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 (Jun 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
Treatments studied
Other
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive expression (positive)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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.
Frequently asked questions
Is NCT06189391 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-CD3/CD19 bispecific antibody, chemotherapy, anti-CD20 antibody disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positive expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages