NCT03189836终止1 期
Phase 1 Study of ACTR707, an Autologous T Cell Product, in Combination With Rituximab, in Subjects With Relapsed or Refractory CD20+ B Cell Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 22
- 主要终点
- Safety as assessed by dose limiting toxicities (DLTs)
研究概览
简要总结
This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and anti-lymphoma activity of an autologous T cell product (ACTR707) in combination with rituximab in subjects with refractory or relapsed CD20+ B cell lymphoma.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed written informed consent obtained prior to study procedures
- •histologically-confirmed relapsed or refractory CD20+ B-cell lymphoma of one of the following types, with documented disease progression or recurrence following the immediate prior therapy: DLBCL (regardless of cell of origin or underlying molecular genetics), MCL, PMBCL, Gr3b-FL, TH-FL (prior dx of FL before transforming to DLBCL).
- •biopsy-confirmed CD20+ expression of the underlying malignancy with disease progression following immediate prior therapy
- •at least 1 measurable lesion on imaging.
- •must have received adequate prior therapy for the underlying CD20+ B-cell lymphoma, defined as an anti-CD20 mAb in combination with an anthracycline-containing chemotherapy regimen (i.e. chemo-immunotherapy) and at least one of the following:
- •biopsy-proven refractory disease after frontline chemo-immunotherapy
- •relapse within 1 year from frontline chemo-immunotherapy and ineligible for autologous hematopoietic stem cell transplant (auto-HSCT)
- •for subjects with DLBCL, PMBCL, and Gr3b-FL: relapsed or refractory disease following at least 2 prior regimens or following an auto-HSCT
- •for subjects with TH-FL: relapsed or refractory disease following at least 2 prior regimens or following an auto-HSCT. At least 1 prior regimen with an anti-CD20 mAb in combination with chemotherapy is required following documented transformation
- •for subjects with MCL (confirmed with cyclin D1 expression or evidence of t(11;14) by cytogenetics, fluorescent in situ hybridization (FISH) or polymerase chain reaction (PCR): relapsed or refractory disease after at least 1 prior regimen with chemo-immunotherapy (prior auto-HSCT is allowable)
- •ECOG 0 or 1
- •life expectancy of at least 6 months
- •platelet count greater than 50,000/µL
排除标准
- •known active central nervous system (CNS) involvement by malignancy.
- •prior treatment as follows:
- •alemtuzumab within 6 months of enrollment
- •fludarabine, cladribine, or clofarabine within 3 months of enrollment
- •external beam radiation within 2 weeks of enrollment
- •mAb (including rituximab) within 2 weeks of enrollment
- •other lymphotoxic chemotherapy (including steroids except as below) within 2 weeks of enrollment
- •experimental agents within 3 half-lives prior to enrollment, unless progression is documented on therapy
- •clinically significant cardiac disease
- •clinically significant active infection
- •clinically significant CNS disorder
- •clinical history, prior diagnosis, or overt evidence of autoimmune disease
- •known bone marrow involvement due to underlying malignant disease, in dose-escalation phase only
结局指标
主要结局
Safety as assessed by dose limiting toxicities (DLTs)
时间窗: 28 days
Dose-limiting toxicities, MTD, incidence and severity of AEs and clinically significant abnormalities of laboratory values
Determination of maximum tolerated dose and proposed recommended Phase 2 dose
时间窗: 24 weeks
次要结局
- Assessment of persistence of ACTR707 as measured by flow cytometry and qPCR(24 weeks)
- Assessment of ACTR707 phenotype and function as measured by flow cytometry(24 weeks)
- Anti-lymphoma activity as measured by overall response rate(24 weeks)
- Anti-lymphoma activity as measured by duration of response(24 weeks)
- Anti-lymphoma activity as measured by progression-free survival(24 weeks)
- Anti-lymphoma activity as measure by overall survival(24 weeks)
- Assessment of inflammatory markers and cytokines/chemokines(24 weeks)
- Rituximab PK(24 weeks)
研究者
研究点 (22)
Loading locations...
相似试验
终止
1 期
Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple MyelomaMultiple Myeloma in RelapseRefractory Multiple MyelomaMultiple MyelomaNCT03266692Cogent Biosciences, Inc.15
已完成
1 期
Study of ACTR087 in Subjects With Relapsed or Refractory B-cell LymphomaLymphomaNCT02776813Cogent Biosciences, Inc.34
终止
1 期
Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor CancersSolid TumorHER-2 Protein OverexpressionNCT03680560Cogent Biosciences, Inc.6
已完成
1 期
Phase I Clinical Trial of Autologous CD7-CAR T Cell Therapy for High-risk Acute T-cell Leukemia/lymphomaT Cell LymphomaT-cell LeukemiaNCT04840875Beijing Boren Hospital16
已完成
1 期
Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD7-Specific CAR-T CellsT-cell Acute Lymphoblastic Leukemia/LymphomaNCT04572308Hebei Senlang Biotechnology Inc., Ltd.20