An Open-label, Multicenter Phase 2 Study Evaluating the Efficacy and Safety of Firi-cel, a CD22-directed Autologous Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed/Refractory Large B-Cell Lymphoma After CD19-directed CAR T-cell Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 101
- 试验地点
- 31
- 主要终点
- Objective response rate - Blinded independent review
研究概览
简要总结
This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL).
详细描述
Firicabtagene autoleucel (firi-cel) is an autologous CAR T-cell therapy targeting CD22, a common B-cell antigen widely expressed in LBCL. This Phase 2 study is designed to evaluate the safety and the efficacy of firi-cel in patients with R/R LBCL that has progressed after CD19-directed CAR T-cell therapy. The study is designed to treat up to 123 patients with a single infusion of firi-cel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Aged ≥18 years
- •Relapsed or refractory, histologically confirmed large B-cell lymphoma.
- •Must have relapsed or refractory diseae after last therapy.
- •For enrollment in cohort 1, patients must have previously received a CD19-directed CAR T-cell therapy
- •For enrollment in cohort 3, patients must have received at least two prior lines of therapy including a bispecific T-cel engaging antibody therapy.
- •Must have at least one radiographically measurable lesion.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate hematological, renal, and liver function
- •Willing and able to remain within 1 hour of the treating center for at least 4 weeks after infusion.
排除标准
- •Clinically significant concurrent medical illness
- •Active fungal, bacterial, viral or other infection.
- •Prior allogeneic stem cell transplant or allogeneic cell therapy
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Experimental Drug (Cohort 1)
Single infusion of firi-cel following conditioning chemotherapy
干预措施: Fludarabine (Conditional therapy) (Drug)
Experimental Drug (Cohort 1)
Single infusion of firi-cel following conditioning chemotherapy
干预措施: Cyclophosphamide Monohydrate (Conditional therapy) (Drug)
Experimental Drug (Cohort 1)
Single infusion of firi-cel following conditioning chemotherapy
干预措施: firi-cel (Experimental drug) (Drug)
Experimental Drug (Cohort 2: non-conforming product)
Single infusion of firi-cel following conditioning chemotherapy (patients in this cohort will receive non-conforming firi-cel that is deemed safe to administer).
干预措施: Fludarabine (Conditional therapy) (Drug)
Experimental Drug (Cohort 2: non-conforming product)
Single infusion of firi-cel following conditioning chemotherapy (patients in this cohort will receive non-conforming firi-cel that is deemed safe to administer).
干预措施: Cyclophosphamide Monohydrate (Conditional therapy) (Drug)
Experimental Drug (Cohort 2: non-conforming product)
Single infusion of firi-cel following conditioning chemotherapy (patients in this cohort will receive non-conforming firi-cel that is deemed safe to administer).
干预措施: firi-cel (Experimental drug) (Drug)
Experimental Drug (Cohort 3)
Patients with relapsed or refractory Large B-cell lymphoma who have previously been treated with bispecific T-cell engaging antibody therapy will receive a single infusion of firi-cel following conditioning chemotherapy.
干预措施: Fludarabine (Conditional therapy) (Drug)
Experimental Drug (Cohort 3)
Patients with relapsed or refractory Large B-cell lymphoma who have previously been treated with bispecific T-cell engaging antibody therapy will receive a single infusion of firi-cel following conditioning chemotherapy.
干预措施: Cyclophosphamide Monohydrate (Conditional therapy) (Drug)
Experimental Drug (Cohort 3)
Patients with relapsed or refractory Large B-cell lymphoma who have previously been treated with bispecific T-cell engaging antibody therapy will receive a single infusion of firi-cel following conditioning chemotherapy.
干预措施: firi-cel (Experimental drug) (Drug)
结局指标
主要结局
Objective response rate - Blinded independent review
时间窗: Up to 24 months
Percentage of patients with complete or partial response determined by a blinded independent review committee
次要结局
- Duration of response(Up to 24-months)
- Progression-free survival(Up to 24-months)
- Objective response rate - Investigator assessment(Up to 24-months)
- Complete response rate(Up to 24-months)
- Duration of complete response(Up to 24-months)
- Incidence rate of adverse events(From Screening up to 15 years at protocol-defined timepoints)
- Overall Survival(Up to 24-months)