A Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of TEG002 Infusion in Relapsed/Refractory Multiple Myeloma Patients
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
- 试验地点
- 6
- 主要终点
- Safety: For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade
研究概览
简要总结
This is a single arm, open-label, multicenter phase I study to assess the safety, tolerability and preliminary efficacy of autologous T cells transduced with a specific γδTCR, i.e. TEG002, in a dose escalation and expansion study in relapsed/refractory Multiple Myeloma patients.
The study will comprise of a Dose Escalation Segment and an Expansion Segment. The study consists of a screening period, leukapheresis of mononuclear cells, and conditioning chemotherapy, followed by TEG002. All subjects continue to be followed regularly for safety and efficacy assessments until 1 year after TEG002 administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Signed informed consent
- •Relapsed or refractory Multiple Myeloma as defined by the IMWG
- •Life expectancy ≥3 months
- •ECOG performance status 0 or 1
- •Adequate vital organ function
- •Adequate bone marrow function
- •Toxicities from prior/ongoing therapies recovered to ≤ Grade 2 or subject's baseline
- •WCBP and men who can father children must be willing and able to use adequate contraception
排除标准
- •Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined
- •Pregnant or lactating women
- •Amyloidosis
- •Uncontrolled infection(s)
- •Active CNS disease
- •Previous allogeneic-HSCT
- •History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year.
- •Subjects that received experimental or systemic therapy < 14 days before TEG002 infusion
- •NYHA Class ≥ II
- •Patients depending on dialysis
- •Patients with a history of pulmonary embolism or deep vein thrombosis
- •T cell mediated active autoimmune disease OR any active autoimmune disease requiring immunosuppressive therapy
结局指标
主要结局
Safety: For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade
时间窗: Until year 2
For the expansion segment: Confirmation of safety determined by the incidence of (S)AEs by type and grade
Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs)
时间窗: Until day 28 following infusion
For the dose escalation segment: Safety determined by incidence of (S)AEs by type and grade, including the occurrence of dose-limiting toxicities (DLTs)
次要结局
- TEG002 efficacy by looking at Duration of response(Until Year 2)
- TEG002 efficacy by looking at Objective response rate(Until Year 2)
- Feasibility of TEG002 generation in r/r MM patients as measured by the number of TEG002 products successfully generated in r/r MM patients(Assessment per subject production run, timeframe: prior to day 0 for each subject)
- TEG002 efficacy by looking at Time to progression(Until Year 2)
- TEG002 pharmacokinetics measured in blood in bone marrow over time(Until Year 2)
- TEG002 efficacy by looking at Overall survival(Until Year 2)
- TEG002 efficacy by looking at Time to response(Until Year 2)
- TEG002 pharmacodynamics as measured by IL6 level in serum over time(until Year 2)
- TEG002 efficacy by looking at Progression free survival(Until Year 2)
- TEG002 pharmacodynamics as measured by CRP level in serum over time(until Year 2)
- TEG002 pharmacodynamics as measured by ferritin level in serum over time(until Year 2)