AB-101 as Monotherapy and In Combination With Rituximab in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Artiva Biotherapeutics, Inc.
• Treatments: Cyclophosphamide; Fludarabine; Interleukin-2; Rituximab

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