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

August 13, 2026 updated by: Umoja Biopharma

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Saint Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Royal North Shore Hospital
        • Contact:
          • Cameron Turtle, MBBS, PhD
          • Phone Number: +61299264377
        • Principal Investigator:
          • Cameron Turtle, MBBS, PhD
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • St. Vincent's Hospital Melbourne
        • Contact:
        • Principal Investigator:
          • Matthew Ku, MD
  • United States
    • California
      • Duarte, California, United States, 91010
        • Not yet recruiting
        • City of Hope
        • Principal Investigator:
          • Tanya Siddiqi, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • The David and Etta Jonas Center for Cellular Therapy
        • Principal Investigator:
          • Michael Bishop, MD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine/Siteman Cancer Center
        • Contact:
        • Principal Investigator:
          • Zachary Crees, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68198-6814
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Matthew Lunning, D.O. F.A.C.P.
    • Ohio
      • Cincinnatti, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnatti Medical Center
        • Contact:
        • Principal Investigator:
          • Zulfa Omer, MD
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutch Cancer Center
        • Contact:
        • Principal Investigator:
          • Ajay Gopal, MD/FACP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with common adverse events (AEs)
Time Frame: Up to 2 years after UB-VV111 administration
Percentage of participants with commonly reported AEs overall and by severity
Up to 2 years after UB-VV111 administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: Up to 2 years after UB-VV111 administration
Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)
Up to 2 years after UB-VV111 administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umoja Biopharma

Investigators

  • Study Director: Luke Walker, MD, Umoja Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UB-VV111-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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