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Gene therapy injection takes aim at Hard-to-Treat blood cancers

NCT ID NCT06533579

Disease control Sponsor: Vironexis Biotherapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This early-stage trial tests a single-dose gene therapy called VNX-101 for people with certain blood cancers (like leukemia or lymphoma) that have returned or not responded to standard treatment. The therapy delivers instructions to the body to make a protein that helps immune cells find and attack cancer cells. About 32 adults and teens will receive one of four dose levels to check safety and how well it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VNX-101 (a gene therapy that delivers instructions to make a protein that helps immune cells attack cancer cells)
What this could lead to
If successful, this could offer a new treatment option for people with certain blood cancers that have not responded to other therapies.
What could go wrong
This is an early, first-in-human trial with only 32 participants. The gene therapy may not work or could cause serious side effects. It is not a cure and long-term safety is unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

13 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute biphenotypic leukemia B-cell acute lymphoblastic leukemia B-cell chronic lymphocytic leukemia Burkitt lymphoma diffuse large B-cell lymphoma follicular lymphoma high grade B-cell lymphoma large B-cell lymphoma leukemia lymphoma Lymphoma, B-Cell, Marginal Zone mantle cell lymphoma marginal zone lymphoma mixed phenotype acute leukemia non-Hodgkin lymphoma primary mediastinal large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-cell acute lymphoblastic leukemia Burkitt lymphoma Chronic lymphocytic leukemia Diffuse large B cell lymphoma Follicular lymphoma High-grade B-cell lymphoma Large B-cell lymphoma Mantle cell lymphoma Marginal zone lymphoma Mixed phenotype acute leukemia Non-Hodgkin lymphoma Primary mediastinal large B-cell lymphoma (PMBCL) Small lymphocytic lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    11 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Colorado Blood Cancer Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Mayo Clinic, Clinical Trials Referral Office

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic, Clinical Trials Referral Office

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • New York Medical College

    RECRUITING

    Valhalla, New York, 10595, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • TriStar BMT

    RECRUITING

    Nashville, Tennessee, 37203, United States

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

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Valkyrie Clinical Trials

    RECRUITING

    Los Angeles, California, 90067, United States

    Contact Email: •••••@•••••

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