Spots Global Cancer Trial Database for Long-Term Follow-Up Study of Subjects Treated With ACTR T Cell Product
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Trial Identification
Brief Title: Long-Term Follow-Up Study of Subjects Treated With ACTR T Cell Product
Official Title: Long-Term Follow-Up Study of Subjects Treated With an Autologous T Cell Product Expressing an Antibody-Coupled T-Cell Receptor (ACTR)
Study ID: NCT02840110
Interventions
Study Description
Brief Summary: Subjects treated with an ACTR product may participate in this long-term follow-up study after the completion of the final scheduled visit in the parent clinical study or other investigational setting, such as compassionate use, named patient Investigational New Drug application, expanded access program, or equivalent setting. No investigational product or treatment will be administered in this study. These subjects will be followed for safety monitoring on a schedule of decreasing frequency through 15 years post-ACTR treatment, in accordance with US FDA Regulatory guidance pertaining to long-term safety follow-up for study subjects receiving recombinant DNA-containing investigational products.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson, Gilbert, Arizona, United States
Mayo Clinic Arizona, Phoenix, Arizona, United States
Yale University, New Haven, Connecticut, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
Loyola University, Maywood, Illinois, United States
Indiana Bone and Marrow Transplantation, Indianapolis, Indiana, United States
University of Maryland, Baltimore, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States
Duke University Medical Center, Durham, North Carolina, United States
Ohio State University, Columbus, Ohio, United States
Tennessee Oncology - Nashville, Nashville, Tennessee, United States
Baylor University Medical Center, Charles Sammons Cancer Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Jessica Sachs, MD
Affiliation: Cogent Biosciences, Inc.
Role: STUDY_DIRECTOR
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