Open Label, Multi-center, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR BCMA T Cells (CT053) in Patients With Relapsed and/or Refractory Multiple Myeloma (LUMMICAR STUDY 2)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
- 试验地点
- 26
- 主要终点
- Objective response rate
研究概览
简要总结
A phase 1b/2, open label, multi-center, Clinical Study of Chimeric Antigen Receptor T Cells targeting BCMA in patients with relapsed and or refractory multiple myeloma.
详细描述
This is an open label, multi-center, phase 1b/2 clinical trial to evaluate the safety and efficacy of autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell; zevor-cel/CT053) in patients with relapsed and or refractory multiple myeloma.
Phase 1b of the study will be dose escalation followed by an expansion cohort. After recommended Phase 2 dose is identified in Phase 1b, the enrollment of Phase 2 will start. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (zevor-cel). Following manufacture of the drug product, subjects will receive lymphodepletion prior to zevor-cel infusion. All subjects who complete the study, as well as those who withdraw from the study after receiving zevor-cel for reasons other than death or meeting the early termination criteria, will be asked to continue to undergo a 15-year long-term follow-up study.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily signed consent;
- •Age of ≥ 18 and < 80 years;
- •Received sufficient prior lines of myeloma therapy;
- •Received treatment with at least one proteasome inhibitor, one IMiD and CD38 anti body.
- •The patient must be refractory to the last line of therapy.
- •The patients should have measurable disease per IMWG definition.
- •Estimated life expectancy > 12 weeks;
- •ECOG performance score 0-1;
- •Patients should have reasonable CBC counts, renal and hepatic functions;
- •Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis;
- •Women of childbearing age must undergo a serum pregnancy test with negative results before screening, and are willing to use effective and reliable method of contraception for at least 12 months after T cell infusion;
- •Men must be willing to use effective and reliable method of contraception for at least 12 months after T cell infusion.
排除标准
- •Pregnant or lactating women;
- •HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection;
- •Any uncontrolled active infection;
- •AEs from previous treatment that have not recovered;
- •Patients who have had anti-BCMA therapy;
- •Patients who have graft versus host disease (GvHD);
- •Patients have received stem cell transplantation one year before leukapheresis;
- •Patients have received any anti-cancer treatment before leukapheresis;
- •Patients have received steroids before leukapheresis or lymphodepletion;
- •Patients have plasma cell leukemia, Waldenström macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome or clinically significant symptomatic immunoglobulin light chain (AL) amyloidosis with evidence of end-organ damage;
- •Patients have been administered live attenuated vaccine before leukapheresis or lymphodepletion;
- •Patients allergic to Flu, Cy, tocilizumab, dimethyl sulfoxide (DMSO) or zevor-cel CAR BCMA T cell;
- •Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients;
- •Patients have clinical significant pulmonary conditions;
- •Patients are known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other needs of long-term immunosuppressive therapy;
- •Patients with second malignancies in addition to MM are not eligible;
- •Patients have central nervous system (CNS) metastases or CNS involvement;
- •Patients have significant neurologic disorders;
- •Patients are unable or unwilling to comply with the requirements of clinical trial;
- •Patients have received major surgery prior to leukapheresis or prior to lymphodepletion.
结局指标
主要结局
Objective response rate
时间窗: Day 1 - Month 60
Objective response rate (ORR) per IMWG by IRC read
Incidence of Treatment Related adverse events (AEs)
时间窗: Day 1 - Month 60
Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)
Identification of Maximum Tolerated Dose (MTD)
时间窗: Day 1 - Month 60
Incidence of dose-limiting toxicities (DLTs)
次要结局
- Evaluate zevor-cel PK profile(Day 1 - Month 60)
- Evaluate HRQoL in patients with rrMM from baseline up to study completion(Day 1 - Month 60)
- Evaluate utilization of hospital resources(Day 1 - Month 60)
- Evaluate additional clinical efficacy outcomes with zevor-cel treatment in patients with rrMM(Day 1 - Month 60)
- Determine the efficacy of zevor-cel treatment in patients with rrMM, by investigator assessment(Day 1 - Month 60)
- Evaluate ADA profile(Day 1 - Month 60)