JPRN-jRCT2031230151招募中2 期
A PHASE 1b/2 STUDY OF PF-07901801, A CD47 BLOCKING AGENT, WITH TAFASITAMAB AND LENALIDOMIDE FOR PARTICIPANTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA NOT ELIGIBLE FOR STEM CELL TRANSPLANTATIO
Kawai Norisuke0 个研究点目标入组 70 人开始时间: 2023年6月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Key Inclusion Criteria:
- •*Histologically confirmed diagnosis of DLBCL
- •*Relapsed or refractory disease
- •*Participant is not be a candidate for or is unwilling to undergo high dose chemotherapy and subsequent stem cell transplant and/or is unable to receive chimeric antigen receptor (CAR) T-cell therapy
- •*Previous treatment with at least one prior line of systemic therapy (for phase 2, at least 1 and no more than 2 prior lines of systemic therapy). Prior therapy must include an anti-CD20 antibody.
- •*Adequate bone marrow, hepatic and renal function
- •*Eastern Cooperative Oncology Group (ECOG) <=2
- •*Must provide a tumor tissue sample (fresh or archival, collected prior to start of treatment) for biomarker analysis
排除标准
- •Key Exclusion Criteria:
- •*Prior treatment with an anti-CD47 or anti-CD19 (other than CAR T) or immunomodulatory agents
- •*Prior allogeneic stem cell transplantation or autologous stem cell transplantation within 12 weeks prior to enrolment
- •*Participants with active, uncontrolled bacterial, fungal or viral infection.
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