Tisagenlecleucel

Summary

Tisagenlecleucel (CHEMBL3301574) is an approved cell (ATC L01XL04); indicated across 15 conditions including b-cell acute lymphoblastic leukemia and diffuse large b-cell lymphoma; with CIViC clinical evidence for 1 variant-indication association (e.g. CD19 delta-ex2, delta-ex5-6 in b-lymphoblastic leukemia/lymphoma).

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Cell
• ATC class: L01XL04
• Indications: 15 conditions
• Clinical trials: 53
• Precision-oncology evidence (CIViC): 1 variant–indication association

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3301574
Name	Tisagenlecleucel
Type	Cell
Max phase	4
ATC	L01XL04

Also known as: CART-19, CART19, CTL-019, CTL019, Kymriah, Tisagenlecleucel, Tisagenlecleucel-t, TISAGENLECLEUCEL

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

15 indications (2 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
B-cell acute lymphoblastic leukemia	4	MONDO:0004947	EFO:0000094
diffuse large B-cell lymphoma	4	MONDO:0018905	EFO:0000403
neoplasm of mature B-cells	3	MONDO:0004949	EFO:0000096
acute lymphoblastic leukemia	3	MONDO:0004967	EFO:0000220
non-Hodgkin lymphoma	3	MONDO:0018908	EFO:0005952
follicular lymphoma	3	MONDO:0018906	MONDO:0018906
B-cell chronic lymphocytic leukemia	2	MONDO:0004948	EFO:0000095
leukemia	2	MONDO:0005059	EFO:0000565
plasma cell myeloma	2	MONDO:0009693	EFO:0001378
acute myeloid leukemia	1	MONDO:0018874	EFO:0000222
lymphoma	1	MONDO:0005062	EFO:0000574
lymphoid leukemia	1	MONDO:0005402	EFO:0004289
Hodgkins lymphoma	0	MONDO:0004952	EFO:0000183

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

Clinical trials

Total trials: 53.

Phase distribution

Phase	Trials
PHASE2	19
PHASE1	13
PHASE1/PHASE2	6
Not specified	6
PHASE3	4
PHASE2/PHASE3	3
EARLY_PHASE1	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04094311	PHASE3	RECRUITING	Study of Out of Specification for Tisagenlecleucel
NCT05888493	PHASE3	ACTIVE_NOT_RECRUITING	A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma
NCT03027739	PHASE2/PHASE3	UNKNOWN	CART-19 Cells For MRD Positive CD19+ ALL
NCT03123939	PHASE3	COMPLETED	Phase III B in Acute Lymphoblastic Leukemia
NCT03391726	PHASE2/PHASE3	UNKNOWN	CART-19 Cells for R/R B-cell Lymphoma
NCT03391739	PHASE2/PHASE3	UNKNOWN	CART-19 Cells For R/R B-ALL
NCT03628053	PHASE3	WITHDRAWN	Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia
NCT03642626	PHASE2	ACTIVE_NOT_RECRUITING	MT2017-45: CAR-T Cell Therapy for Heme Malignancies
NCT03876769	PHASE2	ACTIVE_NOT_RECRUITING	Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients
NCT04234061	PHASE2	ACTIVE_NOT_RECRUITING	Clinical Trial to Assess The Efficacy and Safety of the Combination of Tisagenlecleucel And Ibrutinib in Mantle Cell Lymphoma
NCT05460533	PHASE2	ACTIVE_NOT_RECRUITING	A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL)
NCT05633615	PHASE2	RECRUITING	Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
NCT06101381	PHASE1/PHASE2	RECRUITING	CD19-directed CAR-T Cell Therapy for R/R Acute Leukemia and Lymphoma
NCT06839976	PHASE1/PHASE2	RECRUITING	CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus
NCT01626495	PHASE1/PHASE2	COMPLETED	Phase I/IIA Study of CART19 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma
NCT01747486	PHASE2	COMPLETED	Dose Optimization Trial of CD19 Redirected Autologous T Cells
NCT02030834	PHASE2	COMPLETED	Phase IIa Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRz and 4-Signaling Domains in Patients With Chemotherapy Relapsed or Refractory CD19+ Lymphomas
NCT02030847	PHASE2	COMPLETED	Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCR and 4-1BB Signaling Domains in Patients With Chemotherapy Resistant or Refractory Acute Lymphoblastic Leukemia
NCT02167360	PHASE2	WITHDRAWN	Study of Efficacy and Safety of CTL019 in Adult ALL Patients
NCT02228096	PHASE2	COMPLETED	Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients
NCT02435849	PHASE2	COMPLETED	Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients
NCT02445248	PHASE2	COMPLETED	Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients
NCT02794246	PHASE2	TERMINATED	CART-19 Post-ASCT for Multiple Myeloma
NCT03544021	PHASE1/PHASE2	UNKNOWN	CART-19 FOR Relapsed/Refractory Acute Lymphoblastic Leukemia （ALL）
NCT03568461	PHASE2	COMPLETED	Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma
NCT03610724	PHASE2	COMPLETED	Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients
NCT03896854	PHASE1/PHASE2	UNKNOWN	CART-19 T Cell in CD19 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
NCT04156659	PHASE2	WITHDRAWN	Study of Tisagenlecleucel in Chinese Pediatric and Young Adult Subjects With Relapsed or Refractory B-cell ALL
NCT04161118	PHASE2	TERMINATED	TisaGenlecleucel in Elderly Patients With First-Relapsed or Primary Refractory Aggressive B-cell Non-Hodgkin Lymphoma
NCT04225676	PHASE2	TERMINATED	Study of Efficacy and Safety of Reinfusion of Tisagenlecleucel in Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia (ALL)
NCT04456023	PHASE2	WITHDRAWN	Study of Tisagenlecleucel in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-cell Non-Hodgkin Lymphoma (DLBCL)
NCT04855253	PHASE1/PHASE2	SUSPENDED	Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL
NCT06408194	PHASE1	RECRUITING	Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies
NCT01029366	PHASE1	COMPLETED	CART19 to Treat B-Cell Leukemia or Lymphoma That Are Resistant or Refractory to Chemotherapy
NCT01551043	PHASE1	TERMINATED	Allo CART-19 Protocol
NCT02529813	PHASE1	COMPLETED	CD19-Specific T-cells in Treating Patients With Advanced Lymphoid Malignancies
NCT02799550	PHASE1	UNKNOWN	Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL
NCT02810223	PHASE1	UNKNOWN	Efficacy of CART-19 Cell Therapy in B Cell Acute Lymphoblastic Leukemia
NCT02924753	PHASE1	UNKNOWN	The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL).
NCT03101709	PHASE1	UNKNOWN	The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Lymphoma

Clinical evidence (CIViC)

Variant × indication × effect (1 predictive associations from 1 curated evidence items):

Variant	Indication	Effect	Therapy	Level	CIViC
CD19 delta-ex2, delta-ex5-6	B-lymphoblastic Leukemia/lymphoma	Resistance	Tisagenlecleucel	CIViC D	EID9700

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).