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AzTrials

B-cell Acute Lymphoblastic LeukemiaPhase 1/2NCT06533579

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

A Phase 1/2 study testing Dose Level 1, VNX-101, Dose Level 2, VNX-101 and Dose Level 3, VNX-101 in people with B-cell Acute Lymphoblastic Leukemia and Large B-cell Lymphoma, run by Vironexis Biotherapeutics Inc. at 11 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 13 to 90 years
What is being tested?
Dose Level 1, VNX-101, Dose Level 2, VNX-101 and Dose Level 3, VNX-101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
11 sitesUnited States
Study dates
30 May 2025to Sep 2031
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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 per protocol requirement
  • Protocol-specified ranges for renal, liver, cardiac and pulmonary function
  • Protocol-specified ranges for hematology parameters

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Allen Reha contact

908-938-6019

allen.reha@vironexis.com

Recruitment Partner: PatientWing contact

213-459-2979

studies@patientwing.com

11 sites in 1 country

United States11 sites, 11 recruiting

  • University of North Carolina at Chapel Hill/ University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27599

    Lacey Williams, MD, 919-445-9676, Lacey_Williams@med.unc.edu

    Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Gregory Behbehani, MD, PhD, 614-293-3316, gregory.behbehani@osumc.edu

    Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    Clinical Trial Information Line, 720-754-4835

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Anthony Stein, MD, 877-467-3411, AStein@coh.org

    Anthony Stein, MD

    Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Nicholas J Short, MD, 713-563-4485, NShort@Mdanderson.org

    Recruiting

  • Mayo Clinic, Clinical Trials Referral Office

    Jacksonville, Florida, 32224

    855-776-0015

    Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

    Myo Zaw, 424-535-1874, clinicaltrials@vctcare.com

    Recruiting

  • TriStar BMT

    Nashville, Tennessee, 37203

    Stephen Strickland, MD, 615-329-7274, stephen.strickland@hcahealthcare.com

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Knight Cancer Institute Clinical Trials, 503-949-1080, trials@ohsu.edu

    Recruiting

  • Mayo Clinic, Clinical Trials Referral Office

    Rochester, Minnesota, 55905

    855-776-0015

    Recruiting

  • New York Medical College

    Valhalla, New York, 10595

    Mitchell Cairo, MD, (914) 594-2150, mitchell_cairo@nymc.edu

    Lauren Harrison, lauren_harrison@nymc.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Dose Level 1, VNX-101, Dose Level 2, VNX-101, Dose Level 3, VNX-101, Dose Level 4, VNX-101
Keywords
CD19-positive, Leukemia, Lymphoma
Medical subject headings
Burkitt Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Leukemia, Biphenotypic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dose Level 1, VNX-101Genetic

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

  • Dose Level 2, VNX-101Genetic

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

  • Dose Level 3, VNX-101Genetic

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

  • Dose Level 4, VNX-101Genetic

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

Study groups in NCT06533579
Study groupRoleWhat they receive
Group 1/Group 2/Group 3/Group 4ExperimentalNot described
Receives: Genetic: Dose Level 1, VNX-101; Genetic: Dose Level 2, VNX-101; Genetic: Dose Level 3, VNX-101; Genetic: Dose Level 4, VNX-101

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Change from Baseline to Year 5 post dosing

Secondary outcomes (4)

  1. Change from baseline in B-cell counts

    Measured: Change from baseline to year 5 post dosing

  2. Change baseline in immunoglobulin levels

    Measured: Change from baseline to year 5 post dosing

  3. Change baseline in antitumor activity

    Measured: Change from baseline to year 5 post dosing

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

    Measured: Change from baseline to year 5 post dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start30 May 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionSep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06533579
Sponsor's protocol ID
VNX-101-01
Status last verified
Aug 2026
First submitted
24 Jul 2024
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dose Level 1, VNX-101, Dose Level 2, VNX-101 and Dose Level 3, VNX-101 in people with B-cell Acute Lymphoblastic Leukemia and Large B-cell Lymphoma, run by Vironexis Biotherapeutics Inc. at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Allen Reha (908-938-6019, allen.reha@vironexis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment emergent adverse events (TEAEs) and treatment-emergent serious events (TESAEs) (time frame: Change from Baseline to Year 5 post dosing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06533579.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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