Non Hodgkin Lymphoma Clinical Trial
AB-101 as Monotherapy and In Combination With Rituximab in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Summary
AB-101 is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that are known to kill cancer cells.
This clinical trial is conducted in two phases. The primary objective of Phase 1 is to test the safety of AB-101 given alone or in combination with rituximab. The primary objective of Phase 2 is to determine if AB-101 in combination with rituximab has activity in patients with relapsed/refractory Non-Hodgkin lymphoma of B-cell origin.
Patients will receive eight weekly doses of AB-101 followed by scheduled assessments of overall health and tumor response.
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of indolent or aggressive NHL of B-cell origin
Patient must have progressed or demonstrated intolerance to at least two lines of FDA-approved therapies, one of which must have included anti-CD20 monoclonal antibody therapy. Prior hematopoietic stem cell transplantation or treatment with FDA-approved CAR-T therapy is permitted.
Patient must have disease that allows for response assessment using the Lugano Classification criteria.
For Group 2 patients, confirmed CD20-positive disease
Exclusion Criteria:
Active CNS lymphoma or CNS involvement
Cardiac impairment with symptoms of New York Heart Association Classification of III or IV
Cardiac ejection fraction of < 45% on echocardiogram or MUGA scan at screening assessment
Inadequate pulmonary function
History of a solid organ allograft, or an inflammatory or autoimmune disease likely to be exacerbated by IL-2
Ongoing uncontrolled systemic infections
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There are 10 Locations for this study
Orange California, 92868, United States More Info
Principal Investigator
San Diego California, 92093, United States More Info
Principal Investigator
Atlanta Georgia, 30342, United States More Info
Principal Investigator
Chicago Illinois, 60612, United States More Info
Principal Investigator
Iowa City Iowa, 52242, United States More Info
Principal Investigator
Louisville Kentucky, 40241, United States More Info
Principal Investigator
Portland Oregon, 97239, United States More Info
Principal Investigator
Philadelphia Pennsylvania, 19111, United States More Info
Principal Investigator
Dallas Texas, 75246, United States More Info
Principal Investigator
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