EUCTR2019-001073-86-PL进行中（未招募）1 期
Safety, Pharmacodynamics and Efficacy of MT-3724 for the Treatment of Patients with Relapsed or Refractory DLBC
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must have relapsed or refractory DLBCL
- •Subjects must have received at least 2 standard of care regimens for NHL treatment
- •Subjects must have life expectancy of >3 months from the start of treatment
- •Subjects must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Subjects must not be pregnant or plan to become pregnant during the study until the post-study Follow-up Visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •Received anti-CD20 MAb within 84 days before the start of treatment
- •Subjects who have received anti-CD20 Mab must have levels below a specified threshold to be eligible for study participation
- •Received approved or investigational treatment for NHL, including radiation therapy to target tumor lesions, within 4 weeks before the start of treatment
- •Received systemic immunosuppressive agents (except prescribed corticosteroids at doses =20 mg/day prednisone equivalent) within 2 weeks before the start of treatment
- •Received any vaccines except injectable flu vaccine (inactivated or recombinant) within 4 weeks before the start of treatment
- •Received allogeneic stem cell transplant
- •Evidence of seropositive status for human immunodeficiency virus (HIV), hepatitis B virus (positive for hepatitis B surface antigen (HBsAg) or anti-HBsAg and anti-HBcAg antibodies) or hepatitis C virus (positive for anti-HCV antibody or HCV-RCV-RNA quantitation) at screening
- •History of cardiovascular, renal, hepatic or any other disease within =3 months before the start of treatment that in the investigator’s opinion, may increase the risks associated with study participation or require treatments that may interfere with the conduct of the study or the interpretation of study results
- •History of another primary malignancy within the past 3 years (except for ductal breast cancer in situ, non-melanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ)
- •Current evidence of new or growing brain or spinal metastases during screening
研究者
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