TETRAVI Program for Accessing Special Virus-Fighting Cells for Children in Texas

Sponsor: Baylor College of Medicine

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT07104591

Provider View

This program provides a way for doctors in Texas to access special virus-fighting cells for children who have had stem cell transplants and are dealing with tough viral infections like EBV, CMV, adenovirus, or BK virus.

Patient Parameters

Program Overview

The TETRAVI Expanded Access Program (EAP) is designed to help children in Texas who have had stem cell transplants and are facing ongoing or returning viral infections that don't respond to regular treatments. This program allows doctors to use special virus-fighting cells developed by Baylor College of Medicine to treat these infections when no other options are available.

Description

This program is specifically for children being treated in Texas. Baylor College of Medicine's Center for Cell and Gene Therapy will provide doctors with the necessary documents to set up a treatment plan for each child. This includes a protocol and consent form, and Baylor will also provide a Letter of Authorization to help with the FDA approval process. The special virus-fighting cells will be available to eligible children once the treatment plan is approved by the necessary medical boards and the FDA.

The goal is to provide access to these special cells for children in Texas who have limited treatment options due to ongoing viral infections after a transplant.

Eligibility Criteria

Inclusion Criteria

  • Children under 18 years old.
  • Have had a stem cell transplant or CAR T therapy in Texas.
  • Have ongoing or returning infections with EBV, CMV, adenovirus, or BK virus that don't respond to regular treatments.
  • The child's doctor must be based in Texas.
  • The doctor must get approval from a review board and submit a treatment plan to the FDA with a Letter of Authorization from Baylor.

Exclusion Criteria

  • Children with other uncontrolled infections not related to the viruses mentioned.
  • Use of certain immune-suppressing drugs within the last 28 days.
  • Serious uncontrolled medical conditions or a return of the original disease.

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