Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
United States32 participantsStarted 2025-05-30
Plain-language 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.
Who can participate
Age range13 Years – 90 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Treatment emergent adverse events (TEAEs) and treatment-emergent serious events (TESAEs)
Timeframe: Change from Baseline to Year 5 post dosing