An Open-Label, Multicenter, Phase Ib/II Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination with Polatuzumab Vedotin in Patients with B-Cell Non-Hodgkin Lymphoma - GO40516

F. Hoffmann-La Roche AG0 个研究点目标入组 235 人开始时间: 2023年11月7日最近更新: 2024年7月22日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: F. Hoffmann-La Roche AG
入组人数: 235

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

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Age = 18 years at time of signing Informed Consent Form, Patients must have histologically confirmed R/R FL, DLBCL, or MCL, For DLBCL or FL, must have received at least one prior systemic treatment regimen containing an anti- cluster of differentiation 20 (CD20) - directed therapy, For MCL, must have received at least two prior systemic treatment regimens which include agents from all three classes below: anti-CD20-directed therapy, a Bruton’s tyrosine kinase (BTK) inhibitor, and an anthracycline or bendamustine, Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2, 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., Patients must have histologically confirmed R/R FL, DLBCL, or MCL, For DLBCL or FL, must have received at least one prior systemic treatment regimen containing an anti- cluster of differentiation 20 (CD20) - directed therapy, For MCL, must have received at least two prior systemic treatment regimens which include agents from all three classes below: anti-CD20-directed therapy, a Bruton’s tyrosine kinase (BTK) inhibitor, and an anthracycline or bendamustine, Age = 18 years at time of signing Informed Consent Form, Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2, 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.

排除标准

•Current eligibility for autologous SCT in patients with R/R DLBCL, R/R transformed FL, or R/R Grade 3b FL, Current > Grade 1 peripheral neuropathy, Prior use of any monoclonal antibodies, radioimmunoconjugates or antibody-drug conjugates for anti-lymphoma treatment within 4 weeks before first dose of study treatment, Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease, Pregnant or lactating women, Prior treatment with Mosun or other CD20-directed bispecific antibodies or with Pola, Current > Grade 1 peripheral neuropathy, Prior use of any monoclonal antibodies, radioimmunoconjugates or antibody-drug conjugates for anti-lymphoma treatment within 4 weeks before first dose of study treatment, Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease, Current eligibility for autologous SCT in patients with R/R DLBCL, R/R transformed FL, or R/R Grade 3b FL, Pregnant or lactating women, Prior treatment with Mosun or other CD20-directed bispecific antibodies or with Pola

研究者

发起方

F. Hoffmann-La Roche AG

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