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    DRUG CLASS:

    CD22-targeted antibody-drug conjugate

    Related drugs:
    1d
    ALLight: Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P1/2, N=83, Recruiting, AstraZeneca
    Trial initiation date
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    CD22 (CD22 Molecule)
    |
    CD22 positive
    8d
    Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO) (clinicaltrials.gov)
    P2, N=25, Suspended, University of Chicago | Recruiting --> Suspended
    Trial suspension
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD22 (CD22 Molecule)
    |
    dasatinib • Iclusig (ponatinib) • Besponsa (inotuzumab ozogamicin) • vincristine
    11d
    A041703: Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=84, Recruiting, National Cancer Institute (NCI) | N=64 --> 84
    Enrollment change
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD22 (CD22 Molecule)
    |
    CD22 positive
    |
    Iclusig (ponatinib) • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    21d
    International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020) (clinicaltrials.gov)
    P3, N=750, Not yet recruiting, Charite University, Berlin, Germany
    New P3 trial
    |
    CD22 (CD22 Molecule)
    |
    CD19 positive • CD22 positive
    |
    Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    23d
    Ph-Negative Acute Lymphoblastic Leukemia in the Older Adults: Biology, Therapeutic Strategies and Unmet Needs. (PubMed, Eur J Haematol)
    In this context, monoclonal antibodies such as blinatumomab and inotuzumab ozogamicin (InO), used alone or in combination with reduced-intensity chemotherapy, have emerged as promising frontline approaches capable of deep remissions with improved tolerability. Across all treatment strategies, comprehensive geriatric assessment appears more informative than performance status alone in predicting tolerability and outcome, supporting its integration into trial design and routine decision-making. Overall, the refinement of immunotherapeutic approaches, coupled with biologically and geriatrically tailored treatment algorithms, offers the most promising avenue to improve long-term outcomes for older patients with ALL.
    Review • Journal • IO biomarker
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    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    1m
    Efficacy and Safety of Olverembatinib Plus Inotuzumab Ozogamicin as First-Line Consolidation Therapy Followed by HSCT in Ph+ ALL (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China
    New P2 trial
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD22 (CD22 Molecule)
    |
    Besponsa (inotuzumab ozogamicin) • Nailike (olverembatinib)
    1m
    A041501: Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P3, N=310, Suspended, Alliance for Clinical Trials in Oncology | Trial completion date: Aug 2026 --> Aug 2027 | Trial primary completion date: Mar 2026 --> Mar 2027
    Trial completion date • Trial primary completion date
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD20 (Membrane Spanning 4-Domains A1) • CD22 (CD22 Molecule) • ITGB1 (Integrin Subunit Beta 1)
    |
    CD20 positive • CD22 positive
    |
    Rituxan (rituximab) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Besponsa (inotuzumab ozogamicin) • vincristine • daunorubicin • Oncaspar liquid (pegaspargase) • mercaptopurine • thioguanine
    1m
    Inotuzumab Ozogamicin in Clinical Practice: an Overview of Efficacy, Safety, and Real-World Applications. (PubMed, Curr Hematol Malig Rep)
    Despite recent advancements, patients with B-cell ALL tend to have poorer outcomes, especially in the adult population. Future research and larger scale prospective studies are indicated to evaluate the efficacy of InO in different lines of therapy.
    Review • Journal • Real-world evidence
    |
    CD22 (CD22 Molecule)
    |
    Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    2ms
    D9890C00001: A trial to learn how safe AZD4512 is with and without other cancer drugs and how it works in the bodies of people with B-cell non-Hodgkin lymphoma (B-NHL) (2025-522371-29-00)
    P1/2, N=12, Recruiting, AstraZeneca AB
    New P1/2 trial
    2ms
    ALLight D9891C00001: A trial to learn how safe AZD4512 is and how it works in the bodies of people with B-cell acute lymphoblastic leukemia (B-ALL) (2025-522372-93-00)
    P1/2, N=13, Recruiting, AstraZeneca AB
    New P1/2 trial
    2ms
    IntReALL BCP 2020 International Study for Treatment of Childhood Relapsed Precursor B-cell ALL 2020 (2023-509392-17-00)
    P2/3, N=765, Not yet recruiting, Charite Universitaetsmedizin Berlin KR
    New P2/3 trial
    |
    CD22 (CD22 Molecule)
    |
    CD19 positive • CD22 positive
    |
    cytarabine • Blincyto (blinatumomab) • etoposide IV • Besponsa (inotuzumab ozogamicin) • vincristine • idarubicin hydrochloride • mitoxantrone • mercaptopurine • vindesine
    2ms
    AALL1732: Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy (clinicaltrials.gov)
    P3, N=5951, Recruiting, Children's Oncology Group | Trial completion date: Mar 2030 --> Mar 2032 | Trial primary completion date: Mar 2030 --> Mar 2032
    Trial completion date • Trial primary completion date
    |
    cytarabine • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • Besponsa (inotuzumab ozogamicin) • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine • Hemady (dexamethasone tablets) • Starasid (cytarabine ocfosfate)