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)
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 90
Healthy Volunteers: f
View:
• Age: Part 1: 18-90 years of age, Part 2: 13-90 years of age
• Relapsed or refractory CD-19 positive leukemia or lymphoma as defined in the protocol
• CD19-positive expression
• AAV specified capsid total antibody \<1:400
• Protocol-specified ranges for renal, liver, cardiac and pulmonary function
• Protocol-specified ranges for hematology parameters
Locations
United States
California
City of Hope
RECRUITING
Duarte
Colorado
Colorado Blood Cancer Institute
RECRUITING
Denver
North Carolina
University of North Carolina at Chapel Hill/ University of North Carolina Medical Center
RECRUITING
Chapel Hill
New York
New York Medical College
RECRUITING
Valhalla
Ohio
Oncology Hematology Care
RECRUITING
Cincinnati
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Tennessee
TriStar BMT
RECRUITING
Nashville
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Allen Reha
allen.reha@vironexis.com
908-938-6019
Backup
Recruitment Partner: PatientWing
studies@patientwing.com
213-459-2979
Time Frame
Start Date: 2025-05-30
Estimated Completion Date: 2031-09
Participants
Target number of participants: 32
Treatments
Experimental: Group 1/Group 2/Group 3/Group 4
Related Therapeutic Areas
Sponsors
Leads: Vironexis Biotherapeutics Inc.