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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
CARv3-TEAM-E T cells
DrugAutologous T lymphocyte population that contains cells transduced ex-vivo with a CARv3-TEAM-E lentiviral vector encoding a chimeric antigen receptor (CAR). Administered via Ommaya reservoir.
Treatment groups
21 Participants
are divided into 4 treatment groupsGroup A: Safety Run-In PhaseExperimental treatment 1 intervention
Group B: Arm 1: Recurrent Glioblastoma (GBM), EGFRvIII PositiveExperimental treatment 1 intervention
Group C: Arm 2: Newly Diagnosed GBM, EGFRvIII PositiveExperimental treatment 1 intervention
Group D: Arm 3: Recurrent GBM, EGFRvIII NegativeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Adverse Events (AEs)
Defined as the incidence of ≥ Grade 3-4 adverse events related to CARv3-TEAM-E.
Time frame
From Day 0 to 2 years post-treatment2
Number of Dose-Limiting Toxicities (DLTs)
Defined as any related toxicity experienced by run-in cohort of CTCAE v5 grade ≥ 4 Adverse Event
Time frame
up to 6 monthsSecondary outcomes
1
Proportion of Participants with One Infusion
The study will be deemed feasible if the proportion of participants enrolled that go on to receive at least one infusion of CARv3-TEAM-E cells is 60% or greater. Applies to participants in run-in cohort and Arms 1 and 3.
Time frame
up to 6 months2
Overall Response Rate
Defined as the best response recorded from the start of treatment until disease progression/recurrence and evaluated using the Response Assessment in Neuro-Oncology Criteria (RANO).
Time frame
Day 0 to 2 years post-treatment3
Overall Survival Rate
Defined as the time from registration to death due to any cause.
Time frame
From Day 0 to 2 years post-treatment4
Progression Free Survival (PFS)
Defined as the time from registration to the earlier of progression or death due to any cause.
Time frame
Registration to 2 years post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Marcela V. Maus, M.D.,Ph.D.
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Source ClinicalTrials.gov