eligibility_summary
Women 18–70 with HER2− stage IIIB/IIIC inoperable or stage IV breast cancer, HR+ after endocrine/CDK4/6 failure or chemo‑eligible. No prior adoptive cells or same agents for metastatic disease. Candidates for nab‑paclitaxel or gemcitabine/carboplatin + camrelizumab, accessible tumor‑draining nodes, measurable disease, ECOG 0–1, adequate organ function. Exclude rapid progression, active/unstable CNS mets, serious CV/pulmonary disease, active infection (incl TB), HBV/HCV unless controlled, autoimmune/immunodeficiency, recent thrombosis, live vaccine, transplant, ≥Grade 2 neuropathy, pregnancy/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
NCT05981001 evaluates autologous tumor-draining lymph node–derived lymphocytes (LNLs) plus immunochemotherapy in advanced HER2-negative breast cancer. Interventions: LNL adoptive cell therapy (expanded patient-specific T cells) after lymphodepletion with cyclophosphamide (alkylating agent) and fludarabine (purine analog), followed by interleukin-2 (cytokine) to support T-cell expansion. Post-LNL therapy: camrelizumab (anti–PD-1 monoclonal antibody) with either nab-paclitaxel (taxane microtubule stabilizer) or gemcitabine (antimetabolite) plus carboplatin (DNA cross-linker). Targets/pathways: tumor-reactive T cells, PD-1/PD-L1 checkpoint, IL-2/IL-2R signaling, lymphodepletion to reduce Tregs/enable homeostatic cytokines, tumor cell mitosis and DNA replication/repair.