NCT03630159已完成1 期
Phase Ib Study of Tisagenlecleucel in Combination With Pembrolizumab in Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL) Patients.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Percent of participants recieving pembrolizumab per protocol schedule
研究概览
简要总结
A multi-center, open-label, phase Ib study to evaluate the safety and efficacy of the administration of tisagenlecleucel in combination with pembrolizumab in patients with r/r DLBCL who have received 2 or more lines of systemic therapy, including an anti-CD20 and anthracycline based chemotherapy and having failed to or are not candidates for ASCT. The study will consist of 2 parts: dose timing selection part and expansion part.
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
盲法说明
None (Open label)
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
- •Confirmed DLBCL per local histopathology assessment.
- •Relapsed or refractory disease after having recieved 2 or more lines of systemic therapy, including anti-CD20 and anthracycline based chemotherapy, and either having progressed after (or relapsed after) ASCT, or being not candidates for or not consenting to ASCT.
- •Measurable disease at time of enrollment
- •ECOG performance status that is either 0 or 1 at screening.
排除标准
- •Patients with Richter's transformation, and Burkitt lymphoma, and primary DLBCL of CNS.
- •Prior treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy.
- •Patients with active CNS involvement are excluded, except if the CNS involvement has been effectively treated and provided that local treatment was >4 weeks before enrollment.
- •Prior allogeneic HSCT.
- •Unstable angina and/or myocardial infarction and/or coronary artery bypass graft (CABG), or stroke within 6 months prior to screening, and/or impaired cardiac function or clinically significant cardiac disease
- •Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, other immune checkpoint inhibitors.
- •History of interstitial lung disease or (non-infectious) pneumonitis that required oral or intravenous steroids (other than COPD exacerbation) or current pneumonitis.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Tisagenlecleucel+Pembrolizumab
Experimental
干预措施: Tisagenlecleucel (Biological)
Tisagenlecleucel+Pembrolizumab
Experimental
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Percent of participants recieving pembrolizumab per protocol schedule
时间窗: 21 days after first pembrolizumab infusion
Expansion part: Overall response rate (ORR)
时间窗: 3 month post tisagenlecleucel infusion
Dose Timing part: Incidence of dose limiting toxicities (DLTs)
时间窗: 21 days after first pembrolizumab infusion
次要结局
- Overall Survival (OS)(24 months)
- Impact of pembrolizumab dosing strategy on the cellular kinetics of tisagenlecleucel by qPCR and flow cytometry(24 months)
- Duration of Response (DOR)(24 months)
- Progression Free Survival (PFS)(24 months)
- Immunogenicity measured by antibody titres specific to tisagenlecleucel molecule and by the presence of T lymphocytes activated by the tisagenlecleucel protein(24 months)
- In vivo cellular kinetics of tisagenlecleucel in blood, bone marrow, lymph nodes and other tissues by qPCR and flow cytometry(24 months)
研究者
研究点 (4)
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