RecruitingPhase 1NCT06528301

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

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


Sponsor

Umoja Biopharma

Enrollment

106 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase (Phase 1) study testing a new experimental treatment called UB-VV111 — alone and combined with a drug called rapamycin — in patients whose B-cell blood cancers (such as large B-cell lymphoma or chronic lymphocytic leukemia) have come back or stopped responding to prior treatments. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with relapsed or refractory large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia (CLL) - Your disease is measurable on scans or tests - You have no serious other medical conditions **You may NOT be eligible if...** - Your cancer is not a CD19-positive B-cell cancer - You have serious active infections or organ problems - Your disease is not measurable or evaluable - You are unable to give voluntary informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(8)

City of Hope

Duarte, California, United States

The David and Etta Jonas Center for Cellular Therapy

Chicago, Illinois, United States

Washington University School of Medicine/Siteman Cancer Center

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

University of Cincinnatti Medical Center

Cincinnati, Ohio, United States

Fred Hutch Cancer Center

Seattle, Washington, United States

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT06528301


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