eligibility_summary
Eligibility: Infants (≤365 days) with newly diagnosed CD19+ ALL or acute undifferentiated leukemia, bilineage/biphenotypic allowed if CD19+, CD19+ mature B-cell ALL eligible only with KMT2A rearrangement, limited prior therapy (≤72h hydroxyurea or cytarabine, ≤1 week steroids, one dose vincristine, one intrathecal), consent required. Exclude: other prior therapy, B-cell ALL without KMT2A, AML, or T-ALL, Down syndrome, lack of guardian consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
TINI 2 (Phase 1/2, single-arm) tests multiagent therapy in infants with newly diagnosed CD19+ ALL, adding blinatumomab and ziftomenib. Blinatumomab: bispecific T-cell engager (BiTE) antibody construct that links CD3 on T cells to CD19 on B-lymphoblasts to induce cytotoxic killing (immunotherapy). Ziftomenib: oral small-molecule menin–KMT2A interaction inhibitor targeting KMT2A-rearranged leukemia transcriptional programs (e.g., HOXA/MEIS1). Backbone drugs/mechanisms: dexamethasone (glucocorticoid, lymphoid apoptosis), mitoxantrone (topoisomerase II inhibitor), PEG-asparaginase (asparagine depletion), bortezomib (proteasome/NF-kB inhibition), vorinostat (HDAC inhibitor), mercaptopurine (thiopurine antimetabolite), methotrexate (antifolate/DHFR inhibitor). Targets/pathways: CD19+ B-precursor blasts, menin–KMT2A axis, DNA replication/purine/folate metabolism, proteasome/NF-kB, HDAC/epigenetic control, and asparagine dependence.