AB-101 as Monotherapy and In Combination With Rituximab in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
A Multi-Center, Open-Label, Phase 1/2 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-101 Monotherapy and AB-101 Plus Rituximab in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma of B-Cell Origin
  • Phase

    Phase 1/Phase 2
  • Study Type

  • Status

  • Study Participants

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.
Study Started
Mar 29
Primary Completion
Jun 30
Study Completion
Jun 30
Last Update
Jun 02

Drug AB-101

NK cell therapy

Drug Rituximab

Anti-CD20 antibody therapy

Drug Interleukin-2

Immune cytokine

Drug Cyclophosphamide

Lymphodepleting chemotherapy

Drug Fludarabine

Lymphodepleting chemotherapy

Dose confirmation of AB-101 as monotherapy and in combination with rituximab (Phase 1) Experimental

Indolent NHL arm--AB-101 given with rituximab to patients with indolent B-cell NHL (Phase 2) Experimental

Aggressive NHL arm--AB-101 given with rituximab to patients with aggressive B-cell NHL (Phase 2) Experimental


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
No Results Posted