Clinical trial NCT06528301: A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
Official title: A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed/Refractory (R/R) CD19+ B-cell Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Lymphoma, B-Cell
Lymphoma, Non-Hodgkin (NHL)
Lymphoma, Large B-Cell, Diffuse (DLBCL)
Chronic Lymphocytic Leukemia (CLL)
Keywords: CAR T
CD19
chimeric antigen receptor
Lead sponsor: Umoja Biopharma
Sponsor class: INDUSTRY
First posted: 2024-07-30
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Percentage of participants with common adverse events (AEs)
timeFrame: Up to 2 years after UB-VV111 administration
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: Up to 2 years after UB-VV111 administration
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Saint Louis
country: United States
facility: Washington University School of Medicine/Siteman Cancer Center
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Cincinnati
country: United States
facility: University of Cincinnatti Medical Center
state: Ohio
city: Seattle
country: United States
facility: Fred Hutch Cancer Center
state: Washington
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital Melbourne
state: Victoria
Study officials:
affiliation: Umoja Biopharma
name: Jacob Garcia, MD
role: STUDY_DIRECTOR
References: