Long-Term Follow-Up Study of Subjects Treated With ACTR T Cell Product

Stopped early

Conditions studied: B Cell Lymphomas, Multiple Myeloma, Solid Tumor, HER-2 Protein Overexpression

In brief

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.

Key facts

Study ID

NCT02840110

Run by

Cogent Biosciences, Inc.

People needed

22

Starts

2016-10-01

Expected to finish

2021-02-23

Last updated by the study team

2021-10-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing to provide informed consent for participation in the study
• Received at least 1 dose of an ACTR T cell product in an investigational or other treatment setting, such as compassionate use, named patient IND, expanded access program, or equivalent settings
• Has completed study assessments and follow-up visits in the prior study or other investigational setting to the extent willing and able to do so
• Able to comply with study requirements

You may not qualify if…

• None

Where it is running

• 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

Full record on ClinicalTrials.gov

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