NCT05918250撤回1 期
A Phase 1, Open-Label, Multicenter, Study of mRNA-2736 in Patients With Relapsed or Refractory Multiple Myeloma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 24
- 主要终点
- Number of Participants Experiencing Adverse Events
研究概览
简要总结
This study is designed to evaluate the safety and tolerability of mRNA-2736 in participants with RRMM.
详细描述
This open-label, Phase 1, dose-escalation, first-in-human (FIH) clinical study of mRNA-2736 in participants with RRMM is designed to evaluate the safety and tolerability of escalating doses of mRNA-2736, administered intravenously (IV), to determine maximum tolerated dose and/or recommended Phase 2 dose, pharmacokinetics, pharmacodynamics, and preliminary efficacy of mRNA-2736.
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. Participants must have received at least 3 prior lines of therapy or be triple-class refractory. Participants that are intolerant of a proteasome inhibitor, IMiD, or aCD38 are eligible.
- •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%. History of plasma cell leukemia is allowed.
- •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, radioimmunoconjugate) within 21 days prior to Day 1 (Baseline).
- •Proteasome inhibitor therapy within 14 days prior to Day 1 (Baseline).
- •Immunomodulatory agent therapy within 7 days of 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). Participants should have no evidence or ongoing treatment for acute or chronic graft versus host disease.
- •Genetically modified adoptive 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).
- •Active hepatitis B or C, or laboratory evidence for a chronic infection with hepatitis B or C at the time of screening. Participants with a past or resolved hepatitis B infection (presence of hepatitis B core antibody and absence of hepatitis B surface antigen) are eligible. Participants positive for hepatitis C virus (HCV) antibody are eligible only if negative for HCV RNA.
- •Note: Other inclusion and exclusion criteria may apply.
结局指标
主要结局
Number of Participants Experiencing Adverse Events
时间窗: Up to 1 year
次要结局
- Area Under the Effect Concentration (AUEC)(0 (predose) to 96 hours postdose)
- Area Under the Concentration-time Curve (AUC)(0 (predose) to 96 hours postdose)
- Overall Response Rate (ORR)(Up to 2 years)
- Clinical Benefit Rate (CBR)(Up to 2 years)
- Progression-free Survival (PFS)(Up to 2 years)
- Maximum Plasma Concentration (Cmax)(0 (predose) to 96 hours postdose)
- Maximum Effect/Concentration of the Expressed Protein (Emax)(0 (predose) to 96 hours postdose)
- Duration of Response (DOR)(Up to 2 years)
- Overall Survival (OS)(Up to 3 years)
研究者
研究点 (24)
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