CTIS2023-504264-41-00招募中1 期
A Phase I/II, Open-Label, Single-Arm, Two-Part Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Glofitamab in Monotherapy and in Combination with Chemoimmunotherapy in Pediatric and Young Adult Participants with Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma - CO43810
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 65
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
- 0 至 64（—）
- 性别
- All
入选标准
- •Age 6 months to <18 years at the time of signing Informed Consent for Part 1 and Cohort B of the study, and age 6 months to <=30 years old at the time of signing Informed Consent for Part 2 of the study, Histologically re-confirmed diagnosis, via tissue biopsy, or bone marrow aspirate, pleural effusion, or ascites, prior to study entry of aggressive mature B-cell non-Hodgkin lymphoma (B-NHL) that expresses CD20 (reconfirmed by immunohistochemistry [IHC]), or flow cytometry if IHC is not possible including Burkitt lymphoma (BL), Burkitt leukemia (BAL) (mature B-cell leukemia fragment antigen-binding [FAB] L3), diffuse large B-cell lymphoma (DLBCL), and primary mediastinal large B-cell lymphoma (PMBCL), at the time of first relapsed or refractory (R/R) disease for Cohort A and second or greater R/R disease for Cohort B, Refractory or relapsed disease (i.e., prior treatment was ineffective or intolerable) following first-line standard-of-care chemoimmunotherapy for Cohort A and following at least two prior systemic chemoimmunotherapy regimens and who have exhausted all available established therapies for Cohort B Measurable disease, defined as – At least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension or – Percentage of bone marrow involvement with lymphoma cells defined by cytomorphological analysis of bone marrow aspirates, Adequate performance status, as assessed according to the Lansky or Karnofsky Performance Status scales, Adequate bone marrow, liver and renal function, Negative test results for hepatitis B and hepatitis C viruses (HBV and HCV), human immunodeficiency virus (HIV) and severe-acute-respiratory-syndrome-related coronavirus 2 (SARS-CoV-2).
排除标准
- •Exclusion criteria applicable to both Cohorts A and B - Isolated CNS disease of mature B-NHL without systemic involvement, and primary central nervous system (CNS) lymphoma, Exclusion criteria applicable to both Cohorts A and B - Receipt of glofitamab prior to study enrollment, Exclusion criteria applicable to Cohort A only - Receipt of any R-ICE chemoimmunotherapy prior to study enrollment into Cohort A, Exclusion criteria applicable to Cohort A only - Receipt of more than one prior line of standard-of-care B-NHL chemoimmunotherapy, Exclusion criteria applicable to Cohort B only - Prior treatment with standard radiotherapy, systemic chemotherapy and immunotherapeutic anticancer agents, Exclusion criteria applicable to Cohort B only - Patients with uncontrolled CNS involvement
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