Patient-Centric First-in-Human Dose Selection: An Ex Vivo Minimal Anticipated Biological Effect Level Approach for T-Cell Engagers in Multiple Myeloma.
Article in Clinical pharmacology and therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04557150 (An Open-Label, Multicenter, Phase I Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig), which is not on this map. Not yet cited in PubMed.
0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
2 · The registry
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-Label, Multicenter, Phase I Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig (RO7425781) in Participants With Relapsed or Refractory Multiple Myeloma
TypeinterventionalSponsorHoffmann-La RocheRan2020 to 2026Enrolled225ConditionsMultiple MyelomaArmsForimtamig
3 · Its place in the literature
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
4 · The record
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
5 · Who and what money
Authors and funding
17 authors.
Thomas E KraftRoche Pharma Research & Early Development, Roche Innovation Center Munich, Penzberg, Germany.ORCID 0000-0002-5528-3197
Estelle Marrer-BergerRoche Pharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.ORCID 0000-0002-9677-0549
Sara BelliRoche Pharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.ORCID 0009-0001-5435-0554
Helene HaegelRoche Pharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.ORCID 0000-0003-4792-4000
Anneliese SchneiderRoche Pharma Research & Early Development, Roche Innovation Center Zurich, Zurich, Switzerland.ORCID 0009-0005-3350-5106
Anna Maria GiustiRoche Pharma Research & Early Development, Roche Innovation Center Zurich, Zurich, Switzerland.ORCID 0000-0002-3067-778X
Michael BscheiderRoche Pharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.ORCID 0000-0001-7808-3270
Wolfgang JacobRoche Pharma Research & Early Development, Roche Innovation Center Munich, Penzberg, Germany.ORCID 0000-0002-8171-7542
Martin WeisserRoche Pharma Research & Early Development, Roche Innovation Center Munich, Penzberg, Germany.
Laura BlancoCancer Center Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada, University of Navarra, IDISNA, CIBERONC, Pamplona, Spain.ORCID 0000-0002-1859-0884
Nicolas FrancesRoche Pharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Eva RossmannRoche Pharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.ORCID 0000-0002-3557-6013
Guido SteinerRoche Pharma Research & Early Development, Roche Innovation Center Basel, Basel, Switzerland.
Aintzane Zabaleta AzpirozCancer Center Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada, University of Navarra, IDISNA, CIBERONC, Pamplona, Spain.ORCID 0000-0003-3474-3040
Bruno PaivaCancer Center Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada, University of Navarra, IDISNA, CIBERONC, Pamplona, Spain.ORCID 0000-0003-1977-3815
Ludovic MartinetCancer Research Center of Toulouse (CRCT), Institut National de la Santé et de la Recherche Médicale (INSERM), Centre National de la Recherche Scientifique (CNRS), Université Toulouse III-Paul Sabatier (UPS), Toulouse, France.
Tanja FautiRoche Pharma Research & Early Development, Roche Innovation Center Zurich, Zurich, Switzerland.ORCID 0009-0002-1994-8099
Funding
No grant is acknowledged in the PubMed record.
6 · The paper itself
Abstract
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 antibody under investigation for the treatment of relapsed/refractory multiple myeloma (RRMM). We used in vitro and ex vivo MABEL approaches to calculate the FIH dose for a Phase 1 trial (NCT04557150) in patients with RRMM. In vitro assays used the OPM-2 MM cell line and peripheral blood mononucleocytes from healthy donors and patients with MM. Ex vivo assays used fresh bone marrow aspirates from MM patient donors. Forimtamig increased tumor cell lysis, cytokine release, and T-cell activation in vitro and ex vivo. Tumor cell lysis was considered the most relevant assay for dose calculation. EC
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.
Patient-Centric First-in-Human Dose Selection: An Ex Vivo Minimal Anticipated Biological Effect Level Approach for T-Cell Engagers in Multiple Myeloma. · full record | OpenQuestion