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

Status:	Enrolling by invitation
Conditions:	Blood Cancer, Hematology
Therapuetic Areas:	Hematology, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	12/22/2018
Start Date:	October 2016
End Date:	December 2035

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

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.

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

We found this trial at

sites

Duke Univ Med Ctr

2301 Erwin Rd
Durham, North Carolina 27710

919-684-8111