Drug · Cell Therapy

Tisagenlecleucel

CI-DRUG-00000593Explore in graph →NCIt C102758 CHEMBL3301574 CIViC Approved

Regulatory

Approvals (2)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory2 approval records from 2 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as KYMRIAH (DIN 02480514) under ATC L01XL04 TISAGENLECLEUCEL. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 24, 2019	health-canada-dpd
EU EMA	—	Kymriah is indicated for the treatment of: • Paediatric and young adult patients up to and including 25 years of age with B cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post transplant or in second or later relapse. • Adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy. • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.	approved	Aug 23, 2018	ema

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 14 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	9	4	5	41	2	CA, EU	Aug 23, 2018	Mar 17, 2010
Leukemia	Phase3	Phase 3	6	3	4	22	0	—	—	Mar 17, 2010
Non-Hodgkin Lymphoma	Phase3	Phase 3	5	3	2	20	0	—	—	Mar 17, 2010
Malignant Central Nervous System Neoplasm	Phase1	Phase 1	0	0	0	1	0	—

Curated evidence

Clinical evidence (1)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–1 of 1 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
CD19 delta-ex2, delta-ex5-61
Tisagenlecleucel

Clinical trials

Trials with this intervention (42)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–42 of 42 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04094311	Study of Out of Specification for Tisagenlecleucel	recruiting	Phase 3	200	Novartis PharmaceuticalsINDUSTRY	2	Sep 15, 2026	clinicaltrials
NCT06408194	Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies	recruiting	Phase 1	28	Stanford University

Molecule

Record

Kind: Cell Therapy
Mechanism: B-lymphocyte antigen CD19 binding agent
Targets: 1 gene
Aliases: Car.cd19-redirected t cells, CART-19, CART19, CTL 019, CTL-019, CTL019, CTL019 T-cells, Kymriah, Tisa-cel, Tisagenlecleucel, Tisagenlecleucel-t, Tisagenlecleucel-T

Data updated 22 hours agoSource updated unknown

Identifiers

Codes (4)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01XL04	TISAGENLECLEUCEL
DIN (Health Canada)	02480514	KYMRIAH
DPD drug code	97104