^
    2d
    ARTEMIS: Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant (clinicaltrials.gov)
    P2, N=47, Completed, Marker Therapeutics, Inc. | Active, not recruiting --> Completed | N=180 --> 47 | Trial completion date: Aug 2024 --> Mar 2024
    Trial completion • Enrollment change • Trial completion date
    |
    zedenoleucel (MT-401)
    21d
    CHIRON: ATL001 in Patients with Advanced Unresectable or Metastatic NSCLC (clinicaltrials.gov)
    P1/2, N=27, Terminated, Achilles Therapeutics UK Limited | N=50 --> 27 | Trial completion date: Jul 2027 --> Sep 2024 | Recruiting --> Terminated | Trial primary completion date: Jul 2025 --> Sep 2024; Sponsor decision
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    Keytruda (pembrolizumab) • ATL 001
    21d
    THETIS: ATL001 in Patients With Metastatic or Recurrent Melanoma (clinicaltrials.gov)
    P1/2, N=13, Terminated, Achilles Therapeutics UK Limited | N=40 --> 13 | Trial completion date: Jul 2027 --> Sep 2024 | Recruiting --> Terminated | Trial primary completion date: Jul 2025 --> Sep 2024; Sponsor decision
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2)
    |
    BRAF mutation • BRAF V600
    |
    Opdivo (nivolumab) • ATL 001
    23d
    A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma (clinicaltrials.gov)
    P1, N=20, Recruiting, Memorial Sloan Kettering Cancer Center | N=10 --> 20
    Enrollment change • Metastases
    |
    Amtagvi (lifileucel) • LN-145
    1m
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, BioNTech US Inc. | N=72 --> 22
    Enrollment change • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    2ms
    IOV-END-201: A Study of Lifileucel (tumor-infiltrating Lymphocytes) in Adults with Advanced Endometrial Cancer. (clinicaltrials.gov)
    P2, N=60, Recruiting, Iovance Biotherapeutics, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cyclophosphamide • Amtagvi (lifileucel)
    2ms
    Advancements and Challenges in Personalized Therapy for BRAF-Mutant Melanoma: A Comprehensive Review. (PubMed, J Clin Med)
    Despite these challenges, tumor-infiltrating lymphocyte (TIL) therapy, as exemplified by lifileucel, has demonstrated notable efficacy against BRAF V600-mutant melanoma. Additionally, early response biomarkers, such as COX-2 and MMP2, along with FDG-PET imaging, offer the potential to improve personalized immunotherapy by predicting patient responses and determining the optimal treatment duration. Future efforts should focus on reducing the T-cell harvesting periods and costs associated with TIL therapy to enhance efficiency and accessibility.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    BRAF (B-raf proto-oncogene) • MMP2 (Matrix metallopeptidase 2)
    |
    BRAF mutation • BRAF V600
    |
    Amtagvi (lifileucel)
    2ms
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=72, Active, not recruiting, BioNTech US Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    3ms
    Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants (clinicaltrials.gov)
    P1, N=40, Recruiting, Iovance Biotherapeutics, Inc.
    New P1 trial
    |
    Amtagvi (lifileucel) • LN-145
    4ms
    ARTEMIS: Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant (clinicaltrials.gov)
    P2, N=180, Active, not recruiting, Marker Therapeutics, Inc. | Trial completion date: Jul 2027 --> Aug 2024 | Trial primary completion date: Jul 2024 --> Mar 2024
    Trial completion date • Trial primary completion date
    |
    zedenoleucel (MT-401)
    4ms
    Generation and Characterization of Ex Vivo Expanded Tumor-infiltrating Lymphocytes From Renal Cell Carcinoma Tumors for Adoptive Cell Therapy. (PubMed, J Immunother)
    The Gen 2 manufacturing process used for lifileucel successfully expanded functional TILs from RCC samples, enabling further study in a clinical trial. TIME features such as low CD8/FoxP3 ratio and high PD-1 expression within FoxP3 cells warrant study as potential biomarkers of successful TIL expansion.
