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

RECRUITINGPHASE1

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

A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed/Refractory (R/R) CD19+ B-cell Malignancies

NCT06528301•Umoja Biopharma

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (8)

City of Hope

Duarte, California, United States

The David and Etta Jonas Center for Cellular Therapy

Chicago, Illinois, United States

Washington University School of Medicine/Siteman Cancer Center

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

University of Cincinnatti Medical Center

Cincinnati, Ohio, United States

Fred Hutch Cancer Center

Seattle, Washington, United States

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Key Dates

Start Date

March 10, 2025

Primary Completion Date

March 1, 2029

Completion Date

March 1, 2029

Last Updated

January 12, 2026

Enrollment

106

ESTIMATED participants

Conditions

Lymphoma, B-CellLymphoma, Non-Hodgkin (NHL)Lymphoma, Large B-Cell, Diffuse (DLBCL)Chronic Lymphocytic Leukemia (CLL)

Interventions

UB-VV111

GENETIC

rapamycin

DRUG

Contacts

Jacob Garcia, MD

CONTACT

425-873-8331 jacob.garcia@umoja-biopharma.com

Christine Dehner

CONTACT

christine.dehner@umoja-biopharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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