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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000973-57 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tisagenlecleucel+Pembrolizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tisagenlecleucel | Biological | Gene modified autologous T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | 24 months | |
| Progression Free Survival (PFS) | 24 months | |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University School of Medicine SC CTL019 | Atlanta | Georgia | 30322 | United States | ||
| University of Chicago Medical Center Hematology and Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36044388 | Derived | 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. | |
| 34515338 | Derived |
| Label | URL |
|---|---|
| Novartis results database | View source |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000626284 | tisagenlecleucel |
| C582435 | pembrolizumab |
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None (Open label)
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| Pembrolizumab | Drug | anti PD-1 |
|
| 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 |
| Immunogenicity measured by antibody titres specific to tisagenlecleucel molecule and by the presence of T lymphocytes activated by the tisagenlecleucel protein | 24 months |
| 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 |
| Ernst 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. |
| A Plain Language Trial Summary is available on novctrd.com | View source |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |