Clinical Trials
1,333,610 Total Patients Enrolled
7 Trials studying Glioblastoma
261 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have completed a specific type of chemotherapy called nitrosourea at least 6 weeks ago.You need help to support your blood pressure or have heart rhythm problems that cause symptoms.You need to undergo dialysis treatment.You have seizures that are not well controlled or you have a worsening brain condition.You are expected to live for at least 4 more weeks.You have another type of cancer that is currently active.You are not in need of medication to support your blood pressure, and you do not have any serious heart rhythm problems that cause symptoms.You need extra oxygen to keep your oxygen levels above 95%, and this is not expected to get better within 2 weeks.You do not have frequent or uncontrollable seizures after surgery before starting the first T cell dose.
Research Study Groups:
This trial has the following groups:- Group 1: Stratum IV (T lymphocytes intratumoral and intraventricular)
- Group 2: Stratum III (T lymphocytes intraventricular)
- Group 3: Stratum II (T lymphocytes intracavitary)
- Group 4: Stratum V (T lymphocytes intratumoral and intraventricular)
- Group 5: Stratum I (T lymphocytes intratumoral)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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