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    DRUG CLASS:

    CD22-targeted antibody-drug conjugate

    Related drugs:
    1d
    A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P4, N=44, Completed, Pfizer | Active, not recruiting --> Completed
    Trial completion
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    CD22 (CD22 Molecule)
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    CD22 positive
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    Besponsa (inotuzumab ozogamicin)
    1d
    Evaluation of multi-antigen targeting ADCC strategies in pediatric BCP-ALL. (PubMed, J Immunother Cancer)
    CD24 therefore emerged as an effective target in BCP-ALL, and the combination of CD24 and CD123 as a potential effective double-targeting strategy. The combination of different recognition modalities (eg, a CAR and CD16) should be tested to determine whether it provides synergistic cytotoxic activity in triple targeting.
    Journal
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • CD24 (CD24 Molecule) • IL3RA (Interleukin 3 Receptor Subunit Alpha) • ADAM10 (ADAM Metallopeptidase Domain 10) • ADAM8 (ADAM Metallopeptidase Domain 8)
    |
    Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    1d
    Impact of TP53 mutations and their variant allele frequency in adults with newly diagnosed acute lymphoblastic leukemia. (PubMed, Blood)
    Patients ≥60 years with Ph-negative B-cell ALL and TP53 VAF ≥45% had poor outcomes, with 4-year event-free survival (EFS) and overall survival (OS) of 28%, driven primarily by increased relapse risk, even among patients treated with frontline inotuzumab ozogamicin (INO) and/or blinatumomab. TP53 persistence at remission occurred in 44% of tested patients and was associated with increased ALL relapse risk. These results demonstrate that TP53 VAF is prognostic in older patients with Ph-negative B-cell ALL; high VAF may increase relapse risk but is not independently associated with survival in younger patients.
    Journal
    |
    TP53 (Tumor protein P53)
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    TP53 mutation • TP53 wild-type
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    Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    3d
    AALL1621: Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=80, Recruiting, Children's Oncology Group | Trial completion date: Mar 2026 --> Dec 2026 | Trial primary completion date: Mar 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    CD22 (CD22 Molecule)
    |
    cytarabine • cyclophosphamide • methotrexate • Besponsa (inotuzumab ozogamicin) • vincristine • leucovorin calcium • Oncaspar liquid (pegaspargase) • Asparlas (calaspargase pegol-mknl) • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • Starasid (cytarabine ocfosfate)
    10d
    NCI-2018-02016: ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P1/2, N=37, Terminated, M.D. Anderson Cancer Center | Active, not recruiting --> Terminated; <75% participation
    Trial termination
    |
    CD22 (CD22 Molecule)
    |
    epratuzumab-cys-tesirine (ADCT-602)
    13d
    Inotuzumab Ozogamicin in the Treatment of MRD+ After HSCT of ALL (clinicaltrials.gov)
    P2, N=42, Recruiting, Sheng-Li Xue, MD | Trial completion date: Aug 2025 --> Aug 2026 | Trial primary completion date: Aug 2025 --> Aug 2026
    Trial completion date • Trial primary completion date • Minimal residual disease
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    ABL1 (ABL proto-oncogene 1) • CD22 (CD22 Molecule)
    |
    Besponsa (inotuzumab ozogamicin)
    14d
    A Multi-center Retrospective Study of INO Treating B-ALL (clinicaltrials.gov)
    P=N/A, N=102, Active, not recruiting, Ruijin Hospital
    New trial
    |
    Besponsa (inotuzumab ozogamicin)
    15d
    The emerging role of immunotherapy in improving outcomes in Down syndrome - associated acute lymphoblastic leukemia: an insightful review. (PubMed, Leuk Lymphoma)
    Recent advances in immunotherapy, including blinatumomab, inotuzumab ozogamicin, and CD19-directed CAR T-cell therapy, have shown significant efficacy and favorable tolerability in pediatric and adult DS-ALL. Emerging approaches incorporating early immunotherapy, MRD-guided treatment, and chemotherapy-free regimens may improve survival and quality of life. Prospective DS-specific trials are essential to optimize therapy and close the outcome gap in this high-risk population.
    Review • Journal • IO biomarker
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    ABL1 (ABL proto-oncogene 1) • CRLF2 (Cytokine Receptor Like Factor 2)
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    Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    15d
    Efficacy and safety of inotuzumab ozogamicin and its combination therapies in acute lymphoblastic leukemia: a systematic review and meta-analysis. (PubMed, Front Oncol)
    Further randomized studies are needed to validate these findings. https://www.crd.york.ac.uk/prospero/, identifier CRD42024619042.
    Retrospective data • Review • Journal
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    CD22 (CD22 Molecule)
    |
    Besponsa (inotuzumab ozogamicin)
    16d
    Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy (clinicaltrials.gov)
    P2, N=55, Recruiting, Institute of Hematology & Blood Diseases Hospital, China | N=31 --> 55
    Enrollment change • Minimal residual disease
    |
    Besponsa (inotuzumab ozogamicin)
    1m
    NCI-2018-02016: ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P1/2, N=37, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=57 --> 37
    Enrollment closed • Enrollment change
    |
    CD22 (CD22 Molecule)
    |
    epratuzumab-cys-tesirine (ADCT-602)
    1m
    Lumi-NHL: A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=91, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open