针对晚期血液恶性肿瘤患者的Orca-T扩大可及性计划研究
针对不符合商业发布规格的Orca-T产品的扩大可及计划
This study is not designed to test a hypothesis; rather, this study will provide patients with access to Orca-T if the commercial Orca-T product produced for them is deemed out of specification (OOS). Serious adverse events (SAEs) occurring during the safety reporting period (defined as the day the recipient receives the Orca-T HSPC drug product through day +365 after transplantation or until initiation of new anticancer therapy, whichever occurs sooner) will be reported.
研究概览
研究类型
扩展访问类型
- 治疗 IND/方案
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90095
- 可用的
- UCLA Department of Medicine - Hematology/Oncology
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Palo Alto、California、美国、94304
- 可用的
- Stanford Cancer Institute
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Florida
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Tampa、Florida、美国、33612
- 可用的
- Moffitt Cancer Center
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Kansas
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Kansas City、Kansas、美国、66160
- 可用的
- The University of Kansas Hospital
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Massachusetts
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Boston、Massachusetts、美国、02114
- 可用的
- Massachusetts General Hospital
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New York
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New York、New York、美国、10065
- 可用的
- Memorial Sloan Kettering Cancer Center
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Ohio
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Columbus、Ohio、美国、43210
- 可用的
- The Ohio State University Wexner Medical Center - James Cancer Hospital
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Texas
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Dallas、Texas、美国、75246
- 可用的
- Baylor University Medical Center
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Recipients in this EAP must meet all of the following criteria:
- Commercial Orca-T was prescribed to the patient by their treating physician.
- The final manufactured Orca-T does not meet the commercial release specifications or is delivered past expiry.
- The final manufactured Orca-T is acceptable per joint assessment by Orca Bio and the treating physician, taking into account Orca Bio's release criteria.
- Remanufacturing (ie, repeat leukapheresis and manufacturing) is not clinically appropriate per the treating physician's assessment.
- Recipient must be deemed medically fit and stable to receive Orca-T infusions per the treating physician's evaluation.
Exclusion Criteria:
Recipients with any medical condition identified by the treating physician that may impact the safety or outcomes of the recipient in relation to treatment with Orca-T will not be eligible.
学习计划
研究是如何设计的？
合作者和调查者
出版物和有用的链接
研究记录日期
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.