RecruitingPhase 1NCT06189391

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


Sponsor

MSD R&D (China) Co., Ltd.

Enrollment

100 participants

Start Date

Mar 16, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests MK-1045 (also called CN201), a new investigational drug, in adults with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) — a type of blood cancer that has come back or stopped responding to prior treatments. **You may be eligible if...** - You have a confirmed diagnosis of B-cell non-Hodgkin lymphoma (including DLBCL, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, or related subtypes) that is CD19-positive - Your cancer has returned or has not responded to previous treatments - You meet health and organ function requirements for the trial - You are 18 or older **You may NOT be eligible if...** - Your lymphoma is CD19-negative - You have active brain involvement from lymphoma - You have serious autoimmune conditions or organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMK-1045

IV infusion


Locations(15)

Fifth Medical Center of PLA General Hospital ( Site 0005)

Beijing, Beijing Municipality, China

Beijing Cancer hospital ( Site 0001)

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Xiamen University ( Site 0011)

Xiameng, Fujian, China

Sun Yat-Sen University Cancer Center ( Site 0003)

Guangzhou, Guangdong, China

The Fourth Hospital of Hebei Medical University. ( Site 0004)

Shijiazhuang, Hebei, China

Henan Cancer Hospital ( Site 0009)

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University ( Site 0006)

Zhengzhou, Henan, China

Jiangxi Cancer Hospital ( Site 0007)

Nanchang, Jiangxi, China

The First Hospital Of Jilin University ( Site 0014)

Changchun, Jilin, China

Shandong Cancer Hospital ( Site 0008)

Jinan, Shandong, China

Fudan University Shanghai Cancer Center ( Site 0012)

Shanghai, Shanghai Municipality, China

Zhongshan Hospital,Fudan University ( Site 0013)

Shanghai, Shanghai Municipality, China

Shanghai East Hospital ( Site 0002)

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospital. ( Site 0018)

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital ( Site 0010)

Tianjinc, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06189391


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