Actively Recruiting
CARv3-TEAM-E T Cells in Glioblastoma
Led by Marcela V. Maus, M.D.,Ph.D. · Updated on 2026-02-04
21
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this research study is to determine the best dose of CARv3-TEAM-E T Cells for treating participants with glioblastoma. The name of the treatment intervention used in this research study is: -CARv3-TEAM-E T Cells (or Autologous T lymphocytes).
CONDITIONS
Official Title
CARv3-TEAM-E T Cells in Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically confirmed recurrent or newly diagnosed glioblastoma with specific EGFRvIII mutation or EGFR amplification status depending on study arm
- Participants must be at first progression or recurrence with plans for biopsy or surgical removal of tumor
- Participants must have received prior radiation therapy; prior temozolomide is not required if MGMT unmethylated
- Participants must be at least 2 weeks from prior alkylating therapy or immunotherapy and at least 5 half-lives from another investigational agent
- Participants must have measurable disease with at least one lesion 10 mm or larger on MRI
- Participants cannot have posterior fossa or intramedullary spine-only disease; leptomeningeal disease allowed
- Resolution of adverse events from prior therapy to Grade 1 or baseline, except alopecia and sensory neuropathy
- Medically able and willing to undergo Ommaya reservoir placement
- Steroid dose must be 4 mg dexamethasone daily or less at time of first infusion
- Age 18 years or older
- Karnofsky performance score of 60% or higher
- Must be able to undergo MRI with contrast
- Life expectancy greater than 3 months
- Adequate organ and marrow function as specified in protocol
- No prior history of malignancy unless disease-free for 5 years with exceptions
- Left ventricular ejection fraction greater than 50%
- Women of child-bearing potential and men must agree to use contraception during and after study participation
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Presence of intraparenchymal posterior fossa disease or intramedullary spinal disease only
- Prior treatment with EGFRvIII targeted therapies or bevacizumab
- Prior gene therapy or gene-modified cellular therapy
- Presence of a ventriculoperitoneal shunt or need for shunt in near future
- Ongoing treatment with chronic immunosuppressants above physiologic doses; intermittent topical or inhaled corticosteroids allowed
- Unresolved adverse events from prior anti-cancer therapy greater than Grade 1 except alopecia
- Receiving other investigational agents
- History of allergic reactions to compounds similar to CARv3-TEAM-E
- Uncontrolled intercurrent illness
- Infection with HIV, chronic hepatitis B, or active hepatitis C
- Psychiatric or social conditions limiting study compliance
- Pregnant or breastfeeding women
- For newly diagnosed GBM arm: must have completed at least 75% of planned radiation without temozolomide and no prior cancer-directed therapy other than radiation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
W
William Curry, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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