Brief Summary
This study is a Phase 1 dose-escalation and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV111. The study will enroll patients with relapsed/refractory large B-cell lymphomacancers of the lymphatic system (LBCL) and chronica long-lasting disease that changes slowly over time lymphocytic leukemia (CLL).
Intervention / Treatment
- Genetic: UB-VV111
- Drug: rapamycin
Inclusion Criteria:
- 18 years or older
- Provides voluntary written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.
- 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 Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1
- Adequate organ function
- Patients who have previously received CD19-directed therapy must have biopsyremoval of a section of tissue to analyse for cancer cells confirming CD19 expression following completion of prior CD19-directed therapy.