^
    3d
    SERIL: Safety, Tolerability and Efficacy of JCXH-211 in Patients With Recurrent or Progressive High-Grade Glioma (clinicaltrials.gov)
    P1, N=21, Not yet recruiting, Duke University | Initiation date: Oct 2024 --> Feb 2025
    Trial initiation date
    4d
    SON-1010: an albumin-binding IL-12 fusion protein that improves cytokine half-life, targets tumors, and enhances therapeutic efficacy. (PubMed, Front Immunol)
    We identified and developed a platform technology with prolonged half-life that can target IL-12 and other immune modulators to the TME. Safety and efficacy are being studied using SON-1010 as monotherapy and in combination with checkpoint blockade strategies.
    Journal • IO biomarker
    |
    IFNG (Interferon, gamma)
    |
    SON-1010
    5d
    WTX-330x2101: WTX-330 in Patients with Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=75, Active, not recruiting, Werewolf Therapeutics, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    WTX-330
    5d
    A Clinical Study of T3011 in Subjects With Advanced Melanoma (clinicaltrials.gov)
    P1/2, N=42, Recruiting, Shanghai Pharmaceuticals Holding Co., Ltd | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial primary completion date • Metastases
    |
    T3011
    10d
    20-C-0012: Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies (clinicaltrials.gov)
    P1, N=100, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2027 | Trial primary completion date: Dec 2024 --> Dec 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CD4 (CD4 Molecule)
    |
    PD-L1 expression
    |
    bintrafusp alfa (M7824) • PDS01ADC
    12d
    Genetically Engineered Cells (EGFRt/19-28z/IL-12 CAR T Cells) for the Treatment of Relapsed or Refractory CD19+ Hematologic Malignancies (clinicaltrials.gov)
    P1, N=54, Recruiting, Roswell Park Cancer Institute | N=36 --> 54
    Enrollment change • CAR T-Cell Therapy
    |
    cyclophosphamide • fludarabine IV
    20d
    A Clinical Trial of TG6050 in Patients With Metastatic Non-Small Cell Lung Cancer (Delivir) (clinicaltrials.gov)
    P1, N=36, Recruiting, Transgene | Trial completion date: Mar 2025 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Apr 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    BRAF V600E • KRAS mutation • KRAS G12C • BRAF V600 • HER-2 mutation • RET fusion • RET mutation • ROS1 fusion • RET rearrangement • KRAS G12
    |
    TG6050
    28d
    STAT5 activation enhances adoptive therapy combined with peptide vaccination by preventing PD-1 inhibition. (PubMed, Mol Cancer Ther)
    These findings indicate that TCR-transduced CD8 T cells can undergo antigen-dependent expansion when exposed to TriVax. Additionally, the expression of CA-STAT5 enhances T cell proliferation and persistence, partly by promoting resistance to PD-1/PD-L1-mediated inhibition in antitumor T cells.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • STAT5A (Signal Transducer And Activator Of Transcription 5A)
    |
    PD-1 expression
    |
    Trivax (AV0113)
    1m
    INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM) (clinicaltrials.gov)
    P1/2, N=52, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    temozolomide • Libtayo (cemiplimab-rwlc) • INO-5401 • rocakinogene sifuplasmid (INO-9012)
    1m
    INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma (clinicaltrials.gov)
    P1/2, N=35, Active, not recruiting, Inovio Pharmaceuticals | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Tecentriq (atezolizumab) • INO-5401 • rocakinogene sifuplasmid (INO-9012)
    1m
    Adoptive transfer of membrane-restricted IL-12-TCR T cells promotes antigen spreading and elimination of antigen-negative tumor variants. (PubMed, J Immunother Cancer)
    Expression of caIL-12 by tumor-targeting T cells demonstrated therapeutic effect against target-antigen-negative tumor variants, primarily through the induction of antigen spreading. These findings highlight the potential of caIL-12 to address challenges of antigen escape and tumor heterogeneity that may limit the efficacy of T-cell therapy against solid tumors.
    Journal
    |
    CD8 (cluster of differentiation 8)
    1m
    Non-secreting IL12 expressing oncolytic adenovirus Ad-TD-nsIL12 in recurrent high-grade glioma: a phase I trial. (PubMed, Nat Commun)
    Complete response (according to Response Assessment in Neuro-Oncology Criteria) in one patient, a partial response in one patient and post-treatment infiltrations of CD4+ and CD8 + T cells into the tumour were documented during this trial. In conclusion, Ad-TD-nsIL12 has demonstrated safety and preliminary efficacy in patients with recurrent high-grade glioma.
