Lifileucel

Summary

Lifileucel (CHEMBL4298200) is an approved cell (ATC L01XL11); indicated across 12 conditions including metastatic melanoma and cutaneous melanoma.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Cell
• ATC class: L01XL11
• Indications: 12 conditions
• Clinical trials: 25

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4298200
Name	Lifileucel
Type	Cell
Max phase	4
ATC	L01XL11

Also known as: Amtagvi, Lifileucel, Ln 145, LN-144, Ln-145, LN-145, LIFILEUCEL

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

3 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
metastatic melanoma	4	MONDO:0005191	EFO:0002617
cutaneous melanoma	4	MONDO:0005012	EFO:0000389
melanoma	4	MONDO:0005105	EFO:0000756

7 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
head and neck squamous cell carcinoma	2	MONDO:0010150	EFO:0000181
cervical carcinoma	2	MONDO:0005131	EFO:0001061
non-small cell lung carcinoma	2	MONDO:0005233	EFO:0003060
breast neoplasm	2	MONDO:0021100	MONDO:0007254
endometrium neoplasm	2	MONDO:0021251	MONDO:0011962
mesothelioma	1	MONDO:0005065	EFO:0000588
neoplasm	1	MONDO:0005070	EFO:0000616

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

Clinical trials

Total trials: 25.

Phase distribution

Phase	Trials
PHASE2	13
PHASE1	11
PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06743126	PHASE3	RECRUITING	SUPRAME-ACTengine® IMA203 vs. Investigator’s Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
NCT03449108	PHASE2	ACTIVE_NOT_RECRUITING	LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas
NCT04614103	PHASE2	RECRUITING	Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer
NCT06481592	PHASE2	RECRUITING	A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.
NCT07288073	PHASE2	RECRUITING	TIL Therapy in cSCC and MCC
NCT07288203	PHASE2	ACTIVE_NOT_RECRUITING	A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma
NCT07560111	PHASE2	NOT_YET_RECRUITING	A Phase II Study of GC101 in NSCLC
NCT02360579	PHASE2	COMPLETED	Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma
NCT03083873	PHASE2	COMPLETED	Study of LN-145/LN-145-S1 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck
NCT03108495	PHASE2	TERMINATED	Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma
NCT03419559	PHASE2	WITHDRAWN	Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) In Combo With Durvalumab in Non-Small Cell Lung Cancer
NCT03645928	PHASE2	TERMINATED	Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors
NCT03935347	PHASE2	WITHDRAWN	Adoptive Cell Therapy With (LN-145) in Combination With Pembrolizumab in Treating Patients With Unresectable or Metastatic Transitional Cell Cancer Who Have Failed Cisplatin-Based Chemotherapy
NCT06151847	PHASE2	COMPLETED	Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma
NCT05176470	PHASE1	ACTIVE_NOT_RECRUITING	Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients
NCT05607095	PHASE1	RECRUITING	A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma
NCT05640193	PHASE1	ACTIVE_NOT_RECRUITING	A Study of LN-144 in People With Metastatic Melanoma to the Brain
NCT05903937	PHASE1	NOT_YET_RECRUITING	Locoregional Administration of TIL and Lymphodepletion in Patients With Melanoma and Liver Metastases
NCT06084299	PHASE1	RECRUITING	Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Advanced Liver Cancer
NCT06473961	PHASE1	RECRUITING	A Phase Ib Study of GC101 in NSCLC
NCT06566092	PHASE1	ACTIVE_NOT_RECRUITING	Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants
NCT03991741	PHASE1	TERMINATED	Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors
NCT04812470	PHASE1	COMPLETED	Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver Metastases
NCT05475847	PHASE1	UNKNOWN	Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer
NCT06190249	PHASE1	WITHDRAWN	Efficacy & Safety for LN144 With Pembrolizumab With High Risk Stage IIIb-dResectable Melanoma

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).