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Nonconforming Lisocabtagene Maraleucel Expanded Access Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04400591
Expanded Access Status : Available
First Posted : May 22, 2020
Last Update Posted : November 22, 2021
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 November 22, 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 Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status Available
Contact: Catherine Balint, B.S 1- 908-673-9513
Contact: Sanjay Singh, B.S.( Pharm), MBA 1-908-337-7921
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
Study Director: Mecide Gharibo, MD Celegene/BMS
PRS Account Juno Therapeutics, a Subsidiary of Celgene
Verification Date November 2021