INCIPIENT: INtraventricular CARv3-TEAM-E T Cells for PatIENTs With GBM
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).
Detailed description
This is a non-randomized, open label, single site Phase 1 study to define the appropriate dose of CARv3-TEAM-E and evaluate its safety for the treatment of recurrent or newly diagnosed glioblastoma. The U.S. Food and Drug Administration (FDA) has not approved CARv3-TEAM-E T Cells as a treatment for any disease. This is the first time that CARv3-TEAM-E T Cells will be given to humans. CARv3-TEAM-E T Cells are made from a person's own collected immune cells (T-Cells) that are genetically changed and then delivered back into the body to try to kill their cancerous cells. The research study procedures include screening for eligibility, study treatment, including evaluations and follow up visits, blood collections, echocardiograms, and radiologic imaging of tumors. It is expected participants will receive treatment over a period of short-term (approx. 2 years) and then long-term follow-up of up to 15 years. It is expected that about 21 people will take part in this research study. This research study has received funding through an internal grant program.
Arms & interventions
- DrugCARv3-TEAM-E T cells
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.
Outcome measures
Primary
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-treatment
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 months
Secondary
Proportion of Participants with One Infusion
Time frame: up to 6 months
Overall Response Rate
Time frame: Day 0 to 2 years post-treatment
Overall Survival Rate
Time frame: From Day 0 to 2 years post-treatment
Progression Free Survival (PFS)
Time frame: Registration to 2 years post-treatment
Eligibility criteria
Study locations (1)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
References
- Choi BD, Gerstner ER, Frigault MJ, Leick MB, Mount CW, Balaj L, Nikiforow S, Carter BS, Curry WT, Gallagher K, Maus MV. Intraventricular CARv3-TEAM-E T Cells in Recurrent Glioblastoma. N Engl J Med. 2024 Apr 11;390(14):1290-1298. doi: 10.1056/NEJMoa2314390. Epub 2024 Mar 13.(PubMed)