BATs in Patients With Breast Cancer and Leptomeningeal Metastases

Phase 1 Terminated 3 enrolled University of Virginia

NaSingle-groupOpen-labelTreatment

Summary

This study uses bi-specific antibody (HER2Bi) armed activated T-cells (HER2 BATs) to target breast cancer cells that have metastasized to the membranes surrounding the brain and spinal cord. This is known as leptomeningeal metastases. Two doses will be evaluated in order to determine a safe dose. Study treatment includes a test dose of HER2 BATs followed by 8 weekly infusions of HER2 BATs at the assigned dose level. Before, during and after study treatment, participants will be monitored objectively by brain MRIs and clinically through physical and neurological exams, and blood and cerebrospinal fluid will be collected to evaluate immune responses.

Timeline

Start: 2019-02-26
Primary completion: 2021-12-14
Completion: 2021-12-14

Outcome

Outcome not reported

Stopped (Enrollment): “slow study accrual, partially due to pandemic”

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HER2 BATs	Cell therapy	5 cells	Other
Subject	HER2 BATs	Cell therapy	10 cells	Other