Gene Therapy for CD19-Positive Blood Cancers (SENTRY-CD19)

This study is testing a new gene therapy called VNX-101 for people with certain types of B-cell leukemia and lymphoma that have come back or are not responding to treatment. VNX-101 is designed to help your body's immune cells (T-cells) find and kill cancer cells that have a specific marker called CD19. The study will look at how safe VNX-101 is and how well it works. To join, you must be between 13 and 90 years old, have CD19-positive cancer, and meet other health requirements. The main goal is to track any side effects over five years. The current recruitment status is unclear.

Study design
This is a Phase 1/2, open-label study, meaning you and your doctors will know what treatment you are receiving. It plans to enroll 32 participants to find the right dose of VNX-101.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to five years after receiving the treatment to monitor for side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06533579

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

Recruiting
PHASE1Ages 13–90InterventionalTreatment
Vironexis Biotherapeutics Inc.
~32 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Dose Level 1, VNX-101Dose Level 2, VNX-101Dose Level 3, VNX-101Dose Level 4, VNX-101

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment emergent adverse events (TEAEs) and treatment-emergent serious events (TESAEs)
Measured over Change from Baseline to Year 5 post dosing
B-cell Acute Lymphoblastic Leukemia
Large B-cell Lymphoma
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Marginal Zone Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma
Diffuse Large B Cell Lymphoma
High-grade B-cell Lymphoma
Burkitt Lymphoma
Primary Mediastinal Large B-cell Lymphoma (PMBCL)
Non Hodgkin Lymphoma
Mixed Phenotype Acute Leukemia
11 sites across 10 states
California2
Colorado1
Florida1
Minnesota1
New York1
North Carolina1
Ohio1
Oregon1
  • Vironexis Clinical Trials · STUDY_DIRECTOR · Vironexis Biotherapeutics Inc.

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Eligibility criteria

Inclusion

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

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
  • Treatment emergent adverse events (TEAEs) and treatment-emergent serious events (TESAEs)Change from Baseline to Year 5 post dosing