JPRN-jRCTc030220287招募中1 期
Study for Tolerability of abT-Cell Therapy in Patients Refractory to Immune Checkpoint Inhibitors - Tolerability of abT-Cell Therapy in Patients Refractory to ICIs
Takimoto Rishu0 个研究点目标入组 30 人开始时间: 2022年8月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- •(1) BSC determined to have PD based on imaging findings after at least 3 months of ICIs.
- •(2) Receive abT cells within 30 to 120 days of last administration of ICIs.
- •(3) Have an Eastern Cooperative Oncology Group performance-status score of 0 or 1.
- •(4) Be at age 18 or older.
- •(5) Visit outpatient department on schedule.
- •(6) Have an adequate function of liver, kidney, and bone marrow when the eligibility is confirmed.
- •(7) Provide agreement of the attending doctor to participate in this study.
- •(8) Provide written consent to participate this study.
排除标准
- •(1) Be symptomatic pulmonary fibrosis or interstitial pneumonia, or with a predisposition or history of such disease.
- •(2) Have a history of serious adverse events with treatment with ICIs
- •(3) Have a history of a serious drug allergy.
- •(4) Be HIV or HTLV-1 positive.
- •(5) Have a serious cardiac disorder.
- •(6) Patients who have previously treated allogenic transplantation.
- •(7) Have an active autoimmune disease.
- •(8) Have a concurrent cancer.
- •(9) Have an infectious disorder that is difficult to control.
- •(10) Be a female who is pregnant, nursing, or of childbearing potential.
- •(11) Be determined to be inappropriate by the doctor in charge.
研究者
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