Axicabtagene Ciloleucel
Cell therapy targets CD19, CD22, CD7
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Yescarta | — | 2018-08-23 | europa.eu ↗ |
Trials 51 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 17 trials
Press releases naming this drug 153 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-06 | Kite, A Gilead Company | FDA Approves Label Update for Kite’s Yescarta® for Relapsed/Refractory Primary Central Nervous System Lymphoma kitepharma.com ↗ |
| 2026-02-06 | Gilead Sciences | FDA Approves Label Update for Kite’s Yescarta® for Relapsed/Refractory Primary Central Nervous System Lymphoma gilead.com ↗ |
| 2025-12-07 | Kite, A Gilead Company | Yescarta® Delivers Consistent Safety, Efficacy, and Quality of Life Benefits Across Broad Range of Relapsed/Refractory Large B-cell Lymphoma Patients in New Analysis at ASH 2025 kitepharma.com ↗ |
| 2025-12-07 | Gilead Sciences | Yescarta® Delivers Consistent Safety, Efficacy, and Quality of Life Benefits Across Broad Range of Relapsed/Refractory Large B-cell Lymphoma Patients in New Analysis at ASH 2025 gilead.com ↗ |
| 2025-06-01 | Kite, A Gilead Company | Kite Presents New Real-World Data Supporting Use of Potentially Curative Yescarta® in Outpatient Care Setting for Patients with Relapsed/Refractory Large B-Cell Lymphoma at ASCO 2025 kitepharma.com ↗ |
| 2025-06-01 | Gilead Sciences | Kite Presents New Real-World Data Supporting Use of Potentially Curative Yescarta® in Outpatient Care Setting for Patients with Relapsed/Refractory Large B-Cell Lymphoma at ASCO 2025 gilead.com ↗ |
| 2024-12-09 | Kite, A Gilead Company | Kite’s Yescarta® Only CAR T-Cell Therapy to Show Durable Response and Long-Term Survival After Five Years in Patients With Relapsed/Refractory Non-Hodgkin Lymphomas at ASH 2024 kitepharma.com ↗ |
| 2024-12-09 | Gilead Sciences | Kite’s Yescarta® Only CAR T-Cell Therapy to Show Durable Response and Long-Term Survival After Five Years in Patients With Relapsed/Refractory Non-Hodgkin Lymphomas at ASH 2024 gilead.com ↗ |
| 2024-12-08 | Kite, A Gilead Company | Kite Presents New Data Underscoring Curative Potential of Yescarta® in Relapsed/Refractory Large B-cell Lymphoma at ASH kitepharma.com ↗ |
| 2024-12-08 | Gilead Sciences | Kite Presents New Data Underscoring Curative Potential of Yescarta® in Relapsed/Refractory Large B-cell Lymphoma at ASH gilead.com ↗ |
| 2024-06-14 | Kite, A Gilead Company | New Kite Clinical Research and Real-World Evidence for Yescarta® Demonstrate Benefit From Earlier Lines of Treatment kitepharma.com ↗ |
| 2024-06-14 | Gilead Sciences | New Kite Clinical Research and Real-World Evidence for Yescarta® Demonstrate Benefit From Earlier Lines of Treatment gilead.com ↗ |
| Show all 153 releases opens the full record — a long page | ||
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 73 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Axicabtagene Ciloleucel | “Axicabtagene ciloleucel (Axi-cel) is an autologous anti-CD-19 chimeric antigen receptor(CAR) T-cell therapy approved by FDA in 2017 for the treatment of patients with...” NCT05800067 ↗41“A Single-arm, Multicenter Clinical Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel Injection Manufactured by an Automated Process” NCT07606937 ↗ “Standard of care: Will be given on day 0 and will be either axicabtagene ciloleucel or lisocabtagene maraleucel .” NCT07052305 ↗ “The CAR T-cell therapies to be used in this study are axicabtagene-ciloleucel and lisocabtagene maraleucel.” NCT05934448 ↗ |
| Known as | axi-cel | “ZUMA-12 is a multicenter phase 2 study evaluating axicabtagene ciloleucel (axi-cel) autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy as part of first-line...” PMID 39938019 ↗ May 20259“Axicabtagene ciloleucel (Axi-cel) is an autologous anti-CD-19 chimeric antigen receptor(CAR) T-cell therapy approved by FDA in 2017 for the treatment of patients with...” NCT05800067 ↗ “ZUMA-24 is a Phase 2, open-label, multicenter study that investigated safety and efficacy of axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen...” PMID 40948517 ↗ Aug 2025 “A Phase I Study of Anti-CD19 CAR T-cell Therapy With Axicabtagene Ciloleucel (Axi-cel) in Patients With Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphoma” NCT04608487 ↗ “A single infusion of CAR-transduced autologous T cells administered intravenously at a target dose of 100 × 10\^6 for Relma-cel or 2 × 10\^6/kg for Axi-cel.” NCT05370547 ↗ “Axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy” PMID 29226797 ↗ Dec 2017 “Lymphodepleting Chemotherapy: Axicabtagene Ciloleucel (axi-cel)” NCT07479797 ↗ “axi-cel” NCT03391466 ↗ |
| Known as | Axicabtagen ciloleucel | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989989 ↗ |
| Known as | CAR-T cell therapy | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06238336 ↗ |
| Known as | CAR-T Therapy | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06752785 ↗ |
| Known as | Chimeric Antigen Receptor T-Cell Therapy | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05052528 ↗ |
| Known as | KTE-C19 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02926833 ↗ |
| Known as | Yascarta | “Yascarta is an autologous anti-CD19 CAR T cell therapy manufactured from the patient's own T cells, which have been extracted and then reprogrammed with CAR molecules to help...” NCT06104592 ↗ |
| Known as | YESCARTA | “Yescarta is an autologous anti-CD19 CAR T cell therapy manufactured from the patient's own T cells, which have been extracted and then reprogrammed with CAR molecules to help...” NCT05757219 ↗3“YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting” NCT05108805 ↗ |
| Action | Deplete | “may recognize and kill tumor cells” NCT03696030 ↗ |
| Modality | Cell therapy | “an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy” PMID 39240498 ↗ Sep 2024 |
| Route | Intravenous | “administered intravenously” NCT02348216 ↗ |
| Target | CD19 | “anti-CD19 chimeric antigen receptor (CAR) T cells/kg” NCT02926833 ↗ |