# Lisocabtagene maraleucel

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

## TL;DR

Lisocabtagene maraleucel is the only CAR-T approved for chronic lymphocytic leukaemia, for patients whose disease has outrun both BTK and BCL-2 inhibitors.

## Summary

TRANSCEND CLL 004: in CLL/SLL after BTK and venetoclax failure, CR/CRi 18-20%, ORR 47%, uMRD in blood 64%, durable in complete responders; accelerated approval March 2024. Also approved in LBCL (second line, TRANSFORM), follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma (2025). Defined 1:1 CD4:CD8 composition; 4-1BB costimulation. Lower CRS/ICANS than CD28-based products.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Breyanzi
- Code: liso-cel
- Modality: CAR-T (CD19, defined CD4:CD8)
- Mechanism: Autologous CD19 CAR-T (4-1BB) manufactured as separate CD4 and CD8 components and infused at a fixed ratio.
- Approvals: US 2021: Relapsed/refractory LBCL after ≥2 lines; US 2022: Second-line LBCL (TRANSFORM); US 2024: Relapsed/refractory CLL/SLL after BTK inhibitor and BCL-2 inhibitor (accelerated)
- Dosing: Single IV infusion (two components); 90-110 × 10^6 CAR+ T cells (CLL)
- Toxicity (grade 3+): Cytokine release syndrome 9%; Neurotoxicity 20%; Prolonged cytopenias 54%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Lisocabtagene_maraleucel
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Lisocabtagene%20maraleucel

## Connected records

- cancers: [Chronic lymphocytic leukaemia](https://onco.cc/cancers/cll/), [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/), [Follicular lymphoma](https://onco.cc/cancers/follicular-lymphoma/), [Mantle cell lymphoma](https://onco.cc/cancers/mantle-cell-lymphoma/), [Marginal zone lymphoma](https://onco.cc/cancers/marginal-zone-lymphoma/), [Primary mediastinal (thymic) large B-cell lymphoma](https://onco.cc/cancers/primary-mediastinal-b-cell-lymphoma/), [Relapsed or refractory chronic lymphocytic leukaemia](https://onco.cc/cancers/cll-relapsed/)
- 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/), [CD28](https://onco.cc/targets/cd28/)
- companies: [Bristol Myers Squibb](https://onco.cc/companies/bms/)
- terms: [BTK C481S, PLCG2 and BCL2 G101V resistance mutations](https://onco.cc/terms/btki-bcl2i-resistance-mutations/), [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/), [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 Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma](https://onco.cc/trials/nct07015242/), [TRANSCEND CLL 004](https://onco.cc/trials/transcend-cll-004/), [TRANSCEND NHL 001](https://onco.cc/trials/transcend-nhl-001/)
- key papers: [Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study](https://onco.cc/key-papers/paper-transcend-nhl-001-liso-cel-lancet-2020/), [TRANSFORM: liso-cel CAR-T versus salvage chemotherapy and transplant in early-relapsing large B-cell lymphoma](https://onco.cc/key-papers/paper-transform-liso-cel-lancet-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/)
- 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: [Stanley R. Riddell](https://onco.cc/people/stanley-riddell/)
- biomarkers: [CD19 expression (CD19-positive)](https://onco.cc/biomarkers/cd19-expression/)

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