CARv3-TEAM-E T Cells in Glioblastoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Marcela V. Maus, M.D.,Ph.D.
Study ID
NCT05660369
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CARv3-TEAM-E T cells — DRUG
    Autologous 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.

Study Details

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).

Key Dates

Start date
Mar 22, 2023
Status verified
Feb 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
21 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Run-In Phase
    * Participant enrollment will be staggered by 30 days for up to 3 participants. * Participants will receive 1 infusion of CARv3-TEAM-E. * Phase will be expanded up to 6 participants if any Dose-Limiting Toxicities DLTs occur. * After all participants have been enrolled, there will be an evaluation made by the Data Safety Monitoring Board (DSMB) and the FDA to determine the safety of enrollment into additional arms.
  • Experimental: Arm 1: Recurrent Glioblastoma (GBM), EGFRvIII Positive
    * Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw. * Rituximab will be administered 5-10 days prior to infusion. * Lymphodepletion chemotherapy treatment will occur 5 days prior to infusion. * CARv3-TEAM-E will be administered via Ommaya on D0 * Participants will be followed for 2 years post-treatment. * Participants who are deriving clinical benefit and have sufficient product can be retreated with up to 5 additional doses.
  • Experimental: Arm 2: Newly Diagnosed GBM, EGFRvIII Positive
    * Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw. * Rituximab will be administered 5-10 days prior to infusion. * Lymphodepletion chemotherapy treatment will occur 5 days prior to infusion. * CARv3-TEAM-E will be administered via Ommaya on D0 * Participants will be followed for 2 years post-treatment. * Participants who are deriving clinical benefit and have sufficient product can be retreated with up to 5 additional doses.
  • Experimental: Arm 3: Recurrent GBM, EGFRvIII Negative
    * Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw. * Rituximab will be administered 5-10 days prior to infusion. * Lymphodepletion chemotherapy treatment will occur 5 days prior to infusion. * CARv3-TEAM-E will be administered via Ommaya on D0 * Participants will be followed for 2 years post-treatment. * Participants who are deriving clinical benefit and have sufficient product can be retreated with up to 5 additional doses.

Primary Outcome Measure

Incidence of Adverse Events (AEs) [ Time Frame: From Day 0 to 2 years post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Cancer CenterBostonMassachusetts02215
William Curry, MD
[email protected]
617-724-6226

Find similar trials in Boston, MA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Massachusetts General Hospital Cancer Center· Boston, MA

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