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Taking people in United StatesPhase 1/2

Gene Therapy Tested in Blood Cancers That Return or Do Not Respond

Tests VNX-101 gene therapy in people with relapsed or refractory CD19-positive blood cancers.

Plain-language title generated from the registry record
Registry title: Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)

Key facts

Where
Chapel Hill, Columbus, Denver, Duarte, Houston, Jacksonville, Los Angeles, Nashville, Portland, Rochester, and Valhalla, United StatesSee the 11 sites
Phase
Phase 1/2

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 13 and 90 years old?

Source: NCT06533579, who can take part

Where in United States

  • University of North Carolina at Chapel Hill/ University of North Carolina Medical CenterChapel Hill, United StatesTaking people
  • The Ohio State University -Wexner Medical CenterColumbus, United StatesTaking people
  • Colorado Blood Cancer InstituteDenver, United StatesTaking people
  • City of HopeDuarte, United StatesTaking people
  • University of Texas - MD Anderson Cancer CenterHouston, United StatesTaking people
  • Mayo Clinic, Clinical Trials Referral OfficeJacksonville, United StatesTaking people
  • Valkyrie Clinical TrialsLos Angeles, United StatesTaking people
  • TriStar BMTNashville, United StatesTaking people
  • Oregon Health Science UniversityPortland, United StatesTaking people
  • Mayo Clinic, Clinical Trials Referral OfficeRochester, United StatesTaking people
  • New York Medical CollegeValhalla, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Vironexis Biotherapeutics Inc.
Trial code
NCT06533579
Record updated
26 October 2026
Original description
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.Read full original descriptionShow less

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)

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.

Inclusion: 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 per protocol requirement; Protocol-specified ranges for renal, liver, cardiac and pulmonary function; Protocol-specified ranges for hematology parameters.

Exclusion: Chemotherapy given within the protocol-specified discontinuation timelines; Other Inclusion/Exclusion criteria to be applied per protocol; History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy; 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; Hepatoxicity (AST or ALT > 2x upper limit of normal); Pregnant or nursing (lactating) women.

ClinicalTrials.gov NCT06533579