A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies

Inclusion Criteria

• 18 years or older
• Provides voluntary written informed consent
• Relapsed or refractory large B-cell lymphoma (LBCL)
• Measurable disease according to Lugano 2014 criteria
• Confirmed CD22 expression
• No serious concomitant diseases or active/uncontrolled infections
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ function

Exclusion Criteria

• Women who are pregnant or breastfeeding
• Current isolated central nervous system (CNS) involvement
• Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except tumor-infiltrating lymphocytes, CAR-NK cells, T-cell receptor [TCR] fusion constructs, TCR T cells, and CAR T cells)
• History of or active human immunodeficiency virus (HIV)
• Active or chronic hepatitis B, or active hepatitis C
• Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease
• Ongoing CNS disease that would preclude neurologic assessment
• Uncontrolled angina or other acute heart disease
• Currently receiving treatment in another interventional clinical trial.