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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02840110
Other study ID # UT-201502
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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