🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT06528301
Recruiting Phase 1

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

NCT06528301 · tracked via the Priya Life Science USA tracker
Sponsor
Umoja Biopharma
Phase
Phase 1
Started
2025-03-10
Last updated
2026-08-17

Condition(s) studied

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

Investigational drug(s) / intervention(s)

UB-VV111rapamycin

UB-VV111: UB-VV111 is a gene therapy that generates CD19 CAR T cells in the body.

rapamycin: Rapamycin is an FDA-approved drug.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
City of Hope Duarte California Not Yet Recruiting
The David and Etta Jonas Center for Cellular Therapy Chicago Illinois Recruiting
Washington University School of Medicine/Siteman Cancer Center St Louis Missouri Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
University of Cincinnatti Medical Center Cincinnatti Ohio Recruiting
Fred Hutch Cancer Center Seattle Washington Recruiting
Royal North Shore Hospital Saint Leonards New South Wales Recruiting
St. Vincent's Hospital Melbourne Fitzroy Victoria Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06528301 on ClinicalTrials.gov ↗ ← All trials in the USA