OncoMatch/Clinical Trials/NCT05579132
A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)
Is NCT05579132 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies MK-1045 for acute lymphoblastic leukemia.
Treatment: MK-1045 — Researchers are looking for new ways to treat people with a type of blood cancer called precursor B-cell Acute Lymphoblastic Leukemia (B-ALL) that is relapsed- the cancer has come back after treatment, or refractory - the current treatment has stopped working to slow or stop cancer growth. This study will have two parts. In the first part (dose escalation phase) the goal is to learn about the safety of a study treatment, MK-1045, and to find the best dose level of MK-1045 that is tolerated and may work to treat B-ALL. In the second part (Phase II) researchers want to learn how well MK-1045 works to treat B-ALL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Allowed: ABL1 fusion
Participants with Ph-positive B-ALL who have received 2 (or more) tyrosine kinase inhibitors (TKIs) and meet the refractory/relapse criteria above or, those with the T315I mutation
Allowed: ABL1 T315I
those with the T315I mutation
Prior therapy
Must have received: tyrosine kinase inhibitor
Participants with Ph-positive B-ALL who have received 2 (or more) tyrosine kinase inhibitors (TKIs) and meet the refractory/relapse criteria above
Cannot have received: anti-CD19 therapy
Received anti-CD19 therapy within 3 months prior to entering the study
Cannot have received: allogeneic HSCT
Received allogeneic HSCT within 12 weeks prior to entering the study
Cannot have received: CAR-T cell therapy
Received prior treatment with chimeric antigen receptor T cell (CAR-T) within 3 months prior to entering the study
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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