An Expanded Access Program for Orca-T Products That Are Out of Specification for Commercial Release

Orca Biosystems, Inc.0 个研究点开始时间: 2026年1月16日最近更新: 2026年7月24日

适应症

试验速览

阶段: 不适用
状态: Available
发起方: Orca Biosystems, Inc.

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Expanded Access

入排标准

性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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.

研究者

发起方

Orca Biosystems, Inc.

申办方类型

Industry

责任方

Sponsor

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