An Open-Label, Single-Arm Study of Relma-cel, CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for Relapsed and Refractory (R/R) LBCL
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pharmacokinetic(PK)-AUC of Relma-cel
研究概览
简要总结
This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.
详细描述
This is an open-label, single-arm study conducted in adult subjects with R/R LBCL in China to evaluate the pharmacokinetics(PK), safety and efficacy of relma-cel, monitor the immune response after relma-cel treatment.
Relma-cel was approved by the China National Medical Products Administration(NMPA)in September 2021(Acceptance No:CXSS2000036)for the treatment of adult patients with R/R LBCL after second-line or more systemic therapy.The recommended dose is 1×10^8 CAR+T cells.The indication for this application is R/R LBCL(supplement study) and the recommended dose is 1×10^8 CAR+T cells.
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
- •≥18 years old;
- •Sign on the informed consent;
- •Subjects must have histologically confirmed Large B-cell Lymphoma;
- •Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy include autologous hematopoietic stem cell transplantation(auto-HSCT);
- •Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
- •Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
- •Adequate organ function;
- •Adequate vascular access for leukapheresis procedur;
- •Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still expresss CD19;
- •Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel;
- •Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of Relma-cel.
排除标准
- •Central nervous system(CNS) only involvement by malignancy or primary CNS lymphoma;
- •History of another primary malignancyn that has not been in remission for at least 2 years;
- •Subjects has HBV,HCV,HIV or syphilis nefection at the time of screening;
- •Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
- •Subjects with uncontrolled systemic fungal,bacterial,viral or other infection;
- •Presence of acute or chronic graft-versus-host disease(GVHD);
- •History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
- •Pregnant or nursing woman;
- •Subjects using of any chemotherapy,corticisteriod,experiment agents,GVHD therapies,radiation,allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
- •Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
- •Received CAR T-cell or other genetically-modified T-cell therapy previously.
研究组 & 干预措施
Relma-cel
The PK, safety and efficacy of Relma-cel will be evaluated in 1 x 10^8 CAR+T cells dose level
干预措施: CD19-targeted Chimeric Antigen Receptor(CAR) T Cells (Biological)
结局指标
主要结局
Pharmacokinetic(PK)-AUC of Relma-cel
时间窗: up to 1 year after Relma-cel infusion
Area under the concentration vs time curve of Relma-cel
Pharmacokinetic(PK)-Tmax of Relma-cel
时间窗: up to 1 year after Relma-cel infusion
Time to maximum concentration of Relma-cel in peripheral blood
Pharmacokinetic(PK)-Cmax of Relma-cel
时间窗: up to 1 year after Relma-cel infusion
Maximum observed concentration of Relma-cel in peripheral blood
次要结局
- Adverse events (AEs)(up to 1 year after Relma-cel infusion)
- Duration of response (DOR)(up to 1 year after Relma-cel infusion)
- Overall survival (OS)(up to 1 year after Relma-cel infusion)
- Changes of serum cytokines-IL-2，IL-6，IL-8 and IFN- γ(up to 1 year after Relma-cel infusion)
- Changes of inflammation biomarker-CRP(up to 1 year after Relma-cel infusion)
- Objective response rate (ORR) in LBCL subjects(3 months)
- Complete response rate (CRR) in LBCL subjects(up to 1 year after Relma-cel infusion)
- Best objective response rate ( Best ORR) in LBCL subjects(up to 1 year after Relma-cel infusion)
- Progression-free survival (PFS)(up to 1 year after Relma-cel infusion)
- Changes of inflammation biomarker-serum ferritin(up to 1 year after Relma-cel infusion)