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

Cogent Biosciences

Status: Terminated

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

Treatments: Other: ACTR T Cell Product

Study type: Observational

Funder types: Industry

Identifiers

NCT02840110

UT-201502

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

22 participants in 1 patient group

Post-ACTR

Description:

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

Treatment:

Other: ACTR T Cell Product