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    DRUG CLASS:

    CD33-targeted antibody-drug conjugate

    Related drugs:
    16d
    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, Recruiting, Bristol-Myers Squibb Services Unlimited Company | Not yet recruiting --> Recruiting
    Enrollment open
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    Venclexta (venetoclax) • azacitidine
    26d
    A Study To Learn About the Safety Medicine (Called Mylotarg) In People With Acute Myeloid Leukemia (clinicaltrials.gov)
    P=N/A, N=165, Recruiting, Pfizer | Trial completion date: Apr 2027 --> Jul 2027 | Trial primary completion date: Apr 2027 --> Jul 2027
    Trial completion date • Trial primary completion date
    |
    CD33 (CD33 Molecule)
    |
    CD33 positive
    |
    Mylotarg (gemtuzumab ozogamicin)
    1m
    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
    1m
    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)
    1m
    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)
    2ms
    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
    2ms
    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)
    3ms
    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)
    3ms
    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)
    4ms
    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
    4ms
    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)
    4ms
    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)