eligibility_summary
Adults (≥18) with relapsed/refractory CD22+ ALL (incl. Ph+ after ≥1 TKI) or lymphoblastic lymphoma with ≥5% marrow blasts, Salvage 1 late relapses eligible if poor reinduction candidates, ECOG 0–2, adequate renal/hepatic, women need negative pregnancy test. Exclude isolated extramedullary relapse or active CNS leukemia, allo-HSCT or anti-CD22 within 4 mo or active GvHD, history/evidence of VOD/SOS.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 4, single-arm study in Chinese adults with relapsed/refractory CD22+ B‑cell ALL evaluating inotuzumab ozogamicin (Besponsa), an antibody–drug conjugate (humanized anti‑CD22 IgG4 monoclonal antibody linked to the cytotoxic agent calicheamicin). Mechanism: the mAb binds CD22 on B‑lymphoblasts, is rapidly internalized, and releases calicheamicin intracellularly, which binds DNA (minor groove) to cause double‑strand breaks and apoptosis. Targets: CD22 (Siglec‑2) on malignant B cells, downstream pathways include internalization/endosomal trafficking, DNA damage response, and apoptotic cell death. Dosing: IV weekly x3 per 21–28‑day cycle, up to 6 cycles. Objectives: efficacy, safety, PK.