Study of Tisagenlecleucel in Combination With Ibrutinib in r/r Diffuse Large B-cell Lymphoma Patients

Inclusion Criteria

• Confirmed DLBCL as per the local histopathological assessment.
• Relapsed or refractory disease having received 2 or more lines of systemic therapy, including anti-CD20 and anthracycline based chemotherapy, and either having progressed after (or relapsed after) ASCT, or being ineligible for or not consenting to ASCT.
• Measurable disease at time of enrollment.
• Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening.
• Adequate renal, liver, and bone marrow, organ function, and minimum level of pulmonary reserve.

Exclusion Criteria

• Patients with Richter's transformation, Burkitt's lymphoma, and primary DLBCL of the CNS.
• Prior anti-CD19 directed therapy.
• Prior gene therapy.
• Prior adoptive T cell therapy.
• Prior ibrutinib therapy within the 30 days prior to screening.
• Patients with active CNS involvement are excluded, except if the CNS involvement has been effectively treated and provided that local treatment was > 4 weeks before enrollment.
• Prior allogeneic HSCT
• . Significant cardiac abnormality including history of myocardial infarction within 6 months prior to screening as detailed in the study protocol. Other eligibility criteria may apply.