NCT06528301

Brief 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P75+ for phase_1

Timeline
34mo left

Started Mar 2025

Longer than P75 for phase_1

Geographic Reach
2 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Mar 2025Mar 2029

First Submitted

Initial submission to the registry

July 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

July 25, 2024

Last Update Submit

January 8, 2026

Conditions

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

Keywords

CAR TCD19chimeric antigen receptor

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants with common adverse events (AEs)

    Percentage of participants with commonly reported AEs overall and by severity

    Up to 2 years after UB-VV111 administration

Secondary Outcomes (1)

  • Overall response rate (ORR)

    Up to 2 years after UB-VV111 administration

Study Arms (2)

UB-VV111

EXPERIMENTAL

A single dose of UB-VV111 will be administered.

Genetic: UB-VV111

UB-VV111 + rapamycin

EXPERIMENTAL

A single dose of UB-VV111 will be administered followed by treatment with rapamycin.

Genetic: UB-VV111Drug: rapamycin

Interventions

UB-VV111GENETIC

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

UB-VV111UB-VV111 + rapamycin
rapamycinDRUG

Rapamycin is an FDA-approved drug.

Also known as: Rapamune, sirolimus
UB-VV111 + rapamycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

City of Hope

Duarte, California, 91010, United States

NOT YET RECRUITING

The David and Etta Jonas Center for Cellular Therapy

Chicago, Illinois, 60637, United States

RECRUITING

Washington University School of Medicine/Siteman Cancer Center

St Louis, Missouri, 63110, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198-6814, United States

RECRUITING

University of Cincinnatti Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Fred Hutch Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

RECRUITING

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-CellLymphomaLymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Jacob Garcia, MD

    Umoja Biopharma

    STUDY DIRECTOR

Central Study Contacts

Jacob Garcia, MD

CONTACT

425-873-8331jacob.garcia@umoja-biopharma.com

Christine Dehner

CONTACT

christine.dehner@umoja-biopharma.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2024

First Posted

July 30, 2024

Study Start

March 10, 2025

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)US(6)