A Phase I, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-G39P, a Dual-targeted Cell Preparation Targeting CD19/CD20, in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Incidence, severity and type of TEAEs
研究概览
简要总结
A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma
详细描述
his is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LUCAR-G39P in the patient ≥ 18 years of age with relapsed or refractory B-cell non-Hodgkin lymphoma. Subjects who meet the eligibility criteria will receive a single dose of LUCAR-G39P injection. The study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent.
- •Aged 18-75 years (inclusive).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD
- •At least one evaluable tumor lesion according to Lugano 2014 criteria.
- •Response to prior therapy is consistent with one of the following:
- •Primary refractory.
- •Relapsed or refractory after 2 or more lines of therapy.
- •For LBCL, 3B FL. t-iNHL:
- •Relapse within 12 months after first-line chemoimmunotherapy to achieve CR;
- •Progression or relapse within 12 months after autologous hematopoietic stem cell transplantation;
- •7. Life expectancy≥ 3 months
- •Clinical laboratory values meet screening visit criteria
排除标准
- •Subject eligible for this study must not meet any of the following criteria:
- •Prior antitumor therapy with insufficient washout period ;
- •Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy;
- •Patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy;
- •5. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).
- •6. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39P CAR-T cell or its excipients, including DMSO.
- •7. Pregnant or lactating women;
研究组 & 干预措施
Experimental: LUCAR-G39P cells product
Each subject will be given a single-dose LUCAR-G39P cells infusion at each dose level.
干预措施: LUCAR-G39P cells product (Biological)
结局指标
主要结局
Incidence, severity and type of TEAEs
时间窗: Through study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Pharmacokinetics in peripheral blood
时间窗: ThTrough study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-G39P infusion
The recommended Phase II dose (RP2D) for this cell therapy
时间窗: Within 30 days after LUCAR-G39P infusion
RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion
Pharmacokinetics in bone marrow
时间窗: ThTrough study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-G39P infusion.
次要结局
- Overall Survival (OS)(Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1))
- Time to Response (TTR)(Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1))
- Progression-free survival (PFS)(Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1))
- Duration of Response (DoR)(Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1))
- Overall Response Rate (ORR)(Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1))
- Immunogenicity assessment of LUCAR-G39P cells(Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1))