Patient-Centric First-in-Human Dose Selection: An Ex Vivo Minimal Anticipated Biological Effect Level Approach for T-Cell Engagers in Multiple Myeloma.

In 30 seconds

This Phase I clinical trial investigated a novel ex vivo minimal anticipated biological effect level (MABEL) approach for determining the first-in-human (FIH) dose of forimtamig, a T-cell bispecific antibody for relapsed/refractory multiple myeloma. The calculated FIH starting dose was 6 μg, with clinical activity observed in the second dosing cohort at 18 and 54 μg.

Key findings

• The calculated FIH starting dose of forimtamig was 6 μg based on ex vivo assays.
• Clinical activity was noted in the second dosing cohort at doses of 18 and 54 μg.
• Durable objective responses were observed in the third dosing cohort at 54 and 162 μg.
• Cytokine release syndrome was Grade 1 at the starting dose and absent in the second cohort.

Why it matters

The study highlights an innovative patient-centric approach to dose selection that may reduce the time to observe clinical activity in early-phase trials, potentially improving treatment outcomes for patients with relapsed/refractory multiple myeloma.