Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes for Advanced HER2-Negative Breast Cancer
Summary
RATIONALE: Patients with HER2-negative advanced breast cancer have limited choice on targeted therapies, and often show only modest responses to available immunotherapies. Adoptive cell therapy with tumor-infiltrating lymphocytes has difficulties in preparing enough cells from solid tumors and overcoming the exhaustion and dysfunction of T cells, which limit its clinical use. Tumor-draining lymph node-derived lymphocytes (LNLs) that have abundant tumor-specific T cells, rather than exhausted T cells, are easier to produce. It is not yet known whether LNL treatment is safe and effective in patients with advanced HER2-negative breast cancer. PURPOSE: This open-label phase I/II trial is to study the safety and efficacy of autologous LNL in patients with advanced HER2-negative breast cancer.
Timeline
- Start
- 2023-08-01
- Primary completion
- 2032-04-30
- Completion
- 2035-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Tumor-draining lymph node-derived lymphocyte (LNL) | Unknown | 1e+09 cells | — |
| Subject | Tumor-draining lymph node-derived lymphocyte (LNL) | Unknown | 1.8e+10 cells | — |
| Background | Carboplatin | Small molecule | 2 unknown | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Background | aldesleukin | Protein / enzyme biologic | — | Intravenous |