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    DRUG CLASS:

    TCR modulator

    Related drugs:
    1d
    AFPᶜ³³²T in Advanced HCC (clinicaltrials.gov)
    P1, N=39, Completed, Adaptimmune | Active, not recruiting --> Completed
    Trial completion
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    AFP (Alpha-fetoprotein)
    |
    ADP-A2AFP
    2d
    A Study of Dose Escalation of ES502 in Patients With Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1, N=24, Recruiting, Ruijin Hospital
    New P1 trial
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog) • HLA-DPB1 (Major Histocompatibility Complex, Class II, DP Beta 1)
    |
    KRAS mutation • NRAS mutation • RAS mutation • HRAS mutation • KRAS G12 • NRAS G12
    6d
    NY-ESO-1-specific T Cell Receptor (TCR) T Cell in Sarcoma (clinicaltrials.gov)
    P1, N=2, Completed, Sun Yat-sen University | Active, not recruiting --> Completed | N=20 --> 2 | Trial completion date: May 2024 --> Apr 2026
    Trial completion • Enrollment change • Trial completion date
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    cyclophosphamide • TAEST16001
    6d
    Phase II Study of TAEST16001 in Soft Tissue Sarcoma (clinicaltrials.gov)
    P2, N=8, Terminated, Sun Yat-sen University | N=70 --> 8 | Trial completion date: Sep 2024 --> Aug 2025 | Recruiting --> Terminated | Trial primary completion date: Sep 2024 --> Jul 2025; The study was terminated due to initiation of a new clinical trial with an updated study design.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    TAEST16001
    18d
    MAGE-A4/MAGE-A8-targeted TCR-based bispecific T cell engager in recurrent and/or refractory solid tumors: a phase 1 trial. (PubMed, Nat Med)
    No further DLTs occurred in the RP2D range with dexamethasone premedication. These findings show that the bispecific TCER platform has a manageable safety profile with mostly transient adverse events and promising antitumor activity at the RP2D of IMA401 with or without pembrolizumab. ClinicalTrials.gov identifier: NCT05359445 .
    P1 data • Journal • First-in-human
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MAGEA4 (Melanoma antigen family A, 4)
    |
    Keytruda (pembrolizumab) • dexamethasone • IMA401
    24d
    The Landscape of Clinical Trials for TCR-T Cell Therapy. (PubMed, Am J Clin Oncol)
    NY-ESO-1 is the most prominent target, followed by MAGE-A4, KRAS, PRAME, HPV16 E6/E7, and HBV surface antigen, with letetresgene autoleucel and LioCyx-M004 being the most investigated TCR-T products. Collectively, TCR-T therapy is a promising field in tumor immunotherapy with continuous research investment and advancing clinical progress.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • CTAG1B (Cancer/testis antigen 1B) • MAGEA4 (Melanoma antigen family A, 4) • PRAME (Preferentially Expressed Antigen In Melanoma)
    |
    letetresgene autoleucel (GSK3377794) • LioCyx-M
    1m
    A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer (clinicaltrials.gov)
    P1, N=20, Recruiting, University of Southern California | Suspended --> Recruiting | Trial completion date: Dec 2027 --> Dec 2028 | Trial primary completion date: Dec 2026 --> Dec 2027
    Enrollment open • Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CTAG1B (Cancer/testis antigen 1B)
    |
    HER-2 negative
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • NY-ESO-1 TCR
    1m
    KXV01 Injection in Patients With Advanced Solid Tumor (Including Osteosarcoma and Sarcoma) (clinicaltrials.gov)
    P1, N=30, Recruiting, TCRx Therapeutics Co.Ltd
    New P1 trial
    |
    tirbanibulin oral (KX-01 oral)
    1m
    C2025-009-01: A Study of DCTY1102 Injection in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, Beijing DCTY Biotech Co.,Ltd. | N=110 --> 18 | Trial completion date: May 2028 --> Aug 2028 | Trial primary completion date: May 2028 --> Aug 2028
    Enrollment change • Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    KRAS mutation • NRAS mutation • KRAS G12D • KRAS G12 • NRAS G12
    1m
    NT-175-201: A Study of NT-175 in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation (clinicaltrials.gov)
    P1, N=45, Recruiting, AstraZeneca | Trial primary completion date: Sep 2028 --> Jul 2029
    Trial primary completion date
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    cyclophosphamide • fludarabine IV • NT-175
    1m
    BSB-2002 After Cyclophosphamide and Fludarabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation (clinicaltrials.gov)
    P1, N=19, Not yet recruiting, City of Hope Medical Center
    New P1 trial
    |
    NPM1 (Nucleophosmin 1)
    |
    NPM1 mutation
    |
    cyclophosphamide • fludarabine IV
    1m
    Advances in cell therapy for solid tumours: European perspective and future directions. (PubMed, Lancet Reg Health Eur)
    The recent US FDA approvals of lifileucel (a TIL therapy for advanced melanoma) and afamitresgene autoleucel (a TCR therapy targeting MAGE-A4 in synovial sarcoma) mark the first regulatory recognition of cell therapies for solid tumours and signal a new era for oncology...Emphasis is placed on emerging innovations like gene-edited and allogeneic therapies, as well as future directions for integrating cell therapies into mainstream oncology. We conclude with recommendations for overcoming barriers related to cost, toxicity management, and equitable access across Europe.
    Review • Journal
    |
    MAGEA4 (Melanoma antigen family A, 4)
    |
    Tecelra (afamitresgene autoleucel) • Amtagvi (lifileucel)