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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 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.

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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

Sponsor

Vironexis Biotherapeutics

2 total trials

What the Registry Record Tells You About NCT06533579

The ClinicalTrials.gov registry entry for NCT06533579 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (82% lower). The listed sponsor is Vironexis Biotherapeutics, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 8 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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