EUCTR2017-001748-36-SE进行中（未招募）1 期
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
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
- 786
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
- 性别
- All
入选标准
- •1. Patient must be 18 years of age or older (for expansion: In countries where the legal age is 21 years of age; only patients 21 years of age or older are eligible)
- •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, 1 or 2. For MCL: ECOG PS <2 required for participation.
- •7. For the optimization part, patients must have R/R DLBCL, or FL grades 1-3A, or MCL (according to cohort).
- •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 393
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 393
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. Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment) at the time of enrolment or within the previous 2 weeks prior to the first dose of epcoritamab, including COVID-19 infection.
- •7. Eligible for curative salvage therapy with high dose therapy followed by stem cell rescue
- •8. Active hepatitis B (DNA PCR-positive) or hepatitis C (RNA PCR positive infection). Subjects with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic
- •antiviral therapy.
- •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
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