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

F. Hoffmann-La Roche Ltd0 个研究点目标入组 342 人开始时间: 2021年8月25日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•- Age >= 18 years
•- Able to comply with the study protocol and procedures in the investigator’s judgment
•- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
•- Life expectancy of at least 12 weeks ?
•- Patients must have histologically confirmed FL or 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
•- Adequate hepatic, hematologic and renal function
•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 135
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 205

•- Inability to comply with protocol-mandated hospitalization and activity restrictions
•- 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 antibody, radioimmunoconjugate or antibody-drug conjugate chemotherapy, or other investigational anti-cancer agent within 4 weeks before first dose of study treatment
•- Treatment with radiotherapy within 2 weeks prior to the first dose of study treatment
•- Autologous stem-cell transplantation (SCT) within 100 days prior to first study treatment administration, or any prior allogeneic SCT or solid organ transplantation
•- Prior treatment with chimeric antigen receptor -T therapy within 30 days before first study treatment administration
•- Current or past history of central nervous system (CNS) lymphoma and of CNS disease
•- Significant cardiovascular disease or pulmonary disease
•- Recent major surgery within 4 weeks prior to first study treatment administration
•- Hepatitis B or C or human immunodeficiency virus (HIV)
•- Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
•- History of autoimmune disease (stable autoimmune diseases may be eligible)
•- Systemic immunosuppressive medication within 2 weeks prior to study drug

发起方