Glioblastoma study: CARv3-TEAM-E T cells
Official title CARv3-TEAM-E T Cells in Glioblastoma
ClinicalTrials.gov ID: NCT05660369
What this study is testing
What is CARv3-TEAM-E T cells?
An investigational cell therapy being studied as a potential treatment for glioblastoma. It is designed to recognize and attack tumor cells by using a genetically engineered receptor on the patient’s own T‑cells.
Also referred to as Autologous T lymphocyte.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to discover the safest and most effective dose of CARv3-TEAM-E T cells for treating glioblastoma.
- Who it's for
- Adults who have been diagnosed with glioblastoma (including recurrent cases).
- What's involved
- Participants will have their own T cells modified and infused back into them, with dose levels adjusted as the study progresses, plus routine check‑ups and lab tests.
- Time commitment
- The trial runs for several months and includes multiple clinic visits for treatment and follow‑up assessments.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Participants must be at first progression or recurrence and plan is for biopsy or surgical debulking.
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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.
- Must be at least 3 months from completion of radiation or evidence of progression is outside the high dose radiation field.
- 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.
- 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.
- 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
- 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
- Ability to understand and the willingness to sign a written informed consent document.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.