RECRUITING

Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma

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

The body has different ways of fighting infections and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are molecules that fight infections and protect your body from diseases caused by bacteria and toxic substances. Antibodies work by sticking to those bacteria or substances, which stops them from growing and causing bad effects. T cells are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected. Both antibodies and T cells have been used to treat patients with cancers. They both have shown promise, but neither alone has been enough to cure most patients. This multicenter study is designed to combine both T cells and antibodies in order to create a more effective treatment. The treatment that is being researched is called autologous T lymphocyte chimeric antigen receptor cells (CAR) cells targeted against the disialoganglioside (GD2) antigen that express Interleukin (IL)-15, and the inducible caspase 9 safety switch (iC9), also known as iC9.GD2.CAR.IL-15 T cells.

Official Title

A Phase I Study of Autologous Activated T-Cells Expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch Administered To Patients With Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma

Quick Facts

Study Start:2019-02-19
Study Completion:2039-06-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03721068

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:18 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Lori Stravers
CONTACT
919-445-4208
UNCImmunotherapy@med.unc.edu
Lauren Higgins
CONTACT
+1 (919) 966-4432
UNCImmunotherapy@med.unc.edu

Principal Investigator

George Hucks, MD
PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center

Study Locations (Sites)

Emory - Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • George Hucks, MD, PRINCIPAL_INVESTIGATOR, UNC Lineberger Comprehensive Cancer Center

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 Date2019-02-19
Study Completion Date2039-06-19

Study Record Updates

Study Start Date2019-02-19
Study Completion Date2039-06-19

Terms related to this study

Keywords Provided by Researchers

  • Autologous Chimeric Antigen Receptor (CAR) T Cells
  • Interleukin (IL)-15
  • Disialoganglioside (GD2)
  • Caspase 9
  • Pediatric
  • Rimiducid
  • AP1903
  • modified T cells
  • CAR T

Additional Relevant MeSH Terms

  • Neuroblastoma
  • Osteosarcoma