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

  • Interventional
  • Recruiting
  • NCT03630159
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years and up

Accepting 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.

At a Glance

National Government IDNCT03630159

IRB#IRB18-0699

Lead SponsorNovartis Pharmaceuticals

Lead PhysicianPeter Riedell

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting