2023-503439-16-00招募中2 期
A Phase 1b/2 Dose Escalation and Expansion Study of the Combination of the Bispecific T Cell Redirection Antibodies Talquetamab and Teclistamab in Participants with Relapsed or Refractory Multiple Myeloma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 51
- 试验地点
- 7
- 主要终点
- Part 1 and Part 2 •Incidence and severity of DLTs •Incidence and severity of AEs and SAEs
研究概览
简要总结
Part 1: To identify the RP2R(s) and schedule for the study treatment Part 2: To characterize the safety of the RP2R(s) for the study treatment Part 3: To evaluate the anticancer activity of tal+tec in participants with relapsed or refractory multiple myeloma and EMD
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
Part 1 and Part 2 •Incidence and severity of DLTs •Incidence and severity of AEs and SAEs
Part 1 and Part 2 •Incidence and severity of DLTs •Incidence and severity of AEs and SAEs
Part 3 •ORR as evaluated by IRC
Part 3 •ORR as evaluated by IRC
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen - Cilag International
研究点 (7)
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