Ozmosi | Tisagenlecleucel Drug Profile
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Tisagenlecleucel

Pronounced as: tih-suh-gen-leh-KLOO-sel

Alternative Names: tisagenlecleucel, ctl-019, ctl019, ctl 019, Kymriah
Clinical Status: Active
Latest Update: 2026-07-02
Latest Update Note: Clinical Trial Update

Product Description

a CD19 CAR T-cell therapy for the treatment of patients with relapsed/refractory large B cell lymphoma (r/r LBCL). (Sourced from: http://neoimmunetech.com/news/page01_view.html?number=55)

Mechanisms of Action: CAR-T, CD19

Novel Mechanism: No

Modality: Autologous CAR-T

Route of Administration: Intravenous

FDA Designation: *

Approval Status: Approved

Approved Countries: Australia | Austria | Belgium | Brazil | Canada | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Korea | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Romania | Saudi Arabia | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | United Kingdom | United States

Approved Indications: None

Company: Novartis
Company Location: Europe
Company Founding Year: 1996
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Tisagenlecleucel

Countries in Clinic: Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Romania, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States, Unknown Location

Active Clinical Trial Count: 19

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Acute Lymphoid Leukemia|B-Cell Leukemia|B-Cell Marginal Zone Lymphoma|Burkitt Lymphoma|Diffuse Large B-Cell Lymphoma|Follicular Lymphoma|Inflammation|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|T-Cell Lymphoma

Phase 2: Leukemia|Mantle-Cell Lymphoma

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

JapicCTI-194897

JapicCTI-194897

P3

Active

Diffuse Large B-Cell Lymphoma|B-Cell Marginal Zone Lymphoma|Inflammation|Follicular Lymphoma|T-Cell Lymphoma

2025-10-03

2015-003736-13

2015-003736-13

P2

Active, not recruiting

Lymphoma, B-Cell|Leukemia

2027-09-04

2025-06-18

Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status

NCT04234061

TARMAC

P2

Active, not recruiting

Mantle-Cell Lymphoma

2027-09-01

2021-10-22

Primary Endpoints|Treatments|Trial Status

NCT05888493

LEDA

P3

Active, not recruiting

Follicular Lymphoma

2028-07-25

11%

2026-02-18

Patient Enrollment|Primary Endpoints|Study Completion Date|Treatments|Trial Status

NCT04094311

CCTL019B2302

P3

Recruiting

Diffuse Large B-Cell Lymphoma|Burkitt Lymphoma|B-Cell Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma

2027-03-31

59%

2026-02-18

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments

2023-508343-48-00

CCTL019H2301

P3

Active, not recruiting

Lymphoma, B-Cell|Lymphoma, Non-Hodgkin

2026-02-14

61%

2025-05-02

Treatments

2017-002849-30

2017-002849-30

P2

Active, not recruiting

B-Cell Leukemia|Lymphoma, B-Cell

2023-02-23

2022-03-13

Treatments

2017-005019-15

BIANCA

P2

Active, not recruiting

Lymphoma, Non-Hodgkin|Lymphoma, B-Cell

2022-10-08

2025-05-06

Treatments

2023-503452-27-00

CCTL019E2301

P3

Recruiting

Lymphoma, Non-Hodgkin|Lymphoma, B-Cell|Follicular Lymphoma

2031-02-20

11%

2025-05-02

Treatments

CTR20200561

CTR20200561

P3

Completed

Lymphoma, B-Cell|Lymphoma, Non-Hodgkin

2026-02-03

2026-02-15

Patient Enrollment|Primary Completion Date|Study Completion Date|Treatments|Trial Status

JapicCTI-194988

JapicCTI-194988

P3

Active

Diffuse Large B-Cell Lymphoma|Acute Lymphoid Leukemia|B-Cell Leukemia|Follicular Lymphoma

2022-06-30

JapicCTI-194622

JapicCTI-194622

P3

Planned

B-Cell Leukemia|Acute Lymphoid Leukemia

None

NCT07676877

OSU-25255

P1

Not yet recruiting

Diffuse Large B-Cell Lymphoma

2027-12-31

12%

2026-07-01

Primary Endpoints

jRCT1080224903

jRCT1080224903

P3

Recruiting

Follicular Lymphoma|Diffuse Large B-Cell Lymphoma

None

NCT04890236

DEEP T CELLS

P1

Completed

Diffuse Large B-Cell Lymphoma

2024-03-20

2025-01-22

Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status

2023-508081-15-00

CCTL019G2201J

P2

Active, not recruiting

Acute Lymphoid Leukemia|B-Cell Leukemia

2028-08-30

2025-05-02

Treatments

NCT03876769

CASSIOPEIA

P2

Active, not recruiting

Acute Lymphoid Leukemia|Lymphoma, B-Cell|Burkitt Lymphoma|B-Cell Leukemia

2027-10-19

47%

2026-06-04

NCT05460533

REFUEL

P2

Active, not recruiting

B-Cell Leukemia|Acute Lymphoid Leukemia|Burkitt Lymphoma|Lymphoma, B-Cell

2027-07-01

12%

2026-02-05

Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status

2023-508127-13-00

CCTL019E2202

P2

Completed

Follicular Lymphoma

2025-03-27

2025-05-02

Treatments