JPRN-jRCT2041230077招募中1 期
A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of AZD0486, a Bispecific Antibody Targeting CD19 in Subjects with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Misaki Masako0 个研究点目标入组 9 人开始时间: 2023年9月5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
- 9
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 <= 80age old（—）
- 性别
- All
入选标准
- •Biopsy proven B-NHL, including DLBCL, HGBL, or FL.
- •- For Arm B only: Subject has biopsy proven DLBCL or HGBL
- •- For Arm C only: Subject has biopsy proven FL
- •- Subject has received at least 2 lines of therapy to which the subject has been either refractory or has subsequently relapsed. In order to be eligible for this study subjects must not be candidates for treatment regimens known to provide clinical benefit in B-NHL.
- •- Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 2.
- •- Subject must have adequate liver, bone marrow and kidney function (eGFR >= 50 mL/min).
排除标准
- •- Subject has been diagnosed with or treated for another malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.
- •- Subject has a history of central nervous system (CNS) involvement by their B-NHL.
- •- Subject has a history of leukemic presentation of their B-NHL.
- •- Subject has a history or presence of clinically significant CNS pathology.
- •- Subject has CNS involvement from active or history of autoimmune disease.
- •- Subject experienced Grade >= 3 cytokine release syndrome (CRS) following prior T-cell engager (TCE) or CAR T-cell therapy.
- •- Subject experienced Grade >= 2 neurotoxicity following prior TCE or CAR T-cell therapy.
- •- Subject has received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study drug treatment or has received an SCT and requires ongoing immunosuppressive therapy.
- •- Subjects with human immunodeficiency virus (HIV) infection, or subjects with chronic or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Subjects with chronic HBV may be enrolled if the HBV viral load is undetectable on suppressive therapy, or if the subject has a documented cure. Subjects with HCV who have a documented cure may be enrolled.
- •- Subject has a history of major cardiac abnormalities.
- •- If female, subject must not be pregnant or breastfeeding.
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