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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
None (Open label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tisagenlecleucel+Pembrolizumab
  • Biological: Tisagenlecleucel
    Gene modified autologous T cells
    Other names:
    • CTL019
  • Drug: Pembrolizumab
    anti PD-1

More Details

Status
Completed
Sponsor
Novartis Pharmaceuticals

Study Contact