DLBCL, PMBCL, TFL, HGBCL
Conditions
Interventions
KTE-C19 will be administered to achieve target dose of anti-CD19 CAR T cells 2.0 X 10^6 cells/kg. For a subject weighing > 100 kg, KTE-C19 will be administered to achieve the maximum fixed dose of 2.0
Sponsors
Aso Hiroya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who have been identified and manufactured to meet the requirements for treatment with commercially available axicabtagene ciloleucel. The product does not conform to the commercial product specification and cannot be shipped as a commercial product. However, the product conforms to the clinical trial product specification and the sponsor determines that the product can be diverted to the clinical trial product. 2)Patients for whom the principal investigator or the subinvestigator has assessed the patient's condition and disease, and determined that they cannot wait for remanufacturing of the product that meets the commercially available specifications from the re-leukocyte apheresis or from the excess PBMC frozen at the manufacturing site.
Exclusion criteria
Exclusion criteria: Patients for whom the principal investigator or the subinvestigator judged that participation in the clinical trial was inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate safety of non-standard commercial products based on adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate efficacy of the indication in the package insert based on objective response rate (ORR) and overall survival (OS) in patients with the indication on the package insert. To evaluate pharmacokinetics in vivo of KTE-C19. | — |
Contacts
Public ContactClinical Operations
Gilead Sciences, K.K.
Outcome results
None listed