Study Stopped
Business Decision
Long-Term Follow-Up Study of Subjects Treated With ACTR T Cell Product
1 other identifier
observational
22
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2016
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2016
CompletedFirst Posted
Study publicly available on registry
July 21, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2021
CompletedOctober 11, 2021
October 1, 2021
4.1 years
July 13, 2016
October 4, 2021
Conditions
Outcome Measures
Primary Outcomes (5)
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
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
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
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
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
Study Arms (1)
Post-ACTR
Subjects who have previously been treated with an ACTR T cell product
Interventions
Eligibility Criteria
Study subjects with disease progression after being treated with at least one dose of an ACTR T cell product in the parent study or other investigational setting
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Banner MD Anderson
Gilbert, Arizona, 85234, United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Yale University
New Haven, Connecticut, 06520, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Loyola University
Maywood, Illinois, 60153, United States
Indiana Bone and Marrow Transplantation
Indianapolis, Indiana, 46237, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Ohio State University
Columbus, Ohio, 43210, United States
Tennessee Oncology - Nashville
Nashville, Tennessee, 37203, United States
Baylor University Medical Center, Charles Sammons Cancer Center
Dallas, Texas, 75246, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Biospecimen
Blood for replication competent retrovirus (RCR) testing Remaining biological samples from other protocol procedures (e.g., blood for presence of ACTR+ T cells) may also be stored, at the discretion of the sponsor, for potential future biomarker analyses of T cells, DNA, RNA, and other cells or molecules to study immunology or gene therapy. Optional blood, bone marrow, and tissue samples also may be collected in the event of a subject's death if an autopsy is performed.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jessica Sachs, MD
Cogent Biosciences, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2016
First Posted
July 21, 2016
Study Start
October 1, 2016
Primary Completion
October 23, 2020
Study Completion
February 23, 2021
Last Updated
October 11, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share