Grant Award Details
Complete a Phase 1 study of autologous chimeric antigen receptor engineered stem/memory T Cells for the treatment of HER2-positive brain metastases.
Grant Application Details
- A Phase I Study of Chimeric Antigen Receptor Engineered Stem/Memory T Cells for the Treatment of HER2-Positive Brain Metastases
Therapeutic Candidate or Device
Autologous naïve-stem/memory T cells engineered with a chimeric antigen receptor targeting the HER2 antigen (HER2BBζ-Tn/mem)
HER2-positive brain and/or leptomeningeal metastases, primarily from breast cancer
The proposed therapy aims to provide a safe and effective treatment option for patients with HER2-positive cancers that have metastasized to the central nervous system via direct chimeric antigen receptor (CAR) T cell-mediated tumor cytotoxicity.
Unmet Medical Need
Currently, there are no effective treatment options that provide durable and life-extending therapies to patients with HER2-positive brain and/or leptomeningeal metastatic disease.
Phase 1 trial completed
Major Proposed Activities
- Phase 1 clinical testing of regional intraventricular delivery of HER2BBζ-Tn/mem CAR T cell therapy
- Achieve primary, secondary, and correlative study objectives in phase 1 trial
- Phase 1 clinical trial activities to accelerate initiation of phase 2 trial
In California, breast cancer constitutes the highest cancer incidence with an expected 27,700 new cases and 4,560 deaths in 2019. Up to 25% of breast cancers overexpress HER2, and nearly 50% of these patients will ultimately develop brain and/or leptomeningeal metastases. Our proposal utilizes regional intraventricular delivery of HER2-targeted CAR T cells to treat brain metastases of HER2+ cancers, and aims to provide a durable and life-extending therapeutic option for these patients.