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RecruitingInterventionalPhase 1

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

NCT ID: NCT06528301Sponsor: Umoja BiopharmaLast updated: 2026-05-28

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).

Arms & interventions

  • GeneticUB-VV111

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

  • Drugrapamycin

    Rapamycin is an FDA-approved drug.

Outcome measures

Primary

  • Percentage of participants with common adverse events (AEs)

    Percentage of participants with commonly reported AEs overall and by severity

    Time frame: Up to 2 years after UB-VV111 administration

Secondary

  • Overall response rate (ORR)

    Time frame: Up to 2 years after UB-VV111 administration

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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.

Study locations (6)

City of Hope

Duarte, California, 91010

Not Yet Recruiting
Tanya Siddiqi, MD · Contact
Tanya Siddiqi, MD · Principal Investigator

The David and Etta Jonas Center for Cellular Therapy

Chicago, Illinois, 60637

Recruiting
Michael Bishop, MD · Principal Investigator

Washington University School of Medicine/Siteman Cancer Center

St Louis, Missouri, 63110

Recruiting
Yalda Karamlou · Contact
Zachary Crees, MD · Principal Investigator

University of Nebraska Medical Center

Omaha, Nebraska, 68198-6814

Recruiting
Brooke Tridle, MHA · Contact
Matthew Lunning, D.O. F.A.C.P. · Principal Investigator

University of Cincinnatti Medical Center

Cincinnati, Ohio, 45219

Recruiting
Hani Alrefai, MBBCh, MS, PhD · Contact
Zulfa Omer, MD · Principal Investigator

Fred Hutch Cancer Center

Seattle, Washington, 98109

Recruiting
Shelby Colden · Contact
Ajay Gopal, MD/FACP · Principal Investigator
A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies | Cancerify