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Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)

RecruitingPhase 1, Phase 2Ages 13 Years - 90 YearsAllVironexis Biotherapeutics Inc.
NCT06533579 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 per protocol requirement * 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.
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What it tests

  • Dose Level 1, VNX-101
  • Dose Level 2, VNX-101
  • Dose Level 3, VNX-101
  • Dose Level 4, VNX-101
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Where

11 sites
City of Hope
Duarte, United States
Valkyrie Clinical Trials
Los Angeles, United States
Colorado Blood Cancer Institute
Denver, United States
Mayo Clinic, Clinical Trials Referral Office
Jacksonville, United States
Mayo Clinic, Clinical Trials Referral Office
Rochester, United States
New York Medical College
Valhalla, United States
University of North Carolina at Chapel Hill/ University of North Carolina Medical Center
Chapel Hill, United States
The Ohio State University Wexner Medical Center
Columbus, United States

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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