Non Hodgkin Lymphoma Clinical Trial
AB-101 as Monotherapy and With Immunotherapy 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. The following are permitted: Prior autologous hematopoietic stem cell transplantation, prior treatment with FDA-approved CAR-T therapy, and/or prior treatment with an investigational agent.
Patient must have disease that allows for response assessment using the Lugano classification criteria.
Ability to understand and sign the ICF.
Exclusion Criteria:
Active CNS lymphoma or CNS involvement unless there is a history of at least 3 months of sustained remission of treated disease.
History of clinically significant structural cardiac disease.
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.
Prior allogeneic stem cell transplant.
Positive HIV PCR test
Positive for Hepatitis B or Hepatitis C
Females of childbearing potential must be willing and able to use appropriate contraception for duration of trial and for 6 months following final AB-101 dose. Males must be sterile or commit to using appropriate contraception until at least 4 months following lymphodepleting chemotherapy.
Individuals who are pregnant or lactating are ineligible.
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There are 17 Locations for this study
Tucson Arizona, 85719, United States More Info
Principal Investigator
Orange California, 92868, United States More Info
Principal Investigator
San Diego California, 92093, United States More Info
Principal Investigator
Gainesville Florida, 32608, 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
Wichita Kansas, 67214, United States More Info
Principal Investigator
Louisville Kentucky, 40241, United States More Info
Principal Investigator
Detroit Michigan, 48201, United States More Info
Principal Investigator
Lake Success New York, 11042, United States More Info
Principal Investigator
New York New York, 11021, United States More Info
Principal Investigator
Portland Oregon, 97239, United States More Info
Principal Investigator
Philadelphia Pennsylvania, 19107, 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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