A Phase 1 Study of UB-VV500 With Rapamycin in Relapsed/Refractory Multiple Myeloma

Inclusion criteria

• 18 years or older
• Provides voluntary written informed consent
• Relapsed or refractory multiple myeloma (MM) following treatment with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody
• Measurable disease following completion of most recent anticancer therapy
• No serious concomitant diseases or active/uncontrolled infections
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ function

Exclusion criteria

• Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis
• Solitary plasmacytomas without evidence of systemic disease
• 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.