A Phase I Clinical Trial to Evaluate the Safety and Tolerability of Mesothelin-Specific Chimeric Antigen Receptor-Positive T Cells in Patients With Metastatic Mesothelin-Expressing Breast Cancer

NCT02792114 Phase 1 ACTIVE_NOT_RECRUITING

The purpose of this study is to test the safety of different doses of specially prepared T cells collected from the blood. The investigators want to find a safe dose of these modified T cells for patients who have metastatic HER2-negative breast cancer.

Details

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	186
Start date	2016-06
Completion	2026-06

Conditions

• Breast Cancer
• Metastatic HER2-negative Breast

Interventions

• Cyclophosphamide
• Mesothelin-targeted T cells
• AP1903

Primary outcomes

• Maximum tolerated does (MTD) — 2 years
  We have designed the dose-escalation using a standard 3+3 design. In this design, patients will be treated in sequential groups of 3 to 6 patients per T cell dose. With 4 dose levels, the projected trial size for this study is a minimum of 4 and a maximum of 24 patients.

Countries

United States