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CAR T-cell Therapy
CAR T-Cell Therapy for Brain Tumor
Duarte, CA
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
Karnofsky performance status (KPS) ≥ 70%, Eastern Cooperative Oncology Group (ECOG) ≤ 2
Participant has a prior histologically-confirmed diagnosis of a grade 3 or 4 IDH-mutant astrocytoma or glioblastoma, or has a prior histologically-confirmed diagnosis of a grade 2 or 3 astrocytoma and now has radiographic progression consistent with grade 3 or 4 IDH-mutant astrocytoma
Must not have
Uncontrolled seizure activity and/or clinically evident progressive encephalopathy
Active autoimmune disease requiring systemic immunosuppressive therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety and effectiveness of a new type of treatment called TGFβR2KO/IL13Rα2 chimeric antigen receptor (CAR) T-cell therapy for patients
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Who is the study for?
This trial is for patients with recurrent or progressive glioblastoma or grade 3/4 IDH-mutant astrocytoma. Participants must have a tumor that has returned after treatment or is worsening. Specific eligibility criteria are not provided, but typically include factors like age, health status, and prior treatments.Check my eligibility
What is being tested?
The trial tests TGFβR2KO/IL13Rα2 CAR T-cell therapy given intracranially to see if it's safe and effective against certain brain tumors. It involves modifying the patient's own immune cells to attack tumor cells and monitoring the results using various imaging techniques.See study design
What are the potential side effects?
While specific side effects are not listed, CAR T-cell therapies can cause symptoms like fever, fatigue, headache, and neurological issues due to inflammation in the brain as well as potential complications from procedures involved in cell collection and infusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but may not be able to do active work.
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I have a high-grade IDH-mutant brain tumor.
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I am 18 years old or older.
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My tumor tested positive for IL13Rα2 with a high score.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have seizures or worsening brain function not controlled by medication.
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I am on medication for an autoimmune disease.
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I have a history of HIV or hepatitis B/C.
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I do not have any uncontrolled serious illnesses.
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I am not currently on bevacizumab due to its risk of wound complications.
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I am not pregnant or breastfeeding.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose-limiting toxicities (DLTs)
Incidence of all other AEs
Incidence of cytokine release syndrome
+1 moreSecondary study objectives
Complete response rate
Maximum feasible dose (MFD)
Overall response rate
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (TGFβR2KO/IL13Rα2 CAR T-cells)Experimental Treatment9 Interventions
Patients undergo leukapheresis and standard of care surgical resection with or without placement of Rickham catheter. Starting on day 0, patients receive autologous TGFβR2KO/IL13Rα2-CAR T cells intracranially over approximately 5 minutes QW. Cycles repeat weekly for up to 4 cycles (28 days) in the absence of disease progression or unacceptable toxicity. Patients may receive additional cycles if they continue to meet infusion criteria and have doses available for infusion. Patients also undergo CSF and blood sample collection and fludeoxyglucose F-18 (FDG)-positron emission tomography (PET) and MRI throughout the study. Additionally, patients may undergo echocardiography at screening.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2020
Completed Phase 3
~1180
Biospecimen Collection
2004
Completed Phase 3
~1810
Echocardiography
2013
Completed Phase 4
~11580
Leukapheresis
2016
Completed Phase 2
~710
Resection
2020
Completed Phase 2
~1440
Positron Emission Tomography
2011
Completed Phase 2
~2230
Find a Location
Closest Location:City of Hope Medical Center· Duarte, CA
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
613 Previous Clinical Trials
1,924,012 Total Patients Enrolled
13 Trials studying Glioblastoma
318 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
14,057 Previous Clinical Trials
41,149,377 Total Patients Enrolled
332 Trials studying Glioblastoma
23,235 Patients Enrolled for Glioblastoma
Behnam BadiePrincipal InvestigatorCity of Hope Medical Center
5 Previous Clinical Trials
196 Total Patients Enrolled
5 Trials studying Glioblastoma
196 Patients Enrolled for Glioblastoma