NCT05266768Unknown1 期
An Open, Single-arm Clinical Study Evaluating the Safety and Efficacy of IBI346 Infusion in Relapsed/Refractory Multiple Myeloma
Chunrui Li1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年4月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma
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
- •According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.
- •Subjects must have previously received at least 3 anti-myeloma regimens. Subjects must have documented disease progression (according to IMWG criteria) during or within 12 months of completing their last anti-myeloma regimen prior to study entry; and prior regimens must have included proteasome inhibitor (PI) and immunomodulatory drug (IMiD).
- •Measurable disease as defined by the protocol
- •ECOG score is 0 or
- •Expected survival time ≥12 weeks.
排除标准
- •Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants drugs.
- •Patients who received autologous hematopoietic stem cell transplantation (ASCT) or prior allogeneic hematopoietic stem cell transplantation (ALLo-HSCT) within 12 weeks prior to mononuclear cell collection.
- •No unmobilized mononuclear cells can be collected for CAR T cell production.
- •Screening subjects who were receiving systemic steroids during the previous 7 days or who were determined by the investigator to require long-term systemic steroid use during treatment (except for inhaled or topical use, except at doses < 10mg/ day).
- •Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg).
研究组 & 干预措施
IBI346
Experimental
Single arm
干预措施: IBI346 (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: 21 days post IBI346 administration
Incidence and severity of adverse events: Proportion of subjects with treatment-related adverse events assessed by NCI-CTCAE v5.0 criteria
时间窗: 2 years post IBI346 administration
Presence or absence of replication-competent lentivirus (RCL)
时间窗: Baseline up to 15 years
次要结局
- Duration of Response (DOR)(2 years post IBI346 administration)
- Progression-free Survival (PFS)(2 years post IBI346 administration)
- Pharmacokinetics parameters of IBI346 cells -Time to peak CAR level in blood (Tmax)(2 years post IBI346 administration)
- Pharmacokinetics parameters of IBI346 antibody- half-life (t1/2)(2 years post IBI346 administration)
- Overall Survival (OS)(2 years post IBI346 administration)
- Pharmacokinetics parameters of IBI346 cells -Maximum CAR level in blood (Cmax)(2 years post IBI346 administration)
- Pharmacokinetics parameters of IBI346 antibody- Peak Plasma Concentration (Cmax)(2 years post IBI346 administration)
- Objective Response Rate (ORR)(3 months post IBI346 administration)
- Pharmacokinetics parameters of IBI346 antibody- clearance (CL)(2 years post IBI346 administration)
- Pharmacokinetics parameters of IBI346 cells - Area under the curve of the CAR level in blood (AUC)(2 years post IBI346 administration)
- Pharmacokinetics parameters of IBI346 antibody- Area under the plasma concentration versus time curve (AUC)(2 years post IBI346 administration)
- Pharmacodynamics characteristics - Cytokines Concentrations, cytokines level and the content of soluble BCMA in blood(2 years post IBI346 administration)
研究者
Chunrui Li
Professor
Tongji Hospital
研究点 (1)
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