NCT04400591

Nonconforming Lisocabtagene Maraleucel Expanded Access Protocol

Expanded Access Protocol (EAP) For Subjects Receiving Lisocabtagene Maraleucel That Is Nonconforming For Commercial Release

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Juno Therapeutics, a Subsidiary of Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Lymphoma, Large B-Cell, Diffuse

Interventions

Type	Name	Description
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.

Timeline

• First posted: 2020-05-22
• Last updated: 2025-12-11