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

Fujikawa Ei0 个研究点目标入组 320 人开始时间: 2022年2月19日最近更新: 2023年10月17日

适应症

试验速览

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•Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
•- Part 3: Measurable disease cohort A, cohort B, cohort C: multiple myeloma must be measurable by central laboratory assessment
•- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
•- Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin [hCG]) or urine
•- Willing and able to adhere to the prohibitions and restrictions specified in this protocol

•- Part 3 only: Cohort A and cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B: T cell redirection therapy within 3 months
•- Participants who received or plan to receive any live, attenuated vaccine within 4 weeks prior to the first dose, during treatment, or within 4 weeks of the last dose of talquetamab. Non-live or non-replicating vaccines approved or authorized for emergency use (example, COVID-19) by local health authorities are allowed
•- Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
•- Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
•- Stroke or seizure within 6 months prior to signing the informed consent form (ICF)

发起方

Fujikawa Ei