    Preclinical • Journal • Tumor-infiltrating lymphocyte • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • FOXP3 (Forkhead Box P3)
    |
    Amtagvi (lifileucel)
    5ms
    A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer. (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Iovance Biotherapeutics, Inc.
    New P2 trial • Metastases
    |
    cyclophosphamide • Amtagvi (lifileucel)
    5ms
    Study of Descartes-30 in Acute Respiratory Distress Syndrome (clinicaltrials.gov)
    P1, N=12, Terminated, Cartesian Therapeutics | Phase classification: P1/2 --> P1 | N=30 --> 12 | Trial completion date: May 2024 --> Sep 2023 | Recruiting --> Terminated; Phase 1 enrollment completed. Further clinical development terminated
    Phase classification • Enrollment change • Trial completion date • Trial termination
    6ms
    Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Patients With Metastatic Uveal Melanoma (clinicaltrials.gov)
    P1, N=10, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2024 --> May 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    Amtagvi (lifileucel)
    6ms
    A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV) (clinicaltrials.gov)
    P1, N=55, Recruiting, Cabaletta Bio | N=39 --> 55 | Trial completion date: Sep 2026 --> Jan 2029 | Trial primary completion date: Sep 2026 --> Jan 2029
    Enrollment change • Trial completion date • Trial primary completion date
    |
    cyclophosphamide
    7ms
    IOV-CLL-01: Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL (clinicaltrials.gov)
    P1/2, N=70, Active, not recruiting, Iovance Biotherapeutics, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jul 2024 --> Sep 2025 | Trial primary completion date: Apr 2024 --> Sep 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    TP53 (Tumor protein P53) • IL2 (Interleukin 2)
    |
    TP53 mutation • TP53 mutation + Chr del(17p)
    |
    IOV-2001
    8ms
    IOV-COM-202: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (clinicaltrials.gov)
    P2, N=178, Recruiting, Iovance Biotherapeutics, Inc. | Trial completion date: Dec 2024 --> Aug 2029 | Trial primary completion date: Dec 2023 --> Aug 2029
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • Amtagvi (lifileucel) • LN-145 • LN-145-S1
    8ms
    Lifileucel, an Autologous Tumor-infiltrating Lymphocyte Monotherapy, in Patients with Advanced Non-small Cell Lung Cancer Resistant to Immune Checkpoint Inhibitors. (PubMed, Cancer Discov)
    In this phase 2 multicenter study, we evaluated the efficacy and safety of lifileucel (LN-145), an autologous tumor-infiltrating lymphocyte cell therapy, in patients with metastatic non-small cell lung cancer (mNSCLC) who had received prior immunotherapy and progressed on their most recent therapy. Two patients died of treatment-emergent adverse events: cardiac failure and multiple organ failure. Lifileucel is a potential treatment option for patients with mNSCLC refractory to prior therapy.
