^
    1d
    Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC) (clinicaltrials.gov)
    P1, N=16, Completed, Providence Health & Services | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    cyclophosphamide • citoplurikin (IRX-2)
    6d
    Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumor, Including a Cohort Expansion in Esophageal Cancer. (clinicaltrials.gov)
    P1, N=120, Active, not recruiting, NeoTX Therapeutics Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TPBG (Trophoblast Glycoprotein)
    |
    HER-2 negative
    |
    Imfinzi (durvalumab) • Gazyva (obinutuzumab) • Anyara (naptumomab estafenatox)
    15d
    oHSV2-PD-L1/CD3-BsAb Administered Via Intratumoral Injection (clinicaltrials.gov)
    P1, N=29, Suspended, Binhui Biopharmaceutical Co., Ltd. | Trial completion date: Jan 2026 --> Dec 2026 | Recruiting --> Suspended | Trial primary completion date: Jun 2025 --> Dec 2026
    Trial completion date • Trial suspension • Trial primary completion date
    |
    BS006
    24d
    DIAL: Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas (clinicaltrials.gov)
    P2, N=54, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2025 --> Oct 2026
    Trial completion date
    |
    ALK (Anaplastic lymphoma kinase) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6) • IRF4 (Interferon regulatory factor 4)
    |
    Opdivo (nivolumab) • varlilumab (CDX 1127) • ABP 206 (nivolumab biosimilar)
    1m
    ALLELE: A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy (clinicaltrials.gov)
    P3, N=115, Recruiting, Pierre Fabre Medicament | N=66 --> 115
    Enrollment change
    |
    Rituxan (rituximab) • Tab-cel (tabelecleucel)
    1m
    Characterization of CAR-T cellular kinetics and efficacy in solid tumor patients with and without prior lymphodepletion chemotherapy using a PBPK-PD model. (PubMed, J Pharmacokinet Pharmacodyn)
    Model was developed based on digitized individual level CK, categorical antitumor activity and percentage tumor antigen expression dataset from following phase-1 dose-escalation studies: (A) anti-mesothelin CAR-T in multiple cancer indications (n = 15, cohorts w/ and w/o LDC), (B) gavocabtagene autoleucel (n = 7, w/ and w/o LDC) in multiple indications, (C) anti-glypican 3 CAR-T in advanced hepatocellular carcinoma (n = 13, dose-range 0.7-5.18 billion) and (D) anti-PSMA/TGFβ CAR-T in prostate cancer (n = 10, w/ and w/o LDC)...Using model simulation, CAR-T cell expansion was found to be dependent on initial tumor burden and antigen positive tumor fraction. The developed PBPK-PD model could be leveraged as an effective tool in future to provide mechanistic understanding on CK-PD behavior of cell therapies targeting solid tumors.
    Journal • IO biomarker
    |
    GPC3 (Glypican 3) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    gavocabtagene autoleucel (TC-210)
    1m
    Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors (FH-A11KRASG12V-TCR) in Treating Patients With Metastatic Solid Tumor Cancers With KRAS G12V Mutations (clinicaltrials.gov)
    P1, N=24, Suspended, Fred Hutchinson Cancer Center | Active, not recruiting --> Suspended
    Trial suspension • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • TMB-H • BRAF mutation • HER-2 amplification • ROS1 fusion • KRAS G12 • NTRK fusion
    |
    cyclophosphamide • bendamustine • fludarabine IV
    2ms
    MATCHPOINT: Adoptive T Cell Therapy, DC Vaccines, and Hematopoietic Stem Cells Combined With Immune checkPOINT Blockade in Patients With Medulloblastoma (clinicaltrials.gov)
    P1, N=12, Recruiting, University of Florida | Active, not recruiting --> Recruiting
    Enrollment open • Checkpoint inhibition
    |
    Keytruda (pembrolizumab)
    2ms
    Improving dual targeting selectivity in T-cell engagers via synapse-gated and affinity-tuned trispecific antibody design. (PubMed, MAbs)
    Using an anti-receptor tyrosine kinase-like orphan receptor 1 (ROR1) mAb as a proof-of-concept anchoring arm and an array of affinity-modulated variants of the anti-epidermal growth factor receptor (EGFR) GA201 mAb as active arms, we show in vitro conditional engagement and elimination of double-positive human NCI-H358 non-small cell lung cancer cells over single-positive, non-target NCI-H358.ROR1.KO cells by affinity-modulated TriMab TCEs...Lastly, we demonstrate that the TriMab modality exhibits a favorable developability profile and mAb-like pharmacokinetic properties in human neonatal Fc receptor transgenic mice. Overall, this work presents a generalizable approach to utilizing the TriMab modality by leveraging avidity effects and molecular geometry to achieve conditional AND-gated dual TAA-targeting with a significantly improved TI.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
    |
    EGFR positive
    |
    imgatuzumab (RO5083945)
    2ms
    ALLELE: Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy (clinicaltrials.gov)
    P3, N=66, Recruiting, Pierre Fabre Medicament | Trial primary completion date: Aug 2025 --> May 2030
    Trial primary completion date
    |
    Rituxan (rituximab) • Tab-cel (tabelecleucel)
    2ms
    A Study of CC312 for Relapsed/Refractory Autoimmune Diseases (clinicaltrials.gov)
    P1, N=6, Recruiting, CytoCares Inc
    New P1 trial
    2ms
    Safety Study of CC312 in Adult Patients With Relapsed/Refractory CD19 Positive B-cell Hematologic Malignancies (clinicaltrials.gov)
    P1, N=44, Recruiting, CytoCares Inc | Trial primary completion date: Mar 2025 --> Mar 2026
    Trial primary completion date
    |
    CD19 positive