Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorC. Babis Andreadis

About this trial

This study will assess safety and feasibility of infusing genetically modified autologous T cells transduced to express a chimeric antigen receptor targeting the B cell surface antigen Cluster of Differentiation 19 (CD19).

Eligibility criteria

Qualifiers

Participants must have a diagnosis of relapsed or refractory Burkitt Lymphoma

Participants with Burkitt lymphoma must have relapsed or failed to respond to at least 1 prior line of multiagent chemoimmunotherapy with prior exposure to both an anti-CD20 antibody agent and an anthracycline.

No significant circulating disease, defined as an elevated total lymphocyte count above the upper limit of normal (ULN) due to the presence of malignant cells.

Participants with Burkitt Lymphoma must have Positron Emission Tomography (PET)-positive disease according to "Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification"

Disqualifiers

Autologous transplant within 6 weeks of planned CAR-T cell infusion.

Recipient of prior CAR-T cell therapy targeting CD19 outside of this protocol.

Active other malignancy, other than non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, or breast).

Human immunodeficiency virus (HIV) seropositivity.

Trial design

Treatments tested in this trial

  • Fludarabine
  • Cyclophosphamide
  • anti-CD19 CAR-T cells

Treatment groups

36 Participants
are divided into 2 treatment groups

Sponsors and collaborators

C. Babis Andreadis

Lead sponsor

University of California, San Francisco

Sponsor institution

University of California, Davis

Collaborator