An Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of CD30-Targeted LCAR-HL30 Cells in Patients With Relapsed/Refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pharmacokinetics in peripheral blood
研究概览
简要总结
This is a prospective, single-arm, open-label, exploratory clinical study of LCAR-HL30 in adult subjects with relapsed/refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma.
详细描述
This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of LCAR-HL30, a chimeric antigen receptor(CAR)-T cell therapy in subjects with relapsed/refractory Hodgkin's Lymphoma and Anaplastic Large Cell Lymphoma. Patients who meet the eligibility criteria will receive LCAR-HL30 infusion. The study will include the following sequential stages: screening, pre-treatment (cell product preparation: 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 voluntarily participate in clinical research.
- •Aged 18 to 75 years, either sex.
- •Eastern Cooperative Oncology Group (ECOG) score 0-1 (Dose escalation phase). ECOG score 0-2 (Dose expansion period).
- •Histologically confirmed Hodgkin's lymphoma or Anaplastic large cell lymphoma with positive CD30 expression.
- •At least one evaluable tumor lesion according to Lugano 2014 criteria.
- •Expected survival ≥3 months.
- •Clinical laboratory values in the screening period meet criteria.
- •Effective contraception.
排除标准
- •Prior antitumor therapy with insufficient washout period.
- •Previous treatment with CAR-T therapy, allogeneic hematopoietic stem cell transplantation.
- •Severe underlying diseases;
- •Hepatitis B virus surface antigen (HbsAg), Hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C virus ribonucleic acid (HCV RNA) or human immunodeficiency virus antibody (HIV-Ab) positive.
- •Presence of other serious pre-existing medical conditions that may limit patient participation in the study. Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.
研究组 & 干预措施
Chimeric antigen receptor T cells LCAR-HL30 cells
Each subject will receive LCAR-HL30 cells.
干预措施: LCAR-HL30 cells (Biological)
结局指标
主要结局
Pharmacokinetics in peripheral blood
时间窗: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
CAR positive T cells levels in peripheral blood after LCAR-HL30 infusion.
Pharmacokinetics in bone marrow
时间窗: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
CAR positive T cells levels in bone marrow after LCAR-HL30 infusion.
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
时间窗: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
Recommended Phase 2 Dose (RP2D) regimen finding
时间窗: Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1)
RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.
次要结局
- Objective Response Rate (ORR) after administration(Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1))
- Time to Response (TTR) after administration(Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1))
- Overall Survival (OS) after administration(Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1))
- Duration of Remission (DoR) after administration(Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1))
- Progression-free Survival (PFS) after administration(Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1))
- Incidence of anti-LCAR-HL30 antibody(Minimum 2 years after LCAR-HL30 infusion (Day 1), maximum 4 years after LCAR-HL30 infusion (Day 1))