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

Inclusion Criteria:

- Confirmed DLBCL per local histopathology assessment.

- Relapsed or refractory disease after having recieved 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 not candidates for or not
consenting to ASCT.

- Measurable disease at time of enrollment

- ECOG performance status that is either 0 or 1 at screening.

Exclusion Criteria:

- Patients with Richter's transformation, and Burkitt lymphoma, and primary DLBCL of
CNS.

- Prior treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19
therapy.

- 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.

- Unstable angina and/or myocardial infarction and/or coronary artery bypass graft
(CABG), or stroke within 6 months prior to screening, and/or impaired cardiac function
or clinically significant cardiac disease

- Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2,
anti-CTLA-4 antibodies, other immune checkpoint inhibitors.

- History of interstitial lung disease or (non-infectious) pneumonitis that required
oral or intravenous steroids (other than COPD exacerbation) or current pneumonitis.

Other protocol-defined inclusion/exclusion criteria may apply.