A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 129
- 主要终点
- Event-free survival per independent review committee assessment
研究概览
简要总结
This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation.
In this study, participants with MRD are randomized 1:1 to treatment with cema-cel or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide.
Prior to August 2025, participants may also have received an anti-CD52 monoclonal antibody, ALLO-647, as part of their lymphodepletion regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report.
- •Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have received additional lines of therapy.
- •Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET/CT evaluation
- •Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive.
- •Adult participants ≥18 years of age.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or
- •Adequate hematological, renal, hepatic, pulmonary, and cardiac function
- •Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤
排除标准
- •LBCL with history of central nervous system involvement, transformed from other malignancy (e.g., transformed follicular lymphoma or marginal zone lymphoma, Richter's transformation), or T-cell/histiocyte rich LBCL.
- •Prior treatment with anti-CD19 targeted therapies.
- •Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed.
- •Active and clinically significant autoimmune disease.
- •Active systemic bacterial, fungal, or viral infections requiring systemic treatment.
- •History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.
研究组 & 干预措施
Observation
Participants do not receive any study treatments. They are observed as per the current standard of care.
干预措施: Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™ (Device)
cemacabtagene ansegedleucel
Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine and cyclophosphamide.
干预措施: Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™ (Device)
cemacabtagene ansegedleucel
Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine and cyclophosphamide.
干预措施: cemacabtagene ansegedleucel (Genetic)
cemacabtagene ansegedleucel
Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine and cyclophosphamide.
干预措施: Fludarabine (Drug)
cemacabtagene ansegedleucel
Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine and cyclophosphamide.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Event-free survival per independent review committee assessment
时间窗: Up to 60 months
次要结局
- Progression-free survival per independent review committee assessment(Up to 60 months)
- Overall survival(Up to 60 months)
- Incidence and severity of adverse events and their relationship to cemacabtagene ansegedleucel and ALLO-647(Up to 60 months)
- Incidence and severity of laboratory toxicities related to cemacabtagene ansegedleucel and ALLO-647(Up to 60 months)
- Minimal residual disease clearance(Up to 60 months)