Status:
RECRUITING
Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
Lead Sponsor:
Vironexis Biotherapeutics Inc.
Conditions:
B-cell Acute Lymphoblastic Leukemia
Large B-cell Lymphoma
Eligibility:
All Genders
13-90 years
Phase:
PHASE1
PHASE2
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 malignanc...
Detailed Description
VNX-101 is an investigational adeno-associated virus (AAV) gene therapy developed to express a secreted anti-CD19/anti-CD3 scFv diabody (termed GP101). GP101 binds both cluster of differentiation (CD)...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Other Inclusion/Exclusion criteria to be applied per protocol.
Key Trial Info
Start Date :
May 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2031
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06533579
Start Date
May 30 2025
End Date
September 1 2031
Last Update
September 17 2025
Active Locations (8)
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1
City of Hope
Duarte, California, United States, 91010
2
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
3
New York Medical College
Valhalla, New York, United States, 10595
4
University of North Carolina at Chapel Hill/ University of North Carolina Medical Center
Chapel Hill, North Carolina, United States, 27599