Study on AB-101 Alone and with Immunotherapy for Patients with Relapsed or Hard-to-Treat B-Cell Non-Hodgkin Lymphoma

Sponsor: Artiva Biotherapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04673617

Provider View

This clinical trial is testing a new treatment called AB-101, which uses special immune cells known as natural killer (NK) cells, to see if it can help patients with B-cell Non-Hodgkin Lymphoma that has returned or is not responding to other treatments. The study will explore the safety and effectiveness of AB-101 alone and in combination with other cancer drugs.

Patient Parameters

Program Overview

AB-101 is a new treatment made from natural killer (NK) cells, a type of white blood cell that can kill cancer cells. This study is for patients with B-cell Non-Hodgkin Lymphoma that has come back or is not responding to other treatments. The trial has two phases. In Phase 1, the main goals are to check the safety of AB-101 when given alone or with other drugs like rituximab and bendamustine, and to find the best dose for future studies. In Phase 2, the focus is on seeing if AB-101 combined with these drugs can effectively fight cancer. Patients will receive AB-101 alone or with other drugs and will have regular health checks and tumor assessments. Some patients may receive multiple cycles of treatment depending on their group.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of aggressive B-cell Non-Hodgkin Lymphoma, including specific types like DLBCL.
  • Have tried at least two different treatments approved by the FDA, including one with an anti-CD20 antibody.
  • Previous treatments like stem cell transplants or CAR-T therapy are allowed if the cancer did not progress within 120 days after these treatments.
  • The cancer must be measurable using specific medical criteria.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Have active cancer in the central nervous system unless it has been in remission for at least 3 months.
  • Have significant heart problems or a heart function below 45%.
  • Have poor lung function.
  • Have had a solid organ transplant or certain autoimmune diseases.
  • Have uncontrolled infections or test positive for HIV, Hepatitis B, or Hepatitis C.
  • Have had an allogeneic stem cell transplant.
  • Women who can become pregnant must use birth control during the study and for 6 months after. Men must use birth control until 90 days after the last dose.
  • Cannot be pregnant or breastfeeding.
  • Have had a previous genetically modified cell therapy and the cancer progressed within 120 days after treatment.

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