Results from a first-in-human phase I study of F182112, a B-cell maturation antigen (BCMA)-CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma.

作者：Mingyuan Sun, Lugui Qiu, Yongqiang Wei, Jie Jin, Xin Li, Xue Liu, Shaohong Yin, Junyuan Qi · 发表于：Journal of Clinical Oncology · 年份：2023 · DOI：10.1200/jco.2023.41.16_suppl.8038 · 被引用次数：9 · 研究领域：Multiple Myeloma Research and Treatments、Monoclonal and Polyclonal Antibodies Research、CAR-T cell therapy research

8038 Background: F182112 is a BCMA x CD3 bispecific antibody that redirects CD3+ T cells to mediate T-cell activation and subsequent lysis of BCMA-expressing myeloma cells.NTP-F182112-001 is a First-in-human, Open-label, Multiple center Phase 1 Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetic, Immunogenicity, and Preliminary Efficacy of F182112 in Patients with Relapsed or Refractory Multiple Myeloma. Clinical trial information: NCT04984434. Methods: Eligible patients aged ≥ 18 years had received at least 2 prior multiple myeloma treatment regimens (not including autologous stem cell transplant) including a proteasome inhibitor, an immunomodulatory agent. Three dose cohorts (0.01, 0.1, and 0.3μg/kg) were planned for accelerated titration phase and the following dose cohorts (3, 10,20, and 30 μg/kg) were planed for the i3+3 dose escalation phase. F182112 were administered as QW or Q2W IV infusion. The primary endpoint was safety and tolerability assessed throughout the study by monitoring AEs per the CTCAE 5.0, except CRS per ASTCT 2018. Results: As of Feb 2,2023, 16 pts in the first 7 cohorts received F182112 (0.01-20 μg/kg). Median follow-up was 3.1 mo (range 0.9–11.7; median age 64 y [range 52–74]; 68% female). 9 (56%) pts had received ≥4 prior lines of therapy and 12 (75%) pts were refractory to last lines of therapy. The ORR was 43.8% (95% CI 19.8-70.1) among all enrolled patients (7/16). Of the 9 pts treated with ≥ 10 μg/kg F182112, 6 pts achieved ...