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Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
NCT06533579 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- GENETIC Dose Level 1, VNX-101
- GENETIC Dose Level 2, VNX-101
- GENETIC Dose Level 3, VNX-101
- GENETIC Dose Level 4, VNX-101
Study Locations (8)
California
- City of Hope — Duarte
- Valkyrie Clinical Trials — Los Angeles
Colorado
- Colorado Blood Cancer Institute — Denver
New York
- New York Medical College — Valhalla
North Carolina
- University of North Carolina at Chapel Hill/ University of North Carolina Medical Center — Chapel Hill
Ohio
- The Ohio State University Wexner Medical Center — Columbus
Tennessee
- TriStar BMT — Nashville
Texas
- University of Texas MD Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2025-05-30 |
| Est. Completion | 2031-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06533579
The ClinicalTrials.gov registry entry for NCT06533579 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vironexis Biotherapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 4 interventions — of which Dose Level 1, VNX-101 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06533579 reports 8 study locations spanning 7 distinct geographic areas — top geographies include California, Colorado, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06533579 about?
NCT06533579 is a clinical study titled "Gene Therapy for 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.
What is the current status of trial NCT06533579?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2025-05-30. Estimated completion is 2031-09.
What conditions does trial NCT06533579 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06533579?
The interventions under investigation include: Dose Level 1, VNX-101 (GENETIC), Dose Level 2, VNX-101 (GENETIC), Dose Level 3, VNX-101 (GENETIC), Dose Level 4, VNX-101 (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06533579?
This trial is sponsored by Vironexis Biotherapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06533579 being conducted?
This trial has 8 study locations across California, Colorado, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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