CARv3-TEAM-E T Cells in Glioblastoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarcela V. Maus, M.D.,Ph.D.
About this trial
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).
Eligibility criteria
Qualifiers
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)
Disqualifiers
Intraparenchymal posterior fossa disease
Intramedullary spinal disease as the only site of disease.
Prior EGFRvIII targeted therapies.
Prior bevacizumab treatment.
Trial design
Treatments tested in this trial
- CARv3-TEAM-E T cells
Treatment groups
21 Participants
are divided into 4 treatment groupsSponsors and collaborators
Marcela V. Maus, M.D.,Ph.D.
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Source ClinicalTrials.gov