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

Sponsors and collaborators

Vironexis Biotherapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov