NCT05521802招募中1 期
A Phase Ib/II Study of CBM.BCMA Chimeric Antigen Receptor T Cell Product (C-CAR088) for Treating Patients With Relapsed or Refractory Multiple Myeloma
Shanghai AbelZeta Ltd.1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2022年11月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- [phase Ib] Incidence and severity of Adverse Events
研究概览
简要总结
This is a multicenter, open-label study to evaluate the safety and efficacy of C-CAR088 in patients with relapsed or refractory multiple myeloma. The phase Ib part of this study is to determine the recommended phase 2 dose (RP2D) of C-CAR088 in the targeted patient population.
详细描述
The study includes the following sequential procedures: Screening, Apheresis and C-CAR088 manufacturing, Baseline testing, Lymphodepletion, C-CAR088 infusion, and Follow-up Visit. Two dose levels of C-CAR088 will be tested during the phase Ib part to determine RP2D, which will be further evaluated during the phase II part.
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
- •≥ 18 years of age, male or female patients
- •Relapsed or refractory multiple myeloma
- •Have been treated with ≥ 3 prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory drug, and had progressed during or within 12 months post the last treatment.
- •Had measurable disease as defined by any of the following criteria:
- •Serum M protein ≥ 0.5g/dL
- •Urine M protein ≥ 200mg/24h
- •Serum free light chain (sFLC): abnormal κ/λ ratio with involved sFLC ≥ 100mg/L
- •Adequate liver, renal, bone marrow, and heart function
- •Eastern cooperative oncology group (ECOG) 0-1
排除标准
- •Any known allergies to the components or excipients of the C-CAR088 cell product
- •Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or autologous stem-cell transplantation (ASCT) within 12 weeks prior to apheresis
- •Central nervous system (CNS) involvement
- •Stroke or convulsion history within 6 months prior to signing informed consent form (ICF)
- •Plasma leukemia
- •Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment
- •Uncontrolled active infection; active hepatitis B virus (HBV), hepatitis C virus (HCV) infection; HIV or syphilis infection
- •Severe heart, liver, renal or metabolism disease
- •Inadequate wash-out time for previous anti-tumor treatments prior to apheresis
- •Previous CAR-T cell treatment, genetically modified T-cell therapies or BCMA-directed treatment history
- •History or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial
结局指标
主要结局
[phase Ib] Incidence and severity of Adverse Events
时间窗: 24 months
Incidence and severity of Adverse Events
[phase II] Overall response rate (ORR) at 3 months after C-CAR088 infusion
时间窗: 3 months
the rate of patients with best response of partial response (PR) or better at 3 months after C-CAR088 infusion
次要结局
- Minimal residual disease (MRD) negativity rate(24 months)
- Maximal plasma concentration (Cmax)(24 months)
- Overall response rate (ORR)(24 months)
- Serum free light chain (sFLC)(24 months)
- Time to response (TTR)(24 months)
- Overall survival (OS)(24 months)
- Progression-free survival (PFS)(24 months)
- Time to reach the maximal plasma concentration (Tmax)(24 months)
- Anti-drug (C-CAR088) antibody(24 months)
- [phase Ib] Overall response rate (ORR) at 3 months after C-CAR088 infusion(3 months)
- Duration of response (DOR)(24 months)
- [phase II] Incidence and severity of Adverse Events(24 months)
- Time of last measurable observed concentration (Tlast)(24 months)
- Area under the curve within 28 days (AUC0-28d)(28 days)
- Serum M protein(24 months)
- Urine M protein(24 months)
研究者
研究点 (1)
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