Recruiting

Phase 1

Phase 2

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

Sponsor:

Vironexis Biotherapeutics Inc.

Code:

NCT06533579

Conditions

B-cell Acute Lymphoblastic Leukemia

Large B-cell Lymphoma

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Marginal Zone Lymphoma

Eligibility Criteria

Sex: All

Age: 13 - 70+

Healthy Volunteers: Not accepted

Interventions

Dose Level 1, VNX-101

Dose Level 2, VNX-101

Dose Level 3, VNX-101

Dose Level 4, VNX-101

Study Details

Brief 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

B-cell Acute Lymphoblastic Leukemia

Large B-cell Lymphoma

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Marginal Zone Lymphoma

Study ID

NCT06533579

Start date

May 30, 2025

Status verified date

Aug, 2026

Completion date

Sep, 2031

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 13 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1/Group 2/Group 3/Group 4

Interventions

Dose Level 1, VNX-101

Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion

Dose Level 2, VNX-101

Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion

Dose Level 3, VNX-101

Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion

Dose Level 4, VNX-101

Adeno-associated viral vector encoding the CD3/CD19 Bi-Specific T-Cell Engager (AAV.CD3/CD19), Single IV infusion

Primary outcome measure

Treatment emergent adverse events (TEAEs) and treatment-emergent serious events (TESAEs) [ Time Frame: Change from Baseline to Year 5 post dosing ]

Central Contacts and Locations

Central contacts

Allen Reha

908-938-6019 allen.reha@vironexis.com

Recruitment Partner: PatientWing

213-459-2979 studies@patientwing.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Anthony Stein, MD

877-467-3411 AStein@coh.org

Principal Investigator:

Anthony Stein, MD

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

Contacts

Myo Zaw

424-535-1874 clinicaltrials@vctcare.com

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Contacts

Clinical Trial Information Line

720-754-4835

Mayo Clinic, Clinical Trials Referral Office

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

855-776-0015

Mayo Clinic, Clinical Trials Referral Office

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

855-776-0015

New York Medical College

Recruiting

Valhalla, New York, United States, 10595

Contacts

Mitchell Cairo, MD

(914) 594-2150 mitchell_cairo@nymc.edu

Lauren Harrison

lauren_harrison@nymc.edu

Principal Investigator:

Mitchell Cairo, MD

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

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Lacey Williams, MD

919-445-9676 Lacey_Williams@med.unc.edu

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Gregory Behbehani, MD, PhD

614-293-3316 gregory.behbehani@osumc.edu

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Knight Cancer Institute Clinical Trials

503-949-1080 trials@ohsu.edu

TriStar BMT

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Stephen Strickland, MD

615-329-7274 stephen.strickland@hcahealthcare.com

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Nicholas J Short, MD

713-563-4485 NShort@Mdanderson.org

More Information

Sponsor

Vironexis Biotherapeutics Inc.

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

CD19-positive
Leukemia
Lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vironexis Biotherapeutics Inc. on 2026-08-06.