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

Phase 1

Recruiting

• Conditions: Lymphoma, Non-Hodgkin (NHL); Lymphoma, B-Cell; Chronic Lymphocytic Leukemia (CLL); Lymphoma, Large B-Cell, Diffuse (DLBCL)
• Interventions: Genetic: UB-VV111; Drug: rapamycin

• Registration Number: NCT06528301
• Lead Sponsor: Umoja Biopharma

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-25
• Study First Posted: 2024-07-30
• Study Start: 2025-03-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-28
• Primary Completion: 2029-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
UB-VV111	UB-VV111	A single dose of UB-VV111 will be administered.
UB-VV111 + rapamycin	UB-VV111	A single dose of UB-VV111 will be administered followed by treatment with rapamycin.
UB-VV111 + rapamycin	rapamycin	A single dose of UB-VV111 will be administered followed by treatment with rapamycin.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (6)

University of Cincinnatti Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Fred Hutch Cancer Center; 🇺🇸 Seattle, Washington, United States

City of Hope; 🇺🇸 Duarte, California, United States

Washington University School of Medicine/Siteman Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

St. Vincent's Hospital Melbourne; 🇦🇺 Fitzroy, Victoria, Australia