Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Lauren C. Pinter-Brown, MD

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 will enroll patients with relapsed/refractory non-Hodgkin lymphoma of B-cell origin and is conducted in two phases. The primary objectives of Phase 1 are as follows: 1) to evaluate the safety of AB-101 given alone or in combination with rituximab or in combination with bendamustine and rituximab; 2) to evaluate the potential clinical activity of AB-101 when given in combination with rituximab or in combination with bendamustine and rituximab (combination cohorts only); and 3) to identify the recommended Phase 2 dose (RP2D). The primary objective of Phase 2 is to determine whether AB-101 in combination with rituximab or in combination with bendamustine and rituximab has anti-cancer activity in patients.

Patients will be assigned to receive either AB-101 alone as monotherapy, in combination with rituximab or in combination with bendamustine and rituximab . All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and tumor response. Patients receiving AB-101 in combination with rituximab may receive up to 3 additional cycles of treatment. Patients receiving AB-101 in combination with bendamustine and rituximab may receive up to 5 additional cycles of treatment.

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 With Immunotherapy in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma of B-Cell Origin.

Keywords

Non Hodgkin Lymphoma, lymphoma, NHL, cell therapy, rituximab, NK cell, bendamustine, Non-Hodgkin Lymphoma, Cyclophosphamide, Bendamustine Hydrochloride, 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. The following are permitted: Prior autologous hematopoietic stem cell transplantation, prior treatment with FDA-approved CAR-T therapy, and/or prior treatment with an investigational agent.
  • Patient must have disease that allows for response assessment using the Lugano classification criteria.
  • Ability to understand and sign the ICF.

You CAN'T join if...

  • Active CNS lymphoma or CNS involvement unless there is a history of at least 3 months of sustained remission of treated disease.
  • History of clinically significant structural cardiac disease.
  • 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.
  • Prior allogeneic stem cell transplant.
  • Positive HIV PCR test
  • Positive for Hepatitis B or Hepatitis C
  • Females of childbearing potential must be willing and able to use appropriate contraception for duration of trial and for 6 months following final AB-101 dose. Males must be sterile or commit to using appropriate contraception until at least 4 months following lymphodepleting chemotherapy.
  • Individuals who are pregnant or lactating are ineligible.

Locations

  • University of California, Irvine accepting new patients
    Orange California 92868 United States
  • University of California San Diego Moores Cancer Center accepting new patients
    San Diego California 92093 United States

Lead Scientist at UC Irvine

  • Lauren C. Pinter-Brown, MD
    Health Sciences Professor, Medicine, School of Medicine. Authored (or co-authored) 61 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Artiva Biotherapeutics, Inc.
ID
NCT04673617
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 93 study participants
Last Updated