A Phase 1/2 First-in-Human Open-Label Dose Escalation Study of Talquetamab a Humanized GPRC5D x CD3 Bispecific Antibody in Subjects with Relapsed or Refractory Multiple Myeloma

Brief description of study

The purpose of the study is to determine if talquetamab is safe and useful for treating patients with multiple myeloma and to assess how the disease responds to this study drug. Talquetamab is a humanized IgG4-PAA-based bispecific antibody directed against GPRC5D and the CD3 receptors, produced by cultivation of recombinant Chinese hamster ovary cells, followed by isolation, chromatographic purification, and formulation. The study drug talquetamab is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s20-01395
ClinicalTrials.gov Identifier: NCT04634552
Principal Investigator: Gareth J. Morgan.
Other Investigators: Kenneth B Hymes, Vathveal Mathews, Faith E. Davies, Catherine M Diefenbach, Bruce G Raphael, Yovanna Kolitsopoulos, Maxim Kreditor, Michael L. Grossbard, Shella Saint Fleur-Lominy, David Kaminetzky, Tibor Moskovits, Ivy Mutibura.


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