    P1 data • Journal • Oncolytic virus
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    1m
    KYANITE-1: A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs (clinicaltrials.gov)
    P1/2, N=140, Recruiting, Krystal Biotech, Inc. | Phase classification: P1 --> P1/2 | N=80 --> 140
    Phase classification • Enrollment change
    |
    Keytruda (pembrolizumab)
    1m
    OPAL-1: A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=140, Recruiting, Krystal Biotech, Inc. | Phase classification: P1 --> P1/2 | N=80 --> 140
    Phase classification • Enrollment change
    |
    Opdualag (nivolumab/relatlimab-rmbw)
    1m
    Descartes-25 in Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=9, Terminated, Cartesian Therapeutics | Active, not recruiting --> Terminated; Phase 1 enrollment completed. Further clinical development terminated.
    Trial termination
    2ms
    XTX301-01: XTX301 in Patients with Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=358, Recruiting, Xilio Development, Inc. | Phase classification: P1 --> P1/2 | N=174 --> 358
    Phase classification • Enrollment change • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    XTX301
    2ms
    CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (clinicaltrials.gov)
    P1, N=16, Terminated, Providence Health & Services | Completed --> Terminated; Study was ended prematurely due to lack of efficacy. As per FDA guidance, our site continued to follow enrolled subjects through the 180 day safety visit.
    Trial termination
    |
    Tavo (tavokinogene telsaplasmid)
    2ms
    Neoadjuvant intratumoral plasmid interleukin-12 electro-gene-transfer and nivolumab in patients with operable locoregionally advanced melanoma. (PubMed, Clin Cancer Res)
    The clinical efficacy of neoadjuvant IT TAVO-EP + nivolumab is promising with 80% of patients achieving an MPR. Evidence of potent immune activation both systemically and within the TME along with a favorable safety profile supports the activity of local IL-12 and anti-PD1 based regimens.
    Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    PD-L1 expression • CD8 expression • IFNG expression
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    2ms
    Phase 1/2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=258, Not yet recruiting, Sichuan Huiyu Pharmaceutical Co., Ltd
    New P1/2 trial • Metastases
    2ms
    INO 5401 Vaccination in BRCA1/2 Mutation Carriers (clinicaltrials.gov)
    P1, N=44, Recruiting, University of Pennsylvania | Phase classification: P1b --> P1
    Phase classification
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    INO-5401 • rocakinogene sifuplasmid (INO-9012)
    3ms
    Study of VG2025 Delivered Intraperitoneally in Patients with Advanced Solid Tumors with Carcinomatosis (clinicaltrials.gov)
    P1, N=0, Withdrawn, M.D. Anderson Cancer Center | N=21 --> 0 | Trial completion date: Mar 2030 --> Oct 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Mar 2028 --> Oct 2024
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Metastases
    |
    VG201
    3ms
    M032-HSV-1: Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma (clinicaltrials.gov)
    P1, N=29, Active, not recruiting, University of Alabama at Birmingham | Trial completion date: Sep 2024 --> Sep 2025
    Trial completion date
    3ms
    STEALTH-001: A Study of VET3-TGI in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=60, Recruiting, KaliVir Immunotherapeutics | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab)
    3ms
    Study of IMNN-001 (also Known As GEN-1) with NACT for Treatment of Ovarian Cancer (OVATION 2) (clinicaltrials.gov)
    P1/2, N=130, Active, not recruiting, Imunon | Trial completion date: Dec 2024 --> Nov 2025
    Trial completion date • Combination therapy • Metastases
    |
    carboplatin • paclitaxel • IMNN-001
    3ms
    Clinical Study of VG161 in Subjects with Advanced Primary Liver Cancer (clinicaltrials.gov)
    P1, N=44, Recruiting, CNBG-Virogin Biotech (Shanghai) Ltd. | Trial completion date: Dec 2022 --> Dec 2024
    Trial completion date • Metastases
    |
    VG161
    4ms
    A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=7, Terminated, Xencor, Inc. | N=210 --> 7 | Trial completion date: Sep 2030 --> May 2024 | Recruiting --> Terminated | Trial primary completion date: Sep 2028 --> May 2024; The Sponsor made a business decision to end the study.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab)
    4ms
    T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine M9241 in Localized High- and Intermediate-Risk Prostate Cancer Treated With Androgen Deprivation Therapy (clinicaltrials.gov)
    P2, N=65, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Aug 2025 --> Aug 2026
    Trial completion date • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PDS01ADC
    4ms
    T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination With the Immunocytokine M9241 in Localized High- and Intermediate-Risk Prostate Cancer Treated With Androgen Deprivation Therapy (clinicaltrials.gov)
    P2, N=65, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PDS01ADC
    5ms
    TG6050, an oncolytic vaccinia virus encoding interleukin-12 and anti-CTLA-4 antibody, favors tumor regression via profound immune remodeling of the tumor microenvironment. (PubMed, J Immunother Cancer)
    TG6050 effectively delivers functional IL-12 and @CTLA-4 into the tumor, resulting in strong antitumor activity. The shift towards an inflamed TME correlated with a boost in systemic antitumor T cells. The solid preclinical data and favorable benefit/risk ratio paved the way for the clinical evaluation of TG6050 in metastatic non-small cell lung cancer (NCT05788926 trial in progress).
