Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion
Principal Investigator
by Ayad Hamdan, M.D. (ucsd)
Photo of Ayad Hamdan
Ayad Hamdan

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

Lead Scientist at University of California Health

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