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DRUG CLASS:

CD33-targeted antibody-drug conjugate

23h
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
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RARA (Retinoic Acid Receptor Alpha) • PML (Promyelocytic Leukemia)
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Mylotarg (gemtuzumab ozogamicin) • Vesanoid (tretinoin) • arsenic trioxide
3d
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
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Venclexta (venetoclax) • cytarabine • Mylotarg (gemtuzumab ozogamicin) • daunorubicin • Starasid (cytarabine ocfosfate)
3d
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
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CD33 (CD33 Molecule)
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Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
13d
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
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CD5 (CD5 Molecule) • CD7 (CD7 Molecule)
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Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • Mylotarg (gemtuzumab ozogamicin)
16d
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
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FLT3 (Fms-related tyrosine kinase 3)
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Xospata (gilteritinib) • etoposide IV • methotrexate • Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • mitoxantrone • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • Starasid (cytarabine ocfosfate) • dexrazoxane
17d
New P2/3 trial
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Venclexta (venetoclax) • cytarabine • azacitidine • daunorubicin • BL-M11D1
24d
A PBD-dimer containing antibody drug conjugate targeting CCRL2 for high-risk MDS/AML. (PubMed, Res Sq)
The anti-CCRL2 ADC demonstrated strong CCRL2-selective cytotoxicity against cell lines derived from MDS/AML patients with TP53 mutations and erythroid features, surpassing the cytotoxic effects observed with gemtuzumab and PBD-conjugated anti-CD33 and anti-CD123 ADCs...This agent also suppressed the leukemic growth of TP53- mutated MDS/AML cell line xenografts, improving mice survival and decreasing the leukemic burden in patient-derived TP53 -mutated MDS/AML xenografts. In conclusion, our study introduces CCRL2 as a potential new therapeutic target in high-risk MDS/AML.
Journal
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TP53 (Tumor protein P53) • CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha) • CCRL2 (C-C Motif Chemokine Receptor Like 2)
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TP53 mutation
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Mylotarg (gemtuzumab ozogamicin)
29d
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: Nov 2027 --> Apr 2027 | Trial primary completion date: Nov 2027 --> Apr 2027
Trial completion date • Trial primary completion date
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CD33 (CD33 Molecule)
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CD33 positive
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Mylotarg (gemtuzumab ozogamicin)
1m
CPX-351 versus daunorubicin, cytarabine plus gemtuzumab ozogamicin in older adults with non-adverse risk AML: NCRI AML18. (PubMed, Blood)
For patients entering the course-2 randomisation (n=107) survival was equivalent between standard versus intensified CPX doses (P=0.565).In this population of older patients without known adverse-risk cytogenetics, DAGO2 resulted in superior survival compared to CPX. CPX did not benefit those with MDS-related mutations over DAGO2.
Journal
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FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1)
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FLT3 mutation
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Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
1m
CD33 Epitope Editing Unlocks UM171-Expanded Cord Blood Grafts for AML Immunotherapy. (PubMed, Mol Ther)
Combining UM171-mediated expansion with adenine base editing (ABE), we precisely disrupted the P67 epitope of CD33, centered on phenylalanine 21, which is essential for gemtuzumab ozogamicin (GO) binding. Ultra-deep exome sequencing and GUIDE-seq revealed minimal off-target activity. Together, these findings establish CD33 P67 epitope-directed base editing as a precise, scalable strategy to generate immunotherapy-compatible, UM171-expanded CB grafts that safely enable GO integration into post-transplant care.
Journal • IO biomarker
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CD33 (CD33 Molecule)
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Mylotarg (gemtuzumab ozogamicin) • Zemcelpro (dorocubicel)
1m
NCI-2018-01812: Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (clinicaltrials.gov)
P2, N=50, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Nov 2025 --> Nov 2027 | Trial primary completion date: Nov 2025 --> Nov 2027
Trial completion date • Trial primary completion date
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CD33 (CD33 Molecule)
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CD33 positive
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Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
2ms
Trial completion
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FLT3 (Fms-related tyrosine kinase 3) • CD33 (CD33 Molecule)
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CD33 positive
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cytarabine • midostaurin • Mylotarg (gemtuzumab ozogamicin) • daunorubicin • Starasid (cytarabine ocfosfate)