eligibility_summary
Adults (≥18) with Ph+ CML in chronic or accelerated phase (non-blast), on TKI ≥1 year (same TKI ≥6 months and plan to continue ≥6 months), detectable BCR-ABL >0.01% IS within 28 days (4.5-log assay), ECOG 0–2, contraception required if applicable. Exclude: blast crisis, pregnancy/lactation, recent investigational therapy, significant cytopenias or liver/renal dysfunction, HIV/HBV/HCV, immunosuppression, major comorbidity or recent CV/VTE, hypersensitivity, active autoimmune disease, recent other cancer, active infection.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I (withdrawn pre-enrollment) trial in CML with molecular residual disease testing KDS-1001 plus background TKI. Intervention: KDS-1001, an adoptive natural killer (NK) cell therapy (cellular immunotherapy), 1×10^9 NK cells IV on Day 1 of each 14-day cycle for 6 cycles, given while patients continue their BCR-ABL tyrosine kinase inhibitor (e.g., imatinib, dasatinib, nilotinib, bosutinib, ponatinib). Mechanism of action: NK cells aim to eliminate residual BCR-ABL+ leukemic cells via innate cytotoxicity (activation receptors such as NKG2D/NKp30/44/46) and antibody-dependent cellular cytotoxicity via CD16, TKIs inhibit BCR-ABL kinase signaling to suppress leukemic proliferation. Targets: BCR-ABL–positive CML cells (including MRD/leukemic stem cell compartment), pathways include NK cell–mediated cytotoxicity and BCR-ABL signaling. Objective: achieve RT-PCR negativity (MRD-negative).