Trials / Recruiting
RecruitingNCT05660369
CARv3-TEAM-E T Cells in Glioblastoma
INCIPIENT: INtraventricular CARv3-TEAM-E T Cells for PatIENTs With GBM
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- Sponsor
- Marcela V. Maus, M.D.,Ph.D. · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CARv3-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. |
Timeline
- Start date
- 2023-03-22
- Primary completion
- 2026-09-01
- Completion
- 2027-09-01
- First posted
- 2022-12-21
- Last updated
- 2026-02-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05660369. Inclusion in this directory is not an endorsement.