NCT04602065终止1 期
Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type), a Multicenter, Open-label Phase Ib/II Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- ORR(evaluated by the independent review committee according to Lyric 2016 criteria.)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically diagnosed as extra-nodal NK/T cell lymphoma (nasal type) according to WHO 2016 criteria;
- •Refractory and relapsed ENKTL patients, being relapsed is defined as re-occurrence of the same lymphoma lesions at the primary site or new sites after complete response (CR); being refractory is defined as having any of the following conditions: evaluated as stable disease (SD) or progression disease (PD) after 2 cycles of treatment; not being able to achieve partial response (PR) after 4 cycles of treatment; not being able to achieve complete response (CR) after 6 cycles of treatment. Patients that did not achieve remission, or relapsed/progressed after autologous stem cell transplantation (ASCT) could also be enrolled.
- •Patients must have received asparaginase-based chemotherapy previously (patients with phase I/II disease must have received radiotherapy previously).
- •With measurable foci, defined as: lymph nodes with long diameters>15mm，extra-nodal foci>10mm on CT scan;
- •ECOG PS (Eastern Cooperative Oncology Group Performance Status) point 0 or 1;
排除标准
- •Invasive NK cell leukemia;
- •Primary CNS lymphoma or CNS-involved lymphoma;
- •Patients with hemophagocytic syndrome;
- •Patients with lymphoma invading large pulmonary vessels;
- •Patients primarily resistant to anti-PD1,PD-L1,PD-L2 antibodies (generally considered as those received anti- PD1,PD-L1,PD-L2 antibodies as monotherapy or in combination with chemotherapy, but did not achieve PR or CR in non-maintenance treatment).
研究组 & 干预措施
Patients previously never received anti-PD1/PD-L1 antibodies
Experimental
Patients previously never received anti-PD1/PD-L1 antibodies.
干预措施: IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody) (Drug)
Previously received anti-PD1/PD-L1 antibodies
Experimental
Patients previously received anti-PD1/PD-L1 antibodies, except for those were primarily refractory to them.
干预措施: IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody) (Drug)
结局指标
主要结局
ORR(evaluated by the independent review committee according to Lyric 2016 criteria.)
时间窗: After the last subject completed follow-up visit of up to 24 weeks
To evaluate the objective response rate (ORR) of IBI318 monotherapy for relapsed/refractory extranodal NK/T cell lymphoma (nasal type).
次要结局
- TTR2016 criteria.)(After the last subject completed follow-up visit of up to 24 weeks)
- DCR(After the last subject completed follow-up visit of up to 24 weeks)
- ORR(After the last subject completed follow-up visit of up to 24 weeks)
- CR/PR(After the last subject completed follow-up visit of up to 24 weeks)
- DOR(After the last subject completed follow-up visit of up to 24 weeks)
- PFS(After the last subject completed follow-up visit of up to 24 weeks)
- OS(evaluated by the investigators according to Lugano 2014 criteria and Lyric 2016 criteria.)(After the last subject completed follow-up visit of up to 24 weeks)
- adverse events(from enrollment until the last patient finishes OS follow-up, or finishes 24-month treatment and corresponding safety follow-up, whichever comes first.)
研究者
研究点 (1)
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