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

RECRUITINGPhase 1/2Sponsored by Vironexis Biotherapeutics Inc.
Actively Recruiting
PhasePhase 1/2
SponsorVironexis Biotherapeutics Inc.
Started2025-05-30
Est. completion2027-06
Eligibility
Age13 Years – 90 Years
Healthy vol.Accepted
Locations8 sites
View on ClinicalTrials.gov →

NCT06533579

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.

Eligibility

Age: 13 Years – 90 YearsHealthy volunteers accepted
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.

Conditions14

B-cell Acute Lymphoblastic LeukemiaBurkitt LymphomaCancerChronic Lymphocytic LeukemiaDiffuse Large B-Cell LymphomaFollicular LymphomaHigh-grade B-cell LymphomaLarge B-cell LymphomaMantle Cell LymphomaMarginal Zone Lymphoma

Locations8 sites

City of Hope
Duarte, California, 91010
Anthony Stein, MD877-467-3411AStein@coh.org
Valkyrie Clinical Trials
Los Angeles, California, 90067
Myo Zaw424-535-1874clinicaltrials@vctcare.com
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Clinical Trial Information Line720-754-4835
New York Medical College
Valhalla, New York, 10595
Mitchell Cairo, MD914-594-2150mitchell_cairo@nymc.edu
University of North Carolina at Chapel Hill/ University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599
Lacey Williams, MD919-445-9676Lacey_Williams@med.unc.edu

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