Lifileucel

BIOLOGICAL11 trials

Sponsors

Iovance Biotherapeutics Inc., Iovance Biotherapeutics, Inc., Richard Wu, University of Kansas Medical Center, Immatics US, Inc.

Conditions

Advanced Soft Tissue SarcomaClinical Stage IV Cutaneous Melanoma AJCC v8Dedifferentiated Liposarcoma (DDLPS)Endometrial CancerLocally Advanced MelanomaMelanomaMelanoma (Skin Cancer)Melanoma, Cutaneous Malignant

Phase 1

Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients

Active, not recruitingNCT05176470

Richard WuLocally Advanced Melanoma, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 +2

Start: 2022-07-01End: 2026-12-31Updated: 2026-02-24

Phase 2

Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma

CompletedNCT02360579

Iovance Biotherapeutics, Inc.Metastatic Melanoma

Start: 2015-09-24End: 2024-10-24Updated: 2026-03-25

Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

TerminatedNCT03645928

Iovance Biotherapeutics, Inc.Metastatic Melanoma, Squamous Cell Carcinoma of the Head and Neck, Non-small Cell Lung Cancer

Start: 2019-05-07End: 2026-02-20Updated: 2026-05-15

Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma

CompletedNCT06151847

University of Kansas Medical CenterClinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 +1

Start: 2023-12-21End: 2025-07-10Updated: 2026-04-30

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

Active, not recruitingCTIS2024-510779-39-00

Iovance Biotherapeutics Inc.Neoplasm

Start: 2018-12-19Target: 95Updated: 2026-01-21

A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.

RecruitingNCT06481592

Iovance Biotherapeutics, Inc.Endometrial Cancer

Start: 2024-10-29End: 2029-11-30Target: 60Updated: 2025-10-30

A Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes [TIL]) in participants with previously treated advanced melanoma

Not yet recruitingCTIS2025-522054-40-00

Iovance Biotherapeutics Inc.Previously treated advanced melanoma

Target: 69Updated: 2025-12-01

A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma

Active, not recruitingNCT07288203

Iovance Biotherapeutics, Inc.Melanoma (Skin Cancer), Unresectable Melanoma, Metastatic Melanoma

Start: 2025-11-28End: 2033-12-01Target: 100Updated: 2026-04-20

A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Soft Tissue Sarcoma

Not yet recruitingNCT07741877

Iovance Biotherapeutics, Inc.Sarcoma, Soft Tissue Sarcoma (STS), Advanced Soft Tissue Sarcoma +2

Start: 2026-09-01End: 2034-09-01Target: 80Updated: 2026-08-03

Phase 3

A Phase 3, multicenter, randomized, open-label, parallel group, treatment study to assess the efficacy and safety of the lifileucel (LN-144, autologous tumor-infiltrating lymphocytes [TIL]) regimen in combination with pembrolizumab compared with pembrolizumab monotherapy in participants with untreated, unresectable or metastatic melanoma

RecruitingCTIS2022-503140-41-00

Iovance Biotherapeutics Inc.Melanoma

Start: 2024-11-29Target: 280Updated: 2025-10-31

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma

RecruitingNCT06743126

Immatics US, Inc.Melanoma, Cutaneous Malignant

Start: 2025-01-14End: 2031-10-01Target: 360Updated: 2026-08-18

Related Papers

Patient-level clinical response dynamics in advanced melanoma with anzutresgene autoleucel (anzu-cel), a PRAME-directed T-cell receptor (TCR) T-cell therapy.

Journal of Clinical Oncology2026-05-28

Feasibility of Manufacturing and Antitumor Activity of TIL for Advanced Endometrial Cancers

International Journal of Molecular Sciences2025-07-241 citations

Phase 2, multicenter study of frontline maintenance therapy with lifileucel plus pembrolizumab in advanced non-small cell lung cancer.

Journal of Clinical Oncology2025-05-281 citations

Lifileucel in patients with advanced melanoma: 5-year outcomes of the C-144-01 study.

Journal of Clinical Oncology2025-05-281 citations

Phase 1 clinical update of IMA203, an autologous TCR-T targeting PRAME in patients with PD1 refractory metastatic melanoma.

Journal of Clinical Oncology2025-05-28

SUPRAME: A phase 3 trial comparing IMA203, an engineered T-cell receptor expressing T cell therapy (TCR-T) vs investigator’s choice in patients with previously treated advanced cutaneous melanoma.

Journal of Clinical Oncology2025-05-28

Reduced dose fludarabine and cyclophosphamide lymphodepletion before tumor-infiltrating lymphocyte therapy in melanoma

Future Oncology2025-05-091 citations

Recent Advancements in Cell-Based Therapies in Melanoma.

2024-09-124 citations

Efficacy and safety of lifileucel, an autologous tumor-infiltrating lymphocyte cell therapy, and pembrolizumab in patients with immune checkpoint inhibitor-naive unresectable or metastatic melanoma: Updated results from IOV-COM-202 cohort 1A.

Journal of Clinical Oncology2024-06-0114 citations

Reduced dose fludarabine/cyclophosphamide lymphodepletion for tumor-infiltrating lymphocytes therapy (LN-144, lifileucel) in metastatic melanoma.

Journal of Clinical Oncology2024-06-013 citations

Dynamics of circulating cytokines and chemokines during and after tumor-infiltrating lymphocyte cell therapy with lifileucel in advanced melanoma patients.

Journal of Clinical Oncology2024-06-011 citations

119O Long-term efficacy and patterns of response of lifileucel tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced melanoma: A 4-year analysis of the C-144-01 study

Immuno-Oncology Technology2023-12-0110 citations

776 Long-term efficacy and safety of lifileucel tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced melanoma: a 4-year analysis of the C-144–01 study

Regular and Young Investigator Award Abstracts2023-10-318 citations

Quad-shot-immunotherapy: quad-shot radiotherapy with pembrolizumab for advanced/recurrent head and neck cancer

Future Oncology2023-05-185 citations

789 Lifileucel TIL cell monotherapy in patients with advanced melanoma after progression on immune checkpoint inhibitors (ICI) and targeted therapy: pooled analysis of consecutive cohorts (C-144–01 study)

Regular and Young Investigator Award Abstracts2022-11-015 citations

Tumor mutational burden (TMB) in immune checkpoint inhibitor (ICI)-naïve and -experienced patients with metastatic melanoma treated with lifileucel, a tumor-infiltrating lymphocyte (TIL) cell therapy.

Journal of Clinical Oncology2022-06-014 citations

492 Phase 2 efficacy and safety of autologous tumor-infiltrating lymphocyte (TIL) cell therapy in combination with pembrolizumab in immune checkpoint inhibitor-naïve patients with advanced cancers

Regular and Young Investigator Award Abstracts2021-11-0134 citations

458 First phase 2 results of autologous tumor-infiltrating lymphocyte (TIL; LN-145) monotherapy in patients with advanced, immune checkpoint inhibitor-treated, non-small cell lung cancer (NSCLC)

Regular and Young Investigator Award Abstracts2021-11-0124 citations

Adoptive cell therapy with tumor-infiltrating lymphocytes supported by checkpoint inhibition across multiple solid cancer types

Journal for ImmunoTherapy of Cancer2021-10-0161 citations

Abstract CT008: Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced (unresectable or metastatic) melanoma: durable duration of response at 28 month follow up

Cancer Research2021-07-015 citations

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