A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma - First-in-Human (FIH) Trial in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma

GENMAB A/S0 个研究点目标入组 386 人开始时间: 2020年11月6日最近更新: 2021年8月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: GENMAB A/S
入组人数: 386

研究概览入排标准研究者记录与标识符相似试验

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

•1. Patient must be 18 years of age or older
•2. Documented CD20+ mature non-Hodgkin B-cell lymphoma according to WHO classification
•3. Relapsed, progressive and/or refractory disease (Cheson et al., 2007) following treatment with an anti-CD20 monoclonal antibody
•4. Patients must have received at least 2 prior lines of therapy
•5. Patients must have measurable disease by imaging
•6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (2 for escalation)
•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 347
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 39

排除标准

•1. Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma
•2. AST, and/or ALT > 3 x upper limit of normal
•3. Total bilirubin > 1.5 x upper limit of normal
•4. Creatinine clearance < 45 mL/min
•5. Known clinically significant cardiac disease, including:
•a. Onset of unstable angina pectoris within 6 months of signing ICF
•b. Acute myocardial infarction within 6 months of signing ICF
•c. Congestive heart failure (grade III or IV as classified by the New York Heart Association and/or known decrease ejection fraction of < 45%
•6. Chronic ongoing infectious diseases (except hepatitis B or hepatitis C) requiring treatment (excluding prophylactic treatment) at the time of enrolment or within the previous 2 weeks prior to the first dose of GEN3013
•7. Eligible for curative salvage therapy with high dose therapy followed by stem cell rescue
•8. Active hepatitis B or ongoing hepatitis C infacrion that has not been cured. If laboratory evidence for a chronic infection with hepatitis B close monitoring and prophylactic therapy is required
•9. Known human immunodeficiency virus (HIV) infection
•10. Exposed to live or live attenuated vaccine within 4 weeks prior to signing ICF
•11. Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first GEN3013 administration
•12. Autologous HSCT within 100 days prior to first GEN3013 administration, or any prior allogeneic HSCT or solid organ transplantation
•13. Contraindication to all uric acid lowering agents

研究者

发起方

GENMAB A/S

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