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

a study on Hodgkin's Lymphoma Lymphoma Non-Hodgkin Lymphoma Immunotherapy

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 (including the DLBCL specific cohort) 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 (including DLBCL specific cohort) 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. Patients enrolled into the DLBCL specific cohort receiving AB-101 in combination with rituximab may receive up to 3 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 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) 63 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 108 study participants
Last Updated
Contact us about this trial