Gene Therapy for CD19-Positive Hematologic Malignancies

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

Gene Therapy for CD19-Positive Hematologic Malignancies

Condition
B-cell Acute Lymphoblastic Leukemia
Intervention / Treatment

-

Contacts and Locations

Denver

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

Valhalla

New York Medical College, Valhalla, New York, United States, 10595

Cincinnati

Oncology Hematology Care, Cincinnati, Ohio, United States, 45242

Columbus

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

Nashville

TriStar BMT, Nashville, Tennessee, United States, 37203

Houston

University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

13 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vironexis Biotherapeutics Inc.,

Vironexis Clinical Trials, STUDY_DIRECTOR, Vironexis Biotherapeutics Inc.

Study Record Dates

2031-09