^
    2d
    Biomimetic and personalized nanovaccines in cancer immunotherapy: Design innovations, translational challenges, and future directions. (PubMed, J Adv Res)
    This review synthesizes recent advances in biomimetic and personalized nanovaccine design, highlighting clinical progress in lipid nanoparticle (LNP)-based vaccines such as BNT111 and mRNA-4157, emerging innate immune adjuvants including Toll-like receptor (TLR) and stimulator of interferon genes (STING) agonists, and rational combination strategies with immune checkpoint blockade. Key safety and quality consideration including immunotoxicity, off-target immune activation, and batch heterogeneity are critically evaluated alongside emerging engineering solutions. Finally, future directions integrating AI-guided neoantigen prediction, modular microfluidic manufacturing, and multi-omic biomarker frameworks are discussed to accelerate next generation cancer nanovaccine translation.
    Review • Journal • IO biomarker
    |
    STING (stimulator of interferon response cGAMP interactor 1)
    |
    BNT111 • intismeran autogene (mRNA-4157)
    23d
    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
    28d
    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)
    29d
    BNT111-01: A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of Treatment (clinicaltrials.gov)
    P2, N=184, Completed, BioNTech SE | Active, not recruiting --> Completed
    Trial completion
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Libtayo (cemiplimab-rwlc) • BNT111
    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)
    3ms
    TACTOPS: TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=37, Completed, Baylor College of Medicine | Trial completion date: May 2027 --> Jul 2025 | Active, not recruiting --> Completed
    Trial completion • Trial completion date
    4ms
    Administration of Donor Multi TAA-Specific T Cells for AML or MDS (ADSPAM) (clinicaltrials.gov)
    P1, N=44, Active, not recruiting, Baylor College of Medicine | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    KIT (KIT proto-oncogene, receptor tyrosine kinase) • WT1 (WT1 Transcription Factor) • CD33 (CD33 Molecule) • ANPEP (Alanyl Aminopeptidase, Membrane)
    |
    MultiTAA T cell therapy
    4ms
    Innovative therapeutic cancer vaccine PDC∗lung01 with or without anti-PD-1: an open-label, dose-escalation phase I/II study in non-small-cell lung cancer. (PubMed, ESMO Open)
    PDC∗lung01 was immunogenic and had a manageable safety profile in all cohorts and met the predefined clinical objectives when combined with anti-PD-1 in metastatic NSCLC. Median PFS was positively correlated with antigen-specific T-cell expansions.
    P1/2 data • Journal
    |
    PD-L1 (Programmed death ligand 1) • MUC1 (Mucin 1) • BIRC5 (Baculoviral IAP repeat containing 5) • CTAG1B (Cancer/testis antigen 1B) • MAGEA4 (Melanoma antigen family A, 4)
    |
    PDC*lung
    5ms
    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, Not yet recruiting, Takara Bio Inc.
    New P3 trial
    |
    cyclophosphamide • fludarabine IV • mipetresgene autoleucel (TBI-1301)
    5ms
    TACTIC - TAA Specific Cytotoxic T Lymphocytes in Patients With Breast Cancer (clinicaltrials.gov)
    P2, N=12, Completed, Baylor College of Medicine | Active, not recruiting --> Completed
    Trial completion
    |
    MultiTAA T cell therapy
    6ms
    Adoptive T-Cell Therapy in Sarcomas. (PubMed, Curr Oncol Rep)
    The FDA approval of afamitresgene autoleucel for advanced synovial sarcoma and the breakthrough designation of letetresgene autoleucel for myxoid/round cell liposarcoma signify a major turning point...Tumour infiltrating lymphocyte therapy, including lifileucel, is under investigation with checkpoint inhibitors or oncolytic agents to enhance efficacy and manage toxicity...Challenges include HLA restriction, tumour heterogeneity, and manufacturing complexity. Future strategies involving novel antigens, multi-targeting, and combinatorial regimens could broaden patient eligibility and improve therapeutic outcomes.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • FGFR4 (Fibroblast growth factor receptor 4) • CD276 (CD276 Molecule) • CTAG1B (Cancer/testis antigen 1B) • MAGEA4 (Melanoma antigen family A, 4)
    |
    Tecelra (afamitresgene autoleucel) • Amtagvi (lifileucel) • letetresgene autoleucel (GSK3377794)