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Drug

Tisagenlecleucel

Approved · EMA
ClassB-lymphocyte antigen CD19 binding agentEmerging researchLate-stage developmentSteady momentum
Also known as Adoptive immunotherapy agent CTL019, CAR.CD19-Redirected T cells, Kymriah, Tisagenlecleucel-T+1 more

Adoptive immunotherapy agent CTL019, CAR.CD19-Redirected T cells, Kymriah, Tisagenlecleucel-T, tisagenlecleusel.

4
Research papers
6
Active clinical trials
B-lymphocyte antigen CD19
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Chimeric Antigen Receptor (CAR)-T Cell Therapy for Patients With Hematologic Malignancies

Clinical trial2026-01-23Results posted · ClinicalTrials.gov

Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma.

Research2018-12-01The New England journal of medicine

Approval: Kymriah (EMA)

Regulatory2018-08-23EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Tisagenlecleucel
Aliases & brands
Adoptive immunotherapy agent CTL019CAR.CD19-Redirected T cellsKymriahTisagenlecleucel-Ttisagenlecleusel
RxNorm CUI
1986438
ChEMBL ID
CHEMBL3301574
ATC codes
L01XL04
UNII
Q6C9WHR03O
Primary mechanism
B-lymphocyte antigen CD19 binding agent
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

BINDING AGENTB-lymphocyte antigen CD19 binding agent

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2018-08-23
Latest approval
2018-08-23
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2018-08-23Approval
Approval: Kymriah (EMA)
Indication: 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 isShow full indication

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.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

20 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
20
registered trials across all phases
LATEST COMPLETION 2025
6
Active studies
3
Recruiting
2
Late-stage (III+)
8
Completed
6
Discontinued
PHASE DISTRIBUTIONn = 20
Early Phase 11Phase 17Phase 1 / 21Phase 29Phase 32

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20182021
Major research themes2
Immunotherapy, Adoptive1Receptors, Antigen, T-Cell1
Journals, researchers & institutions
Top journals
  • The New England journal of medicine2
  • Blood1
  • Journal of hematology & oncology1
Leading researchers
  • Grupp SA2
  • Salles G2
  • Ackermann J1
  • Anak Ö1
  • Andreadis C1
  • Awasthi R1
  • Ayuk F1
  • Bachanova V1
Leading institutions
free-text, unnormalised
  • Abramson Cancer Center1
  • and German Cancer Research Center1
  • Center for Childhood Cancer Research and Cancer Immunotherapy Program1
  • Children's Hospital of Philadelphia1
  • Institute for Medical Informatics1
  • Laboratory for Translational Cancer Immunology1

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Acts on the same molecular target as Tisagenlecleucel, with 8 overlapping disease areas.

Shared target8 shared diseases1 shared paper

Studied across 3 of the same disease areas as Tisagenlecleucel in the shared literature.

3 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.