eligibility_summary
Eligible: Currently enrolled in a Novartis sabatolimab parent study, on treatment and benefiting, compliant with protocol, able to follow visits/procedures, and consented. Ineligible: Not on sabatolimab, permanently discontinued, unresolved toxicities causing dosing hold (may enroll once resolved), pregnant/nursing, unwilling to meet contraception per parent protocol, has local commercial access to sabatolimab. Other protocol-defined criteria may apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 open-label rollover assessing long-term safety of sabatolimab (MBG453) in MDS/CMML. Interventions: sabatolimab (anti–TIM-3 IgG4 monoclonal antibody) alone or with azacitidine or decitabine/INQOVI (oral decitabine/cedazuridine, hypomethylating DNMT inhibitors), venetoclax (oral small‑molecule BCL‑2 inhibitor), and spartalizumab (anti–PD‑1 monoclonal antibody). Mechanisms: TIM‑3 checkpoint blockade to reinvigorate exhausted T cells and potentially target TIM‑3–expressing leukemic stem/progenitor cells, PD‑1 blockade to enhance antitumor T‑cell function, HMAs reduce DNA methylation to re-express silenced genes and increase tumor immunogenicity, venetoclax induces apoptosis in BCL‑2–dependent myeloid blasts. Targeted cells/pathways: CD8+ T cells, myeloid blasts/LSCs, TIM‑3/galectin‑9 axis, PD‑1/PD‑L1, DNA methylation, intrinsic apoptosis (BCL‑2).