# Tisagenlecleucel

Source: https://onco.cc/drugs/tisagenlecleucel/  
OnCo record `tisagenlecleucel` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Tisagenlecleucel was the first CAR-T therapy ever approved (2017), for children and young adults whose leukaemia had come back after everything else.

## Summary

ELIANA (n=75 infused, age ≤25): ORR 81% within 3 months, 12-month OS 76%, 5-year EFS ~44% in responders without further therapy (2023 update). Approved 30 August 2017 for relapsed/refractory B-ALL up to age 25; later for DLBCL and follicular lymphoma. 4-1BB costimulation gives long persistence; CD19-negative relapse is the main failure mode. Emily Whitehead, treated in 2012, remains in remission.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Kymriah
- Code: CTL019
- Modality: CAR-T (CD19)
- Mechanism: Autologous T cells transduced with a lentiviral CD19 scFv-4-1BB-CD3ζ CAR; expand in vivo and kill CD19+ blasts.
- Approvals: US 2017: Relapsed/refractory B-ALL, patients up to 25 years; US 2018: Relapsed/refractory DLBCL; US 2022: Relapsed/refractory follicular lymphoma
- Dosing: Single IV infusion; 0.2-5.0 × 10^6 CAR+ cells/kg (≤50 kg) or 0.1-2.5 × 10^8 (>50 kg) after lymphodepletion
- Toxicity (grade 3+): Cytokine release syndrome 46%; Neurotoxicity (ICANS) 13%; Prolonged cytopenias 32%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Tisagenlecleucel
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Tisagenlecleucel

## Connected records

- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [Childhood cancers (all types)](https://onco.cc/cancers/childhood-cancers/), [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/), [Follicular lymphoma](https://onco.cc/cancers/follicular-lymphoma/), [High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL)](https://onco.cc/cancers/all-paediatric-high-risk/), [Infant acute lymphoblastic leukaemia (KMT2A-rearranged, under one year)](https://onco.cc/cancers/all-infant/), [Leukaemia (all types)](https://onco.cc/cancers/leukaemia/), [Philadelphia chromosome-like acute lymphoblastic leukaemia (Ph-like or BCR::ABL1-like ALL)](https://onco.cc/cancers/all-ph-like/), [Philadelphia chromosome-positive acute lymphoblastic leukaemia in children (Ph-positive ALL)](https://onco.cc/cancers/all-paediatric-ph-positive/), [Relapsed and refractory acute lymphoblastic leukaemia in children](https://onco.cc/cancers/all-paediatric-relapsed/), [Standard-risk B-cell acute lymphoblastic leukaemia in children](https://onco.cc/cancers/all-paediatric-standard-risk/)
- technologies: [Autologous CAR-T manufacturing, batch by batch](https://onco.cc/technologies/car-t-manufacturing-process/), [CAR-T cell therapy](https://onco.cc/technologies/car-t/)
- targets: [CD19](https://onco.cc/targets/cd19/)
- companies: [Novartis](https://onco.cc/companies/novartis/)
- terms: [Cytokine release syndrome (CRS)](https://onco.cc/terms/crs/), [Cytokine release syndrome and ICANS: grading and management](https://onco.cc/terms/lymphoma-tx-crs-icans/), [ICANS (neurotoxicity)](https://onco.cc/terms/icans/), [Immunoglobulin replacement after CAR-T, bispecifics and long anti-CD20 treatment](https://onco.cc/terms/lymphoma-tx-immunoglobulin-replacement/), [Lymphoma treatments that did not work: the negative trials worth knowing](https://onco.cc/terms/lymphoma-tx-failed-and-negative/), [POD24: progression of follicular lymphoma within two years, and why it changes the plan](https://onco.cc/terms/lymphoma-tx-pod24/), [The CAR-T pathway in lymphoma: referral, apheresis, bridging and the waiting](https://onco.cc/terms/lymphoma-tx-car-t-pathway/), [What the NHS in England funds for lymphoma, appraisal by appraisal](https://onco.cc/terms/lymphoma-tx-uk-access/)
- trials: [A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma](https://onco.cc/trials/nct05888493/), [ELARA](https://onco.cc/trials/elara/), [ELIANA](https://onco.cc/trials/eliana/), [JULIET](https://onco.cc/trials/juliet/), [Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients](https://onco.cc/trials/nct03876769/), [Study of Out of Specification for Tisagenlecleucel](https://onco.cc/trials/nct04094311/)
- key papers: [ELIANA: the global trial that made tisagenlecleucel the first approved CAR-T therapy for children and young adults with relapsed ALL](https://onco.cc/key-papers/paper-eliana-tisagenlecleucel-nejm-2018/), [JULIET: tisagenlecleucel for adults with relapsed or refractory diffuse large B-cell lymphoma](https://onco.cc/key-papers/paper-juliet-tisagenlecleucel-dlbcl-nejm-2019/), [Maude 2014: CD19 CAR-T cells produce complete remission in 27 of 30 children and adults with relapsed ALL](https://onco.cc/key-papers/paper-maude-ctl019-all-nejm-2014/), [Second-line tisagenlecleucel or standard care in aggressive B-cell lymphoma](https://onco.cc/key-papers/paper-belinda-tisagenlecleucel-second-line-nejm-2022/), [Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial](https://onco.cc/key-papers/paper-elara-tisagenlecleucel-follicular-nat-med-2022/)
- roadmaps: [Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting](https://onco.cc/roadmaps/lymphoma-roadmap/), [Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first](https://onco.cc/roadmaps/paediatric-oncology-roadmap/)
- ideas: [Report the time from apheresis to infusion as a trial endpoint, not a logistics footnote](https://onco.cc/ideas/lymphoma-ev-manufacturing-time-as-a-trial-endpoint/)
- people: [Carl H. June](https://onco.cc/people/carl-june/), [David L. Porter](https://onco.cc/people/david-porter/), [Emily Whitehead](https://onco.cc/people/emily-whitehead/), [Sherry Lansing](https://onco.cc/people/sherry-lansing/)
- bottlenecks: [Manufacturing cost and time for living and radioactive medicines](https://onco.cc/bottlenecks/b-manufacturing-cell-therapy/), [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/)
- institutions: [Children's Hospital of Philadelphia](https://onco.cc/institutions/chop/)
- drugs: [Talicabtagene autoleucel](https://onco.cc/drugs/talicabtagene-autoleucel/), [Tocilizumab](https://onco.cc/drugs/tocilizumab/), [Varnimcabtagene autoleucel](https://onco.cc/drugs/varnimcabtagene-autoleucel/)
- biomarkers: [CD19 expression (CD19-positive)](https://onco.cc/biomarkers/cd19-expression/)

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