Clinical Trial TitleAB-101 as Monotherapy and In Combination with Rituximab in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
National Clinical Trial Number:NCT04673617
Clinical Trial Protocol Description:
B-cell lymphoma is a cancer of B lymphocytes. It is usually aggressive (fast-growing). It is most commonly found in people who are middle-aged or elderly. 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. AB-101 is manufactured from human umbilical cords from healthy newborns and regulated by the FDA for this purpose. It is a cell product made of “natural killer” cells. NK cells are a type of white blood cell that are known to kill cancer cells. This is the first time that AB-101 is being tested in humans.
Approximately 60 participants in total will be included in this study from around 20 cancer centers in the United States. Participants could be in one of 2 different treatments groups; they will only be assigned to one of these groups depending on when they join the study. Group 1 is AB-101 given alone as an injection into a vein (also called an “intravenous injection). For participants in Group 1, AB-101 will be tested at two or more dose levels. The dose a participant receives in Group 1, will be the currently “open” dose level. When the best AB-101 dose is determined, new participants will be enrolled into Group 2.
Group 2 participants will receive AB-101 plus rituximab. Participants in Group 2 will be given a dose of rituximab prior to each dose of AB-101, and AB-101 will be tested at two or more dose levels. The actual AB-101 dose that participants will receive in combination with rituximab in Group 2 will be at the currently “open” dose level. When the best AB-101 dose with rituximab is determined, additional participants will be enrolled at this AB-101 dose level with rituximab.
Each injection of AB-101 will be followed by interleukin-2 (IL-2) given as a subcutaneous (under the skin) injection. The purpose of giving the IL-2 is to support the health and activity of AB-101 in the body. Before a participating subject receives their first dose of AB-101, they will receive 3 days of low-dose chemotherapy drugs.
The study will take place in the Rush University Medical Center’s Cancer Center and the BMT Fast Track Unit.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- You are 18 years or older and weigh more than 88 pounds.
- You have a confirmed diagnosis of indolent or aggressive Non-Hodgkin Lymphoma (NHL) of B-cell origin.
- Your disease must have progressed (gotten worse) or demonstrated intolerance to at least two lines of FDA-approved therapies, one of which must have included an anti-CD20 monoclonal antibody drug.
- You must have a life expectancy of longer than 3 months.
You will be excluded from the study if any of the following criteria apply to you:
- You have active Central Nervous System (CNS) lymphoma, or involvement of the CNS.
- You have history of another life-threatening malignancy within the prior 2 years.
- You have a history of clinically significant structural cardiac disease; history of a myocardial infarction, angina pectoris, acute coronary syndrome, cardiac stenting or coronary artery bypass grafting; history of congestive heart failure.
- You have inadequate pulmonary function.
This is a partial list of inclusion and exclusion criteria.