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

RecruitingPhase 1/2

A Phase 1/2 Safety, Dose-finding, and Pharmacokinetics Study of VNX-101 Gene Therapy in Patients With Relapsed or Refractory CD19-Positive Hematologic Malignancies (SENTRY-CD19)

Who can join

Ages 13 to 90 · All sexes

Full eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Other Inclusion/Exclusion criteria to be applied per protocol.

About the study

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 being tested

Dose Level 1, VNX-101 (genetic)
Dose Level 2, VNX-101 (genetic)
Dose Level 3, VNX-101 (genetic)
Dose Level 4, VNX-101 (genetic)

Sponsor: Vironexis Biotherapeutics Inc. · Participants: 32 · Started: May 30, 2025

Contact the study team

Allen Reha · Phone: 908-938-6019
Recruitment Partner: PatientWing · Phone: 213-459-2979

Official record on ClinicalTrials.gov — NCT06533579

Locations in the U.S.

California	City of Hope, Duarte Valkyrie Clinical Trials, Los Angeles
Colorado	Colorado Blood Cancer Institute, Denver
Florida	Mayo Clinic, Clinical Trials Referral Office, Jacksonville
Minnesota	Mayo Clinic, Clinical Trials Referral Office, Rochester
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
Oregon	Oregon Health & Science University, Portland
Tennessee	TriStar BMT, Nashville
Texas	University of Texas MD Anderson Cancer Center, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.