    Clinical • Journal • Checkpoint inhibition • Tumor mutational burden • Tumor-infiltrating lymphocyte • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    TMB (Tumor Mutational Burden) • STK11 (Serine/threonine kinase 11)
    |
    STK11 mutation • PD-L1 negative • TMB-L • PD-L1 negative + TMB-L
    |
    Amtagvi (lifileucel) • LN-145
    8ms
    Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma (clinicaltrials.gov)
    P1, N=21, Active, not recruiting, M.D. Anderson Cancer Center | N=30 --> 21 | Recruiting --> Active, not recruiting
    Enrollment closed • Enrollment change • Metastases
    |
    cyclophosphamide • fludarabine IV • mesna • OBX-115 • acetazolamide
    8ms
    ARTEMIS: Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant (clinicaltrials.gov)
    P2, N=180, Active, not recruiting, Marker Therapeutics, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    zedenoleucel (MT-401)
    8ms
    Non-Viral TCR Gene Therapy (clinicaltrials.gov)
    P2, N=0, Withdrawn, National Cancer Institute (NCI) | N=210 --> 0 | Trial completion date: Dec 2029 --> Mar 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2028 --> Mar 2024
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • IO biomarker • Gene therapy • Metastases
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    9ms
    NCI-2021-11063: Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients (clinicaltrials.gov)
    P1, N=2, Active, not recruiting, Richard Wu | Recruiting --> Active, not recruiting | N=15 --> 2 | Trial completion date: Dec 2025 --> Dec 2024
    Enrollment closed • Enrollment change • Trial completion date • Tumor mutational burden • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    Keytruda (pembrolizumab) • cyclophosphamide • fludarabine IV • Amtagvi (lifileucel)
    9ms
    A Study of LN-144 in People With Metastatic Melanoma to the Brain (clinicaltrials.gov)
    P1, N=10, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    Amtagvi (lifileucel)
    9ms
    Expert consensus guidelines on management and best practices for tumor-infiltrating lymphocyte cell therapy. (PubMed, J Immunother Cancer)
    Based on the encouraging efficacy, tolerable safety profile, and advancements in a central manufacturing process, lifileucel is now the first US Food and Drug Administration (FDA)-approved TIL cell therapy product...These recommendations provide practical guidelines for optimal clinical management during administration of the TIL cell therapy regimen, and recognition of subsequent management of toxicities. These guidelines are focused on multidisciplinary teams of physicians, nurses, and stakeholders involved in the care of these patients.
    Journal • Tumor-infiltrating lymphocyte
    |
    IL2 (Interleukin 2)
    |
    Amtagvi (lifileucel)
    9ms
    Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov)
    P2, N=12, Recruiting, University of Kansas Medical Center | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial primary completion date • Metastases
    |
    cyclophosphamide • fludarabine IV • Amtagvi (lifileucel) • Imunace (teceleukin)
    9ms
    Hepatic Transarterial Administrations of NKR-2 in Patients With Unresectable Liver Metastases From Colorectal Cancer (clinicaltrials.gov)
    P1, N=1, Terminated, Celyad Oncology SA | Unknown status --> Terminated; Difficulties in patient recruitment and clinical strategy modification based on new clinical data generated in the NKR-2 early development.
    Trial termination
    |
    CYAD-01
    9ms
    A Review of Current and Pipeline Drugs for Treatment of Melanoma. (PubMed, Pharmaceuticals (Basel))
    Lifileucel, an FDA-approved tumor-infiltrating lymphocyte therapy, has demonstrated improved response rates in advanced-stage melanoma...While immunotherapy has significantly advanced melanoma treatment, its success varies, prompting research into new drugs and factors influencing outcomes. This review provides insights into current melanoma treatments and recent therapeutic advances.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    NRAS (Neuroblastoma RAS viral oncogene homolog) • IL2 (Interleukin 2)
    |
    BRAF mutation
    |
    Amtagvi (lifileucel)
    9ms
    Safety and Efficacy of OBX-115 in Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=52, Recruiting, Obsidian Therapeutics, Inc. | N=32 --> 52
    Enrollment change • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • PD-1 (Programmed cell death 1)
    |
    BRAF mutation • BRAF V600
    |
    cyclophosphamide • OBX-115
    11ms
    THETIS: ATL001 in Patients With Metastatic or Recurrent Melanoma (clinicaltrials.gov)
    P1/2, N=40, Recruiting, Achilles Therapeutics UK Limited | Trial completion date: Dec 2027 --> Jul 2027
    Trial completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2)
    |
    BRAF mutation • BRAF V600
    |
    Opdivo (nivolumab) • ATL 001
    11ms
    C-TIL051 in Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, AbelZeta, Inc.
