Clinical Study of Chimeric CD(Cluster of Differentiation)138 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Multiple Myelomas
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Occurrence of study related adverse events
研究概览
简要总结
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells.
PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in treating patients with CD138 positive multiple myeloma that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.
详细描述
PRIMARY OBJECTIVES:
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD138 vector (referred to as CART-138 cells).
II. Determine duration of in vivo survival of CART-138 cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood and bone marrow will be used to detect and quantify survival of CART-138 TCR zeta:CD137 and TCR (T-cell receptor) zeta cells over time.
SECONDARY OBJECTIVES:
I. For patients with detectable disease, measure anti-myeloma response due to CART-138 cell infusions.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with CD138 positive multiple myeloma in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled.
- •CD138 positive multiple myeloma CR can not be achieved after at least 4 prior combination chemotherapy regimens.
- •MM in CR(complete remission)2 or CR3 and not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor.
- •Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval < 1 year).
- •Relapsed after prior autologous or allogenic SCT. MM patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.
- •Residual disease after primary therapy and not eligible for autologous SCT
- •Expected survival > 12 weeks
- •Creatinine < 2.5 mg/dl
- •ALT(alanine aminotransferase)/AST (aspartate aminotransferase)< 3x normal
- •Bilirubin < 2.0 mg/dl
- •Any relapse after prior SCT will make patient eligible regardless of other prior therapy
- •Adequate venous access for apheresis, and no other contraindications for leukapheresis
- •Voluntary informed consent is given
排除标准
- •Pregnant or lactating women
- •The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
- •Uncontrolled active infection.
- •Active hepatitis B or hepatitis C infection.
- •Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- •Previously treatment with any gene therapy products
- •Feasibility assessment during screening demonstrates < 30% transduction of target lymphocytes, or insufficient expansion (< 5-fold) in response to CD3/CD137 costimulation.
- •Any uncontrolled active medical disorder that would preclude participation as outlined.
- •HIV infection.
结局指标
主要结局
Occurrence of study related adverse events
时间窗: Until week 24
defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
次要结局
- Anti-myeloma responses to CART-138 cell infusions(up to 24 weeks)
研究者
Han weidong
principal investigator
Chinese PLA General Hospital