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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
Sponsor:
Information provided by (Responsible Party):
Juno Therapeutics, a Subsidiary of Celgene

Tracking Information
First Submitted Date May 20, 2020
First Posted Date May 22, 2020
Last Update Posted Date September 16, 2021
 
Descriptive Information
Brief Title Nonconforming Lisocabtagene Maraleucel Expanded Access Protocol
Brief Summary

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.
 
Recruitment Information
Expanded Access Status Available
Contacts
Contact: Catherine Balint, B.S 1- 908-673-9513 catherine.balint@bms.com
Contact: Sanjay Singh, B.S.( Pharm), MBA 1-908-337-7921 sanjay.singh@bms.com
Listed Location Countries Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04400591
Responsible Party Juno Therapeutics, a Subsidiary of Celgene
Study Sponsor Juno Therapeutics, a Subsidiary of Celgene
Collaborators Not Provided
Investigators
Study Director: Mecide Gharibo, MD Celegene/BMS
PRS Account Juno Therapeutics, a Subsidiary of Celgene
Verification Date September 2021