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    DRUG CLASS:

    TCR modulator

    Related drugs:
    10d
    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
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    HLA-A (Major Histocompatibility Complex, Class I, A) • MAGEA4 (Melanoma antigen family A, 4)
    |
    Keytruda (pembrolizumab) • dexamethasone • IMA401
    16d
    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
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    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
    22d
    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
    22d
    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)
    23d
    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
    28d
    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
    28d
    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)
    1m
    Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation (clinicaltrials.gov)
    P1, N=19, Recruiting, BlueSphere Bio, Inc
    New P1 trial
    |
    NPM1 (Nucleophosmin 1)
    |
    NPM1 mutation
    2ms
    IMA401-101: IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor (clinicaltrials.gov)
    P1, N=95, Active, not recruiting, Immatics Biotechnologies GmbH | Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2025 --> Mar 2026
    Enrollment closed • Trial primary completion date • Checkpoint inhibition • First-in-human
    |
    MAGEA4 (Melanoma antigen family A, 4)
    |
    Keytruda (pembrolizumab) • IMA401
    2ms
    ALLOHA: A Study of TSC-100 and TSC-101 in AML, ALL and MDS in Patients Undergoing Allogeneic Peripheral Blood Stem Transplantation (clinicaltrials.gov)
    P1, N=75, Recruiting, TScan Therapeutics, Inc. | Trial primary completion date: Dec 2025 --> Jun 2026
    Trial primary completion date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    melphalan • TSC-100 • TSC-101
    2ms
    PNOC018: Genetically Modified Cells (KIND T Cells) for the Treatment of HLA-A*0201-Positive Patients With H3.3K27M-Mutated Glioma (clinicaltrials.gov)
    P1, N=12, Active, not recruiting, University of California, San Francisco | Recruiting --> Active, not recruiting
    Enrollment closed • First-in-human
    |
    H3.3K27M
    |
    cyclophosphamide • fludarabine IV • KIND T