eligibility_summary
Eligibility: Adults ≥18, consent/HIPAA, Karnofsky >60%, histologically confirmed TNBC: ER/PR <1% by IHC and HER2 IHC 0–1+ or FISH ratio <2.0. Exclude: history of symptomatic CNS involvement or multiple brain metastases requiring whole-brain radiation, lack of measurable/evaluable disease per RECIST 1.1. Prior/concurrent malignancy allowed if not expected to interfere with safety/efficacy assessment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06347068 (Phase 1, single-arm) tests an autologous, gene‑modified cellular immunotherapy: iC9‑CAR.B7‑H3 T cells for relapsed/refractory TNBC. Intervention/mechanism: Patient T cells are engineered to express a chimeric antigen receptor targeting B7‑H3 (CD276). CAR engagement activates T‑cell cytotoxicity (perforin/granzyme) and cytokine release to kill B7‑H3–positive tumor cells. An inducible caspase‑9 “suicide switch” enables on‑demand elimination of the CAR‑T cells for safety. Lymphodepletion uses cyclophosphamide (alkylating agent) and fludarabine (purine analog) to reduce host lymphocytes and enhance CAR‑T expansion. Target cells/pathways: B7‑H3–expressing TNBC cells (and tumor stroma/vasculature expressing B7‑H3), T‑cell activation and cytotoxicity pathways.