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
This is a Phase 1/2 first-in-human (FIH) study of the humanized immunoglobulin G4 proline, alanine, alanine (IgG4 PAA) bispecific antibody, talquetamab, which was developed to evaluate the therapeutic potential of targeting GPRC5D for T cell redirection. The antibody binds to the CD3 receptor complex on T cells and to GPRC5D on plasma cells. It is hypothesized that by inducing enhanced T cell-mediated cytotoxicity through recruitment of CD3-expressing T cells to the GPRC5D-expressing cells, treatment with talquetamab will be an effective therapy for subjects with multiple myeloma. Part 1 and Part 2 of the study are considered Phase 1; Part 3 of the study is considered Phase 2. Part 1 and Part 2 will enroll subjects with relapsed or refractory multiple myeloma. Part 3 will enroll subjects with relapsed or refractory multiple myeloma in the following 2 cohorts that differ by prior therapy: ? - Cohort A will enroll subjects with multiple myeloma who have previously received =3 prior lines of therapy that included at least one proteasome inhibitor (PI), one immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody, and have not been exposed to T cell redirection therapies such as CAR-T or bispecific antibodies. ? - Cohort B will enroll subjects with multiple myeloma who have previously received =3 prior lines of therapy that included at least one PI, one IMiD, and an anti-CD38 monoclonal antibody, and have been exposed to T cell redirection therapies such as CAR-T or bispecific antibodies.
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