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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02840110
• Other study ID #: UT-201502
• Status: Terminated
• Start date: October 2016
• Est. completion date: February 23, 2021

Study information

• Verified date: October 2021
• Source: Cogent Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: February 23, 2021
• Est. primary completion date: October 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• ACTR T Cell Product

Locations

Country	Name	City	State
United States	Emory University Winship Cancer Institute	Atlanta	Georgia
United States	University of Maryland	Baltimore	Maryland
United States	Tufts Medical Center	Boston	Massachusetts
United States	Ohio State University	Columbus	Ohio
United States	Baylor University Medical Center, Charles Sammons Cancer Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Banner MD Anderson	Gilbert	Arizona
United States	MD Anderson Cancer Center	Houston	Texas
United States	Indiana Bone and Marrow Transplantation	Indianapolis	Indiana
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Loyola University	Maywood	Illinois
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota
United States	Tennessee Oncology - Nashville	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Mayo Clinic Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Cogent Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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