Genetically Engineered Cells (MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells) and Atezolizumab for the Treatment of Metastatic Triple Negative Breast Cancer, Urothelial Cancer, or Non-small Cell Lung Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8
- Metastatic Lung Non-Small Cell Carcinoma
- Metastatic Malignant Solid Neoplasm
- Metastatic Triple-Negative Breast Carcinoma
- Metastatic Urothelial Carcinoma
- Prognostic Stage IV Breast Cancer AJCC v8
- Stage IV Lung Cancer AJCC v8
- Stage IVA Lung Cancer AJCC v8
- Stage IVB Lung Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
OUTLINE: This is a phase I, dose escalation study of FH-MagIC TCR-T cells followed by a phase II study. LYMPHODEPLETION: Patients receive cyclophosphamide intravenously (IV) and fludarabine IV on days -4, -3, and -2 before each T-cell infusion. T-CELL INFUSION: Patients receive FH-MagIC TCR-T cells ...
OUTLINE: This is a phase I, dose escalation study of FH-MagIC TCR-T cells followed by a phase II study. LYMPHODEPLETION: Patients receive cyclophosphamide intravenously (IV) and fludarabine IV on days -4, -3, and -2 before each T-cell infusion. T-CELL INFUSION: Patients receive FH-MagIC TCR-T cells IV over 15-20 minutes. Six to twelve weeks after first T-cell infusion, patients with progressive disease and non-persisting transgenic TCR T cells may receive a second T-cell infusion. In the Phase 2 portion of the study, atezolizumab will be administered as standard of care beginning 24-72 hours after T-cell infusion. Atezolizumab will be given IV every 3 weeks for at least 1 year in the absence of disease progression or unacceptable toxicity. If an alternative PD1 inhibitor is instead available for a patient, it may be substituted instead. After completion of study treatment, patients are followed up annually for 15 years after final infusion of FH-MagIC TCR-T.
Tracking Information
- NCT #
- NCT04639245
- Collaborators
- SignalOne Bio, Inc.
- Investigators
- Principal Investigator: Michael Schweizer Fred Hutch/University of Washington Cancer Consortium