A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

Inclusion Criteria

• 18 years or older
• Provides voluntary written informed consent
• Relapsed or refractory large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia (CLL)
• Measurable disease according to Lugano 2014 criteria (LBCL) or iwCLL 2018 (CLL).
• No serious concomitant diseases or active/uncontrolled infections
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ function
• Patients who have previously received CD19-directed therapy must have biopsy confirming CD19 expression following completion of prior CD19-directed therapy.

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 CAR T-cell therapy in CAR T-exposed subjects)
• History of or active human immunodeficiency virus (HIV)
• Active hepatitis B or C
• Systemic autoimmune or 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.