A First-in-human Study to Assess OT-C001 (Amplified/Activated Allogenic Natural Killer Cells) in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

Exclusion Criteria

• •Receive concomitantly any antitumor-directed drug therapy
• •Any vaccination with live virus vaccines before or during treatment
• •With severe atopic predisposition who need a treatment with monoclonal antibodies, allergen immunotherapy, or long-term systemic corticosteroids
• •Major surgery within 3 weeks
• •With rapidly progressing disease that includes massive uncontrolled pleural, pericardial, or peritoneal effusions, pulmonary lymphangitis, and over 50% liver involvement
• •Ongoing immune-related tocivities or adverse events grade \>1 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy
• •Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months
• •Primary or secondary immune deficiency
• •Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment
• •Seropositive (except after vaccination or confirmed cure for hepatitis) for HIV, HBV, or HCV
• •Clinically significant cardiac disease including heart failure, uncontrolled hypertension, pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 12 months
• •Dementia or altered mental status that would prohibit informed consent
• •Other malignancy within the last 3 years except adequately treated nonmelanoma skin cancer, in situ carcinoma of the uterine cervix, or myelodysplastic syndromes