Ph I/II Study of E7777 Prior to CAR-T for R/R LBCL

Exclusion Criteria

• •Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to study enrollment to rule out pregnancy. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing)
• •Known bone marrow involvement, if history of bone marrow involvement must have a BM biopsy to rule-out current involvement
• •Prior allogeneic transplant
• •Ocular disease or complaints visual acuity impairment, color or shape distortion, or blurred vision - potential participants are required to have an ophthalmological examine as part of screening
• •Active CNS involvement by malignancy (history of CNS disease with negative CSF by flow cytometry and/or stable findings on brain MRI are acceptable)
• •Uncontrolled active hepatitis B or hepatitis C
• •Active or inactive HIV infection
• •Untreated active bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to enrollment)
• •History of heart failure or pulmonary edema, evidence of pleural effusion or active lower extremity edema
• •Uncontrolled unstable angina and/or myocardial infarction within 3 months of enrollment
• •Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion