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

Launched by UMOJA BIOPHARMA · Jul 25, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called UB-VV111 for patients with certain types of blood cancers, specifically large B-cell lymphoma and chronic lymphocytic leukemia, that have not responded to previous treatments. The study aims to find out how safe this treatment is and how well it works in fighting these cancers. Researchers will gradually increase the dose of UB-VV111 to determine the best amount to use. Patients aged 18 and older who have measurable disease and have experienced a relapse or have not responded to standard treatments may qualify to participate.

If you join the trial, you will receive UB-VV111, and some participants may also receive another medication called rapamycin. Throughout the study, doctors will closely monitor your health to check for side effects and assess how well the treatment is working. It's important to note that certain health conditions or prior treatments may make you ineligible, such as being pregnant, having certain infections, or participating in another clinical trial. This study is currently looking for participants, so if you think you might qualify, it could be a chance to explore a new treatment option.

Gender

ALL

Eligibility criteria

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