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

Terminated

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

• Registration Number: NCT02840110
• Lead Sponsor: Cogent Biosciences, Inc.

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

Not available

Study Timeline

• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-21
• Study Start: 2016-10
• Primary Completion: 2020-10-23
• Study Completion: 2021-02-23
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long-term safety of ACTR T cell product as assessed by serious adverse events related to ACTR T cell product	Total of 15 years after first receiving an ACTR T cell product
Long-term safety of ACTR T cell product as assessed by Grade 3 or 4 adverse events related to ACTR T cell product	Total of 15 years after first receiving an ACTR T cell product
Long-term safety of ACTR T cell product as assessed by overall survival	Total of 15 years after first receiving an ACTR T cell product
Long-term safety of ACTR T cell product as assessed by adverse events of special interest, regardless of grade or relatedness to the ACTR T cell product	Total of 15 years after first receiving an ACTR T cell product
ACTR T cell persistence in subjects previously treated with an ACTR T cell product	Total of 15 years after first receiving an ACTR T cell product

Trial Locations

Locations (16)

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

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