Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer
Summary
RATIONALE: Patients with HER2-negative breast cancer not responding to initial neoadjuvant chemotherapy might have lower chances for a pathologic complete response (pCR) at definitive surgery, indicating worse prognosis. Adoptive cell therapy has demonstrated efficacy in advanced breast cancer, but whether the addition of adoptive cell therapy to neoadjuvant chemotherapy could increase the pCR rate remains unclear. Tumor-draining lymph node-derived lymphocytes (LNLs) that have abundant tumor-reactive T cells, but not exhausted T cells, are easy to produce. It is not yet known whether LNL treatment is safe and effective in patients with HER2-negative breast cancer not responding to neoadjuvant chemotherapy. PURPOSE: This phase I trial is mainly to investigate the safety of autologous LNL in patients with HER2-negative breast cancer not responding to neoadjuvant chemotherapy.
Timeline
- Start
- 2023-11-01
- Primary completion
- 2026-08-31
- Completion
- 2031-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tumor-draining lymph node-derived lymphocyte (LNL) | Unknown | — | — |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | Epirubicin | Small molecule | 100 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 260 mg/m2 | Intravenous |
| Background | aldesleukin | Protein / enzyme biologic | — | Intravenous |