CTIS2023-503439-16-00招募中1 期
A Phase 1b/2 Dose Escalation and Expansion Study of the Combination of the BispecificT Cell Redirection Antibodies Talquetamab and Teclistamab in Participants with Relapsedor Refractory Multiple Myeloma - 64007957MMY1003
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 228
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria, Part 1 and 2: Participant could not tolerate or has disease that is relapsed or refractory to established therapies, including the last line of therapy. Part 3: (a) Relapsed or refractory disease, and exposed to a PI, IMiD, and an anti-CD38 mAb; (b) Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen, Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study drug administration. Part 3: ECOG performance status grade of 0, 1, or 2 at screening and immediately before the start of study drug administration
排除标准
- •All Parts: Targeted therapy, epigenetic therapy, or treatment with an investigational treatment or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less. Part 3: prior BCMA targeted bispecific antibody therapy; prior GPRC5D targeted therapy, All Parts: Allogeneic stem cell transplant within 6 months before the first dose of study treatment., All Parts: Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma., All Parts: Active plasma cell leukemia (greater than [>]2.0*10^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M- protein, and skin changes), or primary amyloid light chain amyloidosis
研究者
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