Clinical Trial TitleMultiple dose regimens of MT-3724 with lenalidomide for the treatment of patients with relapsed/refractory diffuse large B-cell (DLBCL) non-Hodgkin’s lymphoma.
Clinical Trial Protocol Description:
Lymphoma is the most common blood cancer. Lymphoma occurs when cells of the immune system called lymphocytes, a type of white blood cell, grow and multiply uncontrollably. Recurrent disease is the term used to describe disease that returns after an initial remission. Refractory disease is the term used to describe disease that does not fully respond to initial treatment.
MT-3724 is an immunotoxin which is an antibody linked to a toxic substance. Some immunotoxins can bind to cancer cells and kill them. MT-3724 targets the CD20 cell surface antigen present in a variety of lymphomas and leukemias.
Lenalidomide is a thalidomide analog with potential anti-cancer activity. It is approved by the FDA for the treatment of multiple myeloma, Mantle Cell Lymphoma and anemia due to myelodysplastic syndromes.
The study will be conducted in two sequential parts: Part 1 and Part 2. Part 1 will include MT-3724 dose escalation to identify the maximum tolerated dose (MTD) of MT-3724 in combination with fixed standard doses of lenalidomide. Part 2 is the MTD Expansion Cohort. The purpose of Part 2 is to confirm the safety and tolerability of the MTD (or a maximum dose of 50 μg/kg) of MT-3724 given in combination with Lenalidomide. Part 2 can start only after the MTD of MT-3724 in combination with lenalidomide is declared in Part 1. Participants may be treated in one part of the study only.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have B-cell non-Hodgkin’s lymphoma (NHL) that has returned or is not responding to treatment.
- Have received all available approved therapies for NHL.
- Have adequate bone marrow, kidney and liver function.
You will be excluded from the study if any of the following criteria apply to you:
- Have evidence of a new or growing brain or spinal metastases during screening.
- Have had an allogeneic hematopoietic stem cell transplant within 180 days before the start of treatment.
- Have acute or chronic Graft versus Host Disease.
- Have significant cardiovascular disease.
- Have hypersensitivity to any of the study drugs.
This is a partial list of inclusion and exclusion criteria.