Phase 12a Study of BRIA-OTS Cellular Immunotherapy with Checkpoint Inhibitor in Metastatic Recurrent Breast Cancer

What this Trial Is About

Researchers are investigating the safety and effects of a new cellular immunotherapy called BRIA-OTS for patients with metastatic recurrent breast cancer. This open-label Phase 12a study first tests increasing doses of the BC1 cell line alone in a few patients to assess safety. Once safety is established, the study evaluates the combination of BC1 with the Bria-OTS regimen and an FDA-approved checkpoint inhibitor CPI to explore potential benefits in this patient group. In the initial monotherapy phase, patients receive intradermal doses of BC1 every two weeks for six weeks, with dose escalation among the first three patients if tolerated. After confirming safety, participants receive the Bria-OTS regimen every three weeks, which includes BC1 cell inoculation combined with low-dose cyclophosphamide given 2-3 days prior, peginterferon alpha-2a on the day of inoculation, and the CPI administered according to approved dosing. Phase 2 expands enrollment to assess this combination in more patients. Participants undergo imaging at screening, after the monotherapy phase, and regularly during treatment to monitor tumor response. They may continue treatment if clinical benefit is observed. Safety is closely monitored throughout, including adverse events, laboratory tests, and physical exams. Follow-up includes phone or medical record reviews every three months for up to two years to assess survival and disease progression. Total participation time is approximately 16 weeks for primary outcomes, with extended follow-up for long-term results.

A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer