Nonconforming Lisocabtagene Maraleucel Expanded Access Protocol
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|ClinicalTrials.gov Identifier: NCT04400591|
Expanded Access Status : Available
First Posted : May 22, 2020
Last Update Posted : September 16, 2021
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. When this happens the drug is called nonconforming 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. This expanded access protocol is restricted to those subjects who were prescribed lisocabtagene maraleucel as part of their routine care.
Subjects will first receive a lymphodepleting chemotherapy regimen and then be treated with nonconforming lisocabtagene maraleucel as the treatment plan.
|Condition or disease||Intervention/treatment|
|Lymphoma, Large B-Cell, Diffuse||Biological: Nonconforming Lisocabtagene Maraleucel|
|Study Type :||Expanded Access|
|Expanded Access Type :||Intermediate-size Population|
|Official Title:||Expanded Access Protocol (EAP) of Subjects Receiving Nonconforming Lisocabtagene Maraleucel That is Out of Specification (OOS) for Commercial Release|
- Biological: Nonconforming Lisocabtagene Maraleucel
Nonconforming lisocabtagene maraleucel is lisocabtagene maraleucel that does not meet the commercial release specifications, however is deemed acceptable to administer as an investigational product in the Expanded Access Protocol setting.Other Name: JCAR017
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400591
|Contact: Catherine Balint, B.S||1- email@example.com|
|Contact: Sanjay Singh, B.S.( Pharm), MBAfirstname.lastname@example.org|
|Study Director:||Mecide Gharibo, MD||Celegene/BMS|