JPRN-jRCT2031230249招募中1 期
[M23-647]First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants with B-cell Malignancies - [M23-647]First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants with B-cell Malignancies
Satomi Natsuko0 个研究点目标入组 128 人开始时间: 2023年7月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •For Dose Escalation (Part 1) only: Participants with documented diagnosis for one of the following 3L+ B-cell malignancies, from one of the following WHO-defined histologies (Swerdlow et al 2016):
- •--Chronic lymphocytic leukemia (CLL)
- •--Small lymphocytic lymphoma (SLL)
- •--Chimeric antigen receptor T-cells (CAR-T)/hematopoietic cell transplant (HCT) relapsed/refractory (R/R) or ineligible diffuse large b-cell lymphoma (DLBCL) from the following histologies: DLBCL not otherwise specified (NOS) (germinal center B cell [GCB] and non-GCB DLBCL), T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, anaplastic lymphoma kinase positive (ALK+) large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS.
- •--Mantle cell lymphoma (MCL)
- •--Follicular lymphoma [FL] (grades 1-3b)
- •--Marginal zone lymphoma [MZL] (splenic, extranotal, and nodal)
- •--Waldenstorm macroglobulinemia (WM)
- •--Transformed indolent non-Hodgkin's lymphoma (iNHL)
- •-For Dose Expansion (Part 2) only: Participants with documented diagnosis of CLL who are 3L+ including those with Bruton's tyrosine kinase (BTK) mutations or CAR-T/HCT R/R or ineligible non-GCB DLBCL who are 3L+ with histology based on criteria established by the World Health Organization (WHO).
- •-Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2.
- •-Participant has a life expectancy >= 12 weeks.
- •-Prior Bruton's tyrosine kinase inhibitor (BTKi) is allowed.
- •-Adequate hematologic, renal, and hepatic function per the protocol.
- •-Participants with prior central nervous system (CNS) disease that have been effectively treated may be eligible.
排除标准
- •-Previously treated with a Bruton's tyrosine kinase (BTK) degrader.
- •-Known active CNS disease, or primary CNS lymphoma.
- •-Uncontrolled active systemic infection, or active cytomegalovirus infection, known history of human immunodeficiency virus (HIV), active hepatitis B or C infection.
研究者
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