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NCT Number: NCT06528301

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory 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).

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Key information

Conditions

Lymphoma, B-Cell Chronic Disease Chronic Lymphocytic Leukemia (CLL) Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, Large B-Cell, Diffuse (DLBCL) Lymphoma, Non-Hodgkin Lymphoma, Non-Hodgkin (NHL) Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royal North Shore Hospital, Saint Leonards, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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 criteria

  • Women who are pregnant or breastfeeding
  • Current isolated central nervous system (CNS) involvement
  • Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (exceptions include tumor-infiltrating lymphocytes and CAR T cells)
  • History of or active human immunodeficiency virus (HIV)
  • Active hepatitis B or C
  • Systemic 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.

Treatment and study plan

UB-VV111

Genetic

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

Rapamycin

Drug

Rapamycin is an FDA-approved drug.

Other names: Rapamune, sirolimus

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Dehner

CONTACT

[email protected]

Jacob Garcia, MD

CONTACT

[email protected]

425-873-8331

Sponsors and collaborators

Lead sponsor

Umoja Biopharma

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 30, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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