Phase 1 Study of UB-VV111 Alone or With Rapamycin for Relapsed or Refractory CD19 Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia

What this Trial Is About

Researchers are evaluating the safety and antitumor activity of UB-VV111, a gene therapy that generates CD19 CAR T cells in the body, for patients with relapsed or refractory large B-cell lymphoma LBCL and chronic lymphocytic leukemia CLL. This Phase 1, open-label study focuses on these CD19 B-cell malignancies to understand how UB-VV111 works alone and in combination with rapamycin, an FDA-approved drug. Participants will receive either a single dose of UB-VV111 alone or a single dose of UB-VV111 followed by treatment with rapamycin. The study is designed without randomization and includes two experimental arms to compare these approaches. The treatments aim to assess safety and antitumor effects over time. During the study, researchers will monitor participants for common adverse events for up to two years after UB-VV111 administration. They will also evaluate the overall response rate to treatment within this period. Participants will undergo regular assessments to measure disease response and safety, with continuous follow-up to track health outcomes throughout the study duration.

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