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Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
Sponsor: Vironexis Biotherapeutics Inc.
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.
Official title: 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)
Key Details
Gender
All
Age Range
13 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2025-05-30
Completion Date
2031-09
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Dose Level 1, VNX-101
Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion
Dose Level 2, VNX-101
Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion
Dose Level 3, VNX-101
Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion
Dose 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