Study of 19(T2)28z1xx TRAC-Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell Lymphoma

Inclusion Criteria:

• Age ≥ 18 years of age

• Creatinine ≤1.5 mg/100 ml or creatinine clearance ≥ 45ml/min/m2 , direct bilirubin ≤2.0 mg/100 ml, AST and ALT ≤3.0x upper limit of normal (ULN)

• Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air bypulse oximetry.

• Histologically confirmed DLBCL and large B cell lymphoma, including

• DLBCL, not otherwise specified (NOS), or

• Transformed DLBCL from follicular lymphoma, or

• High-grade B cell lymphoma (excluding Burkitt's lymphoma), or

• Primary mediastinal large B cell lymphoma

AND

• Chemotherapy refractory disease, defined as a failure to achieve at least a partialresponse or disease progression within 12 months to the last therapy, OR

• Disease progression or recurrence in ≤12 months of prior autologous stem celltransplant (ASCT), OR

• Relapsed disease after 2 or more prior chemoimmunotherapies with at least onecontaining an anthracycline and CD20 directed therapy

• Patients need to have radiographically documented disease

Exclusion Criteria:

• ECOG performance status ≥2.

• Pregnant or lactating women. Women and men of childbearing age should use effectivecontraception while on this study and continue for 1 year after all treatment isfinished.

• Active CNS disease

• Impaired cardiac function (LVEF <40%) as assessed by ECHO or MUGA scan.

• Patients with the following cardiac conditions will be excluded:

• New York Heart Association (NYHA) stage III or IV congestive heart failure

• Myocardial infarction ≤6 months prior to enrollment

• History of clinically significant ventricular arrhythmia or unexplainedsyncope, not believed to be vasovagal in nature or due to dehydration ≤6 monthsprior to enrollment

• Patients with HIV or active hepatitis B or hepatitis C infection are ineligible.

• Patients with prior allogeneic hematopoietic stem cell transplant are eligible, ifmore than 3 months from transplant and if patients have no active graft versus hostdisease (GvHD) and not on systemic immunosuppressive therapy.

• Prior CD19-directed therapy including commercially approved or investigational CD19CAR T cells or BiTEs is allowed, as long as expression of CD19 is confirmed by flowcytometry or immunohistochemistry.

• Patients with uncontrolled systemic fungal, bacterial, viral or other infection areineligible.

• Patients with any concurrent active malignancies as defined by malignanciesrequiring any therapy other than expectant observation or hormonal therapy, with theexception of squamous and basal cell carcinoma of the skin.

• Patients with presence of clinically significant neurological disorders such asepilepsy, generalized seizure disorder, severe brain injuries are ineligible.

• Any other issue which, in the opinion of the treating physician, would make thepatient ineligible for the study.