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.
Title
- Brief Title: Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients
- Official Title: Phase Ib Study of Tisagenlecleucel in Combination With Pembrolizumab in Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL) Patients.
Clinical Trial IDs
- ORG STUDY ID:
CCTL019J2101
- SECONDARY ID:
2018-000973-57
- NCT ID:
NCT03630159
Conditions
- Diffuse Large B-cell Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Tisagenlecleucel | CTL019 | Tisagenlecleucel+Pembrolizumab |
Pembrolizumab | | Tisagenlecleucel+Pembrolizumab |
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Tisagenlecleucel+Pembrolizumab | Experimental | | - Tisagenlecleucel
- Pembrolizumab
|
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Percent of participants recieving pembrolizumab per protocol schedule |
Time Frame: | 21 days after first pembrolizumab infusion |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Duration of Response (DOR) |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Progression Free Survival (PFS) |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | In vivo cellular kinetics of tisagenlecleucel in blood, bone marrow, lymph nodes and other tissues by qPCR and flow cytometry |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Impact of pembrolizumab dosing strategy on the cellular kinetics of tisagenlecleucel by qPCR and flow cytometry |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Immunogenicity measured by antibody titres specific to tisagenlecleucel molecule and by the presence of T lymphocytes activated by the tisagenlecleucel protein |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- Lymphoma tisagenlecleucel
- Diffuse Large B-cell Lymphoma
- CTL019
- PORTIA
- DLBCL
- tisagenlecleucel
- pembrolizumab
- r/r Diffuse large B-cell Lymphoma
- relapsed/refractory Diffuse large B-cell Lymphoma
Last Updated
June 22, 2021