    Trial completion date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • avipendekin pegol (NKTR-255)
    11ms
    HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA (clinicaltrials.gov)
    P1, N=32, Active, not recruiting, Baylor College of Medicine | Trial primary completion date: Oct 2023 --> Oct 2024
    Trial primary completion date
    |
    Opdivo (nivolumab) • cyclophosphamide • fludarabine IV
    12ms
    Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov)
    P2, N=12, Recruiting, University of Kansas Medical Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cyclophosphamide • fludarabine IV • Amtagvi (lifileucel) • Imunace (teceleukin)
    12ms
    Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov)
    P2, N=12, Not yet recruiting, University of Kansas Medical Center
    New P2 trial
    |
    cyclophosphamide • fludarabine IV • Amtagvi (lifileucel) • Imunace (teceleukin)
    1year
    Long-Term Follow-Up Study of Patients Receiving ATL001 (clinicaltrials.gov)
    P2, N=1, Terminated, Achilles Therapeutics UK Limited | N=90 --> 1 | Trial completion date: Jul 2028 --> Oct 2023 | Not yet recruiting --> Terminated | Trial primary completion date: Jul 2028 --> Oct 2023; The long-term follow-up of patients is being migrated to the original (parent) study protocols (Trial ID: ATX-NS-001 / NCT: NCT04032847;Trial ID: ATX-ME-001 / NCT: NCT03997474). Consequently, the ATX-LTFU-001 study is being terminated by the Sponsor.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    ATL 001
    1year
    Safety and Efficacy of OBX-115 in Advanced/Metastatic Melanoma Resistant to Immune Checkpoint Inhibitors (clinicaltrials.gov)
    P1/2, N=32, Recruiting, Obsidian Therapeutics, Inc. | Active, not recruiting --> Recruiting
    Enrollment open • Checkpoint inhibition • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • PD-1 (Programmed cell death 1)
    |
    BRAF mutation • BRAF V600
    |
    cyclophosphamide • OBX-115
    1year
    Correlative findings following DSG3-CAART infusion with and without preconditioning in patients with Pemphigus Vulgaris (DesCAARTes study) (ESGCT 2023)
    No abstract available
    Clinical
    1year
    Safety and Efficacy of OBX-115 in Advanced/Metastatic Melanoma Resistant to Immune Checkpoint Inhibitors (clinicaltrials.gov)
    P1/2, N=32, Active, not recruiting, Obsidian Therapeutics, Inc.
    New P1/2 trial • Checkpoint inhibition • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • PD-1 (Programmed cell death 1)
    |
    BRAF mutation • BRAF V600
    |
    cyclophosphamide • OBX-115
    1year
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=72, Recruiting, BioNTech US Inc. | N=52 --> 72
    Enrollment change • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    over1year
    NTC-001: A phase I study to test safety and efficacy of BNT221, a non-engineered neoantigen-specific T cell product, in patients with advanced or metastatic melanoma (ESMO 2023)
    Conclusions In this first in human study, BNT221 as a single infusion therapy demonstrated a tolerable safety profile, product persistence, prolonged stable disease, and tumor regressions in patients with checkpoint inhibitor-resistant metastatic melanoma. Additional study is warranted and BNT221 combination with anti-PD-1 is currently underway.
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    BNT221
    over1year
    C-144-01: Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma (clinicaltrials.gov)
    P2, N=178, Active, not recruiting, Iovance Biotherapeutics, Inc. | Trial primary completion date: Jul 2021 --> Jan 2025
    Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    BRAF mutation • BRAF V600
    |
    Amtagvi (lifileucel)
    over1year
    A Study of LN-144 in People With Metastatic Melanoma to the Brain (clinicaltrials.gov)
    P1, N=10, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    Amtagvi (lifileucel)
    over1year
    RAPA-201 Therapy of Solid Tumors (clinicaltrials.gov)
    P1/2, N=22, Recruiting, Rapa Therapeutics LLC | Phase classification: P2 --> P1/2 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Jan 2023 --> Jan 2024
    Phase classification • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • BRCA (Breast cancer early onset)
    |
    EGFR mutation • ALK translocation • BRCA mutation
    |
    carboplatin • paclitaxel • Torisel (temsirolimus) • sirolimus • RAPA-201