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CAR T-Cell Therapy + Immunotherapy for Glioblastoma
Study Summary
This trial is testing IL13Ralpha2-CAR T cells, given alone or with nivolumab and ipilimumab, to treat patients with glioblastoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My cancer has returned or worsened after treatment, and it's been over 12 weeks since my last radiation therapy.I am 18 years old or older.I am not pregnant or breastfeeding.I am still experiencing side effects from my previous cancer treatment.I have had serious heart issues or symptoms in the last 6 months and have had heart tests done recently.I do not have any other active cancer.My tumor tests positive for IL13Rα2.You have a history of an autoimmune disease or currently have an autoimmune disease.I am currently experiencing diarrhea.You have had allergic reactions to similar medicines or substances like the study drug.I have seizures or worsening brain function that isn't controlled.I have a history of HIV or hepatitis B/C.I can care for myself but may not be able to do active work.I have previously received immunotherapy targeting CTLA-4, PD-1, or PD-L1.I am currently taking antibiotics for an infection.I agree to let my previous biopsy samples be used for this study.I do not have any uncontrolled serious illnesses.I need more than 6 mg of dexamethasone daily.My brain tumor is confirmed as grade IV GBM or has progressed to this after treatment.
- Group 1: Arm III (IL13Ra2 CAR T cells)
- Group 2: Arm II (nivolumab, IL13Ra2 CAR T cells)
- Group 3: Arm I (nivolumab, ipilimumab, IL13Ralpha2 CAR T cells)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
Is this research open to geriatric participants?
"This trial seeks participants who are over 18 and below the age of 75."
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."
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."
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