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 : November 22, 2021
|First Submitted Date||May 20, 2020|
|First Posted Date||May 22, 2020|
|Last Update Posted Date||November 22, 2021|
|Brief Title||Nonconforming Lisocabtagene Maraleucel Expanded Access Protocol|
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.
|Detailed Description||Not Provided|
|Study Type||Expanded Access|
|Expanded Access Type||Intermediate-size Population|
|Intervention||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
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Expanded Access Status||Available|
|Listed Location Countries||Japan, United States|
|Removed Location Countries|
|Responsible Party||Juno Therapeutics, a Subsidiary of Celgene|
|Study Sponsor||Juno Therapeutics, a Subsidiary of Celgene|
|PRS Account||Juno Therapeutics, a Subsidiary of Celgene|
|Verification Date||November 2021|