Actively Recruiting
Phase 1b2 Study of MK-1045 Immunotherapy for Treating Follicular and Diffuse Large B-Cell Non-Hodgkin Lymphoma
Led by Merck Sharp & Dohme LLC · Updated on 2026-08-07
280
Participants Needed
30
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MK-1045, an immunotherapy, in people with two types of non-Hodgkin lymphoma NHL follicular lymphoma FL, which grows slowly, and diffuse large B-cell lymphoma DLBCL, which grows more quickly. NHL is a cancer of the lymphatic system causing swollen lymph nodes. This study aims to assess the safety and tolerability of MK-1045 and to see if it can shrink or eliminate these lymphomas. Participants are randomly assigned to one of four groups receiving different doses or methods of MK-1045 administration. Dosages A, B, and D are given by intravenous IV infusion, while Dosage C is given by subcutaneous SC injection. Treatment lasts for up to approximately one year or until participants stop treatment for any reason. During the study, participants will be monitored for adverse events and treatment side effects, with measurements including tumor response using specific criteria. Blood levels of MK-1045 will also be tracked. The study involves regular visits for infusions and assessments. Participant safety and treatment effects will be followed for up to about 49 months in total.
CONDITIONS
Brief Title
A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Diagnosed with follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL)
- Disease that has relapsed or is refractory after at least 2 prior systemic treatments
- For DLBCL participants: progressed after or ineligible for transplant and CAR-T therapy
- Provided tumor tissue sample (archival or newly obtained)
- Retained CD19 expression in tumor tissue if disease progressed after CD19-targeting therapy
- Well-controlled HIV on antiretroviral therapy if HIV positive
- Undetectable hepatitis B viral load and on antiviral therapy if HBsAg-positive
- Undetectable hepatitis C viral load and treated if history of HCV infection
- Radiographically measurable disease per Lugano Response Criteria
You will not qualify if you...
- Received a solid organ transplant
- Has or had clinically relevant central nervous system diseases
- History of serious cardiovascular or cerebrovascular diseases
- Prior allogenic stem cell transplantation with acute graft-versus-host disease or ongoing chronic GVHD requiring systemic immunosuppression
- HIV infection with history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Received live or live-attenuated vaccine within 30 days before randomization
- Received CAR-T therapy within 3 months before first study dose
- Known additional malignancy progressing or treated within past 2 years
- Active central nervous system lymphoma or involvement
- Active autoimmune disease requiring systemic treatment in past 2 years
- Active infection requiring systemic therapy
- History of severe bleeding disorders
- Not recovered from major surgery or with ongoing surgical complications
- Diagnosis of primary mediastinal B-cell lymphoma
Research Team
T
Toll Free Number
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here