Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorKite, A Gilead Company
About this trial
The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.
Eligibility criteria
Qualifiers
Have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria
Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential)
Deemed medically fit and stable to receive the product per the investigator's evaluation
Repeat leukapheresis is not feasible per the investigator's assessment
Disqualifiers
History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel
Uncontrolled active infection or inflammation per physician assessment
Primary central nervous system lymphoma
Trial design
Treatments tested in this trial
- Axicabtagene Ciloleucel
Treatment groups
No treatment groups listed
Locations
128Japan
Aichi Medical University Hospital480-1195, Aichi Japan
Anjo Kosei Hospital446-8602, Aichi Japan
Nagoya City University Hospital467-8602, Aichi Japan
Nagoya Medical Center460-0001, Aichi Japan
Sponsors and collaborators
Kite, A Gilead Company
Lead sponsor
Source ClinicalTrials.gov