    Journal • Oncolytic virus • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    TG6050
    5ms
    Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    cyclophosphamide • fludarabine IV • JCAR020
    5ms
    PuMP: Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of the Oncolytic HSV1 MVR-C5252 (clinicaltrials.gov)
    P1, N=51, Recruiting, Duke University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    MVR-C5252
    5ms
    Preliminary results from a phase I study of T3011, an oncolytic HSV expressing IL-12 and anti-PD-1 antibody, for BCG-failure non-muscle-invasive bladder cancer (NMIBC) (ESMO 2024)
    Intravesical T3011 demonstrates a promising anti-tumor efficacy and an excellent safety profile in patients with high risk BCG-failure NMIBC.
    P1 data
    |
    IFNG (Interferon, gamma)
    |
    UroVysion™ Bladder Cancer Kit (UroVysion Kit)
    |
    T3011
    5ms
    A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers (clinicaltrials.gov)
    P1/2, N=107, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Jun 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    Jingzhuda (entinostat) • bintrafusp alfa (M7824) • PDS01ADC
    6ms
    DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov)
    P2, N=41, Terminated, M.D. Anderson Cancer Center | N=77 --> 41 | Active, not recruiting --> Terminated; Project delays
    Enrollment change • Trial termination • Metastases
    |
    CD4 (CD4 Molecule)
    |
    Imfinzi (durvalumab) • MEDI0457
    6ms
    20-C-0012: Bintrafusp Alfa (M7824) and NHS-IL12 (M9241) Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies (clinicaltrials.gov)
    P1, N=100, Recruiting, National Cancer Institute (NCI) | N=66 --> 100
    Enrollment change • Combination therapy • Metastases
    |
    CD4 (CD4 Molecule)
    |
    bintrafusp alfa (M7824) • PDS01ADC
    6ms
    SERIL: A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 (SElf-Replicating RNA IL-12) Intratumoral Injection in Patients With Recurrent or Progressive High-Grade Glioma (clinicaltrials.gov)
    P1, N=21, Not yet recruiting, Duke University
    New P1 trial
    6ms
    Descartes-25 in Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=9, Active, not recruiting, Cartesian Therapeutics | Recruiting --> Active, not recruiting | Phase classification: P1/2 --> P1 | N=20 --> 9
    Enrollment closed • Phase classification • Enrollment change
    6ms
    A Study of MEDI9253 in Combination With Durvalumab in Select Solid Tumors (clinicaltrials.gov)
    P1, N=40, Completed, AstraZeneca | Active, not recruiting --> Completed | Trial completion date: Nov 2024 --> May 2024 | Trial primary completion date: Nov 2024 --> May 2024
    Trial completion • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Imfinzi (durvalumab) • MEDI9253
    7ms
    CLN-617 retains IL-2 and IL-12 in injected tumors to drive robust and systemic immune-mediated antitumor activity. (PubMed, Cancer Immunol Res)
    However, the only approved human IL-2 therapy, Proleukin, is rarely used in the clinic due to systemic toxicities, and no IL-12 product has been approved to date due to severe dose-limiting toxicities. We found that IT administration of a murine surrogate of CLN-617, mCLN-617, eradicated established treated and untreated tumors in syngeneic models, significantly improved response to anti-PD1 checkpoint therapy, and generated a robust abscopal response dependent on cellular immunity and antigen cross-presentation. CLN-617 is being evaluated in a clinical trial in patients with advanced solid tumors (NCT06035744).
    Journal
    |
    IL2 (Interleukin 2)
    |
    Proleukin (aldesleukin) • CLN-617
    7ms
    STEALTH-001: A Study of VET3-TGI in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=60, Not yet recruiting, KaliVir Immunotherapeutics
    New P1 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab)
    7ms
    Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Jul 2025 --> Jun 2028 | Trial primary completion date: Jul 2023 --> Jun 2028
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    7ms
    Clinical Study of T3011 Intravesical Instillation for Treatment of NMIBC Patients (clinicaltrials.gov)
    P1, N=20, Recruiting, Fudan University
    New P1 trial
    |
    T3011