CARv3-TEAM-E T Cells for Recurrent Glioblastoma
This study is testing a new treatment called CARv3-TEAM-E T Cells for people with recurrent glioblastoma (a type of brain cancer) that has a specific genetic change called EGFRvIII. This treatment uses your own immune cells (T-cells) that are specially modified in a lab to target and fight cancer. Researchers want to find the safest and most effective dose of CARv3-TEAM-E T Cells. This is the first time this treatment is being given to people. About 21 people are expected to join this study. The main goals are to see how safe the treatment is and to identify any serious side effects. The U.S. FDA has not yet approved CARv3-TEAM-E T Cells for any disease.
- Study design
- This is a Phase 1, non-randomized, open-label study at a single location, aiming to enroll about 21 participants. It is designed to find the right dose of CARv3-TEAM-E T Cells and check its safety.
- What's involved
- You would undergo screening, receive the study treatment, have evaluations, follow-up visits, blood draws, echocardiograms, and tumor imaging. This will involve short-term treatment over approximately 2 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are expected to have long-term follow-up for up to 15 years after treatment.
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NCT05660369
CARv3-TEAM-E T Cells in Glioblastoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentMarcela V. Maus, M.D.,Ph.D.Investigator-initiated
~21 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:CARv3-TEAM-E T cells
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events (AEs)
Measured over From Day 0 to 2 years post-treatment
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Study leadership
- William Curry, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Safety Run In Arm and ARM 1: Recurrent GBM, EGFRvIII mutant
Participants must have histologically confirmed recurrent GBM or molecular features of GBM with presence of EGFRvIII mutation detected at initial diagnosis. MGMT methylated, unmethylated, or unknown is allowed.
Participants must be at first progression or recurrence and plan is for biopsy or surgical debulking. Participants must have at least received prior radiation. Prior temozolomide is not required if the participant is MGMT unmethylated.
ARM 2: Newly Diagnosed GBM, EGFRvIII mutant (will only open once safety is confirmed in Arms 1 and 3)
Participants must have histologically confirmed newly diagnosed GBM with presence of EGFRvIII mutation and their tumors must be MGMT unmethylated.
Treatment planned with involved field radiation alone without concomitant or sequential temozolomide.
ARM 3: Recurrent GBM, EGFRvIII negative
Participants must have histologically confirmed recurrent GBM with EGFR amplification but no EGFRvIII mutation based on initial diagnostic tissue.
Participants must be at first recurrence and plan is for biopsy or surgical debulking. Participants must have at least received prior radiation. Prior temozolomide is not required if the participant is MGMT unmethylated.
ARM 1: Recurrent GBM, EGFRvIII mutant and ARM 3: Recurrent GBM, EGFRvIII negative:
Must be at least 3 months from completion of radiation or evidence of progression is outside the high dose radiation field.
Safety Run-In Arm and ARM 1: Recurrent GBM, EGFRvIII mutant and ARM 3: Recurrent GBM, EGFRvIII negative:
Participants must have measurable disease, defined as at least one lesion ≥10 mm (≥1 cm) with MRI. See Section 11 (Measurement of Effect) for the evaluation of measurable disease.
ALL ARMS:
Patients cannot have posterior fossa or intramedullary spine-only disease. Leptomeningeal disease is allowed anywhere in the neuroaxis. See Section 11 (Measurement of Effect) for the evaluation of measurable disease.
Resolution of AEs from any prior systemic anticancer therapy or radiotherapy to Grade 1 or baseline (except Grade 2 alopecia and Grade 2 sensory neuropathy)
Medically able and willing to undergo placement of an Ommaya reservoir.
Steroid dose anticipated to be ≤ 4 mg of dexamethasone a day or equivalent at time of first CAR-v3-TEAM-E infusion.
Age ≥18 years
Karnofsky ≥60%
Must be able to undergo an MRI with contrast.
Life expectancy of greater than 3 months.
Participants must have adequate organ and marrow function as defined below:
Absolute neutrophil count ≥1,000/mcL
Platelets ≥80,000/mcL
Total bilirubin ≤ institutional upper limit of normal (ULN); For patients with Gilbert's syndrome, total bilirubin can be ≤ 3xULN.
AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
CrCl ≥ 60 mL/min
Participant has no prior history of malignancy, unless the subject has been free of the disease for ≥5 years with the exception of the following noninvasive malignancies:
Basal cell carcinoma of the skin
Squamous cell carcinoma of the skin
Carcinoma in situ of the cervix
Carcinoma in situ of the breast
Incidental histologic finding of prostate cancer (T1a or T1b) or prostate cancer that is curative
Left ventricular ejection fraction \>50% as determined by TTE.
The effects of CARv3-TEAM-E on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of CARv3-TEAM-E administration.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion
Intraparenchymal posterior fossa disease
Intramedullary spinal disease as the only site of disease.
Prior EGFRvIII targeted therapies.
Prior bevacizumab treatment.
Treatment with an any prior gene-therapy or gene-modified cellular therapy.
Patients with a VP shunt or patients needing a shunt in the immediate future are excluded from participating
Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed
Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.
Participants who are receiving any other investigational agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to CARv3-TEAM-E (ex. cetuximab).
Participants with uncontrolled intercurrent illness.
Human immunodeficiency virus (HIV)-infected participants are not eligible.
Participants with evidence of chronic hepatitis B virus (HBV) infection or active hepatitis C virus (HCV) infection are not eligible.
Participants with psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CARv3-TEAM-E , breastfeeding should be discontinued if the mother is treated with CARv3-TEAM-E.
For Arm 2, prior to CARv3-TEAM-E Infusion, the following criteria should be confirmed in addition to the relevant criteria above:
Participants must have completed 75% of the planned 6 weeks of involved field radiation without temozolomide
Tumor location and size criteria as in 3.1.7 above.
Prior cancer directed therapy other than radiation is not allowed.
What this trial measures
- Incidence of Adverse Events (AEs)From Day 0 to 2 years post-treatment
Defined as the incidence of ≥ Grade 3-4 adverse events related to CARv3-TEAM-E.
- Number of Dose-Limiting Toxicities (DLTs)up to 6 months
Defined as any related toxicity experienced by run-in cohort of CTCAE v5 grade ≥ 4 Adverse Event