Study on MK-1045 for Treating Non-Hodgkin Lymphoma
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT07519772
This clinical trial is exploring a new immunotherapy treatment, MK-1045, for two types of non-Hodgkin lymphoma: follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). The study aims to determine if MK-1045 is safe and effective in shrinking or eliminating these cancers.
Patient Parameters
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Program Overview
Researchers are testing a new treatment called MK-1045 for two types of non-Hodgkin lymphoma (NHL): follicular lymphoma (FL), which grows slowly, and diffuse large B-cell lymphoma (DLBCL), which grows quickly. NHL affects the lymphatic system, part of the immune system, and can cause swollen lymph nodes. MK-1045 is an immunotherapy, meaning it helps the immune system fight cancer. The study's main goals are to see if MK-1045 is safe, if people can tolerate it, and if it helps reduce or eliminate the cancer.
Eligibility Criteria
Inclusion Criteria
- Have non-Hodgkin lymphoma (NHL) that has returned after treatment or did not respond to at least two previous treatments.
- Have a confirmed diagnosis of follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL).
- For DLBCL patients: must have progressed after or be ineligible for transplant and CAR-T therapy.
- Provide a tumor tissue sample, either from previous tests or a new biopsy.
- If previously treated with CD19-targeting therapy, must show CD19 expression in a new biopsy after the cancer progressed.
- If living with HIV, must have it well-controlled with medication.
- If previously infected with hepatitis B or C, must have an undetectable viral load and be on antiviral therapy.
- Have cancer that can be measured by scans according to specific criteria.
Exclusion Criteria
- Have had a solid organ transplant.
- Have or had significant central nervous system (CNS) diseases.
- Have a history of serious heart or blood vessel diseases.
- Have had a stem cell transplant with complications like graft-versus-host disease (GVHD) or need ongoing treatment for GVHD.
- Have HIV with a history of certain related diseases.
- Have received a live vaccine within 30 days before starting the study.
- Have had CAR-T therapy within 3 months before starting the study.
- Have another active cancer that needed treatment in the past 2 years.
- Have active CNS lymphoma.
- Have an autoimmune disease needing treatment in the past 2 years.
- Have an active infection needing treatment.
- Have a history of severe bleeding disorders.
- Have not fully recovered from major surgery or have ongoing complications.
- Have primary mediastinal B-cell lymphoma.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| SCRI Oncology Partners ( Site 0100) | 37203 | Nashville | Tennessee |
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