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

NCT ID: NCT02840110

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2021-02-23

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.

Conditions

B Cell Lymphomas; Multiple Myeloma; Solid Tumor; HER-2 Protein Overexpression

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Post-ACTR

Subjects who have previously been treated with an ACTR T cell product

ACTR T Cell Product

Intervention Type: OTHER

Interventions

ACTR T Cell Product

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cogent Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Sachs, MD

Role: STUDY_DIRECTOR

Cogent Biosciences, Inc.

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

Countries

United States

Other Identifiers

UT-201502

Identifier Type: -

Identifier Source: org_study_id