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CAR T-cell Therapy

CAR T-Cell Therapy + Immunotherapy for Glioblastoma

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
Relapsed/refractory disease: radiographic evidence of recurrence/progression of measurable disease after standard therapy, and ≥ 12 weeks after completion of front-line radiation therapy.
Ages ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

Study Summary

This trial is testing IL13Ralpha2-CAR T cells, given alone or with nivolumab and ipilimumab, to treat patients with glioblastoma.

Who is the study for?
This trial is for adults over 18 with grade IV glioblastoma (GBM) or those whose lower-grade glioma has progressed to GBM after standard treatment. Participants must have a life expectancy of at least 4 weeks, be able to use birth control, and not require high doses of steroids. They can't join if they've had certain heart issues without clearance, uncontrolled seizures, active infections needing antibiotics, or are pregnant/breastfeeding.Check my eligibility
What is being tested?
The study is testing IL13Ralpha2-CAR T cells alone or combined with nivolumab and ipilimumab in patients with recurrent or refractory GBM. It aims to see how well these treatments work together compared to when the CAR T cells are used by themselves.See study design
What are the potential side effects?
Possible side effects include immune system reactions that may affect normal organs, infusion-related symptoms like fever and chills, fatigue, potential worsening of autoimmune diseases for those predisposed, and risks associated with live vaccines due to immune suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has returned or worsened after treatment, and it's been over 12 weeks since my last radiation therapy.
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I am 18 years old or older.
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I have had serious heart issues or symptoms in the last 6 months and have had heart tests done recently.
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My tumor tests positive for IL13Rα2.
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I can care for myself but may not be able to do active work.
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I agree to let my previous biopsy samples be used for this study.
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My brain tumor is confirmed as grade IV GBM or has progressed to this after treatment.

Timeline

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
Dose-limiting toxicity (DLT)
Feasibility (adjuvant therapy)
Feasibility (neoadjuvant therapy)
+2 more
Secondary outcome measures
Area under the curve (AUC) for CD3, IFNgamma, and IP-10 levels over time for the DLT evaluation period
Biomathematical modeling of tumor growth
CAR T and endogenous cells detected in tumor tissue
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm III (IL13Ra2 CAR T cells)Experimental Treatment3 Interventions
Patients receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (ICV/ICT) every week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly at the discretion of the principal investigator and oncologist.
Group II: Arm II (nivolumab, IL13Ra2 CAR T cells)Experimental Treatment4 Interventions
Patients receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (ICV/ICT) every week and nivolumab IV over 30 minutes every other week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly and nivolumab IV every other week or monthly at the discretion of the principal investigator and oncologist.
Group III: Arm I (nivolumab, ipilimumab, IL13Ralpha2 CAR T cells)Experimental Treatment5 Interventions
Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90 minutes on day -14. Patients then receive IL13Ralpha2 CAR T cells infusion over 5 minutes via Rickham catheter (ICV/intracranital ICT) every week and nivolumab IV over 30 minutes every other week. Treatment repeats weekly for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After cycle 4, patients may receive additional CAR T cells weekly and nivolumab IV every other week or monthly at the discretion of the principal investigator and oncologist.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2670
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
561 Previous Clinical Trials
1,918,192 Total Patients Enrolled
12 Trials studying Glioblastoma
296 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,287 Total Patients Enrolled
316 Trials studying Glioblastoma
22,608 Patients Enrolled for Glioblastoma
Behnam BadiePrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
153 Total Patients Enrolled
4 Trials studying Glioblastoma
153 Patients Enrolled for Glioblastoma

Media Library

IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04003649 — Phase 1
Glioblastoma Research Study Groups: Arm III (IL13Ra2 CAR T cells), Arm II (nivolumab, IL13Ra2 CAR T cells), Arm I (nivolumab, ipilimumab, IL13Ralpha2 CAR T cells)
Glioblastoma Clinical Trial 2023: IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells Highlights & Side Effects. Trial Name: NCT04003649 — Phase 1
IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04003649 — Phase 1

Frequently Asked Questions

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

Has the FDA endorsed Quality-of-Life Assessment as a reliable diagnostic tool?

"Our team at Power gives Quality-of-Life Assessment a rating of 1 due to the limited evidence available on its efficacy and safety in this Phase 1 clinical trial."

Answered by AI

How many participants are involved in this experiment?

"Affirmative, the information on clinicaltrials.gov reveals that this study is actively recruiting participants. It was first published on September 26th 2019 and was recently updated November 15 2022; 60 subjects are needed at a single centre."

Answered by AI

What is the ultimate goal of this research?

"This clinical trial, spanning nine months in duration, aims to measure Overall Survival as its primary outcome. Secondary objectives involve evaluating Cytokine levels via TCF, PB and CSF with the help of statistical and graphical methods; PD-L1 levels on tumor cells through flow cytometry; T cell numbers via CAR T and endogenous T cell detection within TCF, PB and CSF."

Answered by AI

Is enrollment for this research study still open?

"This clinical trial is searching for 60 individuals aged 18 to 75 who have glioblastoma. Furthermore, these participants must agree to the use of archived tissue from their initial biopsy and possess a H-score higher than 50 (as stated in Appendix B). Additionally, they should exhibit an Eastern Cooperative Oncology Group performance status rating lower than or equal to 2 as well as a Karnofsky Performance Status score of at least 60%. Finally, life expectancy needs to exceed 4 weeks."

Answered by AI

Are there any extant investigations that have utilized Quality-of-Life Assessment?

"Currently, there are 764 active clinical trials for Quality-of-Life Assessment with 86 of the studies at Phase 3. Pittsburgh, Pennsylvania is hosting a handful of these trials; however, 42751 sites worldwide have programs dedicated to this assessment technique."

Answered by AI

Is this research open to geriatric participants?

"This trial seeks participants who are over 18 and below the age of 75."

Answered by AI

How does Quality-of-Life Assessment typically aid medical professionals?

"Quality-of-Life Assessment can be used to combat the effects of past anti-angiogenic therapies, malignant tumours, and inoperable melanoma."

Answered by AI

Are there currently any openings to participate in this experiment?

"Affirmative, the details of this trial located on clinicaltrials.gov suggest it is actively recruiting participants. Posting initially on September 26th 2019 and most recently edited November 15th 2022, the research team seeks 60 individuals to be recruited from just 1 location."

Answered by AI
~4 spots leftby Jul 2024