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)
1 other identifier
interventional
32
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2025
Longer than P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2024
CompletedFirst Posted
Study publicly available on registry
August 1, 2024
CompletedStudy Start
First participant enrolled
May 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2031
March 30, 2026
March 1, 2026
2 years
July 24, 2024
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment emergent adverse events (TEAEs) and treatment-emergent serious events (TESAEs)
Change from Baseline to Year 5 post dosing
Secondary Outcomes (4)
Change from baseline in B-cell counts
Change from baseline to year 5 post dosing
Change baseline in immunoglobulin levels
Change from baseline to year 5 post dosing
Change baseline in antitumor activity
Change from baseline to year 5 post dosing
Proportion/duration of subjects achieving response, progression free survival, and disease free survival.
Change from baseline to year 5 post dosing
Other Outcomes (2)
Exploratory Measure: Change in VNX-101 gene product levels
Change from baseline to year 5 post dosing
Exploratory Measure: Change in VNX-101 vector shedding
Change from baseline to year 5 post dosing
Study Arms (1)
Group 1/Group 2/Group 3/Group 4
EXPERIMENTALInterventions
Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion
Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion
Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion
Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Hepatoxicity (AST or ALT \> 2x upper limit of normal)
- History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy
- Pregnant or nursing (lactating) women
- Acute Graft versus Host Disease (GvHD): Grade 2-4 or chronic GvHD of any grade
- History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity
- Chemotherapy given within the protocol-specified discontinuation timelines
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
City of Hope
Duarte, California, 91010, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
New York Medical College
Valhalla, New York, 10595, United States
University of North Carolina at Chapel Hill/ University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
TriStar BMT
Nashville, Tennessee, 37203, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Vironexis Clinical Trials
Vironexis Biotherapeutics Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2024
First Posted
August 1, 2024
Study Start
May 30, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
September 1, 2031
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share