Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Non Hodgkin Lymphoma Lymphoma Lymphoma, Non-Hodgkin Cyclophosphamide Rituximab Fludarabine Interleukin-2

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego Moores Cancer Center accepting new patients
    San Diego California 92093 United States
  • Oregon Health Sciences Center accepting new patients
    Portland Oregon 97239 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Artiva Biotherapeutics, Inc.
ID
NCT04673617
Phase
Phase 1/2
Study Type
Interventional
Last Updated