All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
A multi-center, open-label, phase Ib study to evaluate the safety and efficacy of the administration of tisagenlecleucel in combination with pembrolizumab in patients with r/r DLBCL who have received 2 or more lines of systemic therapy, including an anti-CD20 and anthracycline based chemotherapy and having failed to or are not candidates for ASCT. The study will consist of 2 parts: dose timing selection part and expansion part.
Diffuse Large B-cell Lymphoma
Oct 09, 2018
Nov 15, 2023
18 Years and older (Adult, Older Adult)
Gene modified autologous T cells
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.
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.
Emory University School of Medicine SC CTL019
University of Chicago Medical Center Hematology and Oncology
University of Kansas Hospital and Medical Center U of Kansas Cancer Center
Kansas City, 66160
University of Pennsylvania Perelman School of Medicine