^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG CLASS:

    CD33-targeted antibody-drug conjugate

    Related drugs:
    2d
    A Study of BL-M11D1 in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia (clinicaltrials.gov)
    P2/3, N=216, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=80 --> 216 | Initiation date: Dec 2025 --> Mar 2026
    Enrollment change • Trial initiation date
    |
    Venclexta (venetoclax) • cytarabine • azacitidine • daunorubicin • BL-M11D1
    2d
    A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and Relapsed /Refractory Pediatric Acute Leukemia Patients (clinicaltrials.gov)
    P1, N=32, Not yet recruiting, M.D. Anderson Cancer Center | Initiation date: Dec 2025 --> Dec 2027
    Trial initiation date
    |
    KMT2A (Lysine Methyltransferase 2A) • NUP98 (Nucleoporin 98 And 96 Precursor 2)
    |
    cytarabine • Mylotarg (gemtuzumab ozogamicin) • daunorubicin • Revuforj (revumenib)
    11d
    MM1YA-A04: Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MyeloMATCH Treatment Trial) (clinicaltrials.gov)
    P2, N=162, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Feb 2026 --> Jun 2026
    Trial initiation date
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • RUNX1 (RUNX Family Transcription Factor 1) • RUNX1T1 (RUNX1 Partner Transcriptional Co-Repressor 1)
    |
    Venclexta (venetoclax) • cytarabine • Mylotarg (gemtuzumab ozogamicin) • daunorubicin • Starasid (cytarabine ocfosfate)
    17d
    CA235-0001: A Phase I Study of BMS-986497 alone or in combination with Azacitidine (Aza) and Azacitidine plus Venetoclax (AZA+VEN) in relapsed or refractory (R/R) AML or MDS (2024-519537-29-00)
    P1, N=35, Not yet recruiting, Bristol-Myers Squibb Services Unlimited Company
    New P1 trial
    |
    Venclexta (venetoclax) • azacitidine
    24d
    Humanized anti-CD33 CAR-T cells and antibody-drug conjugates for targeted therapy in acute myeloid leukemia. (PubMed, Front Med (Lausanne))
    In the in vivo experiments, mice bearing Molm13-Luciferase tumor cells were assigned to different treatment groups and were administered with saline, Gemtuzumab-MMAE, or Clone3HM-MMAE...Clone3HM-MMAE, in particular, demonstrated excellent anti-tumor activity along with a strong safety profile. These results strongly support the further development of targeted therapeutic strategies for AML.
    Journal
    |
    CD33 (CD33 Molecule)
    |
    Mylotarg (gemtuzumab ozogamicin)
    2ms
    AGORA-1: A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML (clinicaltrials.gov)
    P2, N=19, Active, not recruiting, Centre Antoine Lacassagne | Recruiting --> Active, not recruiting | N=50 --> 19 | Trial completion date: Mar 2027 --> Jul 2028 | Trial primary completion date: Mar 2027 --> Jul 2028
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3) • CD33 (CD33 Molecule)
    |
    FLT3-ITD mutation • FLT3-TKD mutation • CD33 positive
    |
    cytarabine • Xospata (gilteritinib) • Mylotarg (gemtuzumab ozogamicin)
    2ms
    Cancer Throughlines: 25 Years after First Approval, ADCs Continue to Pick up Steam. (PubMed, Cancer Discov)
    Twenty-five years ago, the FDA gave the first approval to an antibody-drug conjugate (ADC), the CD33-targeting gemtuzumab ozogamicin for acute myeloid leukemia. As the drug faced setbacks and redemption-it was withdrawn in 2010 following poor phase III trial results but reapproved in 2017 at a lower dose-a surge of pharmaceutical interest in ADCs has yielded newly approved agents and new strategies for developing them.
    Journal
    |
    CD33 (CD33 Molecule)
    |
    Mylotarg (gemtuzumab ozogamicin)
    3ms
    Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia (clinicaltrials.gov)
    P2, N=151, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    RARA (Retinoic Acid Receptor Alpha) • PML (Promyelocytic Leukemia)
    |
    Mylotarg (gemtuzumab ozogamicin) • Vesanoid (tretinoin) • arsenic trioxide
    3ms
    MM1YA-A04: Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MyeloMATCH Treatment Trial) (clinicaltrials.gov)
    P2, N=162, Not yet recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2028 --> Nov 2027 | Initiation date: Nov 2025 --> Feb 2026 | Trial primary completion date: Jul 2028 --> Nov 2027
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    Venclexta (venetoclax) • cytarabine • Mylotarg (gemtuzumab ozogamicin) • daunorubicin • Starasid (cytarabine ocfosfate)
    3ms
    MCC-21450: CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML (clinicaltrials.gov)
    P1, N=18, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Nov 2025 --> Apr 2027 | Trial primary completion date: Nov 2025 --> Apr 2027
    Trial completion date • Trial primary completion date
    |
    CD33 (CD33 Molecule)
    |
    Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    3ms
    Where do immunotherapies stand in management of acute leukemia in adults? (PubMed, Hematology Am Soc Hematol Educ Program)
    Blinatumomab and inotuzumab ozogamicin have become established treatments, enhancing remission rates, measurable residual disease clearance, and overall survival in relapsed/refractory disease, and these agents, are now increasingly incorporated into frontline therapy...In acute myeloid leukemia (AML), gemtuzumab ozogamicin has shown significant clinical benefits, particularly in molecularly defined subsets...This review highlights how immunotherapy has reshaped treatment paradigms across acute leukemias, underscoring successful experiences in B-ALL. These insights emphasize the need for continued innovation to overcome existing hurdles in AML and T-ALL, ultimately aiming to enhance patient outcomes and quality of life.
    Review • Journal • IO biomarker
    |
    CD5 (CD5 Molecule) • CD7 (CD7 Molecule)
    |
    Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • Mylotarg (gemtuzumab ozogamicin)
    3ms
    AAML1831: A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations (clinicaltrials.gov)
    P3, N=1186, Recruiting, Children's Oncology Group | Trial completion date: Sep 2027 --> Jun 2029 | Trial primary completion date: Sep 2027 --> Jun 2029
    Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    Xospata (gilteritinib) • etoposide IV • methotrexate • Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • mitoxantrone • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • Starasid (cytarabine ocfosfate) • dexrazoxane