drugset / Trial / NCT05579132

A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)

NCT05579132

Phase 1/2 Recruiting 203 enrolled MSD R&D (China) Co., Ltd.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2022-11-01
Primary completion
2028-06-30
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-1045 Other / unclassified 320 ug Intravenous
Subject MK-1045 Other / unclassified 600 ug Intravenous
Subject MK-1045 Other / unclassified 60000 ug Intravenous
Subject MK-1045 Other / unclassified 120000 ug Intravenous