NL-OMON48105已完成2 期
A Phase 1/2 open-label, multi-center, safety, preliminary efficacy and pharmacokinetic (PK) study of isatuximab in combination with other anti-cancer therapies in participants with lymphoma - ACT15320
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Participants must be >= 18 years of age inclusive, at the time of signing the
- •informed consent, - Disease location amenable to tumor biopsy at baseline, -
- •Measurable disease, - For Cohort A1 (classic Hodgkin's lymphoma [cHL]
- •anti-programmed cell death protein 1/ligand 1 [PD-1/PD-L1] inhibitor naïve):
- •Histologically confirmed advanced cHL that has relapsed or progressed after at
- •least 3 lines of systemic therapy that may include autologous hematopoietic
- •stem cell transplant (auto-HSCT) or auto-HSCT and brentuximab vedontin (BV), -
- •For Cohort A2 (cHL anti-PD-1/PD-L1inhibitor progressor): Histologically
- •confirmed advanced cHL which has relapsed or progressed after one previous
- •anti-PD-1/PD-L1 containing regimen as the most recent prior therapy but no more
- •than 4 lines of previous chemotherapy including the anti-PD-1/PD-L1 containing
- •regimen and documentation of benefit during or after the anti-PD-1/PD-L1
- •containing regimen within 4 months prior to initiation of investigational
- •medicinal product (IMP), - For Cohort B (diffuse large B-cell lymphoma
- •[DLBCL]):Histologically confirmed advanced DLBCL that has relapsed or
- •progressed after 2 lines of systemic therapy including auto-HSCT or 2 lines of
- •systemic therapy for participants who are not eligible for auto-HSCT, - For
- •Cohort C (peripheral T-cell lymphoma [PTCL]): Histologically confirmed advanced
- •PTCL that has relapsed or progressed after either first-line chemotherapy and
- •auto-HSCT as consolidation of first remission or first-line chemotherapy if
- •participants are ineligible for auto-HSCT, - Body weight of > 45 kg
排除标准
- •-Prior exposure to agent that blocks CD38, - For patients with cHL (PD-1/PD-L1
- •naïve), DLBCL or PTCL prior exposure to any agent (approved or investigational)
- •that blocks the PD-1/PD-L1, PD-L2, CD137, CTLA-4 or LAG-3, - Evidence of other
- •immune related disease /conditions, - Has received a live-virus vaccination
- •within 28 days of planned treatment start; seasonal flu vaccines that do not
- •contain live virus are permitted, - Eastern Cooperative Oncology Group (ECOG)
- •performance status (PS) >=2, - Poor bone marrow reserve, - Poor organ function
研究者
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