RecruitingPhase 1NCT06528301

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

Sponsor

Umoja Biopharma

Enrollment

106 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Inclusion Criteria8

years or older
Provides voluntary written informed consent
Relapsed or refractory large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia (CLL)
Measurable disease according to Lugano 2014 criteria (LBCL) or iwCLL 2018 (CLL).
No serious concomitant diseases or active/uncontrolled infections
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function
Patients who have previously received CD19-directed therapy must have biopsy confirming CD19 expression following completion of prior CD19-directed therapy.

Exclusion Criteria9

Women who are pregnant or breastfeeding
Current isolated central nervous system (CNS) involvement
Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except CAR T-cell therapy in CAR T-exposed subjects)
History of or active human immunodeficiency virus (HIV)
Active hepatitis B or C
Systemic autoimmune or immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease
Ongoing CNS disease that would preclude neurologic assessment
Uncontrolled angina or other acute heart disease
Currently receiving treatment in another interventional clinical trial.

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.

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

View Full Details on ClinicalTrials.gov

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NCT06528301

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