Chimeric Receptor T Cells With Trastuzumab in HER2+ Advanced Breast Cancer and Other Solid Tumors
NCT06027983 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2025-09-23
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.
Conditions
- HER2+ Advanced Breast Cancer
- Other Solid Tumors
Interventions
- 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
Sponsors & Collaborators
-
National University Hospital, Singapore
lead OTHER
Principal Investigators
-
Soo Chin Lee · National University Hospital, Singapore
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 21 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-11-01
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
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