Trial | NCT04673617  Report issue

Title

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

    Interventional

  • Status

    Recruiting

  • Study Participants

    60
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
2021
Primary Completion
Jun 30
2023
Anticipated
Study Completion
Jun 30
2023
Anticipated
Last Update
Jun 02
2022

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

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
No Results Posted