Long-Term Follow-Up Study of Clinical Study Subjects Treated with An Autologous T Cell Product Expressing An Antibody-Coupled T-Cell Receptor (ACTR)
Hodgkin's Lymphoma | Non-Hodgkin's Lymphoma
What is the purpose of this trial?
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.
- Trial withUnum Therapeutics
- Start Date03/23/2019
- End Date11/30/2035
- Last Updated08/20/2019
- Study HIC#2000024211