Trials Today

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

Purpose

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).

Conditions

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

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Phase: Phase 1
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental UB-VV111	A single dose of UB-VV111 will be administered.	Genetic: UB-VV111 UB-VV111 is a gene therapy that generates CD19 CAR T cells in the body. Drug: rapamycin Rapamycin is an FDA-approved drug. Other names: Rapamune, sirolimus
Experimental UB-VV111 + rapamycin	A single dose of UB-VV111 will be administered followed by treatment with rapamycin.	Genetic: UB-VV111 UB-VV111 is a gene therapy that generates CD19 CAR T cells in the body. Drug: rapamycin Rapamycin is an FDA-approved drug. Other names: Rapamune, sirolimus

Recruiting Locations

The David and Etta Jonas Center for Cellular Therapy
Chicago 4887398, Illinois 4896861 60637

Contact:
Michael Bishop, MD
773-702-6149
cancerclinicaltrials@bsd.uchicago.edu

Washington University School of Medicine/Siteman Cancer Center
St Louis 4407066, Missouri 4398678 63110

Contact:
Yalda Karamlou
314-273-3776
yalda@wustl.edu

University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198-6814

Contact:
Brooke Tridle, MHA
402-559-5101
brtridle@unmc.edu

University of Cincinnatti Medical Center
Cincinnatti, Ohio 5165418 45219

Contact:
Hani Alrefai, MBBCh, MS, PhD
513-584-8438
alrefahd@ucmail.uc.edu

Fred Hutch Cancer Center
Seattle 5809844, Washington 5815135 98109

Contact:
Shelby Colden
206-667-5134
scolden2@fredhutch.org

More Details

NCT ID: NCT06528301
Status: Recruiting
Sponsor: Umoja Biopharma

Study Contact

Jacob Garcia, MD
425-873-8331
jacob.garcia@umoja-biopharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.