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

March 24, 2026 updated by: Vironexis Biotherapeutics Inc.

A Phase 1/2 Safety, Dose-finding, and Pharmacokinetics Study of VNX-101 Gene Therapy in Patients With Relapsed or Refractory CD19-Positive Hematologic Malignancies (SENTRY-CD19)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

VNX-101 is an investigational adeno-associated virus (AAV) gene therapy developed to express a secreted anti-CD19/anti-CD3 scFv diabody (termed GP101). GP101 binds both cluster of differentiation (CD)19 and CD3, inducing T-cells to kill both benign and malignant B-cells. Following a single intravenous (IV) infusion, the vector induces the liver and key tissues to continuously secrete GP101 into the bloodstream, resulting in long-term, consistent serum levels of GP101. Potential advantages of VNX-101 over autologous CAR-T therapy include it is off-the-shelf, provides a gentle onset of action, does not require lymphodepletion chemotherapy, engages all T-cells continuously (including those freshly produced from the bone marrow), and utilizes highly efficient signaling through the native T-cell receptor.

In this 2-part study, dose-finding data from Part 1 of the study (n=~12 patients) will be used determine the dose for Part 2 in patients. Part 1 is a dose-finding PK study in adults ≥18 years old designed to determine the minimal dose that achieves target PK serum levels of GP101 at steady state (8-week timepoint) without dose-limited toxicities, defined as the recommended Part 2 dose (RP2D). Prior to VNX-101 dosing, subjects may undergo standard of care chemotherapy to meet dosing criteria. Part 2 (n=~20) will be opened following data safety monitoring board review of Part 1 data and is designed to determine the safety and pharmacokinetics (PK) of VNX-101 at the RP2D in a broader array of subjects. The age range for Part 2 will be expanded to include subjects ≥13 years old. Patients will be followed for safety and efficacy up to 5 years post VNX-101 dosing. Long-term follow-up assessments for safety will be conducted for 6 to 15 years post VNX-101 dosing.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Principal Investigator:
          • Anthony Stein, MD
        • Contact:
      • Los Angeles, California, United States, 90067
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Colorado Blood Cancer Institute
        • Contact:
          • Clinical Trial Information Line
          • Phone Number: 720-754-4835
    • New York
      • Valhalla, New York, United States, 10595
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill/ University of North Carolina Medical Center
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
          • Knight Cancer Institute Clinical Trials
          • Phone Number: 503-949-1080
          • Email: trials@ohsu.edu
    • Tennessee
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1/Group 2/Group 3/Group 4
Genetic: Dose Level 1, VNX-101
Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion
Genetic: Dose Level 2, VNX-101
Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion
Genetic: Dose Level 3, VNX-101
Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion
Genetic: Dose Level 4, VNX-101
Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment emergent adverse events (TEAEs) and treatment-emergent serious events (TESAEs)
Time Frame: Change from Baseline to Year 5 post dosing
Change from Baseline to Year 5 post dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in B-cell counts
Time Frame: Change from baseline to year 5 post dosing
Change from baseline to year 5 post dosing
Change baseline in immunoglobulin levels
Time Frame: Change from baseline to year 5 post dosing
Change from baseline to year 5 post dosing
Change baseline in antitumor activity
Time Frame: Change from baseline to year 5 post dosing
Change from baseline to year 5 post dosing
Proportion/duration of subjects achieving response, progression free survival, and disease free survival.
Time Frame: Change from baseline to year 5 post dosing
Change from baseline to year 5 post dosing

Other Outcome Measures

Outcome Measure
Time Frame
Exploratory Measure: Change in VNX-101 gene product levels
Time Frame: Change from baseline to year 5 post dosing
Change from baseline to year 5 post dosing
Exploratory Measure: Change in VNX-101 vector shedding
Time Frame: Change from baseline to year 5 post dosing
Change from baseline to year 5 post dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vironexis Biotherapeutics Inc.

Investigators

  • Study Director: Vironexis Clinical Trials, Vironexis Biotherapeutics Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2031

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VNX-101-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Follicular Lymphoma

Clinical Trials on Dose Level 1, VNX-101

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe