LGH 20424 Expanded Access Protocol (EAP) for Subjects Receiving Lisocabtagene Maraleucel that is Nonconforming for Commercial Release
Study of Expanded Access to Investigational Treatment for Medication Not Meeting All Standards
Brief description of study
This is an expanded access protocol that will be conducted at sites qualified and approved to treat subjects with lisocabtagene maraleucel. Sometimes when lisocabtagene maraleucel is manufactured the drug does not pass all the testing results to be called lisocabtagene maraleucel. The expanded access protocol will be used to allow subjects to receive nonconforming lisocabtagene maraleucel only if the potential benefit is better than the potential risk.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: 99 years or below
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Gender: All
TBD
This study investigates the use of investigational treatment for patients who receive a nonconforming version of a specific investigational medication. The purpose is to evaluate whether the potential benefits of using this nonconforming treatment outweigh the potential risks for patients.
Participants in this study will receive a nonconforming version of the investigational medication. The study is conducted at sites that are qualified and approved to provide this treatment, ensuring that all safety and procedural standards are met.
- Who can participate: Eligibility criteria are to be determined.
- Study details: Participants will receive a nonconforming version of the investigational medication under close supervision at approved sites.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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