eligibility_summary
Eligibility: CD19+ B-ALL, ECOG 0-2, >12-week survival, ≥5% marrow blasts, refractory/relapsed Ph– (incl post-HSCT) or Ph+ after ≥1 TKI failure/intolerance or T315I, recovered AEs, adequate organs, contraception/negative pregnancy test. Exclusions: Burkitt’s, recent anticancer therapy/transplant/surgery, active GVHD/CNS disease, CV disease/QTc, mAb/Ig allergy, prior CD19 with ADA, steroids/immunosuppression, active HBV/HCV/HIV/infections/effusions, pregnancy, poor compliance/serious illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drug/intervention: YK012, a bispecific T-cell–engager antibody (immunotherapy) given IV once weekly. Mechanism of action: Bridges B cells and T cells, binding CD19 on B cells and engaging T cells to trigger T-cell activation and a cytotoxic response against CD19-expressing cells. Targets: CD19+ B-ALL blasts (B-lineage cells) and T-cell effector activation pathways leading to tumor cell lysis. Context: Phase Ib/II, open-label monotherapy evaluating safety, PK, and preliminary efficacy in relapsed/refractory CD19+ B-ALL.