JPRN-jRCT2071230043尚未招募1 期
A PHASE 1b/2, OPEN-LABEL STUDY OF PF-07901801 IN COMBINATION WITH GLOFITAMAB AFTER A FIXED, SINGLE DOSE OF OBINUTUZUMAB IN 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7月19日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 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
排除标准
- •Key Exclusion Criteria:
- •* Prior treatment with anti-CD47 and/or prior glofitamab or anti-CD20 x CD3 containing regimen. Refractoriness to an obinutuzumab monotherapy containing regimen.
- •* Prior allogeneic stem cell transplantation or autologous stem cell transplantation within 12 weeks prior to enrolment - Double or triple hit DLBCL lymphoma
- •* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection.
研究者
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