Patient-Centric First-in-Human Dose Selection: An Ex Vivo Minimal Anticipated Biological Effect Level Approach for T-Cell Engagers in Multiple Myeloma.
Testing a new cancer drug directly in patient bone marrow samples improved safe dose selection and early clinical benefit.
Roche developed an ex vivo MABEL approach using fresh patient bone marrow aspirates for first-in-human dose selection of forimtamig, a T-cell bispecific antibody targeting RRMM, which was accepted by regulators and resulted in clinical activity appearing in the second dose cohort with manageable toxicity. This methodology may accelerate dose escalation for T-cell engagers by better predicting patient-specific sensitivity than in vitro assays.
What the study was
- Study design
- Translational pharmacology / FIH dose selection methodology
- Population
- Relapsed/refractory multiple myeloma patients (ex vivo bone marrow aspirates + Phase 1 trial cohort)
- Category
- Drug Development
- Maturity
- Exploratory
- Journal
- Clin Pharmacol Ther
Why it surfaced
Novel patient-centric FIH dose selection methodology using ex vivo bone marrow aspirates for T-cell bispecifics in myeloma, with regulatory acceptance and clinical validation. Methodological advance for bispecific antibody development.
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