Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Dose Level 1, VNX-101

    Genetic

    Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion

  • Dose Level 2, VNX-101

    Genetic

    Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion

  • Dose Level 3, VNX-101

    Genetic

    Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion

  • Dose Level 4, VNX-101

    Genetic

    Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Group 1/Group 2/Group 3/Group 4Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Treatment emergent adverse events (TEAEs) and treatment-emergent serious events (TESAEs)

Time frame
Change from Baseline to Year 5 post dosing

Secondary outcomes

1

Change from baseline in B-cell counts

Time frame
Change from baseline to year 5 post dosing
2

Change baseline in immunoglobulin levels

Time frame
Change from baseline to year 5 post dosing
3

Change baseline in antitumor activity

Time frame
Change from baseline to year 5 post dosing
4

Proportion/duration of subjects achieving response, progression free survival, and disease free survival.

Time frame
Change from baseline to year 5 post dosing

Other outcomes

1

Exploratory Measure: Change in VNX-101 gene product levels

Time frame
Change from baseline to year 5 post dosing
2

Exploratory Measure: Change in VNX-101 vector shedding

Time frame
Change from baseline to year 5 post dosing

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vironexis Biotherapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov
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