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This trial tests if a cell therapy can delay cancer return in GBM patients when combined with standard chemo. If it works, it should be studied further.
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- You are able to perform daily activities with a certain level of independence and function at 70% or higher.In Arms A and C, you must have recently been diagnosed with glioblastoma and have not received any treatment for it before.You have received certain types of treatments, such as gene therapy or surgery, in the past six weeks. You have also received specific types of chemotherapy or experimental immunotherapy at any time.You cannot be taking any other experimental drugs at the same time as this study.You had brain infections like encephalitis or multiple sclerosis less than a year before being diagnosed with glioblastoma.You have had HIV or hepatitis in the past or currently have an autoimmune condition.You are able to perform daily activities with at least 70% of your normal ability.
- Group 1: 1) Autologous: Phase 2 Arm A
- Group 2: 2) Allogeneic: Phase 1b
- Group 3: 3) Allogeneic: Phase 2 Arm B
- Group 4: 4) Allogeneic: Phase 2 Arm C
- 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
Is there still room to enroll in this experiment?
"According to the information on clinicaltrials.gov, this trial has been inactive since its last update in December 16th 2022. As such, it is not currently accepting new recruits; however there are 443 other studies that can be considered for participation at present."
What objectives is this research endeavor attempting to fulfill?
"The central goal of this study, monitored over a period of 12 months, is to determine the recommended phase 2 dose (RP2D) for allogeneic arms and identify any patient or product characteristics which could improve manufacturing. Secondary objectives include assessing tolerability through treatment emergent adverse events and serious adverse events in addition to clinical laboratory tests such as liver function tests, renal function and complete blood counts; monitoring vital signs including heart rate, temperature and pulse oximetry; analyzing overall response rates based on CR or PR responses;and measuring time-to-progression from first dose until objective tumor progression."
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