Drug

Lifileucel

In clinical development

Emerging researchLate-stage development

Also known as Amtagvi, Autologous tumor infiltrating lymphocytes, Tumor infiltrating lymphocytes, autologous.

RxNorm2675860 ChEMBLCHEMBL4298200 ATCL01XL11UNIIR0835E18NH

Research papers

Active clinical trials

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Prospective, Multicenter, Open-label, Randomized, Actively Controlled, Parallel-group Phase 3 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of IMA203 Versus Investigator's Choice of Treatment in Patients With Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (ACTengine® IMA203-301)

Clinical trial2026-06-10Results expected Q1 2028 · ClinicalTrials.gov

An Open-Label, Phase II Study to Evaluate the Safety and Efficacy Using Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) in Patients With Non-Small Cell Lung Cancer

Clinical trial2026-04-30Results expected Q2 2027 · ClinicalTrials.gov

A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Melanoma

Clinical trial2026-04-20Results expected Q4 2032 · ClinicalTrials.gov

A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma

Clinical trial2026-03-25Results posted · ClinicalTrials.gov

A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN 144/LN-145/LN-145-S1) in Patients With Solid Tumors

Clinical trial2026-02-20Terminated · ClinicalTrials.gov

An Open, Single-armed, Phase Ib Study to Evaluate the Safety and Efficacy Using Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) in Patients With Non-Small Cell Lung Cancer

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

A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Endometrial Cancer.

Clinical trial2025-10-30Results expected Q2 2028 · ClinicalTrials.gov

Locoregional or Systemic Administration of Autologous Tumor Infiltrating Lymphocytes in Patients With Metastatic Melanoma

Clinical trial2025-09-19Results expected Q1 2028 · ClinicalTrials.gov

Pilot Trial of Lifileucel (LN-144) for Patients With Asymptomatic Melanoma Brain Metastases and Progression on Prior PD1 Therapy

Clinical trial2025-09-12Results expected Q4 2026 · ClinicalTrials.gov

Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Advanced Liver Cancer

Clinical trial2025-08-19Results expected Q3 2026 · ClinicalTrials.gov

Lifileucel, an Autologous Tumor-Infiltrating Lymphocyte Monotherapy, in Patients with Advanced Non-Small Cell Lung Cancer Resistant to Immune Checkpoint Inhibitors.

Research2024-08-01Cancer discovery

Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma.

Research2021-05-12Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

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

Canonical name

Lifileucel

Aliases & brands

AmtagviAutologous tumor infiltrating lymphocytesTumor infiltrating lymphocytes, autologous

RxNorm CUI

2675860

ChEMBL ID

CHEMBL4298200

ATC codes

L01XL11

UNII

R0835E18NH

Clinical trials

18 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

registered trials across all phases

LATEST COMPLETION 2025

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 18

Phase 110Phase 1 / 21Phase 26Phase 31

Late-stage studies

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

RecruitingPH IIIImmatics US, Inc.n=3602031

Recent completions

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

Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion Before Tumor-Infiltrating Lymphocyte Therapy With Lifileucel in Metastatic Melanoma

CompletedPH IIUniversity of Kansas Medical Centern=112025

A Phase I Study Using Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver Metastases

CompletedPH IVastra Gotaland Regionn=82025

A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma

CompletedPH IIIovance Biotherapeutics, Inc.n=2202024

Phase I/II Study Evaluating the Infusion of Tumor-Infiltrating Lymphocytes (TILs) & Low-Dose Interleukin-2 (IL-2) Therapy Following a Preparative Regimen of Non-myeloablative Lymphodepletion Using Cyclophosphamide & Fludarabine in Patients With Malignant Pleural Mesothelioma

CompletedPH I/IIUniversity Health Network, Toronton=92020

Research activity

2 papers

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

Publications over time

20212024

Most influential

Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021 · 309 cites

Lifileucel, an Autologous Tumor-Infiltrating Lymphocyte Monotherapy, in Patients with Advanced Non-Small Cell Lung Cancer Resistant to Immune Checkpoint Inhibitors.

Cancer discovery · 2024 · 80 cites