EUCTR2020-000845-15-DK进行中（未招募）1 期
A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination with Other Agents in Subjects with B-cell Non-Hodgkin Lymphoma - EPCORE™ NHL-2
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
- 662
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. Subject must sign an ICF
- •2. At least 18 years of age
- •3. Measurable disease defined as =1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or =1 measurable extra-nodal lesion (long axis >1.0 cm) on CT or MRI
- •4. ECOG PS score of 0, 1 or 2
- •5. Acceptable organ function at screening
- •6. CD20-positive NHL at most recent representative tumor biopsy
- •7. If of childbearing potential subject must practicing a highly effective method of birth control
- •8. A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control
- •9. Life expectancy >2 months with SOC treatment.
- •Arm 1: One of these confirmed histologies:
- •- DLBCL, NOS
- •- T-cell/histiocyte rich DLBCL
- •- double-hit or triple-hit DLBCL
- •- FL Grade 3B
- •Arm 2 and Arm 9: R/R FL
- •Arm 3: Newly diagnosed, previously untreated FL grade 1-3A
- •Arm 4 and Arm 10: One of these confirmed histologies and eligible for HDT-ASCT
- •- DLBCL, NOS
- •- T-cell/histiocyte rich DLBCL
- •- double-hit or triple-hit DLBCL
- •- FL Grade 3B
- •Arm 5: One of these confirmed histologies and ineligible for HDT-ASCT
- •- DLBCL, NOS
- •- T-cell/histiocyte rich DLBCL
- •- double-hit or triple-hit DLBCL
- •- FL Grade 3B
- •Arm 6: previously untreated CD20+ FL
- •Arm 7: FL and in CR or PR per Lugano criteria following first-line or second-line treatment with SOC regiment at last treatment received, and last dose of SOC within 6 months prior to enrollment
- •Arm 8: One of these confirmed histologies:
- •- DLBCL, NOS
- •- T-cell/histiocyte rich DLBCL
- •- double-hit” or triple-hit” DLBCL
- •-FL Grade 3B
- •For Arm8, subjects must be ineligible to receive full-dose anthracycline (as part of R-CHOP) per eligibility criteria
- •Arm 9: Must have received only 1 prior line of therapy. This first-line therapy must have included an anti-CD20 antibody in combination with chemotherapy. Progressed within 24 months of initiating first-line treatment
- •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 331
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 331
排除标准
- •1. Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
- •2. Any prior treatment with a bispecific antibody targeting CD3 and CD20.
- •3. Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab
- •4. Clinically significant cardiovascular disease
- •5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
- •6. Primary CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture
- •7. Active HBV or HBC (DNA PCR positive infection)
- •8. Known history of seropositivity for human immunodeficiency virus (HIV)
- •9. Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
- •10. Subject has current seizure disorder requiring anti-epileptic therapy
研究者
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