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Final clinical data of a phase 1 dose-escalation study of WVT078, a BCMA×CD3 bispecific antibody, alone and in combination with γ-secretase inhibitor WHG626 in patients with relapsed and/or refractory

5 hours ago
  • #γ-secretase inhibitor combination
  • #BCMA×CD3 bispecific antibody
  • #relapsed refractory multiple myeloma
  • Final clinical data from a phase 1 dose-escalation study of WVT078 (a BCMA×CD3 bispecific antibody) alone and combined with γ-secretase inhibitor WHG626 in relapsed/refractory multiple myeloma patients.
  • Primary objectives: assess safety, tolerability, and determine recommended doses/regimens. Secondary objectives: evaluate preliminary antitumor activity, pharmacokinetics, and immunogenicity.
  • 56 patients treated in dose-escalation; dose-limiting toxicities occurred in 7. Cytokine release syndrome was the most common treatment-related adverse event.
  • WVT078 monotherapy: overall response rate (ORR) 27.3%, complete response rate (CRR) 12.1%. Combination with WHG626: ORR 47.8%, CRR 21.7%, showing numerical improvement.
  • Recommended doses were not declared, and dose expansion was not initiated. The combination demonstrated manageable safety and preliminary activity, supporting further evaluation of WHG626 as a combination partner for BCMA-targeting agents.