CLBR001 + ABBV-461

CLBR001 + ABBV-461 is a combination therapy currently being investigated for the treatment of locally advanced or metastatic breast cancer. This combination consists of CLBR001, an engineered autologous T cell product (CAR-T cell therapy), and ABBV-461, an antibody-based biologic. The combination is currently in Phase 1 clinical trials (NCT05917227). A Phase 1, open-label, dose-escalation study is evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of this combination therapy. The study began in April 2025 and is actively recruiting patients. The clinical trial aims to establish the safety and efficacy of the combination therapy while determining the optimal biologic doses. The treatment protocol involves administering a single infusion of CLBR001 cells followed by cycles of ABBV-461, with regular assessments of safety and disease response. The therapy is being studied in patients with: - Hormone receptor (HR)+ breast cancer, including estrogen receptor (ER) and progesterone receptor positive disease - Human epidermal growth factor receptor 2 (HER2)+ breast cancer - Triple-negative breast cancer (TNBC) Eligible patients must have refractory or relapsed locally advanced or metastatic breast cancer and have received prior standard treatments.

Other names

ABBV-461-CalibrABBV461-CalibrABBV 461-CalibrCLBR001 and ABBV-461CLBR-001 and ABBV-461CLBR 001 and ABBV-461