NCT03758417终止2 期
A Phase 2, Open-Label Study of LCAR-B38M CAR-T Cells, a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA in Chinese Subjects With Relapsed or Refractory Multiple Myeloma
Nanjing Legend Biotech Co.11 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2019年1月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 123
- 试验地点
- 11
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of LCAR-B38M chimeric antigen receptor T (CAR-T) cells.
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
- •Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- •Measurable disease at Screening
- •Received at least 3 prior lines of treatment for multiple myeloma
- •a) Undergone at least 1 complete cycle of treatment for each line, unless progressive disease (PD) was documented by IMWG criteria as the best response to the regimen
- •Received a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD)
- •Participant must have documented evidence of progressive disease based on investigator's determination of response consistent with IMWG criteria on or within 12 months of their last regimen. Non-responsive disease is defined as either failure to achieve minimal response or development of progressive disease (PD) while on therapy. Also, participants with documented evidence of PD disease (as above) within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are eligible
- •Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1
排除标准
- •Prior treatment with chimeric antigen receptor T (cells) CAR-T therapy directed at any target
- •Any therapy that is targeted to B-cell maturation antigen (BCMA)
- •The following cardiac conditions: a) New York Heart Association (NYHA) stage III or IV congestive heart failure b) Myocardial infarction or coronary artery bypass graft (CABG) 6 months prior to enrollment c) History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration d) History of severe non-ischemic cardiomyopathy e) Impaired cardiac function (left ventricular ejection fraction [LVEF] less than [<]45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan (performed less than or equal to (<=) 8 weeks of apheresis)
- •Have received a cumulative dose of corticosteroids equivalent to greater than or equal to(>=)70 milligram (mg) of prednisone within 7 days prior to apheresis
- •Diagnosed or treated for invasive malignancy other than multiple myeloma, except:
- •Malignancy treated with curative intent and with no known active disease present for greater than or equal to (>=) 2 years before enrollment; or
- •Adequately treated non-melanoma skin cancer without evidence of disease
- •Prior antitumor therapy with insufficient washout period
- •Toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
- •Received either of the following:
- •An allogeneic stem cell transplant for multiple myeloma
- •An autologous stem cell transplant less than or equal to (<=) 12 weeks before apheresis
- •Known active, or prior history of, central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
研究组 & 干预措施
LCAR-B38M Chimeric Antigen Receptor T Cell
Experimental
Participants will receive LCAR-B38M CAR-T cells as a single infusion which consists of autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).
In addition, participants will enroll in additional cohort to further characterize the safety profile and accumulate efficacy data of LCAR-B38M CAR-T cells.
干预措施: LCAR-B38M CAR-T Cell (Biological)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Minimum 2 years after LCAR-B38M chimeric antigen receptor T (CAR-T) infusion (Day 1)
The ORR is defined as the percentage of participants who achieve at least a partial response (PR) or better according to international myeloma working group (IMWG) criteria.
次要结局
- Number of Participants With Adverse Events(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Transgene Levels of LCAR-B38M CAR-T Cells(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Number of Participants With Anti- LCAR-B38M CAR-T Cell Antibodies(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Percentage of Participants with Very Good Partial Response (VGPR) or Better Rate(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Percentage of Participants with Negative Minimal Residual Disease (MRD)(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Time to Response (TTR)(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Systemic Cytokine Concentrations(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Overall survival (OS)(Mnimum 2 years after LCAR-B38M CART infusion (Day 1))
- Levels of CAR-T cell Activation Markers(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Duration of Response (DOR)(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Percentage of Participants with Complete Response (CR)(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Levels of LCAR-B38M CAR-T cell Expansion (proliferation)(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Levels of LCAR-B38M CAR-T Persistence(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Percent Reduction in BCMA Expression Cells(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Percentage of Participants who Achieve Clinical Benefit(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Percentage of Participants with Stringent Complete Response (sCR)(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Progression-Free Survival (PFS)(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
- Circulating Soluble B-Cell Maturation Antigen (sBCMA) Levels(Minimum 2 years after LCAR-B38M CART infusion (Day 1))
研究者
研究点 (11)
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