RECRUITING

Gene Therapy for CD19-Positive Hematologic Malignancies

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Conditions

B-cell Acute Lymphoblastic LeukemiaLarge B-cell LymphomaChronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMarginal Zone LymphomaFollicular LymphomaMantle Cell LymphomaDiffuse Large B Cell LymphomaHigh-grade B-cell LymphomaBurkitt LymphomaPrimary Mediastinal Large B-cell Lymphoma (PMBCL)Non Hodgkin LymphomaMixed Phenotype Acute LeukemiaCD19-positiveLeukemiaLymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-05-30
Study Completion:2031-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06533579

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: Part 1: 18-90 years of age, Part 2: 13-90 years of age
  2. * Relapsed or refractory CD-19 positive leukemia or lymphoma as defined in the protocol
  3. * CD19-positive expression
  4. * AAV specified capsid total antibody \<1:400
  5. * Protocol-specified ranges for renal, liver, cardiac and pulmonary function
  6. * Protocol-specified ranges for hematology parameters
  1. * Hepatoxicity (AST or ALT \> 2x upper limit of normal)
  2. * History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy
  3. * Pregnant or nursing (lactating) women
  4. * Acute Graft versus Host Disease (GvHD): Grade 2-4 or chronic GvHD of any grade
  5. * History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity
  6. * Chemotherapy given within the protocol-specified discontinuation timelines

Contacts and Locations

Study Contact

Allen Reha
CONTACT
908-938-6019
allen.reha@vironexis.com

Principal Investigator

Vironexis Clinical Trials
STUDY_DIRECTOR
Vironexis Biotherapeutics Inc.

Study Locations (Sites)

Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
New York Medical College
Valhalla, New York, 10595
United States
Oncology Hematology Care
Cincinnati, Ohio, 45242
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
TriStar BMT
Nashville, Tennessee, 37203
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Vironexis Biotherapeutics Inc.

  • Vironexis Clinical Trials, STUDY_DIRECTOR, Vironexis Biotherapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-30
Study Completion Date2031-09

Study Record Updates

Study Start Date2025-05-30
Study Completion Date2031-09

Terms related to this study

Keywords Provided by Researchers

  • CD19-positive
  • Leukemia
  • Lymphoma

Additional Relevant MeSH Terms

  • B-cell Acute Lymphoblastic Leukemia
  • Large B-cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Marginal Zone Lymphoma
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Diffuse Large B Cell Lymphoma
  • High-grade B-cell Lymphoma
  • Burkitt Lymphoma
  • Primary Mediastinal Large B-cell Lymphoma (PMBCL)
  • Non Hodgkin Lymphoma
  • Mixed Phenotype Acute Leukemia