NL-OMON54276招募中不适用
The 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 - GCT3013-02 / EPCORE* NHL-2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Genmab
- 入组人数
- 50
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
- 18 至 99（—）
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 representative (previous or current) 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 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 Arm 8, 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
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 cardiac disease
- •5. Evidence of significant, uncontrolled concomitant diseases that could affect
- •compliance with the protocol or interpretation of results
- •6. 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 of 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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