drugset / Trial / NCT05378464
Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer
Phase 1
Suspended
28 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Vaccinex Inc. · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this study is to test the safety of Adoptive T-Cell therapy following the Dendritic Cell (DC1) study vaccine given in combination with pepinemab added to standard of care therapy, trastuzumab to help people with HER2 positive breast cancer.
Timeline
- Start
- 2022-05-31
- Primary completion
- 2026-08
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dendritic Cell (DC1) Vaccine | Vaccine | 1e+07 cells | Other |
| Subject | Dendritic Cell (DC1) Vaccine | Vaccine | 2e+07 cells | Other |
| Subject | IL-15 expanded CD4 T cells | Unknown | 2.5e+08 cells | Intravenous |
| Subject | IL-15 expanded CD4 T cells | Unknown | 1.2e+09 cells | Intravenous |
| Subject | IL-15 expanded CD4 T cells | Unknown | 2.5e+09 cells | Intravenous |
| Subject | IL-7 expanded CD4 T cells | Unknown | 2.5e+08 cells | Intravenous |
| Subject | IL-7 expanded CD4 T cells | Unknown | 1.2e+09 cells | Intravenous |
| Subject | IL-7 expanded CD4 T cells | Unknown | 2.5e+09 cells | Intravenous |
| Subject | Pepinemab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |