NCT04649073终止1 期
A Multicenter, Uncontrolled, Nonrandomized, Open-Label, Phase 1/2 Trial Investigating the Safety and Efficacy of OPC 415 in MMG49 Antigen-Positive Patients With Relapsed and/or Refractory Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 13
- 主要终点
- Phase1: Dose Limiting Toxicity
研究概览
简要总结
The purpose of this study is to evaluate the tolerability,safety and efficacy of OPC-415 in patients with relapsed and/or refractory Multiple Myeloma (MM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 20 and 80 (75 for the phase 1 part) years, both inclusive, at the time of consent
- •Patients with a definitive diagnosis of active multiple myeloma
- •Patients who have had 2 or more prior regimens (including all proteasome inhibitors, immunomodulators, and anti-CD38 antibody)
- •Patients with relapsed and/or refractory Multiple Myeloma
- •Patients who are positive for MMG49 antigen
- •Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or
- •Those with an ECOG-PS score of 2 due solely to MM bone lesions can be enrolled
- •Patients who are expected to survive for at least 3 months
排除标准
- •Patients who are scheduled to receive high-dose chemotherapy in combination with autologous stem cell transplantation as the next treatment.
- •Patients who have other active double/multiple cancers
- •Patients on continuous and systemic (oral or intravenous) medication with corticosteroids or other immunosuppressive agents
- •Patients with graft-versus-host disease that requires treatment.
- •Patients who underwent a highly invasive and extensive surgical procedure within 2 weeks.
- •Patients who previously underwent allogeneic stem cell transplantation or organ transplantation.
- •Patients who underwent autologous stem cell transplantation within 90 days.
- •Patients with systemic amyloidosis (except localized amyloidosis without organ derangement) or plasma cell leukemia.
- •Patients with prior or current central nerve involvement in MM.
- •Patients whose best ever response to MM treatment is PD.
- •Patients who previously received gene therapy or cell therapy (except hematopoietic stem cell transplantation).
- •Pregnant women, nursing mothers, or women with a positive pregnancy test.
研究组 & 干预措施
OPC-415 (up to 1×10^7cells/kg)
Experimental
干预措施: OPC-415 (Biological)
结局指标
主要结局
Phase1: Dose Limiting Toxicity
时间窗: Day1~Day28
Phase2: Response rate
时间窗: Day1~Day366
The proportion of subjects who achieved partial response or better outcomes by central assessment based on IMWG Uniform Response Criteria for Multiple Myeloma will be calculated.
次要结局
未报告次要终点
研究者
研究点 (13)
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