UCD19 CAR T Cells for the Treatment of Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Inclusion Criteria

• Provision of signed and dated informed consent form (ICF)
• Stated willingness to comply with all study procedures and availability for the duration of the parent study and the long-term follow-up observational study
• Male or non-pregnant, non-lactating females, aged 18 to 80 years
• Performance status according to the Eastern Cooperative Oncology Group =< 2
• Failed two or more lines of systemic therapy and no available standard of care
• Unable to receive commercially available CD19 CAR T Cells
• Relapsed or primary refractory CD19 positive (i.e. CD19 expressing) B-NHL of the following types as confirmed by either flow cytometry, immunohistochemistry (IHC), or both: * Diffuse large B-cell lymphoma (DLBCL) * Burkitt lymphoma * Intermediate lymphoma between Burkitt and DLBCL * Primary mediastinal B-cell lymphoma (PMBL) * Follicular lymphoma * Mantle cell lymphoma (MCL) * Marginal zone lymphoma (MZL) * High grade B cell lymphoma * High grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements * Transformed lymphoma
• No active graft-versus-host disease (GvHD)
• In women of childbearing potential, willingness to use effective means of birth control for 1 year after UCD19 CAR T Cell infusion

Exclusion Criteria

• Prior therapies: * Received monoclonal antibody therapy within 14 days of the apheresis; or * Received immunomodulatory drugs (lenalidomide, tyrosine kinase inhibitors) within 14 days of the apheresis; or * Received corticosteroids more than 7.5 mg/day within 14 days of the apheresis (physiologic replacement allowed up until apheresis, as clinically indicated); or * Allogeneic hematopoietic stem cell transplant with 90 days (immunosuppressive therapy for at least 4 weeks) of apheresis; or * Donor lymphocyte infusion within 4 weeks of apheresis; * CD3 count < 0.15 x 10^6 cells/mL
• Severe psychiatric illness that could impede the participant’s ability to provide informed consent and/or adhere to the parent protocol and/or the long-term follow-up protocol
• Active human immunodeficiency virus (HIV) (acquired immune deficiency syndrome) or history of HIV infection, as directed by schedule or if known
• Active hepatitis B or hepatitis C infection
• Diffusion capacity of the lungs for carbon monoxide < 40% predicted prior to lymphodepletion
• Left ventricular ejection fraction < 40% (evaluated by echocardiogram [ECHO] or multigated acquisition scan [MUGA]) prior to lymphodepletion
• Transaminases > 5 x upper limit of normal prior to lymphodepletion
• Serum bilirubin > 4 mg/dL prior to lymphodepletion
• Serum creatinine > 1.6 mg/dL or measured creatinine clearance < 50 mL/min prior to lymphodepletion
• Active infection that is unresponsive to antimicrobial therapy prior to lymphodepletion
• Females planning to become pregnant during the course of the study
• Unwillingness or inability to comply with study visits and study procedures for the entire duration of study participation
• Unsuitable for cellular therapy for any reason, in the opinion of the Investigator
• Any prior gene therapy, including prior CAR T cell therapy
• Active central nervous system (CNS) disease