OncoMatch/Clinical Trials/NCT06189391
A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)
Is NCT06189391 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies MK-1045 for relapsed or refractory b-cell non-hodgkin lymphoma.
Treatment: MK-1045 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive expression (positive)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-CD20 monoclonal antibody
Participants who are unresponsive to standard of care (e.g., monotherapy or combination therapy containing anti-CD20 monoclonal antibody)
Must have received: autologous hematopoietic stem cell transplantation
Participants who are not eligible for autologous hematopoietic stem cell transplantation (ASCT) and have relapsed PD after receiving ASCT
Must have received: CAR-T cell therapy
Participants who have failed on chimeric antigen receptor T cell (CAR-T) immunotherapy, but the first dose of the study intervention must be at least 3 months after discontinuation of CAR-T therapy, and CD19 positive expression is still present in tumor tissue
Cannot have received: anti-CD3/CD19 bispecific antibody
Has been treated with anti-CD3/CD19 bispecific antibody (BsAb) prior to first dose of study intervention
Cannot have received: chemotherapy
Has received chemotherapy, endocrine therapy, radiotherapy (palliative radiotherapy 2 weeks prior to the first administration of the investigational drug), or biologic therapy, and small molecule targeted agents within 2 weeks prior to the first administration of the investigational drug or within 5 half-lives of the drug, whichever is shorter
Cannot have received: anti-CD20 antibody
Has received anti-CD20 antibody or anti-CD19 antibody within 4 weeks prior to first use of the investigational drug
Cannot have received: anti-CD19 antibody
Has received anti-CD20 antibody or anti-CD19 antibody within 4 weeks prior to first use of the investigational drug
Cannot have received: anti-tumor immunotherapy
Has received anti-tumor immunotherapy or other unlisted clinical study intervention within 4 weeks prior to the first dose of study intervention, or within 5 half-lives of the drug, whichever is shorter
Lab requirements
Blood counts
essentially normal bone marrow function; coagulation function
Kidney function
essentially normal kidney function
Liver function
essentially normal liver function
Cardiac function
essentially normal heart function
Has essentially normal: bone marrow function; coagulation function; liver function; kidney function; lung function; and heart function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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