Chronic Lymphocytic Leukemia (CLL), Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma, Non-Hodgkin (NHL)
Conditions
Keywords
CAR T, CD19, chimeric antigen receptor
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 lymphoma (LBCL) and chronic lymphocytic leukemia (CLL).
Interventions
GENETICUB-VV111
UB-VV111 is a gene therapy that generates CD19 CAR T cells in the body.
DRUGrapamycin
Rapamycin is an FDA-approved drug.
Sponsors
Umoja Biopharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Australia, United States
Contacts
CONTACTLuke Walker, MD
CONTACTChristine Dehner
STUDY_DIRECTORLuke Walker, MD
Umoja Biopharma
Outcome results
None listed