Actively Recruiting

Phase 1
Phase 2
Age: 13Years - 90Years
All Genders
NCT06533579

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

Led by Vironexis Biotherapeutics Inc. · Updated on 2026-03-30

32

Participants Needed

9

Research Sites

326 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 13Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age: Part 1: 18-90 years, Part 2: 13-90 years
  • Relapsed or refractory CD19-positive leukemia or lymphoma as defined in the protocol
  • Positive expression of CD19
  • AAV specified capsid total antibody less than 1:400
  • Kidney, liver, heart, and lung functions within protocol-specified ranges
  • Hematology parameters within protocol-specified ranges
Not Eligible

You will not qualify if you...

  • Hepatotoxicity with AST or ALT greater than 2 times the upper limit of normal
  • History of thrombotic microangiopathy or cardiomyopathy
  • Evidence of sensory neuropathy
  • Pregnant or nursing women
  • Acute Graft versus Host Disease (GvHD) grade 2-4 or any grade of chronic GvHD
  • History of hypersensitivity or toxicity related to corticosteroids
  • Chemotherapy given within protocol-specified discontinuation timelines
  • Other criteria as applied per protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

City of Hope

Duarte, California, United States, 91010

Actively Recruiting

2

Valkyrie Clinical Trials

Los Angeles, California, United States, 90067

Actively Recruiting

3

Colorado Blood Cancer Institute

Denver, Colorado, United States, 80218

Actively Recruiting

4

New York Medical College

Valhalla, New York, United States, 10595

Actively Recruiting

5

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

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

6

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

7

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

8

TriStar BMT

Nashville, Tennessee, United States, 37203

Actively Recruiting

9

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

A

Allen Reha

CONTACT

R

Recruitment Partner: PatientWing

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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