NCT06478381招募中1 期
A Phase 1, Open-label, Dose Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of L218CAR19 in Patients With CD19 Positive Relapsed/Refractory B-cell Lymphomas
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Treatment-emergent adverse event (AE)
研究概览
简要总结
L218CAR19 is a kind of chimeric antigen receptor T-cell immunotherapy targeting CD19 on B cells. The goal of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of L218CAR19 in patients with B-cell lymphomas who have received at least two lines of systemic treatment.
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
- •Age 18-75 years at the time of inclusion
- •Written informed consent
- •Patients with relapsed/refractory CD19 positive B-cell lymphomas, who have received at least two lines of treatment
- •With measurable disease
- •ECOG PS 0-2 at protocol entry
- •Estimated life expectancy of 3 months or longer
- •Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count ≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrow involvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN), or ≤3 x ULN if elevation is due to hepatic involvement by lymphoma; Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma; Serum creatinine ≤ 1.5 x ULNb; left ventricular ejection fraction (LVEF) ≥ 50%
- •Women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 6 months after the administration of study drug; Male patients must use contraception for the duration of the study and 6 months after the administration of study drug if his partner is of childbearing potential
排除标准
- •Patients with heart disease: atrial fibrillation; History of Class III or IV New York Heart Association (NYHA) heart failure, myocardial infarction or other significant cardiac disease within 12 months of screening; LVEF<50%; clinical significant pericardial effusion; Long QT syndrome
- •History of severe pulmonary function impairment
- •With other uncontrolled malignancy
- •With active bacterial, viral, or fungal infections
- •WIth uncontrolled autoimmune disease or congential immunodeficiency
- •HIV antibody positive patients
- •Known severe hypersensitivity to biological product
- •Patients with known active central nervous system (CNS) disease, including lymphoma CNS involvement
- •Patients with prior CAR-T therapy
- •History of allogeneic stem cell transplantation
- •History of autogeneic stem cell transplantation within 6 months of screening
- •History of major surgery within 4 weeks of screening
- •Patients receiving live (attenuated) vaccines within 6 weeks of screening
- •Pregnant or lactating women, or pregnant plan within 12 months
- •Involvement of cardiac tissue by lymphoma
- •with emergency due to oncothlipsis
- •Unwillingness or inability to comply with the protocol
- •Deemed 'unfit' by the treating physician
研究组 & 干预措施
Dose Escalation
Experimental
L218CAR19 is administered via infusion with ascending dose levels to determine the maximum tolerated dose (MTD)
干预措施: L218CAR19 (Drug)
结局指标
主要结局
Treatment-emergent adverse event (AE)
时间窗: Up to 1 year
Incidence of treatment-emergent AEs
Dose limiting toxicity (DLT)
时间窗: Up to 4 weeks
Occurrence of DLTs
次要结局
- Quantification of L218CAR19 in peripheral blood(Up to 1 year)
- Clearance (CL) of L218CAR19(Up to 3 months)
- Immunogenic response to L218CAR19(Up to 1 year)
- Serum cytokine concentrations(Up to 3 months)
- Area under the curve (AUC) of L218CAR19(Up to 3 months)
- Time to reach Cmax (Tmax) of L218CAR19(Up to 3 months)
- ORR(Up to 1 year)
- OS(Up to 1 year)
- PFS(Up to 1 year)
研究者
Yanyan Liu
Professor
Henan Cancer Hospital
研究点 (1)
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