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CAR T-cell Therapy
CAR T-cell Therapy for Glioblastoma
Phase 1
Recruiting
Led By Stephen Bagley, MD, MSCE
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with glioblastoma, IDH-wildtype that has recurred following prior radiotherapy
Male or female age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
Study Summary
This trial tests safety and effectiveness of new cell therapy for glioblastoma brain tumors that have come back after treatment.
Who is the study for?
This trial is for adults over 18 with recurrent glioblastoma, IDH-wildtype, after radiotherapy. Candidates must have adequate organ function, EGFR-amplified tumors confirmed by specific tests, and agree to use birth control. Excluded are those with active hepatitis B/C, severe comorbidities, recent bevacizumab treatment, autoimmune diseases needing high-dose steroids or pregnant/nursing women.Check my eligibility
What is being tested?
The study is testing the safety of CART-EGFR-IL13Ra2 cells in patients whose glioblastoma has returned despite prior treatments. It's an early-phase trial where participants receive genetically modified T cells targeting two specific molecules on their cancer.See study design
What are the potential side effects?
Potential side effects may include immune reactions due to modified T cell activity against the tumor which can affect normal tissues as well. Specific side effects aren't listed but typically involve flu-like symptoms, fatigue, and possible organ inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My glioblastoma has returned after radiation treatment.
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I am 18 years old or older.
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I have mild or no shortness of breath and my oxygen level is above 92% without assistance.
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My tumor is EGFR positive, as confirmed by NeoGenomics.
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My kidneys work well enough, not requiring dialysis.
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I can care for myself but may need occasional help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determination of maximum tolerated dose assessed by collection of adverse events as graded by CTCAE.
Number of Subjects with treatment related adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Number of subjects with dose-limiting toxicities
Secondary outcome measures
Duration of response (DOR)
Frequency of manufacturing failures
Objective Response Rate (ORR)
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Dose Level 3Experimental Treatment1 Intervention
Cohort 3 (N = 3-6): will receive a single fixed dose of 5x10^7 CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0.
Group II: Dose Level 2Experimental Treatment1 Intervention
Cohort 2 (N = 3-6): will receive a single fixed dose of 2.5x10^7 CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0.
Group III: Dose Level 1Experimental Treatment1 Intervention
Cohort 1 (N = 3-6): will receive a single fixed dose of 1x10^7 CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0.
Group IV: Dose Level -1Experimental Treatment1 Intervention
Cohort-1 (N = 3-6): will receive a single fixed dose of 5x10^6 CART-EGFR-IL13Ra2 cells via intrathecal administration on Day 0.
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Who is running the clinical trial?
Tmunity TherapeuticsIndustry Sponsor
6 Previous Clinical Trials
131 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
848,461 Total Patients Enrolled
3 Trials studying Glioblastoma
561 Patients Enrolled for Glioblastoma
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,191 Total Patients Enrolled
7 Trials studying Glioblastoma
187 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My glioblastoma has returned after radiation treatment.I am allergic to some ingredients in the study medication.I am 18 years old or older.My doctor recommends surgery or a biopsy to manage or confirm my cancer's return.I have not received bevacizumab in the last 3 months.I have a tumor sample from my initial surgery or from when my cancer came back.I have mild or no shortness of breath and my oxygen level is above 92% without assistance.My tumor is EGFR positive, as confirmed by NeoGenomics.It's been over 12 weeks since my first radiotherapy for a tumor with MGMT promoter methylation.I have an active hepatitis B or C infection.My kidneys work well enough, not requiring dialysis.I have severe limitations due to heart problems.I do not have any active, uncontrolled infections.I am on strong medication for an autoimmune disease, but it's not a neurological one.I can care for myself but may need occasional help.My tumor is mainly in my brain stem or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 1
- Group 2: Dose Level -1
- Group 3: Dose Level 3
- Group 4: Dose Level 2
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the traditional purpose of Cohort 1?
"Cohort 1 is widely used to treat multiple sclerosis, yet it also exhibits efficacy in managing mixed-cell type lymphoma, acute myeloid leukemia and retinoblastoma."
Answered by AI
What adverse effects may be experienced by members of Cohort 1?
"Due to its designation as a Phase 1 trial, Cohort 1 was assigned an initial safety rating of 1 on the Power team's scale. This implies that there is limited clinical data supporting both efficacy and safety for this particular intervention."
Answered by AI
Are there opportunities for people to join this medical experiment at present?
"Affirmative. The information available on clinicaltrials.gov shows that the enrollment for this medical test is ongoing, which began on February 23rd 2023 and was revised lastly in 27th of the same month. There is a requirement to enroll 18 individuals from one facility."
Answered by AI
How many individuals are being recruited to participate in this research?
"Yes, the information on clinicaltrials.gov reveals that this medical experiment is presently looking for participants since it was initially posted on February 23rd 2023 and last updated a few days later. The research requires 18 individuals to be recruited from one site."
Answered by AI
What additional research has been conducted on the participants of Cohort 1?
"Presently, there are 840 active studies exploring the effects of Cohort 1. Of those, 151 have advanced to Phase 3 testing. Primarily centered in Philadelphia, Pennsylvania, these trials span 27151 clinical locations globally."
Answered by AI
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