Nonconforming Lisocabtagene Maraleucel Expanded Access Protocol
ConditionLymphoma, Large B-Cell, Diffuse
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorJuno Therapeutics, a Subsidiary of Celgene
About this trial
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.
Eligibility criteria
Qualifiers
Subject and/or LAR must understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted.
Subject was prescribed lisocabtagene maraleucel (liso-cel) for a diagnosis that is approved per local prescribing information, per treating physician assessment.
Subject is ≥ 18 years of age at the time of signing the informed consent form.
Subject had a subject-specific batch of liso-cel manufactured intended for commercial treatment; however, the final manufactured product did not meet the local commercial release criteria.
Disqualifiers
Subject has a hypersensitivity to the active substance or to any of the excipients.
Subject should not experience a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of adverse events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming liso-cel.
Subject has any significant medical condition, laboratory abnormality, or psychiatric illness, sociologic or geographic condition that would prevent the subject from participating in the Expanded Access Protocol complying with protocol requirements in the Investigator's judgement.
Subject has any condition and/or laboratory abnormality that places the subject at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement
Trial design
Treatments tested in this trial
- Nonconforming Lisocabtagene Maraleucel
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov