NCT07116616招募中1 期
A Phase 1/2, Open-label, Multicenter Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 10
- 主要终点
- Number of Participants with Dose-limiting Toxicity
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of mRNA-2808 in participants with relapsed or refractory multiple myeloma (RRMM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RRMM with prior exposure to a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD38) monoclonal antibody.
- •Measurable disease defined as at least 1 of the following:
- •Serum M-protein ≥0.5 grams/deciliter
- •Urine M-protein ≥200 milligrams (mg)/24-hour
- •Involved free light chain (FLC) ≥100 mg/liter and an abnormal FLC ratio
- •Plasmacytoma with a single diameter ≥2 centimeters
- •Bone marrow plasma cells >30%
排除标准
- •Known central nervous system (CNS) myeloma or clinical signs and symptoms of CNS involvement of myeloma.
- •Active plasma cell leukemia, defined as peripheral blood plasma cells ≥20%.
- •Radiotherapy or cytotoxic chemotherapy within 2 weeks prior to Day 1 (Baseline), except palliative radiotherapy of limited field is permissible within 2 weeks after discussion with the Sponsor medical monitor.
- •Antibody-based immunotherapy (monoclonal antibody, bispecific antibody, antibody drug conjugate) within 21 days prior to Day 1 (Baseline).
- •Proteasome inhibitor therapy or immunomodulatory agent within 14 days prior to Day 1 (Baseline).
- •Autologous hematopoietic cell transplant within 100 days prior to Day 1 (Baseline).
- •Allogeneic hematopoietic cell transplant within 180 days prior to Day 1 (Baseline).
- •Genetically modified adoptive autologous or allogeneic cellular therapy (for example, chimeric antigen receptor T cell, chimeric antigen receptor natural killer) within 12 weeks prior to Day 1 (Baseline).
- •Corticosteroid therapy ≥140 mg prednisone or equivalent cumulative dose within 14 days prior to Day 1 (Baseline).
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
mRNA-2808
Experimental
Participants will receive mRNA-2808.
干预措施: mRNA-2808 (Drug)
结局指标
主要结局
Number of Participants with Dose-limiting Toxicity
时间窗: Up to 28 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 15 months
次要结局
- Maximum Plasma Concentration (Cmax)(Up to 1 year)
- Area Under the Concentration-time Curve (AUC)(Up to 1 year)
- Maximum Effect/Concentration of the Expressed Protein (Emax)(Up to 1 year)
- Area Under the Effect Concentration (AUEC)(Up to 1 year)
- Overall Response Rate (ORR)(Up to 3 years)
- Progression-free Survival (PFS) based on International Myeloma Working Group (IMWG) Response Criteria(Up to 3 years)
- Overall Survival (OS)(Up to 3 years)
- Number of Participants with Minimal Residual Disease Negativity Status(Up to 3 years)
- Duration of Response (DOR)(Up to 3 years)
- Number of Participants with Antibodies to mRNA-2808 Derived Proteins(Up to 1 year)
- Number of Participants with Antibodies to mRNA-2808 Components(Up to 1 year)
研究者
研究点 (10)
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