CARv3-TEAM-E T Cells in Glioblastoma (NCT05660369) | Clinical Trial Compass
RecruitingPhase 1
CARv3-TEAM-E T Cells in Glioblastoma
United States21 participantsStarted 2023-03-22
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion 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. Prior temozolomide is not required if the participant is MGMT unmethylated.
Participants must be 2 weeks from prior alkylating therapy or immunotherapy and ā„ 5 half-lives from another investigational agent before proceeding with collection or treatment. No washout is required from radiation since participants will need histological confirmation of recurrence to participate.
* 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. Participantā¦