NCT06189391

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

An Open-Label, Dose Escalation Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of MK-1045 (CN201) in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: MSD R&D (China) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Researchers are looking for new ways to treat people with relapsed or refractory B-Cell Non-Hodgkin Lymphoma (B-NHL). B-cells are a type of white blood cells that make antibodies and help fight infections. Non-Hodgkin Lymphoma is a type of cancer in the lymphatic system causing enlarged lymph nodes and/or organs in belly or chest. Relapsed means a disease or condition comes back after treatment Refractory means a disease does not respond to treatment or stops responding to a treatment. MK-1045, the study medicine, is designed to treat relapsed or refractory B-NHL. MK-1045 is an immunotherapy, which is a treatment that helps the immune system fight cancer. This is the first study in which MK-1045 will be given to people. The goal of this study is to learn about: * The safety of MK-1045 and how well people tolerate it. * The highest dose of MK-1045 that is well tolerated. * How well MK-1045 works to treat relapsed or refractory B-NHL.

Conditions

• Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	MK-1045	IV infusion

Timeline

• Start date: 2021-03-16
• Primary completion: 2028-09-30
• Completion: 2029-03-30
• First posted: 2024-01-03
• Last updated: 2026-03-19

Locations

15 sites across 1 country: China