Clinical Trial TitleA phase 1b open-label study investigating the safety and pharmacokinetics of administration of subcutaneous blinatumomab for the treatment of relapsed/refractory indolent non-Hodgkin’s lymphoma.
National Clinical Trial Number:NCT02961881
Clinical Trial Protocol Description:
Lymphoma occurs when cells of the immune system called lymphocytes, a type of white blood cell, grow and multiply uncontrollably. Lymphoma may arise in any one of three types of lymphocytes: B lymphocytes (B cells), T lymphocytes (T cells) and natural killer (NK) cells.
Blinatumomab is a monoclonal antibody, a type of protein made in the laboratory that can bind to substances in the body. Monoclonal antibodies are being used to treat cancer. They can be used alone or to carry drugs, toxins, or radioactive substances directly to cancer cells. Blinatumomab possesses two antigen-recognition sites, one for the CD3 complex (a group of T cell surface glycoproteins with the T cell receptor), and one for CD19, a tumor-associated antigen over-expressed on the surface of B-cells. Blinatumomab brings CD19-expressing tumor B-cells, cell-destroying T-lymphocytes, and helper T-lymphocytes together, which may result in cell death of the CD19-expressing B-cell lymphocytes.
The purpose of this study is to examine the effectiveness, safety, and tolerability of blinatumomab injected subcutaneously (just beneath the skin) in participants whose indolent Non-Hodgkin’s Lymphoma has recurred or is difficult to treat.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age old or older.
- Have follicular, marginal zone, lymphoplasmocytic, mantle cell or small lymphocytic lymphoma that has returned or did not respond to at least one prior treatment.
- Have adequate organ and bone marrow function.
You will be excluded from the study if any of the following criteria apply to you:
- Are currently receiving a different investigational treatment for your disease.
- Have a known hypersensitivity to immunoglobulins.
- •Have had an allogeneic stem cell transplantation.
- •Have had anti-CD 19 targeted therapy, CAR-T cell therapy or other cellular therapies before for your disease.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.