Refractory or relapsed (relapse after transplant or relapse after medication in patients ineligible for transplant) diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL), transformed follicular lymphoma (TFL) or High-grade B cell lymphoma
Conditions
Interventions
investigational material(s)
Generic name etc : Anti-CD19 CAR T cells
INN of investigational material : axicabtagene ciloleucel
Therapeutic category code : --- Other
Dosage and Administration for Inves
Sponsors
Gilead Sciences K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject who satisfies all the criteria below will be enrolled in the study. 1)Histologically confirmed aggressive B-cell NHL (including the following types defined by the WHO 2016) i)DLBCL a)DLBCL, NOS - Germinal center B-cell lymphoma - Activated B-cell lymphoma b)Intravascular large B-cell lymphoma c)T-cell/histiocyte-rich large B-cell lymphoma d)DLBCL associated with chronic inflammation e)Epstein-Barr virus (EBV)positive diffuse large B-cell lymphoma, NOS ii)PMBCL iii)TFL iv)High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement v)High-grade B-cell lymphoma, NOS 2)Chemotherapy-refractory disease, defined as one or more of the following: i)No response to first-line therapy (primary refractory disease); subjects who are intolerant to first-line therapy chemotherapy are excluded a)Progressive Disease (PD) as best response to first-line therapy b)Stable Disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP) with SD duration no longer than 6 months from last dose of therapy ii)No response to second or greater lines of therapy a)PD as best response to most recent therapy regimen b)SD as best response after at least 2 cycles of last line of therapy with SD duration no longer than 6 months from last dose of therapy iii)Relapsed post-ASCT a)Disease progression or relapsed =< 12 months of ASCT (must have biopsy proven relapse in relapsed subjects) b)if salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy (must have biopsy proven recurrence in relapsed subjects) 3)Subjects must have received at least the following therapy: i)Anti-CD20 monoclonal antibody (unless the investigator or subinvestigator determines that tumor is CD20 negative) ii)An anthracycline containing chemotherapy regimen; iii)Prior chemotherapy for follicular lymphoma for subjects with transformed TFL (subsequently have a chemorefractory disease after transformation to DLBCL) 4)At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
Exclusion criteria
Exclusion criteria: A patient who meets any of the following criteria is not eligible. 1)History of malignancy within the past 3 years (patients with skin cancer [except for melanoma] or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma are eligible even with a history within 3 years) 2)History of Richter's transformation of CLL 3)Autologous stem cell transplant within 6 weeks of planned KTE-C19 infusion 4)History of allogeneic stem cell transplant 5)Prior CD19 targeted therapy (except for subjects who are eligible for re-treatment of KTE-C19 in this study) 6)Prior CAR T cell therapy or other genetically modified T cell therapy (except for subjects who are eligible for re-treatment of KTE-C19 in this study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - ORR (percentage of patients judged CR or PR) assessed by the investigator or subinvestigator based on the criteria of the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma (Cheson 2007) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory pharmacokinetics other - ORR assessed by the central image evaluation organization - DOR - PFS - OS | — |
Countries
Japan
Contacts
Public ContactClinical Operations
Gilead Sciences, K.K.
Outcome results
None listed