NCT06533579

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)

Study 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.

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Interventions

Dose Level 1, VNX-101GENETIC
Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion
Dose Level 2, VNX-101GENETIC
Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion
Dose Level 3, VNX-101GENETIC
Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion
Dose Level 4, VNX-101GENETIC
Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion

Study Locations

FacilityCityStateCountry
City of HopeDuarteCaliforniaUnited States
Valkyrie Clinical TrialsLos AngelesCaliforniaUnited States
Colorado Blood Cancer InstituteDenverColoradoUnited States
New York Medical CollegeValhallaNew YorkUnited States
University of North Carolina at Chapel Hill/ University of North Carolina Medical CenterChapel HillNorth CarolinaUnited States
The Ohio State University Wexner Medical CenterColumbusOhioUnited States
Oregon Health & Science UniversityPortlandOregonUnited States
TriStar BMTNashvilleTennesseeUnited States
University of Texas MD Anderson Cancer CenterHoustonTexasUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026