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

Launched by MSD R&D (CHINA) CO., LTD. · Oct 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CN201 for patients with a type of cancer called Precursor B-cell Acute Lymphoblastic Leukemia (B-ALL). The trial has two parts: the first part will help determine the best dose of CN201 to use, and the second part will focus on testing how safe and effective that dose is. Researchers believe CN201 could be a promising option for both adults and children who have not responded well to other treatments or have relapsed.

To participate, adults must be at least 18 years old and have a specific type of B-ALL with a certain level of disease in their bone marrow. They need to have had previous treatments that didn't work or have experienced a relapse. Children under 18 can also join if they meet similar criteria. Participants will receive the treatment and be monitored closely by the study team for any side effects and to see how well the treatment works. It's important to note that there are specific health criteria and previous treatment restrictions that could affect eligibility, so potential participants should discuss this with their healthcare provider.

Gender

ALL

Eligibility criteria

• The main inclusion criteria include but are not limited to:
• • Adult participants must be age 18 or older
• • Pediatric participants must be at least 2 years old and less than 18 years old.
• • Diagnosis of precursor B-cell acute lymphoblastic leukemia (B-ALL) and have more than 5% blasts in the bone marrow by morphological assessment
• * Participants with Ph-negative B-ALL with any of the following refractory/relapse criteria:
• • Failure to achieve complete remission after initial induction therapy;
• • Failure to achieve complete remission after salvage treatment;
• • Relapse with first remission duration ≤12 months
• • Second or later relapse
• • Relapse after allogeneic HSCT
• • 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
• The main exclusion criteria include but are not limited to:
• • History of Burkitt's leukemia.
• • Received anti-CD19 therapy within 3 months prior to entering the study
• • Received allogeneic HSCT within 12 weeks prior to entering the study
• • Received prior treatment with chimeric antigen receptor T cell (CAR-T) within 3 months prior to entering the study
• • History or presence of clinically relevant central nervous system (CNS) pathology
• • History of clinically symptomatic metastases to the central nervous system or meninges, or other evidence of uncontrolled metastases to the CNS or meninges
• • History of immunodeficiency, including history of any positive test result for human immunodeficiency virus (HIV) antibody.
• • History of serious cardiovascular and cerebrovascular disease
• • Has active autoimmune diseases that may relapse