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

Phase Ib Study of Tisagenlecleucel in Combination With Pembrolizumab in Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL) Patients.

ClinicalTrials.gov Identifier: NCT03630159

Novartis Reference Number: CCTL019J2101

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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. 

Study Description

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.

Condition 
Diffuse Large B-cell Lymphoma
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
32 participants
Start date 
Oct 09, 2018
Completion date 
Nov 15, 2023
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Biological
Tisagenlecleucel
Gene modified autologous T cells
Drug
Pembrolizumab
anti PD-1

Eligibility Criteria

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.

Study Locations

United States
Emory University School of Medicine SC CTL019
Recruiting
Atlanta, 30322
Georgia
United States
University of Chicago Medical Center Hematology and Oncology
Recruiting
Chicago, 60637
Illinois
United States
University of Kansas Hospital and Medical Center U of Kansas Cancer Center
Recruiting
Kansas City, 66160
Kansas
United States
University of Pennsylvania Perelman School of Medicine
Recruiting
Philadelphia, 19104
Pennsylvania
United States
Austria
Novartis Investigative Site
Recruiting
Wien, 1090
-
Austria
Canada
Novartis Investigative Site
Recruiting
Montreal, H1T 2M4
Quebec
Canada
Germany
Novartis Investigative Site
Recruiting
Koeln, 50937
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]