NCT02840110

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

Long-Term Follow-Up Study of Subjects Treated With an Autologous T Cell Product Expressing an Antibody-Coupled T-Cell Receptor (ACTR)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: Cogent Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	ACTR T Cell Product

Timeline

• Start date: 2016-10-01
• Primary completion: 2020-10-23
• Completion: 2021-02-23
• First posted: 2016-07-21
• Last updated: 2021-10-11

Locations

16 sites across 1 country: United States