A Phase Ib/II Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 17
- 主要终点
- Percentage of Participants With Adverse Events - Phase 1b
研究概览
简要总结
This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab in combination with tiragolumab, with or without atezolizumab, in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who have received at least two previous lines of systemic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged >/= 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Life expectancy of at least 12 weeks
- •Histologically documented FL or DLBCL that has relapsed or failed to respond to at least two prior systemic treatment regimens and for which no suitable therapy of curative intent or higher priority exists (e.g., standard chemotherapy, ASCT, CAR T cells)
- •At least one bi-dimensionally measurable (> 1.5 cm) nodal lesion, or at least one bi-dimensionally measurable (> 1.0 cm) extranodal lesion
- •Participants with FL (including trFL) for whom a bone marrow biopsy and aspirate can be collected
- •Adequate hematologic and organ function
排除标准
- •Received any of the following treatments prior to study entry: mosunetuzumab or other CD20/CD3-directed bispecific antibodies; tiragolumab or other anti-TIGIT agent; allogenic SCT; solid organ transplantation
- •Currently eligible for autologous SCT
- •Current or past history of CNS lymphoma or leptomeningeal infiltration
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
- •Contraindication to atezolizumab (if applicable) or tocilizumab
- •Clinically significant toxicities from prior treatment have not resolved to Grade </= 1 (per NCI CTCAE v5.0) prior to the first study drug administration with exceptions defined by the protocol
- •Treatment-emergent immune-mediated adverse events associated with prior immunotherapeutic agents as defined by the protocol
- •Evidence of any significant, concomitant disease as defined by the protocol
- •Major surgery within 4 weeks prior to first study treatment administration, with the exception of protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies)
- •Significant cardiac, pulmonary, CNS, or liver disease, or known active infections
- •History of other malignancy that could affect compliance with the protocol or interpretation of results
- •History of autoimmune disease with exceptions as defined in the protocol
研究组 & 干预措施
Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IV
Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)
Note: This arm did not enroll any participants.
干预措施: Tiragolumab (Drug)
Subcutaneous (SC) Mosunetuzumab in Combination with Intravenous (IV) Tiragolumab
Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)
干预措施: Mosunetuzumab SC (Drug)
Subcutaneous (SC) Mosunetuzumab in Combination with Intravenous (IV) Tiragolumab
Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)
干预措施: Tiragolumab (Drug)
Subcutaneous (SC) Mosunetuzumab in Combination with Intravenous (IV) Tiragolumab
Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)
干预措施: Tocilizumab (Other)
Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IV
Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)
Note: This arm did not enroll any participants.
干预措施: Mosunetuzumab SC (Drug)
Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IV
Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)
Note: This arm did not enroll any participants.
干预措施: Atezolizumab (Drug)
Mosunetuzumab SC in Combination with Tiragolumab IV and Atezolizumab IV
Participants will receive at least 8 and up to 17 cycles of treatment (cycle length = 21 days)
Note: This arm did not enroll any participants.
干预措施: Tocilizumab (Other)
结局指标
主要结局
Percentage of Participants With Adverse Events - Phase 1b
时间窗: From the start of treatment until 90 days after the final dose of study treatment (up to 36 weeks)
Best Objective Response Rate (ORR) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 2
时间窗: Up to Cycle 17 (cycle length = 21 days)
次要结局
- Best ORR as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b(Assessed at screening and then every 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal (through Cycle 8; cycle length = 21 days))
- Serum Concentration of Mosunetuzumab - Phase 1b(Cycle 1 Day 1 - Cycle 8 Day 1 (cycle length = 21 days))
- Best Complete Response (CR) Rate as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b(Assessed at screening and then every 3-6 months until disease progression, start of new anti-cancer therapy, or withdrawal (through Cycle 8; cycle length = 21 days))
- Duration of Response (DOR) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 1b and Phase 2(From the first occurrence of a documented response (CR or partial response (PR)) to disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years))
- Progression-Free Survival (PFS) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 2(From the first study treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years))
- Event-Free Survival (EFS) as Determined by the Investigator Using Lugano 2014 Criteria - Phase 2(From the first study treatment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs first (up to approximately 4 years))
- Overall Survival (OS) - Phase 2(From the time of first study treatment to death from any cause (up to approximately 4 years))
- Percentage of Participants With Adverse Events - Phase 2(From the start of treatment until 90 days after the final dose of study treatment)