Health Trials

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

ConditionsB-cell Acute Lymphoblastic LeukemiaLarge B-cell LymphomaChronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMarginal Zone LymphomaFollicular LymphomaMantle Cell LymphomaDiffuse Large B Cell LymphomaHigh-grade B-cell LymphomaBurkitt LymphomaPrimary Mediastinal Large B-cell Lymphoma (PMBCL)Non Hodgkin LymphomaMixed Phenotype Acute Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age13-90
SponsorVironexis Biotherapeutics Inc.

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

32 Participants
are divided into 1 treatment group

Locations

9
California
City of Hope91010, Duarte United States
Valkyrie Clinical Trials90067, Los Angeles United States
Colorado
Colorado Blood Cancer Institute80218, Denver United States
New York
New York Medical College10595, Valhalla United States

Sponsors and collaborators

Vironexis Biotherapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov