Intraventricular CARv3-TEAM-E T Cells in Recurrent Glioblastoma.
Bryan D Choi, Elizabeth R Gerstner, Matthew J Frigault...
https://pubmed.ncbi.nlm.nih.gov/38477966Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID05660369
INCIPIENT: Intraventricular CARv3-TEAM-E T Cells for Patients With Glioblastoma
Led by Marcela V. Maus, M.D.,Ph.D. · Updated on 2026-02-04
21
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CARv3-TEAM-E T Cells to find the best dose and assess safety for treating glioblastoma, including recurrent or newly diagnosed cases. This Phase 1, open-label study is the first time CARv3-TEAM-E T Cells, made from a patient's own modified immune cells, will be given to humans. The study aims to understand how these genetically changed cells may help target cancerous brain cells in glioblastoma patients. Participants will receive one infusion of CARv3-TEAM-E T Cells through an Ommaya reservoir after a process that includes collection of their immune cells via leukapheresis, pre-treatment with rituximab, and lymphodepletion chemotherapy five days before infusion. The study includes a safety run-in phase and several arms for different glioblastoma subtypes based on EGFRvIII mutation status. Participants may receive up to five additional doses if they benefit clinically and have sufficient product. Follow-up lasts about two years after treatment. During the study, participants undergo eligibility screening, treatment, and follow-up visits with evaluations such as blood tests, echocardiograms, and imaging of tumors. Researchers monitor for adverse events and dose-limiting toxicities up to two years post-treatment. The main outcomes include safety measures, response rates, survival rates, and progression-free survival. The study may continue long-term follow-up up to 15 years to assess ongoing effects and safety.
CONDITIONS
Brief Title
CARv3-TEAM-E T Cells in Glioblastoma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed recurrent or newly diagnosed glioblastoma with specific EGFRvIII mutation status depending on study arm
- At first progression or recurrence with biopsy or surgical debulking planned (for recurrent arms)
- Prior radiation therapy received (except for some newly diagnosed participants)
- At least 2 weeks from prior alkylating therapy or immunotherapy and 5 half-lives from other investigational agents
- Measurable disease with at least one lesion 10 mm or larger on MRI (for recurrent arms)
- No posterior fossa or intramedullary spine-only disease; leptomeningeal disease allowed
- Ability and willingness to undergo placement of an Ommaya reservoir
- Steroid dose at or below 4 mg dexamethasone daily or equivalent at first infusion
- Karnofsky performance status of 60% or higher
- Ability to undergo MRI with contrast
- Life expectancy greater than 3 months
- Adequate organ and marrow function as defined by specific blood count and organ function thresholds
- No prior history of malignancy within 5 years except certain noninvasive cancers
- Left ventricular ejection fraction above 50%
- Agreement to use adequate contraception during and after study participation
- Ability to understand and sign informed consent
You will not qualify if you...
- Intraparenchymal posterior fossa disease or intramedullary spinal disease as only disease site
- Prior EGFRvIII targeted therapies
- Prior bevacizumab treatment
- Previous gene therapy or gene-modified cellular therapy
- Presence of or need for a ventricular-peritoneal shunt
- Ongoing treatment with chronic immunosuppressants above physiologic doses
- Unresolved adverse events from prior cancer therapy above Grade 1 (except alopecia)
- Receiving other investigational agents
- History of allergic reactions to compounds similar to CARv3-TEAM-E
- Uncontrolled intercurrent illness
- HIV infection
- Active or chronic hepatitis B or C infection
- Psychiatric or social issues limiting study compliance
- Pregnancy or breastfeeding
- For newly diagnosed arm, prior cancer treatment other than radiation is not allowed
- For newly diagnosed arm, must have completed at least 75% of planned radiation without temozolomide
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 infusion with possible additional doses over 2 years
Participants receive a leukapheresis procedure or blood draw to collect T cells, followed by administration of rituximab 5 to 10 days prior to infusion. Lymphodepletion chemotherapy occurs 5 days before infusion. CARv3-TEAM-E T Cells are then administered via an Ommaya reservoir. Participants may receive up to 6 infusions if deriving clinical benefit and product is available.
Multiple visits including leukapheresis, rituximab administration, chemotherapy, infusion day, and follow-up visits over 2 years
Follow-up
Duration - Up to 2 years
Participants are followed for safety and treatment response for up to 2 years after the initial treatment.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
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Research Team
W
William Curry, MD
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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