Retreatment With CTL019/CTL119 in Patients With Late Relapse of B-Cell Lymphomas
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
研究概览
简要总结
This research study is designed to evaluate the effects of retreatment with CTL019/CTL119 in patients with late relapse of B-cell lymphomas.
详细描述
This is a single arm open label trial that will assess the safety and efficacy of retreatment with CTL019/CTL119 chimeric antigen receptor (CAR) modified T cells in patients who have late relapse of diffuse large B-cell or follicular lymphoma after achieving complete remission from prior CTL019/CTL119 treatment. Patients eligible for this protocol will have been treated initially with CTL019/CTL119 under UPCC13413/NCT02030834, have experienced a durable complete response (defined as ≥ 6 months duration), and have a residual manufactured CTL019/CTL119 product available. This protocol will serve subjects with no available potentially curative treatment options (such as autologous or allogeneic stem cell transplantation) who have a limited prognosis (months to < 2 year expected survival) with available therapies.
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
- •Diffuse Large B-Cell Lymphoma or Follicular lymphoma, previously identified as CD19+
- •Previously treated on UPCC13413/ NCT02030834 with CTL019/CTL119, with historical manufactured product available at Penn for reinfusion
- •Previous complete response to CAR T-cells with a duration ≥ 6 months (defined as 168 days)
- •No available curative treatment options (such as autologous or allogeneic HSCT) with limited prognosis (several months to < 2 year survival) with currently available therapies.
- •Age ≥18 years
- •Creatinine < 1.6 mg/dL
- •ALT/AST < 3x upper limit of normal
- •Bilirubin < 2.0 mg/dL, unless subject has Gilbert's Syndrome (≤3.0 mg/dL)
- •Measurable or assessable disease according to the "Revised Response Criteria for Malignant Lymphoma" (Cheson et al., J. Clin. Onc., 2007)
- •Patients in complete remission with no evidence of disease are not eligible.
- •Performance status (ECOG) 0 or
- •Left Ventricle Ejection Fraction (LVEF) > 40% confirmed by ECHO/MUGA
- •Agree to contraceptive requirements outlined in Section 4.
- •Provide written informed consent.
排除标准
- •Uncontrolled active infection.
- •Active hepatitis B or hepatitis C infection.
- •Any uncontrolled active medical disorder that would preclude participation as outlined.
- •Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 1).
- •HIV infection.
- •Patients with active CNS involvement by malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment
- •Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.
研究组 & 干预措施
Retreatment with CTL019/CTL119
All subjects will receive retreatment with CTL019/CTL119 and be followed per the schedule of procedures.
干预措施: CD19 redirected autologous T cells (CTL019 or CTL119 cells) (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: At time of consent through 1 year after the subject received CTL019/CTL119
Safety of retreatment with CTL019/CTL119 as measured by treatment-related events
次要结局
- Overall response rate using Cheson 2007 criteria(Month 3 post-infusion)