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    DRUG CLASS:

    TCR modulator

    Related drugs:
    8d
    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, Suspended, University of Southern California | Recruiting --> Suspended
    Trial suspension • 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
    8d
    Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=33, Terminated, Sanofi | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns
    Trial termination • First-in-human
    |
    ALK (Anaplastic lymphoma kinase) • GPC3 (Glypican 3)
    |
    Tecentriq (atezolizumab) • SAR444200
    10d
    Cell therapy in sarcoma: current landscape and future directions. (PubMed, J Immunother Cancer)
    This constituted only the second approval of a cell therapy in a solid tumor following lifileucel in melanoma and demonstrated the potential of cell therapies in sarcomas...However, the broader application of these therapies is hindered by the lack of targetable sarcoma-restricted immunogenic epitopes, spatiotemporal intratumoral heterogeneity, and a profoundly immunosuppressive tumor microenvironment that impedes effector-cell trafficking, expansion and persistence. While cell therapies hold promise for integration into precision medicine approaches for sarcomas, their successful implementation will require careful evaluation of clinical feasibility, logistical considerations and cost-effectiveness to optimize patient outcomes.
    Review • Journal
    |
    MAGEA4 (Melanoma antigen family A, 4)
    |
    Tecelra (afamitresgene autoleucel) • Amtagvi (lifileucel)
    13d
    Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma (clinicaltrials.gov)
    P3, N=5, Recruiting, Takara Bio Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    cyclophosphamide • fludarabine IV • mipetresgene autoleucel (TBI-1301)
    22d
    AN EVALUATION OF AFAMITRESGENE AUTOLEUCEL FOR THE TREATMENT OF ADVANCED SYNOVIAL SARCOMA AND MYXOID ROUND CELL LIPOSARCOMA. (PubMed, Expert Rev Anticancer Ther)
    However, challenges remain regarding HLA restriction, tumor microenvironment resistance, manufacturing delays and cost. Future efforts should focus on broadening applicability, optimizing combinations, and ensuring equitable access.
    Review • Journal
    |
    MAGEA4 (Melanoma antigen family A, 4)
    |
    Tecelra (afamitresgene autoleucel)
    29d
    TITAN: A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis. (clinicaltrials.gov)
    P1, N=72, Recruiting, AstraZeneca | N=54 --> 72
    Enrollment change
    1m
    RaPTR-101: An Early Phase Trial of RPTR-1-201 in Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=150, Not yet recruiting, Repertoire Immune Medicines
    New P1/2 trial
    1m
    A Study of YTS109 Cell in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia (clinicaltrials.gov)
    P1, N=13, Not yet recruiting, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    New P1 trial
    1m
    Personalized KXV01 Lentinvivo (TCR) Injection as the Therapy for Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, TCRx Therapeutics Co.Ltd
    New P1 trial
    |
    tirbanibulin oral (KX-01 oral)
    2ms
    Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=24, Recruiting, AstraZeneca | Trial completion date: Apr 2044 --> Nov 2043
    Trial completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    2ms
    Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, University Health Network, Toronto | Trial completion date: Sep 2025 --> Nov 2026 | Trial primary completion date: Sep 2025 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
    |
    cyclophosphamide • fludarabine IV • mipetresgene autoleucel (TBI-1301)
    2ms
    T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers (clinicaltrials.gov)
    P1, N=36, Terminated, National Cancer Institute (NCI) | Completed --> Terminated; Site plans to become a site for a multicenter study of this therapy
    Trial termination • IO biomarker
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin) • Zuplenz (ondansetron oral dispersible film)