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NCT06528301PHASE1Recruiting

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

Umoja Biopharma

Start Date

3/10/2025

Completion Date

3/1/2029

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

Age Range: 18 years to No maximum

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.

Interventions

GENETIC

UB-VV111

DRUG

rapamycin

Interested in This Trial?

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Conditions

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

Locations

City of Hope

Duarte, California 91010

United States

The David and Etta Jonas Center for Cellular Therapy

Chicago, Illinois 60637

United States

Washington University School of Medicine/Siteman Cancer Center

St Louis, Missouri 63110

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198-6814

United States

University of Cincinnatti Medical Center

Cincinnati, Ohio 45219

United States

Fred Hutch Cancer Center

Seattle, Washington 98109

United States

Royal North Shore Hospital

Saint Leonards, New South Wales 2065

Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria 3065

Australia