Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients
PORTIA
Phase Ib Study of Tisagenlecleucel in Combination With Pembrolizumab in Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL) Patients.
2 other identifiers
interventional
12
3 countries
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2018
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2018
CompletedFirst Posted
Study publicly available on registry
August 14, 2018
CompletedStudy Start
First participant enrolled
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2021
CompletedAugust 15, 2022
August 1, 2022
2.8 years
August 1, 2018
August 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percent of participants recieving pembrolizumab per protocol schedule
21 days after first pembrolizumab infusion
Dose Timing part: Incidence of dose limiting toxicities (DLTs)
21 days after first pembrolizumab infusion
Expansion part: Overall response rate (ORR)
3 month post tisagenlecleucel infusion
Secondary Outcomes (6)
Duration of Response (DOR)
24 months
Progression Free Survival (PFS)
24 months
Overall Survival (OS)
24 months
In vivo cellular kinetics of tisagenlecleucel in blood, bone marrow, lymph nodes and other tissues by qPCR and flow cytometry
24 months
Impact of pembrolizumab dosing strategy on the cellular kinetics of tisagenlecleucel by qPCR and flow cytometry
24 months
- +1 more secondary outcomes
Study Arms (1)
Tisagenlecleucel+Pembrolizumab
EXPERIMENTALInterventions
Gene modified autologous T cells
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Emory University School of Medicine SC CTL019
Atlanta, Georgia, 30322, United States
University of Chicago Medical Center Hematology and Oncology
Chicago, Illinois, 60637, United States
University of Kansas Hospital and Medical Center U of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Novartis Investigative Site
Vienna, 1090, Austria
Novartis Investigative Site
Montreal, Quebec, H1T 2M4, Canada
Related Publications (2)
Jaeger U, Worel N, McGuirk JP, Riedell PA, Fleury I, Du Y, Han X, Pearson D, Redondo S, Waller EK. Safety and efficacy of tisagenlecleucel plus pembrolizumab in patients with r/r DLBCL: phase 1b PORTIA study results. Blood Adv. 2023 Jun 13;7(11):2283-2286. doi: 10.1182/bloodadvances.2022007779.
PMID: 36044388DERIVEDErnst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
PMID: 34515338DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Masking Details
- None (Open label)
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2018
First Posted
August 14, 2018
Study Start
October 9, 2018
Primary Completion
July 20, 2021
Study Completion
July 20, 2021
Last Updated
August 15, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share