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A Study of ATA3219 for Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

RecruitingPhase 1
2 recruiting sites
Start: Feb 5, 2024
NCTNCT06256484

This trial is currently recruiting participants

2 locations available for registration

Brief Summary

This study is for adults with B-cell non-Hodgkin Lymphoma that has either returned or stopped responding to previous treatments. Researchers are investigating a new type of treatment called ATA3219. This is a special cell therapy that uses T-cells, a type of immune cell, from a healthy donor. These cells are modified in a lab to find and attack cancer cells that have a specific marker called CD19. Before receiving the therapy, participants will get chemotherapy to prepare their bodies. The main goals are to find a safe dose for the new treatment and see how well it works against the lymphoma.

Eligibility

Age Range

18 Years - 120 Years

Gender

All

Healthy Volunteers

Not Accepted

Detailed Criteria

This trial is for adults aged 18 or older with specific types of B-cell non-Hodgkin Lymphoma that have returned or not responded to at least two prior treatments. Participants must have measurable disease, be generally well, and able to stay near the study site for monitoring. Individuals cannot join if they have active lymphoma in the central nervous system, certain heart conditions, active infections, or have received a prior donor stem cell or organ transplant. The study also excludes those who are pregnant or breastfeeding, have a history of other cancers within the last year, or have certain autoimmune disorders.

Inclusion Criteria

  • Aged 18 years or older
  • Confirmed diagnosis of relapsed or refractory B-cell non-Hodgkin Lymphoma, specifically Large B-cell Lymphoma, Follicular Lymphoma Grade 3b, or Mantle Cell Lymphoma
  • Lymphoma has not responded to, or has returned after, at least two previous lines of therapy
  • If a prior autologous stem cell transplant was received, lymphoma must have relapsed within 12 months
  • Have lymphoma that can be measured on scans
  • Must provide a new tumor biopsy if a recent sample is not available
  • If previously treated with a CD19-targeted therapy, must have responded for at least 3 months and still have CD19-positive disease
  • Generally well enough to perform daily activities with some assistance (ECOG performance status of 2 or less)
  • Have adequate organ function
  • Able and willing to provide written informed consent
  • Able to be hospitalized for the initial part of the study
  • Must stay within 1 hour of the study site for 28 days after each infusion

Exclusion Criteria

  • History of HIV, or an active Hepatitis B or C infection
  • History or presence of significant brain or nervous system diseases
  • Unresolved neurological side effects from a previous cell therapy
  • Current graft-versus-host disease (GvHD) or a history of severe GvHD from any prior therapy
  • History of certain heart conditions within the last 6 months, including severe heart failure, heart attack, or unstable angina
  • History of other cancers, unless disease-free for at least 1 year
  • Active lymphoma in the central nervous system (brain or spinal cord), unless it has been successfully treated
  • Active autoimmune or inflammatory conditions that require systemic immunosuppressive drugs or steroids
  • Received a prior stem cell transplant from a donor or a solid organ transplant
  • Have an active, uncontrolled infection or have had a fever within 48 hours of enrollment
  • Have a serious uncontrolled medical or psychiatric condition
  • Recent use of certain therapies, including corticosteroids, specific chemotherapy, live vaccines, or other cancer treatments
  • Currently pregnant or breastfeeding
  • Unable or unwilling to follow the study's procedures
  • Unwilling to use the required methods of contraception during the study
  • Life expectancy of 8 weeks or less
  • For those being considered for a second dose, must not have had a severe, dose-limiting side effect from the first dose

Conditions

Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Interventions

ATA3219

ATA3219 is allogeneic anti-CD19 chimeric antigen receptor T-cell, administered intravenously on Day 1.

DRUG

Trial Locations

2 locations currently accepting registrations. Choose a recruiting location below to register your interest.

AdventHealth Cancer Institute

Orlando, Florida, United States

Active_not_recruiting

Norton Cancer Institute - Saint Matthews

Louisville, Kentucky, United States

Active_not_recruiting

Sidney Kimmel Cancer Center - Jefferson Health

Philadelphia, Pennsylvania, United States

Active_not_recruiting

University of Virgina

Charlottesville, Virginia, United States

Active_not_recruiting

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Recruiting

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Recruiting

Sponsor Information

Lead Sponsor

Atara Biotherapeutics

Type: INDUSTRY