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Expanded Access Study for the Treatment of Patients with Commercially Out-of-Specification Axicabtagene Ciloleucel

Primary Investigator
Ghosh, Monalisa
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT05776160
UM Number
2023.094
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Bone Marrow Transplant
ID (Protocol)
46795
Secondary Protocol No
HUM00241412
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Non-Hodgkin's Lymphoma
Summary
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: Inclusion Criteria
  •   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
  •   Be diagnosed with 1 of the approved labeled indications for axicabtagene ciloleucel that is intended for release
  •   In the investigator's opinion, there is no satisfactory alternative therapy available to the individual
Exclusion Criteria
  •   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