Actively Recruiting
Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
Led by Vironexis Biotherapeutics Inc. · Updated on 2026-03-30
32
Participants Needed
9
Research Sites
326 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age: Part 1: 18-90 years, Part 2: 13-90 years
- Relapsed or refractory CD19-positive leukemia or lymphoma as defined in the protocol
- Positive expression of CD19
- AAV specified capsid total antibody less than 1:400
- Kidney, liver, heart, and lung functions within protocol-specified ranges
- Hematology parameters within protocol-specified ranges
You will not qualify if you...
- Hepatotoxicity with AST or ALT greater than 2 times the upper limit of normal
- History of thrombotic microangiopathy or cardiomyopathy
- Evidence of sensory neuropathy
- Pregnant or nursing women
- Acute Graft versus Host Disease (GvHD) grade 2-4 or any grade of chronic GvHD
- History of hypersensitivity or toxicity related to corticosteroids
- Chemotherapy given within protocol-specified discontinuation timelines
- Other criteria as applied per protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
3
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
4
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
5
University of North Carolina at Chapel Hill/ University of North Carolina Medical Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
6
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
7
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
8
TriStar BMT
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Allen Reha
CONTACT
R
Recruitment Partner: PatientWing
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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