Anti-CD19 Chimeric Antigen Receptor Modified T Cells Infusion in Mantle Cell Lymphoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Occurrence of study related adverse events
研究概览
简要总结
Patients receive anti-CD19-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells over a period of 4 or 5 consecutive days in an escalating dose. After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 10 years.
详细描述
PRIMARY OBJECTIVES:
I. Determine the safety and efficacy of the chimeric antigen receptor T cells transduced with the anti-CD19 (cluster of differentiation antigen 19 ) vector (referred to as CART-19 cells) in elderly patients with MCL.
II. Determine duration of in vivo survival of CART-19 cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood will be used to detect and quantify survival of CART-19 TCR (T-cell receptor) zeta:CD137 and TCR zeta cells over time.
SECONDARY OBJECTIVES:
For patients with detectable disease, measure anti-tumor response due to CART-19 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
- 50 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 with CD19+ relapsed or refractory MCL, and 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.
- •Not eligible or appropriate for conventional allogeneic SCT
- •Patients who achieve only a partial response to FCR(fludarabine, cyclophosphamide and Rituxan) as initial therapy will be eligible.
- •Beyond 1st CR (complete remission) with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous SCT
- •Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc...)
- •Relapsed after prior autologous SCT
- •Residual disease after primary therapy and not eligible for autologous SCT
- •Relapsed after prior autologous SCT
- •Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate of conventional allogeneic or 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 autologous 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 2 years
defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to the study.
次要结局
- Clinical responses to CART-19 cell therapy(Until 24 weeks)
研究者
Quanshun Wang
Dr.
Chinese PLA General Hospital