NCT03630159 (PORTIA) is a Phase 1 clinical trial of Tisagenlecleucel in Diffuse Large B-cell Lymphoma, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT03630159?

NCT03630159 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT03630159?

Interventions in NCT03630159: Tisagenlecleucel, Pembrolizumab.

What condition does NCT03630159 study?

NCT03630159 studies Diffuse Large B-cell Lymphoma.

Is NCT03630159 still recruiting?

NCT03630159 is currently completed. Last updated 15 August 2022.

Last reviewed 2022-08-15 · How we verify

NCT03630159: PORTIA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 15 August 2022

What this trial tests

Phase 1 trial testing Tisagenlecleucel in Diffuse Large B-cell Lymphoma in 12 participants. Completed in 20 July 2021.

Timeline

9 October 2018

Primary endpoint
20 July 2021

20 July 2021

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	9 October 2018
Primary completion	20 July 2021
Estimated completion	20 July 2021
Sites	5 locations across Austria, Canada, United States

Drugs / interventions tested

Tisagenlecleucel (TISAGENLECLEUCEL) — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

Diffuse Large B-cell Lymphoma — all drugs for Diffuse Large B-cell Lymphoma →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Diffuse Large B-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Exploring treatment options in cancer: Tumor treatment strategies.
Liu B, Zhou H, Tan L, Siu KTH, et al · · 2024 · cited 536× · PMID 39013849 · DOI 10.1038/s41392-024-01856-7
Current status and perspective of CAR-T and CAR-NK cell therapy trials in Germany.
Albinger N, Hartmann J, Ullrich E. · · 2021 · cited 171× · PMID 33753909 · DOI 10.1038/s41434-021-00246-w
Efficacy and safety of CD19-directed CAR-T cell therapies in patients with relapsed/refractory aggressive B-cell lymphomas: Observations from the JULIET, ZUMA-1, and TRANSCEND trials.
Westin JR, Kersten MJ, Salles G, Abramson JS, et al · · 2021 · cited 163× · PMID 34310745 · DOI 10.1002/ajh.26301
CAR T-cell therapy for B-cell lymphomas: clinical trial results of available products.
Chavez JC, Bachmeier C, Kharfan-Dabaja MA. · · 2019 · cited 163× · PMID 31019670 · DOI 10.1177/2040620719841581
Pembrolizumab for B-cell lymphomas relapsing after or refractory to CD19-directed CAR T-cell therapy.
Chong EA, Alanio C, Svoboda J, Nasta SD, et al · · 2022 · cited 148× · PMID 34496014 · DOI 10.1182/blood.2021012634
Immune checkpoint blockade and CAR-T cell therapy in hematologic malignancies.
Wang H, Kaur G, Sankin AI, Chen F, et al · · 2019 · cited 138× · PMID 31186046 · DOI 10.1186/s13045-019-0746-1
Advances in targeted therapy for malignant lymphoma.
Wang L, Qin W, Huo YJ, Li X, et al · · 2020 · cited 88× · PMID 32296035 · DOI 10.1038/s41392-020-0113-2
CAR-T cell therapy for cancer: current challenges and future directions.
Zugasti I, Espinosa-Aroca L, Fidyt K, Mulens-Arias V, et al · · 2025 · cited 81× · PMID 40610404 · DOI 10.1038/s41392-025-02269-w

Verify or expand the search:

Other trials of Tisagenlecleucel

Trials testing the same drug.

NCT06785818 — Long-term Follow up Local Registry Study of Kymriah in South Korea · recruiting
NCT05888493 — A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphom · Phase 3 · active not recruiting
NCT05633615 — Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma · Phase 2 · recruiting
NCT04456023 — Study of Tisagenlecleucel in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-cell Non-Hodgkin Lymphom · Phase 2 · withdrawn
NCT04890236 — Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Recurrent or Refractory Diffuse Large B-Cell L · EARLY_PHASE1 · completed

Other recruiting trials for Diffuse Large B-cell Lymphoma

Currently open trials in the same condition.

NCT06977711 — Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large · Phase 1 · recruiting
NCT06846463 — Zanubrutinib in Patients With DLBCL and MYD88 or NOTCH1 Mutation or CD5+ · Phase 2 · recruiting
NCT06870487 — A Study to Learn About the Study Medicine Called PF-08046032 in People With Advanced Cancers · Phase 1 · active not recruiting
NCT06651853 — Large Fraction Radiation Therapy Combined With Lenalidomide, and Glofitamab in Refractory Relapsed DLBCL · Phase 2 · recruiting
NCT06503263 — Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL · Phase 2 · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03630159 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 15 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03630159.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing