Sponsor Overview
Explore verified public information about Lion TCR's expanded access programs, compassionate use policies, and patient eligibility pathways. This report aggregates official statements, independent research, and regulatory data to help patients, providers, and sponsors collaborate efficiently.
Unique references curated across 1 content categories.
ClinicalTrials.gov data sources power this status.
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Expanded Access Intelligence
Official Statements
Score contribution: 100 — 4 supporting sources.
“There may, however, be circumstances when patients who are seriously ill have exhausted all available treatment and are not be eligible for our clinical trials. In those cases, patients may be eligible for treatment with an investigational therapy through programs referred to as ‘Expanded Access Programs’ (EAPs) or ‘compassionate use’. For our EAP, please click here for more information.”
“There may, however, be circumstances when patients who are seriously ill have exhausted all available treatment and are not be eligible for our clinical trials. In those cases, patients may be eligible for treatment with an investigational therapy through programs referred to as ‘Expanded Access Programs’ (EAPs) or ‘compassionate use’. For our EAP, please click [here](https://drive.google.com/file/d/1d9bjsBW4w7WpsBFcXEZT8fwd8OvB8GAx/view?usp=sharing) for more information.”
“在某些情况下，重病患者已经用尽了所有可用的治疗方法，而没有资格参加我们的临床试验。在这些情况下，患者可通过称为 “扩大使用计划” 或 “同情性用药” 接受研究性治疗。请 [单击此处](https://drive.google.com/file/d/1d9bjsBW4w7WpsBFcXEZT8fwd8OvB8GAx/view?usp=sharing) 以了解更多关于我们产品的扩大使用政策信息。”
“在某些情况下，重病患者已经用尽了所有可用的治疗方法，而没有资格参加我们的临床试验。在这些情况下，患者可通过称为 “扩大使用计划” 或 “同情性用药” 接受研究性治疗。请 [单击此处](https://drive.google.com/file/d/1d9bjsBW4w7WpsBFcXEZT8fwd8OvB8GAx/view?usp=sharing) 以了解更多关于我们产品的扩大使用政策信息。”
Reagan-Udall Foundation Insights
Single-Patient EA Policies/Criteria SCOPE This policy applies to provision of access to Lion TCR’s investigational product(s) that is not approved for any purpose in the country from which the request is intended to be used. This also includes the time period between regulatory approval of an investigational product and its commercial availability in a country. POLICY STATEMENTS Any use of Lion TCR’s investigational product(s) outside a clinical study in a country must be in accordance with local laws and regulations governing such programs, including our policies and procedures. In general, where permitted by local regulation, the investigational product supplied via Expanded Access may no longer be provided by Lion TCR when it becomes available via the local healthcare system. Lion TCR may decide not to provide an investigational product under this policy if the Company does not intend to market the product in the country. A treating physician, who is able to comply with the requirements that are stated in this document, may request information about how to apply for access to Lion TCR's investigational products by contacting the Company at clinicaltrials@liontcr.com . We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 5 business days after receipt. Lion TCR is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician; Lion TCR may require more detailed information in order to fully evaluate a request. Requests will be considered on a case-by-case basis. Lion TCR will consider providing a requesting physician with pre-approval access to a specific investigational drug outside of a clinical trial, when the following conditions are met: A. Patient Eligibility Criteria To be eligible for access to an investigational product, patients must meet the following criteria: B. Investigational Product Criteria In addition to the patient eligibility requirements, the investigational product must meet the following criteria: C. Treating Physician Criteria and Responsibilities The physician(s) attending to the patient(s) who is/are receiving an investigational product through compassionate use access is (are) properly licensed and fully qualified to administer the product. The physician must agree in writing to comply with: Available Therapies via Single-Patient EA LioCyx-M for hepatocellular carcinoma Disease/Category-Specific EA Policies/Criteria https://drive.google.com/file/d/1d9bjsBW4w7WpsBFcXEZT8fwd8OvB8GAx/view
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