A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC T Cells Targeting CD19 in Relapsed or Refractory Large B-Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Incidence of dose-limiting toxicities (DLTs)
研究概览
简要总结
Phase I/II study to evaluate TAC01-CD19 in subjects with relapsed or refractory B-cell lymphomas. TAC technology is a novel way to genetically modify T cells and to redirect these T cells to target cancer antigens by co-opting the natural T cell receptor. The dose finding portion of this study will evaluate the safety and tolerability of increasing dose levels of TAC01-CD19 to identify a Maximal Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D). The dose expansion portion of the study will further evaluate the safety, efficacy and pharmacokinetics of TAC01-CD19 at the RP2D.
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
- •Histologically confirmed CD19+ Large B-Cell Lymphoma including Diffuse Large B-cell Lymphoma (DLBCL) not otherwise specified (including de novo and transformed lymphoma), Primary Mediastinal Large B-cell Lymphoma, High-Grade B-cell Lymphoma with MYC and BCL2 and/or BCL6 rearrangement per WHO 2016 classification.
- •Relapsed or refractory disease after greater than 2 lines of therapy including anthracycline and anti-CD20 therapy and either having failed autologous stem cell transplant (ASCT) or being ineligible for ASCT.
- •Adequate organ function.
排除标准
- •Prior treatment with any of the following: allogeneic bone marrow transplantation, gene therapy, adoptive cell transfer of any kind, including CAR T cells.
- •Active central nervous system (CNS) lymphoma involvement.
- •History or presence of clinically relevant CNS pathology.
- •Active inflammatory neurological disorders, autoimmune disease, or infections.
结局指标
主要结局
Incidence of dose-limiting toxicities (DLTs)
时间窗: First 28 days after dosing
Measurement of occurrence of study-defined DLTs
Incidence of adverse events (AEs)
时间窗: Informed consent through 2 years after dosing
Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities
次要结局
未报告次要终点