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NCT06533579 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, sponsored by Vironexis Biotherapeutics.

Recruiting
Registry status
Phase 1
Development phase
32
Enrollment target
8
Study locations

NCT06533579: Recruiting Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, sponsored by Vironexis Biotherapeutics.

NCT06533579 is a Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma that is actively recruiting participants, run by Vironexis Biotherapeutics. The registered enrollment target is 32 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (82% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06533579, a Phase 1 study of Chronic Lymphocytic Leukemia and Diffuse Large B Cell Lymphoma, is actively recruiting participants, sponsored by Vironexis Biotherapeutics.

RECRUITING
Registry status
Phase 1
Development phase
32 participants
Enrollment target
8
Study locations

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.

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

FieldValue
Enrollment Target 32 participants
Start Date 2025-05-30
Est. Completion 2031-09
Phase Phase 1
Vironexis Biotherapeutics

2 total trials

What NCT06533579 shows while recruiting

NCT06533579 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (82% lower).

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.

NCT06533579 lists 8 locations in 7 states (California, Colorado, New York).

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, Diffuse Large B Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma.

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).

Who is sponsoring clinical trial NCT06533579?

This trial is sponsored by Vironexis Biotherapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Chronic Lymphocytic Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06533579's enrollment target sits among peer trials

32 131st of 187 higher than 55 of 187 other Chronic Lymphocytic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06533579, the US trial registry maintained by the National Library of Medicine. NCT06533579 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.