Phase I 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 phase I trial is mainly to study the safety of autologous LNL in patients with advanced HER2-negative breast cancer.
Timeline
- Start
- 2023-11-01
- Primary completion
- 2026-12-31
- Completion
- 2031-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tumor-draining lymph node-derived lymphocyte (LNL) | Unknown | 1e+09 unknown | — |
| Subject | Tumor-draining lymph node-derived lymphocyte (LNL) | Unknown | 1.8e+10 unknown | — |
| Background | Camrelizumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Background | Camrelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | aldesleukin | Protein / enzyme biologic | — | Intravenous |