RecruitingPhase 1Phase 2NCT06533579

Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)

A Phase 1/2 Safety, Dose-finding, and Pharmacokinetics Study of VNX-101 Gene Therapy in Patients With Relapsed or Refractory CD19-Positive Hematologic Malignancies (SENTRY-CD19)


Sponsor

Vironexis Biotherapeutics Inc.

Enrollment

32 participants

Start Date

May 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1/2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.


Eligibility

Min Age: 13 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study (SENTRY-CD19) tests a gene therapy approach for treating certain blood cancers — specifically leukemias and lymphomas that carry a protein called CD19 — that have come back or stopped responding to other treatments. The therapy uses a modified virus to deliver a new gene into the patient's own blood stem cells, causing them to produce cancer-fighting immune cells (CAR-T cells) inside the body itself, potentially providing a longer-lasting effect than standard CAR-T infusions. **You may be eligible if...** - You are 13 to 90 years old (age 18+ for the first part of the study) - You have CD19-positive leukemia or lymphoma that has relapsed or is refractory - Your heart, lung, liver, and kidney function meet minimum thresholds - Your blood counts are within the required range - You do not have high levels of antibodies to the specific viral vector used **You may NOT be eligible if...** - You have significantly elevated liver enzymes (indicating liver damage) - You have a history of a blood clotting disorder (thrombotic microangiopathy) or cardiomyopathy - You are pregnant or breastfeeding - You have active Graft versus Host Disease - You have a history of severe reactions to corticosteroids - Your most recent chemotherapy was too recent (per protocol timelines) 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

GENETICDose Level 1, VNX-101

Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion

GENETICDose Level 2, VNX-101

Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion

GENETICDose Level 3, VNX-101

Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion

GENETICDose Level 4, VNX-101

Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion


Locations(9)

City of Hope

Duarte, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

New York Medical College

Valhalla, New York, United States

University of North Carolina at Chapel Hill/ University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

TriStar BMT

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06533579


Related Trials