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

Janssen-Cilag International NV0 sites403 target enrollmentJanuary 11, 2021

Overview

No summary available.

Registry

who.int

Start Date

January 11, 2021

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. \=18 years of age.
•2\. Criterion modified per Amendment 11
•2\.1\. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic a criteria
•3\. Criterion modified per Amendment 1
•3\.1\. Criterion modified per Amendment 11
•3\.2\. Part 1:
•Subjects with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies.
•Subjects with multiple myeloma measurable by central laboratory assessment who have progressed on, or could not tolerate, all available established therapies:
•Serum monoclonal paraprotein (M\-protein) level \=1\.0 g/dL or urine M\-protein level \=200 mg/24 hours;
•Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin FLC \=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio

•1\. Criterion modified per Amendment 11
•1\.1\. Prior Grade 3 CRS (Per Lee Criteria 2014\) related to any T cell redirection (eg, CD\-3 redirection technology or CAR\-T cell therapy) or any prior GPRC5D targeting therapy
•2\. Criterion modified per Amendment 10\.
•2\.1 Criterion modified per Amendment 11
•2\.2 Prior antitumor therapy as follows, prior to the first dose of study drug:
•. Gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells \[CAR\-T], natural killer \[NK] cells) within 3 months.
•. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or at least 5 half\-lives, whichever is less.
•. Monoclonal antibody treatment for multiple myeloma within 21 days.
•. Cytotoxic therapy within 21 days.
•. Proteasome inhibitor therapy within 14 days.