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
- Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
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.
结局指标
主要结局
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.
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.
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))