^
    4d
    Combination of Tagraxofusp With Pacritinib in Patients With Intermediate-1 or Higher Myelofibrosis, Who Have Had Prior Therapy With the Approved JAK Inhibitors or in Which Therapy With the Approved JAK Inhibitors is Not Appropriate, Contraindicated or Declined (clinicaltrials.gov)
    P1, N=20, Recruiting, University of Kansas Medical Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Elzonris (tagraxofusp-erzs) • Vonjo (pacritinib)
    19d
    Vebectotamab Vedotin Combined With Pucotelimab in the Treatment of Locally Advanced Laryngeal Carcinoma (clinicaltrials.gov)
    P1/2, N=10, Not yet recruiting, Tang-Du Hospital
    New P1/2 trial
    |
    vibecotamab (XmAb14045)
    1m
    TAGALONG: Tagraxofusp and Azacitidine With Venetoclax in Newly Diagnosed Secondary AML After Hypomethylating Agents (clinicaltrials.gov)
    P2, N=53, Recruiting, Joshua Zeidner | Trial completion date: Dec 2027 --> Jul 2031 | Trial primary completion date: Aug 2027 --> Jul 2030
    Trial completion date • Trial primary completion date
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    Venclexta (venetoclax) • azacitidine • Elzonris (tagraxofusp-erzs)
    2ms
    Efficacy and Safety of SBRT Combined With Becotatug Vedotin in EGFR-Positive Metastatic Tumor Patients With Oligometastases (clinicaltrials.gov)
    P3, N=200, Not yet recruiting, Ming-Yuan Chen
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    Meiyouheng (becotatug vedotin) • becotarug (JMT101) • vibecotamab (XmAb14045)
    3ms
    A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1/2 Study of Tagraxofusp, Azacitidine, and Venetoclax (clinicaltrials.gov)
    P1/2, N=31, Recruiting, Jacqueline Garcia, MD | Trial completion date: Dec 2028 --> Dec 2030 | Trial primary completion date: Dec 2026 --> Dec 2028
    Trial completion date • Trial primary completion date
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    Venclexta (venetoclax) • Elzonris (tagraxofusp-erzs)
    3ms
    Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies (clinicaltrials.gov)
    P1, N=13, Completed, City of Hope Medical Center | Active, not recruiting --> Completed | Trial completion date: May 2026 --> Aug 2025 | Trial primary completion date: May 2026 --> Aug 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    flotetuzumab (MGD006)
    4ms
    PEPN1812: Flotetuzumab for the Treatment of Pediatric Recurrent or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=16, Active, not recruiting, Children's Oncology Group | Trial completion date: Sep 2025 --> Mar 2026
    Trial completion date
    |
    cytarabine • flotetuzumab (MGD006) • Starasid (cytarabine ocfosfate)
    4ms
    Phase I/II Study of Tagraxofusp in Combination With Decitabine for Patients With Myelomonocytic/Myeloproliferative Neoplasm and High Risk Myelodysplastic Syndromes (clinicaltrials.gov)
    P1/2, N=64, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    decitabine • Elzonris (tagraxofusp-erzs)
    4ms
    Sustained response to minimal-dose tagraxofusp in a patient with BPDCN and advanced chronic kidney disease. (PubMed, Ann Hematol)
    To our knowledge, this is the first reported case demonstrating the use of tagraxofusp in a patient with BPDCN and advanced chronic kidney disease, showing that even a minimum of tolerated treatment dose can induce a sustained response. Despite the risk of adverse events, tagraxofusp should be considered a viable treatment option for elderly patients with poor performance status and significant comorbidities who are ineligible for intensive chemotherapy or stem cell transplantation, as even limited exposure may achieve meaningful clinical responses.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • TET2 (Tet Methylcytosine Dioxygenase 2) • CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha) • ZRSR2 (Zinc Finger CCCH-Type, RNA Binding Motif And Serine/Arginine Rich 2)
    |
    KRAS mutation • TET2 mutation • CBL mutation
    |
    Elzonris (tagraxofusp-erzs)
    4ms
    A phase I/II study of tagraxofusp in Japanese patients with blastic plasmacytoid dendritic cell neoplasm. (PubMed, Int J Hematol)
    Common adverse events included increased alanine aminotransferase (81.8%) and aspartate aminotransferase (72.7%), hypoalbuminemia, hypokalemia, and capillary leak syndrome (54.5%). The results indicate that TAG was effective and had a manageable safety profile in Japanese BPDCN patients.
    P1/2 data • Journal
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    Elzonris (tagraxofusp-erzs)
    4ms
    Hematopoietic effects of tagraxofusp in treatment-naive patients with blastic plasmacytoid dendritic cell neoplasm. (PubMed, Cancer)
    These findings demonstrate the on-target effect and unique BM-sparing profile of tagraxofusp, which are paramount when treating myelosuppressive, CD123-positive hematologic diseases. The results support single-agent tagraxofusp as standard-of-care, nonmyelosuppressive first-line treatment for BPDCN and as a potential combination partner for other CD123-positive hematologic malignancies.
    Journal
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    Elzonris (tagraxofusp-erzs)
    5ms
    The role of targeted therapies in blastic plasmacytoid dendritic cell neoplasm. (PubMed, Expert Opin Biol Ther)
    The approval of tagraxofusp established a foundation for targeted therapy in BPDCN and demonstrated high response rates, leading to the development of additional antibody - drug conjugates and cellular therapies targeting CD123. Other promising targeted approaches include BCL2 inhibitors, proteasome inhibitors, and therapies directed against surface antigens such as CD38 and CD303, as well as bromodomain and extraterminal (BET) inhibitors. Collectively, these strategies represent important advances that may significantly improve the historically poor outcomes associated with BPDCN.
    Review • Journal
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha) • CLEC4C (C-Type Lectin Domain Family 4 Member C)
    |
    Venclexta (venetoclax) • Elzonris (tagraxofusp-erzs)