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Nonconforming Lisocabtagene Maraleucel Expanded Access Protocol

NCT04400591 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-12-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Juno Therapeutics, a Subsidiary of Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04400591 on ClinicalTrials.gov