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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ARM 2: Newly Diagnosed GBM, EGFRvIII mutant
Participants must have histologically confirmed recurrent GBM with absence of EGFRvIII mutation within 30 days of consent but with EGFR amplification.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upregistration to 2 years post-treatment
Awards & highlights
No Placebo-Only Group
Study Summary
This trial seeks to find the best dose of CARv3-TEAM-E T Cells to treat glioblastoma, a type of brain cancer.
Eligible Conditions
- Glioblastoma
- Malignant Glioma
- Brain Tumor
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You need to be able to have a special type of body scan called an MRI with a special dye.
Select...
You have a type of brain cancer called recurrent GBM with a specific mutation called EGFRvIII.
Select...
You are planning to receive radiation therapy without also taking temozolomide at the same time or afterwards.
Select...
You have a type of brain tumor called recurrent GBM, but you do not have a specific gene mutation called EGFRvIII.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ registration to 2 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~registration to 2 years post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events (AEs)
Number of Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
Overall Response Rate
Overall Survival Rate
Progression Free Survival (PFS)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Safety Run-In PhaseExperimental Treatment1 Intervention
Participant enrollment will be staggered by 30 days for up to 3 participants.
Participants will receive 1 infusion of CARv3-TEAM-E.
Phase will be expanded up to 6 participants if any Dose-Limiting Toxicities DLTs occur.
After all participants have been enrolled, there will be an evaluation made by the Data Safety Monitoring Board (DSMB) and the FDA to determine the safety of enrollment into additional arms.
Group II: Arm 3: Recurrent GBM, EGFRvIII NegativeExperimental Treatment1 Intervention
Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw.
CARv3-TEAM-E will be administered 1x weekly for 6 doses on Days 0, 7, 14, 21, 28, and 36.
Participants will be followed for 2 years post-treatment.
Group III: Arm 2: Newly Diagnosed GBM, EGFRvIII PositiveExperimental Treatment1 Intervention
Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw.
CARv3-TEAM-E will be administered 1x weekly for 6 doses on Days 0, 7, 14, 21, 28, and 36.
Participants will be followed for 2 years post-treatment.
Group IV: Arm 1: Recurrent Glioblastoma (GBM), EGFRvIII PositiveExperimental Treatment1 Intervention
Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw.
CARv3-TEAM-E will be administered 1x weekly for 6 doses on Days 0, 7, 14, 21, 28, and 36.
Participants will be followed for 2 years post-treatment.
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Who is running the clinical trial?
Marcela V. Maus, M.D.,Ph.D.Lead Sponsor
4 Previous Clinical Trials
75 Total Patients Enrolled
William Curry, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
29 Total Patients Enrolled
1 Trials studying Glioblastoma
18 Patients Enrolled for Glioblastoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received any gene therapy or treatment involving modified cells in the past.You have had allergic reactions to similar medicines like cetuximab.You are not currently taking any experimental medications.The location and size of your tumor must fit specific criteria outlined in section 3.1.7.You need to be able to have a special type of body scan called an MRI with a special dye.You are planning to receive radiation therapy without also taking temozolomide at the same time or afterwards.You have a type of brain tumor called recurrent GBM, but you do not have a specific gene mutation called EGFRvIII.You have a type of brain cancer called recurrent GBM with a specific mutation called EGFRvIII.You only have spinal disease and no other areas of the body affected.
Research Study Groups:
This trial has the following groups:- Group 1: Safety Run-In Phase
- Group 2: Arm 1: Recurrent Glioblastoma (GBM), EGFRvIII Positive
- Group 3: Arm 2: Newly Diagnosed GBM, EGFRvIII Positive
- Group 4: Arm 3: Recurrent GBM, EGFRvIII Negative
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 risks would participants in a Safety Run-In Phase be exposed to?
"As this is the first clinical trial of its kind, it was assigned a safety rating of 1. This reflects that there has been limited research into both the efficacy and security profile of Safety Run-In Phase."
Answered by AI
Are there opportunities for volunteer participants in this research effort?
"According to clinicaltrials.gov, this medical research is no longer actively recruiting participants as it was last edited on December 13th 2022. Despite that fact, there are still 1,612 other studies seeking volunteers at the present time."
Answered by AI
What key goals are being pursued with this research endeavor?
"This trial seeks to evaluate the number of Dose-Limiting Toxicities (DLTs) over two years. Secondary endpoints include Overall Response Rate, assessed using RANO Criteria; Overall Survival rate; and Progression Free Survival rates."
Answered by AI
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