Publication
Patient-Centric First-in-Human Dose Selection: An Ex Vivo Minimal Anticipated Biological Effect Level Approach for T-Cell Engagers in Multiple Myeloma.
Thomas E Kraft, Estelle Marrer-Berger, Sara Belli, Helene Haegel, Anneliese Schneider, Anna Maria Giusti, Michael Bscheider, Wolfgang Jacob, Martin Weisser, Laura Blanco, Nicolas Frances, Eva Rossmann, Guido Steiner, Aintzane Zabaleta Azpiroz, Bruno Paiva, Ludovic Martinet, Tanja Fauti
- Source
- PubMed
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-PUBMED-20260912-000001
Abstract
Abstract (excerpt)
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The minimal anticipated biological effect level (MABEL) approach to first-in-human (FIH) dose calculation can lead to long dose-escalation periods before observing clinical activity. We used a novel ex vivo MABEL approach to calculate the FIH starting dose for forimtamig, a T-cell bispecific…
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Validated 1
- trialNCT04557150registry_reference1.00
Candidate 1
- cancerMultiple Myelomadictionary0.60
Registered trialsNCT04557150
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