Axicabtagene Ciloleucel

Summary

Axicabtagene Ciloleucel (CHEMBL3989989) is an approved gene (ATC L01XL03); indicated across 8 conditions including neoplasm of mature b-cells and diffuse large b-cell lymphoma.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Gene
• ATC class: L01XL03
• Indications: 8 conditions
• Clinical trials: 42

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3989989
Name	Axicabtagene Ciloleucel
Type	Gene
Max phase	4
ATC	L01XL03

Also known as: Axicabtagen ciloleucel, Axicabtagene ciloleucel, KTE-C19, Yescarta, AXICABTAGENE CILOLEUCEL

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

8 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
neoplasm of mature B-cells	4	MONDO:0004949	EFO:0000096
diffuse large B-cell lymphoma	4	MONDO:0018905	EFO:0000403
follicular lymphoma	4	MONDO:0018906	MONDO:0018906
mantle cell lymphoma	2	MONDO:0018876	EFO:1001469
lymphoid neoplasm	2	MONDO:0005157	EFO:0001642
lymphoma	1	MONDO:0005062	EFO:0000574
non-Hodgkin lymphoma	1	MONDO:0018908	EFO:0005952

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 42.

Phase distribution

Phase	Trials
PHASE2	20
PHASE1	6
PHASE3	5
Not specified	5
PHASE1/PHASE2	4
PHASE4	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06609304	PHASE4	RECRUITING	Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
NCT05108805	PHASE4	COMPLETED	Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting
NCT05371093	PHASE3	ACTIVE_NOT_RECRUITING	Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma
NCT05605899	PHASE3	ACTIVE_NOT_RECRUITING	Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma
NCT07188558	PHASE3	RECRUITING	A Study to Investigate Ronde-cel Versus Investigator’s Choice CD19 CAR T-Cell Therapy
NCT07479797	PHASE3	RECRUITING	Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy
NCT03391466	PHASE3	COMPLETED	Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma
NCT03642626	PHASE2	ACTIVE_NOT_RECRUITING	MT2017-45: CAR-T Cell Therapy for Heme Malignancies
NCT04257578	PHASE1/PHASE2	ACTIVE_NOT_RECRUITING	Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma
NCT04531046	PHASE2	ACTIVE_NOT_RECRUITING	Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B Lymphoma Ineligible to Autologous Stem Cell Transplantation
NCT05633615	PHASE2	RECRUITING	Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
NCT06043323	PHASE2	RECRUITING	A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma
NCT06550141	PHASE2	RECRUITING	Emapalumab Prevention of CAR-T Cell Associated Toxicities
NCT06826118	PHASE2	RECRUITING	Axicabtagene Ciloleucel Injection in Patients With Relapsed/Refractory Follicular Lymphoma
NCT07042438	PHASE2	RECRUITING	Fecal Microbiome Transplant to Remodel Intestinal Microbiota for Patients With Relapsed or Refractory Lymphoma With Exposure to High-Risk Antibiotics Who Are Receiving Chimeric Antigen Receptor T Cells
NCT07254754	PHASE2	RECRUITING	Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma
NCT07326371	PHASE2	NOT_YET_RECRUITING	Glofitamab Combined With CAR-T Therapy in R/R DLBCL
NCT07538635	PHASE2	RECRUITING	CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.
NCT02348216	PHASE1/PHASE2	COMPLETED	Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma
NCT02601313	PHASE2	COMPLETED	Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)
NCT02926833	PHASE1/PHASE2	COMPLETED	Study of Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Adults With Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
NCT03105336	PHASE2	COMPLETED	A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
NCT03761056	PHASE2	COMPLETED	Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma
NCT04002401	PHASE2	COMPLETED	Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma
NCT04071366	PHASE2	COMPLETED	A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
NCT04150913	PHASE2	COMPLETED	A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity
NCT04205838	PHASE2	TERMINATED	Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients With Recurrent or Refractory Large B-cell Lymphoma
NCT04432506	PHASE2	COMPLETED	Anakinra for the Reduction of CAR-T Toxicity in Patients With Relapsed or Refractory Large B-cell Lymphoma
NCT04855253	PHASE1/PHASE2	SUSPENDED	Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL
NCT05459571	PHASE2	COMPLETED	Study of Axicabtagene Ciloleucel Given With Steroids In Participants With Relapsed Or Refractory Large B-Cell Lymphoma
NCT06912529	PHASE2	TERMINATED	Axicabtagene Ciloleucel CAR T-cells in Patients With Relapsed or Refractory Primary Mediastinal B-cell Lymphoma
NCT04608487	PHASE1	ACTIVE_NOT_RECRUITING	Axi-cel in CNS Lymphoma
NCT05077527	PHASE1	RECRUITING	Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma
NCT05794958	PHASE1	RECRUITING	Evaluate Safety of Axicabtagene Ciloleucel Reinfusion (Axi-Cel-2) in Patients With Relapsed and/or Refractory Second Line High-Risk Non-Hodgkin Lymphoma After Standard of Care Axi-Cel
NCT03704298	PHASE1	TERMINATED	Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Utomilumab in Adults With Refractory Large B-cell Lymphoma
NCT04314843	PHASE1	TERMINATED	Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma
NCT05075603	PHASE1	COMPLETED	Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy
NCT05041309	Not specified	ENROLLING_BY_INVITATION	Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
NCT05776160	Not specified	AVAILABLE	Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel
NCT06935136	Not specified	NOT_YET_RECRUITING	Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection as First-Line Therapy of High-Risk Large B-Cell Lymphoma

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).