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

• UB-VV111 (Genetic): UB-VV111 is a gene therapy that generates CD19 CAR T cells in the body.
• rapamycin (Drug), also known as Rapamune, sirolimus: Rapamycin is an FDA-approved drug.

Primary outcomes

• Percentage of participants with common adverse events (AEs) [Up to 2 years after UB-VV111 administration]: Percentage of participants with commonly reported AEs overall and by severity

Secondary outcomes

• Overall response rate (ORR) [Up to 2 years after UB-VV111 administration]: Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

1. Women who are pregnant or breastfeeding
2. Current isolated central nervous system (CNS) involvement
3. Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (exceptions include tumor-infiltrating lymphocytes and CAR T cells)
4. History of or active human immunodeficiency virus (HIV)
5. Active hepatitis B or C
6. Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease
7. Ongoing CNS disease that would preclude neurologic assessment
8. Uncontrolled angina or other acute heart disease
9. Currently receiving treatment in another interventional clinical trial.

• Luke Walker, MD, Study director, Umoja Biopharma