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CAR T-cell Therapy
CARv3-TEAM-E T Cells for Glioblastoma
Phase 1
Recruiting
Led By William Curry, MD
Research Sponsored by Marcela V. Maus, M.D.,Ph.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up registration to 2 years post-treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial seeks to find the best dose of CARv3-TEAM-E T Cells to treat glioblastoma, a type of brain cancer.
Who is the study for?
This trial is for adults with recurrent glioblastoma, a type of brain tumor. Participants must have had prior radiation, measurable disease, and be able to undergo an MRI. They should not have other ongoing serious illnesses or a history of certain cancers within the last 5 years (with some exceptions). Adequate organ function and agreement to use contraception are required.
What is being tested?
The study is testing CARv3-TEAM-E T cells to find the best dose for treating glioblastoma. These are modified immune cells designed to target and destroy cancer cells in patients who've seen their cancer return after initial treatment.
What are the potential side effects?
While specific side effects aren't listed here, similar therapies can cause immune reactions, fatigue, fever, headaches, and potential harm to organs where T-cells may attack healthy tissue. The full range of side effects will be monitored throughout the trial.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Adverse Events (AEs)
Number of Dose-Limiting Toxicities (DLTs)
Secondary study objectives
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
5 Previous Clinical Trials
91 Total Patients Enrolled
William Curry, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
56 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has returned for the first time and I've had radiation before.My cancer has returned or worsened for the first time and I've had radiation before.I have received treatments targeting EGFRvIII before.I've completed most of my radiation therapy without using temozolomide before getting CARv3-TEAM-E Infusion.I expect to take 4 mg or less of dexamethasone daily at the start of my CAR-v3-TEAM-E treatment.I am breastfeeding and receiving CARv3-TEAM-E treatment.I am willing and able to have an Ommaya reservoir placed.I am currently on long-term immune system suppressing drugs.I have not received any cancer treatment other than radiation.I am scheduled for radiation therapy without temozolomide.My brain tumor is located in the back part of my brain.I am using effective birth control methods during the trial.My tumor fits the specified size and location criteria.I have been cancer-free for over 5 years, except for certain noninvasive cancers.I can care for myself but may need occasional help.My GBM has recurred, lacks the EGFRvIII mutation but shows EGFR amplification.I am 18 years old or older.My side effects from previous cancer treatments have mostly gone away.I do not have any uncontrolled illnesses.I have chronic hepatitis B or active hepatitis C.I have recovered from side effects of previous cancer treatments, except for hair loss.My brain tumor has returned or shows specific genetic changes, including the EGFRvIII mutation.I haven't had alkylating therapy or immunotherapy in the last 4 weeks, and it's been long enough since my last investigational drug.I have not had gene therapy or gene-modified cell treatments.My blood counts and liver/kidney functions are within normal ranges.My newly diagnosed brain tumor has a specific EGFR mutation and lacks a certain chemical change in its DNA.My only cancer site is within my spinal cord.I have a tumor larger than 1 cm that can be measured with an MRI, not only in my spine or back of the brain.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: Newly Diagnosed GBM, EGFRvIII Positive
- Group 2: Arm 1: Recurrent Glioblastoma (GBM), EGFRvIII Positive
- Group 3: Safety Run-In Phase
- 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.
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