Actively Recruiting
A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)
Led by MSD R&D (China) Co., Ltd. · Updated on 2026-03-19
100
Participants Needed
15
Research Sites
419 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with relapsed or refractory B-cell Non-Hodgkin's lymphoma (B-NHL) that is CD19-positive by pathology
- Relapse defined as disease progression after complete or partial response post-treatment
- For diffuse large B-cell lymphoma (DLBCL), relapse after at least two lines of therapy; for others, at least one line
- Refractory includes patients unresponsive to standard care or who failed CAR-T therapy at least 3 months prior
- At least one measurable tumor lesion per Lugano 2014 criteria by CT or MRI
- ECOG performance score of 2 or less and estimated survival over 3 months
- Normal bone marrow, coagulation, liver, kidney, lung, and heart function
You will not qualify if you...
- Any other non-Hodgkin lymphoma type not listed in inclusion
- Prior treatment with anti-CD3/CD19 bispecific antibody before study drug
- Chemotherapy, endocrine, radiotherapy, biologic, or targeted therapy within 2 weeks or 5 half-lives before study drug
- Anti-CD20 or anti-CD19 antibody treatment within 4 weeks before study drug
- Anti-tumor immunotherapy or other investigational drugs within 4 weeks or 5 half-lives before study drug
- Major organ surgery or serious trauma within 4 weeks before study drug
- Systemic corticosteroids over prednisone 10 mg/day or other immunosuppressants within 14 days before study drug
- Use of immunomodulatory agents or Chinese patent/herbal medicines within 14 days before study drug
- Live attenuated vaccine within 4 weeks before study drug
- Central nervous system infiltration or serious CNS diseases
- Prior or current malignancies except certain cured tumors
- Uncontrolled active infections requiring therapy within 3 days before study drug
- Active hepatitis B or C infection
- HIV positive
- Serious cardiovascular or cerebrovascular disease within 6 months
- Previous or current interstitial lung disease
- Acute or active chronic graft-versus-host disease
- Active or history of autoimmune diseases with relapse risk
- Prior immunotherapy causing severe immune-related adverse events
- Unresolved severe non-hematologic adverse reactions from previous therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Fifth Medical Center of PLA General Hospital ( Site 0005)
Beijing, Beijing Municipality, China, 100071
Actively Recruiting
2
Beijing Cancer hospital ( Site 0001)
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
3
The First Affiliated Hospital of Xiamen University ( Site 0011)
Xiameng, Fujian, China, 361000
Actively Recruiting
4
Sun Yat-Sen University Cancer Center ( Site 0003)
Guangzhou, Guangdong, China, 510060
Actively Recruiting
5
The Fourth Hospital of Hebei Medical University. ( Site 0004)
Shijiazhuang, Hebei, China, 050035
Actively Recruiting
6
Henan Cancer Hospital ( Site 0009)
Zhengzhou, Henan, China, 450000
Actively Recruiting
7
The First Affiliated Hospital of Zhengzhou University ( Site 0006)
Zhengzhou, Henan, China, 451161
Actively Recruiting
8
Jiangxi Cancer Hospital ( Site 0007)
Nanchang, Jiangxi, China, 330029
Actively Recruiting
9
The First Hospital Of Jilin University ( Site 0014)
Changchun, Jilin, China, 130021
Actively Recruiting
10
Shandong Cancer Hospital ( Site 0008)
Jinan, Shandong, China, 250117
Active, Not Recruiting
11
Fudan University Shanghai Cancer Center ( Site 0012)
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
12
Zhongshan Hospital,Fudan University ( Site 0013)
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
13
Shanghai East Hospital ( Site 0002)
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
14
Sichuan Cancer Hospital. ( Site 0018)
Chengdu, Sichuan, China, 610041
Actively Recruiting
15
Tianjin Medical University Cancer Institute and Hospital ( Site 0010)
Tianjinc, Tianjin Municipality, China, 300060
Active, Not Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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