NCT03266692终止1 期
A Phase 1 Study of ACTR087, an Autologous T Cell Product, in Combination With SEA-BCMA, a Monoclonal Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 13
- 主要终点
- Safety and tolerability of ACTR087 in combination with SEA-BCMA
研究概览
简要总结
This is a phase 1, multi-center, single-arm, open-label study evaluating the safety, tolerability, and anti-myeloma activity of ACTR087 (an autologous T cell product) in combination with SEA-BCMA (a monoclonal antibody) in subjects with relapsed or refractory Multiple Myeloma.
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- or cytologically-confirmed relapsed or refractory multiple myeloma (MM) with measurable disease
- •Must have received at least 3 prior lines of therapy to include treatment with a proteasome inhibitor (eg, bortezomib, carfilzomib, or ixazomib) and an immunomodulatory agent (eg, lenalidomide, pomalidomide) unless double-refractory to both; and a hematopoietic stem cell transplant (HSCT), for those subjects considered HSCT-eligible.
- •Quantitative serum IgG levels for subjects with IgG MM must not exceed the institutional upper limit of normal (ULN)
- •ECOG 0 or 1
- •Life expectancy of at least 6 months
- •Absolute neutrophil (ANC) count greater than 1000/ µL
- •Platelet count greater than 50,000/µL
- •Estimated GFR >30mL/min/1.73m2
排除标准
- •Known active central nervous system (CNS) involvement by MM
- •Systemic rheumatic or autoimmune diseases or acute or chronic infections
- •Uncontrolled thromboembolic events or recent severe hemorrhage
- •Subjects who are currently using more than 5mg/day of prednisone (or an equivalent glucocorticoid exceeding physiologic replacement levels)
- •Prior treatment as follows:
- •T cell-directed antibody therapy (eg. Alemtuzumab, anti-thymocyte globulin) within 6 months of enrollment
- •Any prior myeloma-directed therapy including cytotoxic chemotherapy, biologic therapy, or radiotherapy within 2 weeks of enrollment
- •Any mAb or other protein therapeutic containing Fc-domains within 4 weeks of enrollment
- •Experimental agents within 3 half-lives prior to enrollment, unless progression is documented on therapy
- •Prior BCMA-directed investigational agents at any time
- •Prior cell or gene therapy, excluding transfers of genetically unmodified autologous cells (eg. Hematopoietic stem cell transplantation), at any time; or prior allogeneic HSCT at any time
- •Pregnant or breastfeeding
结局指标
主要结局
Safety and tolerability of ACTR087 in combination with SEA-BCMA
时间窗: 28 days
Composite outcome measure assessed by committee review of dose limiting toxicities (DLTs), incidence and severity of AEs and clinically significant abnormalities of laboratory values
Determination of recommended Phase 2 dosing regimen
时间窗: 52 weeks
Review of DLTs, Maximum tolerated contour (MTC), incidence and severity of AEs and clinically significant abnormalities of laboratory values
次要结局
- Anti-myeloma activity as measured by overall survival(52 weeks)
- Anti-myeloma activity as measured by progression-free survival(52 weeks)
- Safety of SEA-BCMA as measured by incidence of Treatment Emergent Adverse Events (TEAEs)(21 days)
- Anti-myeloma activity as measured by overall response rate (per IMWG response criteria)(52 weeks)
- Anti-myeloma activity as measured by duration of response(52 weeks)
- Assessment of persistence of ACTR087 as measured by flow cytometry and qPCR(52 weeks)
- Assessment of ACTR087 phenotype and function as measured by flow cytometry(52 weeks)
- Assessment of anti-drug antibodies (ADA) after SEA-BCMA administration(52 weeks)
- Assessment of induction of inflammatory markers and cytokines/chemokines after ACTR087 administration(52 weeks)
- SEA-BCMA PK(52 weeks)
研究者
研究点 (13)
Loading locations...
相似试验
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 ACTR707 in Combination With Rituximab in Subjects With Relapsed or Refractory B Cell LymphomaLymphomaNCT03189836Cogent Biosciences, Inc.26
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
招募中
1 期
SCG142 TCR-T Cells for Human Papillomavirus-Associated CarcinomasHuman Papillomavirus Associated CarcinomasCervical CancerHead and Neck CancersVulva CancerHPV-Related MalignancyPenile CancerAnal CancerVaginal CancerNCT06544720The Affiliated Hospital of Qingdao University18