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Drug

Axicabtagene ciloleucel

Approved · EMA
ClassB-lymphocyte antigen CD19 binding agentEmerging researchLate-stage developmentSteady momentum

Also known as Axi-cel, Axicel, Yescarta, Autologous T cells transduced with retroviral vector encoding an anti-CD-19 CD28/CD3-zeta chimeric antigen receptor.

RxNorm1987398ChEMBLCHEMBL3989989ATCL01XL03UNIIU2I8T43Y7R
4
Research papers
22
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.

A Phase 2 Trial of Emapalumab for the Prevention of CAR-T Cell Associated Toxicities

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Study of Yescarta patients reveals genetic red flags for CAR-T therapy side effects

Research2026-07-24Research news · Fierce Biotech

A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy

Clinical trial2026-07-15Results expected Q2 2031 · ClinicalTrials.gov

Axicabtagene Ciloleucel in Relapsed or Refractory HIV-Associated Aggressive B-Cell Non-Hodgkin Lymphoma

Clinical trial2026-07-10Results expected Q1 2028 · ClinicalTrials.gov

Acalabrutinib in Combination With Anti-CD19 Chimeric Antigen Receptor T-Cells (CART) in B-Cell Lymphoma

Clinical trial2026-06-25Results posted · ClinicalTrials.gov

A Phase 2 Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma

Clinical trial2026-06-15Results expected Q3 2027 · ClinicalTrials.gov

A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel , an Autologous, Dual-targeting CD19/CD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting

Clinical trial2026-06-08Results expected Q4 2029 · ClinicalTrials.gov

A systematic review and meta-analysis of nonrelapse mortality after CAR T cell therapy.

Research2024-07-08Nature medicine

Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma.

Research2021-12-11The New England journal of medicine

CAR-HEMATOTOX: a model for CAR T-cell-related hematologic toxicity in relapsed/refractory large B-cell lymphoma.

Research2021-12-01Blood

Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial.

Research2018-12-02The Lancet. Oncology

Approval: Yescarta (EMA)

Regulatory2018-08-23EMA

Profile

Identifiers & mechanism

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

Canonical name
Axicabtagene ciloleucel
Aliases & brands
Axi-celAxicelYescartaAutologous T cells transduced with retroviral vector encoding an anti-CD-19 CD28/CD3-zeta chimeric antigen receptor
RxNorm CUI
1987398
ChEMBL ID
CHEMBL3989989
ATC codes
L01XL03
UNII
U2I8T43Y7R
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.

B-lymphocyte antigen CD19
CD19 · P15391
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: Yescarta (EMA)
Indication: Yescarta is indicated for the treatment of adult patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from… Show full indication

Yescarta is indicated for the treatment of adult patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. Yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) DLBCL and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy. Yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (FL) after three 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

40 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
40
registered trials across all phases
LATEST COMPLETION 2025
22
Active studies
16
Recruiting
9
Late-stage (III+)
12
Completed
6
Discontinued
PHASE DISTRIBUTIONn = 40
Phase 16Phase 1 / 23Phase 222Phase 35Phase 42Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Prospective Clinical Study of Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma

RecruitingPH IVZhengzhou Universityn=202027

Safety and Feasibility Study of Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting

CompletedPH IVVanderbilt-Ingram Cancer Centern=252023

A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel , an Autologous, Dual-targeting CD19/CD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting

RecruitingPH IIILyell Immunopharma, Inc.n=4002032

A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy

RecruitingPH IIIKite, A Gilead Companyn=5502031

An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel Versus Standard of Care Therapy as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-23)

Active, not recruitingPH IIIKite, A Gilead Companyn=3002031

Recent completions

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

A Phase 2 Open-Label, Multicenter Study Evaluating The Safety And Efficacy of Axicabtagene Ciloleucel Concomitant With Prophylactic Steroids In Subjects With Relapsed Or Refractory Large B-Cell Lymphoma In The Outpatient Setting

CompletedPH IIKite, A Gilead Companyn=352025

A Phase 1b Study Evaluating the Safety, Tolerability and Preliminary Anti-tumor Activity of NT-I7 (Efineptakin Alfa) a Long-acting Human IL-7, Post-Kymriah® (Tisagenlecleucel), Post-Yescarta® (Axicabtagene Ciloleucel), or Post-Breyanzi® (Lisocabtagene Maraleucel) in Subjects With Relapsed/Refractory Large B-cell Lymphoma

CompletedPH INeoImmuneTechn=172025

A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)

CompletedPH IIKite, A Gilead Companyn=1592024

A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)

CompletedPH IIIKite, A Gilead Companyn=3592024

A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity

CompletedPH IIMarcela V. Maus, M.D.,Ph.D.n=152024

Pilot Study of Anakinra to Mitigate CAR-T Toxicity in Subjects With Relapsed or Refractory Large B-Cell Lymphoma

CompletedPH IIM.D. Anderson Cancer Centern=222024

Research activity

4 papers

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

Publications over time
20192024
Major research themes4
Immunotherapy, Adoptive2Lymphoma1Multiple Myeloma1Receptors, Antigen, T-Cell1
Journals, researchers & institutions
Top journals
  • Blood1
  • Nature medicine1
  • The Lancet. Oncology1
  • The New England journal of medicine1
Leading researchers
  • Locke FL3
  • Farooq U2
  • Flinn IW2
  • Ghobadi A2
  • Jacobson CA2
  • Miklos DB2
  • Oluwole OO2
  • Perales MA2
Leading institutions
free-text, unnormalised
  • Dana-Farber Cancer Institute2
  • Moffitt Cancer Center2
  • and German Cancer Research Center1
  • Banner MD Anderson Cancer Center1
  • Brigham and Women's Hospital1
  • Broad Institute of Massachusetts Institute of Technology and Harvard1

Related diseases

1 conditions

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

Related drugs

4 matches

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

Tisagenlecleucel

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

Shared target8 shared diseases1 shared paper
Cyclophosphamide

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

3 shared diseases1 shared paper
Fludarabine

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

3 shared diseases1 shared paper
Vidarabine

Studied across 3 of the same disease areas as Axicabtagene ciloleucel 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.