NCT06027983

Chimeric Receptor T Cells With Trastuzumab in HER2+ Advanced Breast Cancer and Other Solid Tumors

Phase IB Followed by Phase II Study of Trastuzumab Combined With Autologous Chimeric Receptor T Cells in HER2+ Advanced Breast Cancer and Other Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This phase Ib study aims to assess the safety and feasibility of combination of chimeric receptor T cells with trastuzumab in patients with HER2+ solid tumors, with further expansion of study population in HER2+ metastatic breast cancer once safety has been established.

Detailed description

Hypothesis Investigators hypothesize that trastuzumab-mediated cytotoxicity will be augmented by the infusion of autologous chimeric receptor T-cells. Primary Objectives 1. To determine the safety of autologous chimeric receptor T-cells in patients with HER2+ advanced solid tumors 2. To determine the clinical benefit rate (CBR) of autologous chimeric receptor T-cells in patients with HER2+ advanced breast cancer Secondary Objectives 1. To determine the expansion and persistence of autologous chimeric receptor T-cells after a single infusion in patients with advanced solid tumors 2. To determine anti-tumor efficacy in terms of objective response rate (ORR) and progression-free survival (PFS) of autologous chimeric receptor T-cells in patients with HER2+ advanced breast cancer

Conditions

• HER2+ Advanced Breast Cancer
• Other Solid Tumors

Interventions

Type	Name	Description
DRUG	Chimeric receptor T-cells + Trastuzumab	Chimeric receptor T-cells will be administered by infusion. Trastuzumab will be administered intravenously.
DRUG	Fludarabine and Cyclophosphosphamide	3-day chemotherapy regimen of fludarabine and cyclophosphamide for lymphodepletion

Timeline

• Start date: 2026-11-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2023-09-07
• Last updated: 2025-09-23